Dibase

Patient Information Leaflet

DIBASE 1,000 IU Hard Capsules

Colecalciferol (Vitamin D)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE contains colecalciferol, better known as vitamin D.
DIBASE 1,000 I.U. hard capsules are indicated for the prevention and treatment of vitamin D deficiency in adults and adolescents over 12 years of age.

2. What you need to know before taking DIBASE

Do not take DIBASE

• If you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
Your doctor may recommend taking DIBASE to prevent vitamin D deficiency in the following cases:

• During the last trimester of pregnancy,
• During breastfeeding,
• If you are elderly,
• If you have insufficient or ineffective exposure to sunlight,
• If you follow special diets or eating patterns (e.g. low in calcium, vegetarian, etc.),
• If you have dark skin pigmentation,
• If you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
• If you have digestive disorders or liver disease (hepatic insufficiency),
• If you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines,
• If you suffer from gastrointestinal disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis).

Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D, calcium, or phosphate levels in the following cases:

• If you need to take DIBASE for a long time and at high doses;
• If you are elderly and already receiving treatment with medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• If you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• If you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• If you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are found to be high, your doctor will reduce the dose or stop treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “DIBASE with food, beverages and alcohol”).
You must not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be necessary:

• If you are on long-term treatment with certain medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• If you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• If you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• If you are obese;
• If you suffer from intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, cystic fibrosis or mucoviscidosis) or have undergone bariatric surgery;
• If you have liver disease (hepatic insufficiency).

Children
DIBASE hard capsules are not recommended for children aged between 0 and 12 years due to the pharmaceutical form and difficulty in swallowing.
For children aged between 0 and 12 years, other formulations of DIBASE should be used.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will closely monitor you and carefully assess whether additional tests are needed:

• Digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• Warfarin, a medicine used to prolong blood clotting time and reduce the risk of blood clots;
• Magnesium-containing preparations;
• Thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of DIBASE:

• Antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• Corticosteroids, medicines used to treat inflammation;
• Certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• Antacids containing aluminium, medicines used to treat excessive stomach acid; the combination with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• Lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• Medicines used to treat obesity, such as orlistat;
• Laxatives such as paraffin oil;
• Actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
• Imidazole antifungal agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, beverages and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total daily intake of vitamin D can be monitored and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If necessary, your doctor may prescribe low-dose vitamin D during the last trimester of pregnancy.
DIBASE 1,000 IU hard capsules may be taken during the last trimester of pregnancy (see section 3 “How to take DIBASE”).

Breastfeeding
If necessary, you may take vitamin D while breastfeeding. However, this does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are excreted in breast milk: your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as a rare side effect of DIBASE treatment.

3. How to take DIBASE

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition. If you suffer
from kidney or liver disease, skin disorders, gastrointestinal disorders, or in other cases, at the doctor's discretion,
a dosage adjustment may be necessary compared to the doses indicated below.
Adults
Prevention:
The recommended dose is as follows:

• 1 hard capsule per day (equivalent to 1,000 IU).

In the presence of multiple risk factors for vitamin D deficiency, as determined by the physician, the
dosage may be increased up to:

• 2 hard capsules per day (equivalent to 2,000 IU).

Treatment:
The recommended daily doses range between 1,000 and 4,000 IU. These doses should be adjusted
according to the desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the
disease, and the patient's response to treatment. Your doctor will determine the appropriate dose and
may subsequently prescribe a lower maintenance dose.
The recommended dosage is as follows:

• from 1 hard capsule (equivalent to 1,000 IU) up to a maximum of 4 hard capsules per day (equivalent to 4,000 IU).

Pregnant women (third trimester)
The recommended dosage, to be adjusted at the physician's discretion, is as follows:

• 1 hard capsule per day (equivalent to 1,000 IU). However, in women considered deficient in vitamin D, a higher dose may be required (up to 2 hard capsules per day, equivalent to 2,000 IU).

Use in children and adolescents
Children (0–12 years)
For children aged between 0 and 12 years, it is advisable to use other formulations of DIBASE.
Adolescents (>12 years)
Prevention:
The recommended dosage is as follows:

• from 1 hard capsule (equivalent to 1,000 IU) on alternate days to 1 capsule per day.
  Treatment: The recommended daily doses range between 1,000 and 4,000 IU. These doses should be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the disease, and the patient's response to treatment. Your doctor will determine the appropriate dose and may subsequently prescribe a lower maintenance dose. The recommended dosage is as follows:
• from 1 hard capsule (equivalent to 1,000 IU) up to a maximum of 4 hard capsules per day (equivalent to 4,000 IU).

Instructions for use
DIBASE hard capsules are for oral use.
Take DIBASE during meals.
Swallow the capsule whole; do not chew or open it.
If you take more DIBASE than you should
In case of accidental ingestion or overdose of DIBASE, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with symptoms such as: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
If you are pregnant, taking an excessive dose of vitamin D may cause serious harm to the newborn (see section “Pregnancy, breastfeeding and fertility”).
If you forget to take DIBASE
Do not take a double dose to make up for the missed dose.
If you stop taking DIBASE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, classified by frequency:
uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach ache (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• decreased appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• hives (urticaria)
• increased urine production (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from the available data)

• thirst
• excessive deposition of calcium in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What DIBASE contains

• The active substance is colecalciferol (vitamin D) 0.025 mg, equivalent to 1,000 IU.
• The other components are: gelatin, titanium dioxide (E171), red iron oxide (E172), refined olive oil.

Description of the appearance of DIBASE and package contents
It is presented as hard capsules with a transparent body and white cap, with a pink sealing band.
Available in packs of 30 capsules (3 blisters of opaque white color, each containing 10 capsules).
Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Patient information leaflet

DIBASE 25,000 IU hard capsules

colecalciferol (vitamin D)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dibase is and what it is used for
2. What you need to know before taking Dibase
3. How to take Dibase
4. Possible side effects
5. How to store Dibase
6. Contents of the pack and other information

1. What Dibase is and what it is used for

Dibase contains colecalciferol, better known as vitamin D.
Dibase 25,000 IU hard capsules is indicated for:

• prevention of vitamin D deficiency in adults, only in cases where therapeutic compliance cannot be achieved with daily administration of low doses of colecalciferol;
• treatment of vitamin D deficiency in adults (age over 18 years).

2. What you need to know before taking Dibase

Do not take Dibase

• if you are allergic to colecalciferol (vitamina D) or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”);
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dibase.
Your doctor may recommend taking Dibase 25,000 IU hard capsules for prevention of vitamin D deficiency in the following cases:

• elderly people;
• insufficient sun exposure;
• special diets or eating patterns (e.g. low in calcium, vegetarian, etc.);
• dark skin pigmentation;
• extensive skin diseases, infectious diseases (such as tuberculosis, leprosy);
• liver diseases (hepatic insufficiency);
• gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• treatment with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D, calcium, and phosphate levels in the following cases:

• if you are to undergo long-term treatment with DIBASE at high doses;

• if you are elderly and already receiving treatment with medicines for certain heart conditions (cardiac glycosides) or medicines that lower blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “DIBASE with food, beverages and alcohol”).
You must not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.

Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be necessary:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
Dibase 25,000 IU hard capsules is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Dibase
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking the following medicines, as you will need close monitoring and further tests may be required:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Also, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminium-containing antacids, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various strains of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

Dibase with food, beverages and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total vitamin D intake can be monitored to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Dibase 25,000 IU hard capsules is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
Dibase 25,000 IU hard capsules is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are excreted in breast milk; your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data available on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, you should be aware that drowsiness may occur as a rare side effect of treatment with DIBASE.

3. How to take Dibase

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be determined by your doctor according to your health status. If you suffer
from kidney or liver disease, skin disorders, gastrointestinal diseases, or in other cases, as deemed necessary by your doctor,
a dosage adjustment may be required compared to the doses indicated below.
The recommended dose is:
Adults and Elderly
Prevention: 1 capsule (equivalent to 25,000 IU of vitamin D₃) once a month.
Treatment: 1 capsule (equivalent to 25,000 IU of vitamin D₃) once a week for 8–12 weeks.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.
Pregnant and breastfeeding women
The use of Dibase 25,000 IU hard capsules is not recommended during pregnancy and breastfeeding.
Use in children and adolescents
The use of Dibase 25,000 IU hard capsules is not recommended in newborns, children, and adolescents under 18 years of age.
Instructions for use
Dibase hard capsules are for oral use.
Take Dibase during meals.
Swallow the capsule whole; do not chew or open it.
If you take more Dibase than you should
In case of accidental ingestion or overdose of Dibase, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include elevated calcium levels in blood and urine, with symptoms such as: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
If you forget to take Dibase
Do not take a double dose to make up for the missed dose.
If you stop treatment with Dibase
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, by frequency:
uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach ache (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• reduced appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• hives (urticaria)
• increased urination (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from the available data)

• thirst
• excessive deposition of calcium in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dibase

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures help protect the environment.
Store in the original packaging to protect the medicine from light.
Store below 25°C. Do not freeze.

6. Package contents and other information

What Dibase contains
The active substance is colecalciferol (vitamin D) 0.625 mg, equivalent to 25,000 IU.
The other components are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), refined olive oil.

Description of the appearance of Dibase and contents of the pack
Dibase 25,000 IU hard capsules appear as hard capsules with a transparent body and white cap, with a green sealing band.
Available in packs containing 1 capsule, 2 capsules, 4 capsules, 8 capsules or 12 capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Patient information leaflet

DIBASE 2,000 IU hard capsules, 6,000 IU hard capsules

Colecalciferol (vitamin D )
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Package contents and other information

1. What DIBASE is and what it is used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 2,000 IU hard capsules and 6,000 IU hard capsules is indicated for the prevention and treatment of vitamin D deficiency in adults and adolescents over 12 years of age.

2. What you need to know before taking DIBASE

Do not take DIBASE

• If you are allergic to colecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
Your doctor may recommend taking DIBASE for prevention of vitamin D deficiency:

• during the last trimester of pregnancy,
• during breastfeeding,
• if you are elderly,
• if you have insufficient or ineffective sun exposure,
• if you follow special diets or eating patterns (e.g. low in calcium, vegetarian, etc.),
• if you have dark skin pigmentation,
• if you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
• if you have digestive disorders or liver disease (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines,
• if you suffer from gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).

Your doctor may prescribe periodic blood tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take DIBASE for a long time and at high doses;
• if you are elderly and already taking medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that can affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you have significant reduction in kidney function (see “Do not take DIBASE”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers DIBASE treatment absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor in the following cases, as dosage adjustments from those indicated in section 3 “How to take DIBASE” may be needed:

• if you are on long-term therapy with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may also rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children
DIBASE hard capsules are not recommended for children aged between 0 and 12 years due to the pharmaceutical form and difficulty in swallowing.
For children aged between 0 and 12 years, other formulations of DIBASE should be used.

Other medicines and DIBASE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking the following medicines, inform your doctor, who will closely monitor you and carefully assess whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time and reduce the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Moreover, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• antacids containing aluminium, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of bacteria of the species Streptomyces;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If necessary, your doctor will prescribe vitamin D at low doses during the last trimester of pregnancy.
DIBASE 2,000 IU hard capsules and DIBASE 6,000 IU hard capsules may be taken during the last trimester of pregnancy (see section 3 “How to take DIBASE”).
Breastfeeding
If necessary, you may take vitamin D while breastfeeding. This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are present in breast milk: your doctor will take this into account when prescribing vitamin D for a breastfed infant.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as a side effect of treatment with DIBASE, although this is rare.

3. How to take DIBASE

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be determined by your doctor according to your health condition. If you suffer
from kidney or liver disease, skin disorders, gastrointestinal disorders, or in other cases, at the doctor's discretion,
a dosage adjustment may be necessary compared to the doses indicated below.
Adults
Prevention:
The recommended dose is as follows:

• 2,000 IU hard capsules: 1 capsule on alternate days.
• 6,000 IU hard capsules: 1 capsule every 6–8 days.

In the presence of multiple risk factors for vitamin D deficiency, according to the doctor's judgment, the
dosage may be increased up to:

• 2,000 IU hard capsules: 1 capsule daily.
• 6,000 IU hard capsules: 1 capsule every 3 days.

Treatment:
The recommended daily doses range between 1,000 and 4,000 IU. These doses should be adjusted
according to the desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the
condition, and the patient's response to treatment. Your doctor will determine the appropriate dose and
may subsequently prescribe a lower maintenance dose.
The recommended dosage is as follows:

• 2,000 IU hard capsules: from 1 capsule on alternate days up to a maximum of 2 capsules daily.
• 6,000 IU hard capsules: from 1 capsule every 6 days up to a maximum of 2 capsules every 3 days.

Pregnant women (third trimester)
The recommended dosage is as follows, to be adjusted at the doctor's discretion:

• 2,000 IU hard capsules: 1 capsule on alternate days. However, in women considered vitamin D deficient, a higher dose may be required (up to 1 capsule daily).
• 6,000 IU hard capsules: 1 capsule every 6–8 days. However, in women considered vitamin D deficient, a higher dose may be required (up to 1 capsule every 3 days).

Use in children and adolescents
Children (0–12 years)
For children aged between 0 and 12 years, other formulations of DIBASE are recommended.
Adolescents (>12 years)
Prevention:
The recommended dosage is as follows:

• 2,000 IU hard capsules: from 1 capsule every 4 days to 1 capsule every 2 days.
• 6,000 IU hard capsules: from 1 capsule every 12 days to 1 capsule every 6 days.

Treatment:
The recommended daily doses range between 1,000 and 4,000 IU. These doses should be adjusted
according to the desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the
condition, and the patient's response to treatment. Your doctor will determine the appropriate dose and
may subsequently prescribe a lower maintenance dose.
The recommended dosage is as follows:

• 2,000 IU hard capsules: from 1 capsule on alternate days up to a maximum of 2 capsules daily.
• 6,000 IU hard capsules: from 1 capsule every 6 days up to a maximum of 2 capsules every 3 days.

Instructions for use
DIBASE hard capsules are for oral use.
Take DIBASE during meals.
Swallow the capsule whole; do not chew or open it.
If you take more DIBASE than you should
In case of accidental ingestion or overdose of DIBASE, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
If you are pregnant, taking an excessive dose of vitamin D may cause serious harm to the
newborn (see section “Pregnancy, breastfeeding and fertility”).
If you forget to take DIBASE
Do not take a double dose to make up for the missed dose.
If you stop taking DIBASE
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, according to frequency:
uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
• headache (cephalaea)
• stomach ache (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• reduced appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from the available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
DIBASE 2,000 IU hard capsules
Store below 25°C.
Do not freeze.
Keep in the original packaging to protect from light.
DIBASE 6,000 IU hard capsules
Store below 25°C.
Do not freeze.
Keep in the original packaging to protect from light.

6. Package contents and other information

What DIBASE contains
DIBASE 2,000 IU hard capsules

• The active substance is colecalciferol (vitamin D) 0.050 mg equivalent to 2,000 IU.
• The other components are: gelatin, titanium dioxide (E171), refined olive oil.

DIBASE 6,000 IU hard capsules

• The active substance is colecalciferol (vitamin D) 0.150 mg equivalent to 6,000 IU.
• The other components are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 2,000 IU hard capsules:
They are hard capsules with a transparent body and white cap, with a white sealing band.
Available in packs of 30 capsules (3 white opaque blisters containing 10 capsules each).

DIBASE 6,000 IU hard capsules:
They are hard capsules with a transparent body and white cap, with a yellow sealing band.
Available in packs of 4 capsules (1 white opaque blister containing 4 capsules) or 12 capsules (3 white opaque blisters containing 4 capsules each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Patient information leaflet

DIBASE 50,000 IU hard capsules, 100,000 IU hard capsules

colecalciferol (vitamin D )
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dibase is and what it is used for
2. What you need to know before taking Dibase
3. How to take Dibase
4. Possible side effects
5. How to store Dibase
6. Contents of the pack and other information

1. What is Dibase and what is it used for

Dibase contains colecalciferol, better known as vitamin D.
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules are indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking Dibase

Do not take Dibase

• if you are allergic to colecalciferol (vitamina D) or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria);
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”);
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dibase.
Your doctor may prescribe periodic blood or urine tests to monitor vitamin D, calcium, and phosphate levels in the following cases:

• if you need to take Dibase for a long time and/or at high doses;
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the whole body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are found to be high, your doctor will reduce the dose or stop treatment with Dibase.
Inform your doctor if you are taking vitamin D from other sources, including medicines or foods (see section “Dibase with food, drink, and alcohol”).
You must not take Dibase if you have significantly reduced kidney function (see “Do not take Dibase”). If you have mild to moderate reduction in kidney function (mild or moderate renal failure), and your doctor considers Dibase treatment absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Dibase.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take Dibase” may be needed:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and Dibase”);
• if you are taking antacids containing aluminium, medicines used to treat excess stomach acid that may rise into the oesophagus (see section “Other medicines and Dibase”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Dibase”);
• if you are obese;
• if you have intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis), or if you have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
At these dosages, Dibase is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Dibase
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will monitor you closely and carefully evaluate whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of Dibase:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminium-containing antacids, medicines used to treat excess stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various strains of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g., ketoconazole).

Dibase with food, drink, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses if necessary.

Breastfeeding
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules are not recommended during breastfeeding.
If necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are excreted in breast milk: your doctor will take this into account when prescribing vitamin D to a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of Dibase on the ability to drive.
However, it should be noted that drowsiness may occur as a side effect of Dibase treatment, although this is rare.

3. How to take Dibase

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition. If you suffer
from kidney or liver disease, skin disorders, gastrointestinal disorders, or other conditions, as judged by your doctor,
a dosage adjustment may be necessary compared to the doses indicated below.

The recommended dose is:
Adults and Elderly
Dibase 50,000 I.U. hard capsules
1 capsule (equivalent to 50,000 I.U. of vitamin D) once weekly for up to 6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.
Dibase 100,000 I.U. hard capsules
1 capsule (equivalent to 100,000 I.U. of vitamin D) monthly for up to 3 months. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Pregnant and breastfeeding women
The use of Dibase at these dosages is not recommended during pregnancy or while breastfeeding.

Use in children and adolescents
The use of Dibase at these dosages is not recommended in newborns, children, or adolescents under 18 years of age.

Instructions for use
Dibase hard capsules are for oral use.
Take Dibase during meals.
Swallow the capsule whole; do not chew or open it.

If you take more Dibase than you should
If you accidentally ingest/overdose on Dibase, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.

If you forget to take Dibase
Do not take a double dose to make up for the missed dose.

If you stop taking Dibase
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects listed below are categorized by frequency:

Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• reduced appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• taste disturbance (dysgeusia)
• hives (urticaria)
• increased urine production (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

Not known (frequency cannot be estimated from the available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dibase

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
Store in the original packaging to protect the medicine from light.
Store below 25°C. Do not freeze.

6. Package contents and other information

What Dibase contains
Dibase 50,000 I.U. hard capsules

• The active substance is colecalciferol (vitamin D) 1.25 mg, equivalent to 50,000 I.U.
• The other components are: gelatin, titanium dioxide (E171), red iron oxide (E172), refined olive oil.

Dibase 100,000 I.U. hard capsules

• The active substance is colecalciferol (vitamin D) 2.5 mg, equivalent to 100,000 I.U.
• The other components are: gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), refined olive oil.

Description of the appearance of Dibase and contents of the pack

Dibase 50,000 I.U. hard capsules
Dibase is presented as hard capsules with a transparent body and white cap, with a red sealing band.
It is available in packs of 1 capsule, 2 capsules, 4 capsules or 6 capsules in blisters.

Dibase 100,000 I.U. hard capsules
Dibase is presented as hard capsules with a transparent body and white cap, with a brown sealing band.
It is available in packs of 1 capsule, 2 capsules or 3 capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Package leaflet: Information for the patient

DIBASE 100,000 IU/ml injectable solution, 300,000 IU/ml injectable solution

colecalciferol (vitamin D )
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before using DIBASE
3. How to use DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE contains colecalciferol, better known as vitamin D.
DIBASE 100,000 IU and 300,000 IU is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking DIBASE

Do not take DIBASE

• If you are allergic to colecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
Your doctor may prescribe periodic blood tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need long-term treatment with DIBASE at high doses;
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to the formation of nodules;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicines or food (see section “DIBASE with food, drink, and alcohol”).
You must not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or stop treatment with DIBASE.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be needed:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may also rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
At these dosages, DIBASE is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will keep you under close monitoring and carefully assess whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Also, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• antacids containing aluminium, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drink, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
DIBASE 100,000 IU and DIBASE 300,000 IU are not recommended during pregnancy. However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
DIBASE 100,000 IU and DIBASE 300,000 IU are not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D at lower doses during breastfeeding.
This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are excreted in breast milk; your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as a side effect of treatment with DIBASE, although this is rare.

3. How to take DIBASE

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition. Do not exceed the doses indicated by your doctor.
This medicine must be administered by intramuscular injection (intramuscular use). Intramuscular administration is indicated in malabsorption syndromes.

Adults and Elderly
Treatment:
DIBASE 100,000 I.U.
1 vial (equivalent to 100,000 I.U. of vitamin D) per month for 3 months. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.
DIBASE 300,000 I.U.
1 vial (equivalent to 300,000 I.U. of vitamin D). Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

Use in children and adolescents
The use of DIBASE at these dosages is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of DIBASE at these dosages is not recommended during pregnancy.

Instructions for use

The vials contained in the package are equipped with a pre-break ring. Follow the instructions below for use.
BEFORE OPENING: it is recommended to use finger protection devices (e.g. a clean cloth, a cotton pad).
INSTRUCTIONS FOR OPENING
a. hold the lower part of the vial with one hand;
b. place the other hand on the upper part of the vial, positioning the thumb above the white ring;
c. while keeping the lower body of the vial steady with one hand, apply pressure with the other hand by bending downwards and simultaneously twisting the upper part of the vial.
AFTER OPENING: to avoid the risk of cuts, do not touch the sharp edges or any sharp points resulting from the breakage.
If you take more DIBASE than you should
If you accidentally ingest or take an excessive dose of DIBASE, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to deposits of calcium salts in blood vessels and organs.
If you forget to take DIBASE
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with DIBASE
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, by frequency:
Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• rash
• itching (pruritus)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• decreased appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine production (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

Not known (frequency cannot be estimated from the available data)

• thirst
• excessive deposition of calcium in the kidneys (nephrocalcinosis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C. Do not freeze.
Store in the original packaging to protect the medicine from light.

6. Contents of the pack and other information

What DIBASE contains
DIBASE 100,000 IU/ml injectable solution

• The active substance is colecalciferol (vitamin D) (one vial contains 2.5 mg, equivalent to 100,000 IU).
• The other component is refined olive oil for injectable use.

DIBASE 300,000 IU/ml injectable solution

• The active substance is colecalciferol (vitamin D) (one vial contains 7.5 mg, equivalent to 300,000 IU).
• The other component is refined olive oil for injectable use.

Description of the appearance of DIBASE and contents of the pack
DIBASE 100,000 IU/ml and 300,000 IU/ml injectable solution is presented as a solution contained in amber glass vials with a break-ring.
DIBASE 100,000 IU/ml injectable solution
Available in packs of 1, 3 or 6 vials of 100,000 IU/ml.
DIBASE 300,000 IU/ml injectable solution
Available in packs of 1 or 2 vials of 300,000 IU/ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Patient information leaflet

DIBASE 10,000 IU/mL oral drops, solution

colecalciferol (vitamin D)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE contains colecalciferol, better known as vitamin D.
DIBASE 10,000 IU/ml oral drops, solution is indicated for the prevention and treatment of
vitamin D deficiency.

2. What you need to know before taking DIBASE

Do not take DIBASE

• if you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE. Your doctor may recommend taking DIBASE to prevent vitamin D deficiency in the following cases:

• in newborns (especially premature infants) and infants,
• during the last trimester of pregnancy,
• in breastfeeding women at the end of winter and in spring,
• in elderly people,
• if you have insufficient sun exposure, particularly in children and adolescents,
• if you follow special diets or eating patterns (e.g. low-calcium diets, vegetarian diets, etc.),
• if you have dark skin pigmentation,
• if you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
• if you have liver diseases (hepatic insufficiency),
• if you have gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis),
• if you are being treated with antiepileptic drugs or long-term treatment with certain anti-inflammatory medicines.

Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D, calcium, and phosphate levels in the following cases:

• if you need to take DIBASE for a long time and at high doses;
• if you are elderly and already taking medicines to treat certain heart conditions (cardiac glycosides) or medicines that lower blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your vitamin D, calcium, or phosphate levels are elevated, your doctor will reduce the dose or stop treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “DIBASE with food, beverages, and alcohol”).
You must not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers DIBASE treatment absolutely necessary, regular blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are high, your doctor will reduce the dose or stop treatment with DIBASE.

Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be needed:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking the following medicines. Your doctor will closely monitor you and carefully consider whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time and reduce the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Also, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminium-containing antacids, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering medicines (hypolipidemic agents) such as cholestyramine and colestipol;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, beverages, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total vitamin D intake can be assessed and excessive dosing avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If necessary, your doctor may prescribe low-dose vitamin D during the last trimester of pregnancy.
DIBASE 10,000 IU/ml oral drops, solution can be taken during the last trimester of pregnancy (see section 3 “How to take DIBASE”).

Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. However, this does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are excreted in breast milk: your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, you should be aware that drowsiness may occur as a side effect of treatment with DIBASE, although this is rare.

3. How to take DIBASE

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take DIBASE during meals.

Use in children and adolescents
Newborns (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D) daily.
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 4 drops (equivalent to 1,000 IU of vitamin D).

Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D) daily. From the second year of life, in the presence of multiple risk factors for vitamin D deficiency and according to the doctor's judgment, the dosage may be increased up to 3 drops daily (equivalent to 750 IU of vitamin D).
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 8 drops (equivalent to 2,000 IU of vitamin D).

Adolescents (12–17 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D).
Treatment: 4–16 drops daily (equivalent to 1,000–4,000 IU of vitamin D). Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D).

Pregnant women
The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D) during the last trimester. However, in women considered to be deficient in vitamin D, a higher dose may be necessary (up to 2,000 IU daily – 8 drops).

Adults and elderly
Prevention: The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D). In the presence of multiple risk factors for vitamin D deficiency, according to the doctor's judgment, the dosage may be increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D) daily. Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher doses should be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D).

Instructions for use of the bottle with separate dropper
The package contains 1 bottle and 1 dropper. The bottle is equipped with a child-resistant cap. The dropper comes with a plastic protective cover. Follow the instructions below for use:
a. Open the bottle by removing the cap as follows: press down and simultaneously unscrew (see Figure 1);
b. Unscrew the plastic cover from the tip of the dropper (see Figure 2);
c. Insert the dropper into the bottle to draw up the liquid. Dispense the number of drops prescribed by your doctor into a teaspoon and take it;
d. Close the bottle with its cap (see Figure 3);
e. Screw the plastic cover back onto the tip of the dropper;
f. Store the bottle and dropper in the original packaging.

Instructions for use of the dropper bottle
The package contains 1 dropper bottle, closed with a child-resistant cap. Follow the instructions below for use:
a. Open the dropper bottle by removing the cap as follows: press down and simultaneously unscrew;
b. Invert the dropper bottle and, keeping it in a vertical position, dispense the prescribed number of drops into a spoon and take it;
c. Close the dropper bottle;
d. Store the dropper bottle in the original packaging.

If you take more DIBASE than you should
If you accidentally ingest or take an excessive dose of DIBASE, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Taking excessive doses of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn (see section “Pregnancy, breastfeeding and fertility”).

If you forget to take DIBASE
Do not take a double dose to make up for the missed dose.

If you stop taking DIBASE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects listed below are categorized by frequency:
uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• decreased appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• hives (urticaria)
• increased urine production (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from the available data)

• thirst
• excessive deposition of calcium in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.
The shelf life of the medicine after first opening the bottle is 5 months (record the date of first opening
in the designated space on the carton).
After this period, any remaining medicine must be discarded.

6. Package contents and other information

What DIBASE contains
The active substance is colecalciferol (vitamin D ) 2.5 mg equivalent to 100,000 IU.
Each drop contains: 250 IU of vitamin D .
The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 10,000 IU/ml oral drops, solution is presented as a solution contained in an amber glass bottle holding 10 ml of solution.
It is available in packaging containing 1 bottle closed with a child-resistant cap and 1 separate dropper, or 1 bottle-dropper closed with a child-resistant cap.

Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Patient information leaflet

DIBASE 100,000 IU oral solution in single-dose container

colecalciferol (vitamin D)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE 100,000 IU oral solution in single-dose container contains colecalciferol, better known as vitamin D.
DIBASE 100,000 IU oral solution in single-dose container is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you should know before taking DIBASE

Do not take DIBASE

• if you are allergic to colecalciferol (vitamina D) or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE 100,000 IU oral solution in single-dose container.
Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D, calcium, and phosphate levels in the following cases:

• if you are to be treated with DIBASE for a long period and at high doses;
• if you are elderly and already taking medicines to treat certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.

Inform your doctor if you are taking vitamin D from other sources, either medicines or foods (see section “DIBASE with food, drink, and alcohol”).
You must not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.

Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be necessary:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you suffer from intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
DIBASE 100,000 IU oral solution in single-dose container is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking the following medicines, as you will need close monitoring and further tests may be required:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminium-containing antacids, medicines used to treat excessive stomach acid; concomitant use with vitamin D should be avoided as it may increase the risk of aluminium toxicity;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various strains of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g., ketoconazole).

DIBASE with food, drink, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total daily intake of vitamin D can be monitored and excessive dosing avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
DIBASE 100,000 IU oral solution in single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
DIBASE 100,000 IU oral solution in single-dose container is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are present in breast milk; your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, you should be aware that drowsiness may occur as a rare side effect of treatment with DIBASE.

3. How to take DIBASE

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor based on your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take DIBASE during meals. The single-dose container
should be used for a single administration, making sure to take the entire dose.

Adults
Treatment: The recommended dose is 1 single-dose container (equivalent to 100,000 IU of vitamin D) every
2 weeks for 6 weeks (for a maximum of three administrations). Your doctor will determine the appropriate
dose for you and may subsequently prescribe a lower dose.

Use in children and adolescents
DIBASE 100,000 IU oral solution in single-dose container is not recommended for neonates,
children and adolescents (˂ 18 years of age).

Pregnant women
The use of DIBASE 100,000 IU oral solution in single-dose container is not recommended during
pregnancy.

If you take more DIBASE than you should
In case of accidental ingestion or intake of an excessive dose of DIBASE, contact your doctor immediately
or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms:
nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation and
dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.

If you forget to take DIBASE
Do not take a double dose to make up for the forgotten dose.

If you stop taking DIBASE
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, by frequency:
uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
• headache (cephalaea)
• stomach ache (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• loss of appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• hives (urticaria)
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from the available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What DIBASE contains
In a single-dose container:

• The active substance is colecalciferol (vitamin D): one 2.5 ml single-dose container of solution contains 2.5 mg (equivalent to 100,000 IU) of colecalciferol.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 100,000 IU oral solution in single-dose container is a clear, colourless or slightly yellowish-green, transparent solution contained in an amber glass bottle closed with a polypropylene cap.
It is available in packs containing 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
November 2024

Package leaflet: Information for the patient

DIBASE 25,000 IU/2.5 ml oral solution in single-dose container

colecalciferol (vitamin D )
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 25,000 IU/2.5 ml oral solution in single-dose container is indicated for:

• the prevention of vitamin D deficiency in adults, solely in cases where therapeutic adherence cannot be achieved with daily administration of low-dose cholecalciferol;
• the treatment of vitamin D deficiency in adults (age over 18 years).

2. What you need to know before taking DIBASE

Do not take DIBASE

• If you are allergic to colecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
Your doctor may recommend taking DIBASE 25,000 IU/2.5 ml oral solution in single-dose containers for the prevention of vitamin D deficiency in the following cases:

• elderly people,
• insufficient sun exposure,
• special diets or eating patterns (e.g. low in calcium, vegetarian, etc.),
• dark skin pigmentation,
• extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• liver diseases (hepatic insufficiency),
• gastrointestinal disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis),
• treatment with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Your doctor may prescribe periodic blood tests to monitor vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take DIBASE for a long time and at high doses;
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the whole body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your vitamin D, calcium, or phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “DIBASE with food, drink and alcohol”).
Do not take DIBASE if you have significantly reduced kidney function (see “Do not take DIBASE”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be necessary:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excess stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, cystic fibrosis or mucoviscidosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
DIBASE 25,000 IU/2.5 ml oral solution in single-dose container is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking the following medicines, inform your doctor, who will closely monitor you and carefully assess whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• antacids containing aluminium, medicines used to treat excess stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drink and alcohol
Inform your doctor if you are taking other products containing vitamin D, foods fortified with vitamin D, or if you consume vitamin D-enriched milk, so that your total vitamin D intake can be taken into account to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
DIBASE 25,000 IU/2.5 ml oral solution in single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
DIBASE 25,000 IU/2.5 ml oral solution in single-dose container is not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are present in breast milk: your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as a side effect of treatment with DIBASE, although this is rare.

3. How to take DIBASE

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health status.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take DIBASE during meals.
Adults and Elderly
Prevention: 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a month.
Treatment: 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a week for 8–
12 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.
Use in children and adolescents
The use of DIBASE 25,000 IU/2.5 ml oral solution in single-dose containers is not recommended in
neonates, children, and adolescents under 18 years of age.
Pregnant women
The use of DIBASE 25,000 IU/2.5 ml oral solution in single-dose containers is not recommended during
pregnancy.
If you take more DIBASE than you should
In case of accidental ingestion or intake of an excessive dose of DIBASE, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
If you forget to take DIBASE
Do not take a double dose to make up for the missed dose.
If you stop treatment with DIBASE
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, classified by frequency:

Uncommon (may affect up to 1 in 100 people)

• Increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
• Headache (cephalaea)
• Stomach ache (abdominal pain)
• Nausea
• Diarrhoea
• Vomiting
• Skin rash
• Itching (pruritus)

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions (hypersensitivity)
• Loss of appetite
• Excessive thirst (polydipsia)
• Drowsiness
• Confusion
• Constipation (stipsis)
• Passage of gas (flatulence)
• Dry mouth
• Taste disturbance (dysgeusia)
• Urticaria
• Increased urine production (polyuria)
• Weakness (asthenia)
• Dizziness
• Cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

• Kidney disease (renal failure)

Not known (frequency cannot be estimated from the available data)

• Thirst
• Excessive calcium deposition in the kidneys (nephrocalcinosis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What DIBASE contains
In a single-dose container:

• The active substance is colecalciferol (vitamin D ) 0.625 mg, equivalent to 25,000 IU.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 25,000 IU/2.5 ml oral solution in single-dose container is a solution contained in an amber glass container, closed with a cap made of polypropylene.
It is available in packs containing 1, 2, 3, 4, 6, 8, 10 or 12 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

Package leaflet: information for the patient

DIBASE 50,000 IU/2.5 ml oral solution in single-dose container

colecalciferol (vitamin D )
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIBASE is and what it is used for
2. What you need to know before taking DIBASE
3. How to take DIBASE
4. Possible side effects
5. How to store DIBASE
6. Contents of the pack and other information

1. What DIBASE is and what it is used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 50,000 IU/2.5 ml oral solution in single-dose container is indicated for the treatment of
vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking DIBASE

Do not take DIBASE

• if you are allergic to colecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D, calcium, and phosphate levels in the following cases:

• if you need long-term treatment with DIBASE at high doses;
• if you are elderly and are already taking medicines to treat certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or stop treatment with DIBASE.
Inform your doctor if you are taking vitamin D from other sources, including medicines or foods (see section “DIBASE with food, beverages, and alcohol”).
You must not take DIBASE if you have significant reduction in kidney function (see “Do not take DIBASE”). If you have mild to moderate reduction in kidney function (mild or moderate renal failure), and your doctor considers treatment with DIBASE absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with DIBASE.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take DIBASE” may be necessary:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents, or orlistat (used to treat obesity) (see section “Other medicines and DIBASE”);
• if you are taking antacids containing aluminium, medicines used to treat excess stomach acid that may rise into the oesophagus (see section “Other medicines and DIBASE”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
• if you are obese;
• if you have intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis), or if you have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
At this dosage, DIBASE is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will monitor you closely and carefully evaluate whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminium-containing antacids, medicines used to treat excess stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
• lipid-lowering medicines (hypolipidaemic agents) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various strains of Streptomyces bacteria;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g., ketoconazole).

DIBASE with food, beverages, and alcohol
Inform your doctor if you are taking other products containing vitamin D, foods fortified with vitamin D, or using vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
DIBASE 50,000 IU/2.5 ml oral solution in single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
DIBASE 50,000 IU/2.5 ml oral solution in single-dose container is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are excreted in breast milk; your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as a rare side effect of treatment with DIBASE.

3. How to take DIBASE

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by the doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take DIBASE during meals.

Adults and Elderly
Treatment:
1 single-dose container (equivalent to 50,000 IU of vitamin D) once a week for up to
6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

Use in children and adolescents
The use of DIBASE 50,000 IU/2.5 ml oral solution in single-dose containers is not recommended in
neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of DIBASE 50,000 IU/2.5 ml oral solution in single-dose containers is not recommended during
pregnancy.

If you take more DIBASE than you should
In case of accidental ingestion/overdose of DIBASE, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.

If you forget to take DIBASE
Do not take a double dose to make up for the missed dose.

If you stop taking DIBASE
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, by frequency:

Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
• headache (cephalalgia)
• stomach ache (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching (pruritus)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity)
• reduced appetite
• excessive thirst (polydipsia)
• drowsiness
• confusion
• constipation (stipsis)
• passing wind (flatulence)
• dry mouth
• altered taste (dysgeusia)
• hives (urticaria)
• increased urine production (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

Not known (frequency cannot be estimated from the available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIBASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What DIBASE contains
In a single-dose container:

• The active substance is colecalciferol (vitamin D ) 1.25 mg, equivalent to 50,000 IU.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 50,000 IU/2.5 ml oral solution in single-dose container is a solution contained in an amber glass vial closed with a cap made of polypropylene.
It is available in packs containing 1, 2, 3, 4 or 6 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy