Colecalciferol ABC

Package leaflet: Information for the patient

Colecalciferol ABC 10,000 IU/ml oral drops, solution

colecalciferol (vitamin D)
Equivalent medicine
Please read all of this leaflet carefully before you start 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 may 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 Colecalciferol ABC is and what it is used for
2. What you need to know before taking Colecalciferol ABC
3. How to take Colecalciferol ABC
4. Possible side effects
5. How to store Colecalciferol ABC
6. Contents of the pack and other information

1. What Colecalciferolo ABC is and what it is used for

Colecalciferolo ABC contains colecalciferol, better known as vitamin D. The main function of vitamin D is to ensure adequate calcium absorption in the intestine and to promote proper bone mineralization.
Colecalciferolo ABC 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 Colecalciferolo ABC

Do not take Colecalciferolo ABC

• 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 the blood (hypercalcemia) or in the urine (hypercalciuria);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo ABC.
Your doctor may recommend taking Colecalciferolo ABC 10,000 IU/ml oral drops, solution as
prevention of vitamin D deficiency:

• in newborns (especially if premature) and infants;
• during the last trimester of pregnancy;
• during breastfeeding;
• in the elderly;
• in case of insufficient or ineffective sun exposure, particularly in children and adolescents;
• in case of special diets or eating regimens (e.g. low in calcium, vegetarian, etc.);
• in case of dark skin pigmentation;
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy);
• in case of liver diseases (hepatic insufficiency);
• in case of gastrointestinal disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis, celiac disease);
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines.

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 Colecalciferolo ABC 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 with medicines that lower 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, or other granulomatous diseases;
• 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 Colecalciferolo ABC.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colecalciferolo ABC with food, beverages and alcohol”).
Do not take Colecalciferolo ABC if you have significantly reduced kidney function (see section “Do not take Colecalciferolo ABC”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with Colecalciferolo ABC 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 Colecalciferolo ABC.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take Colecalciferolo ABC” 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 (such as colestipol, cholestyramine), or orlistat (used to treat obesity) (see section “Other medicines and Colecalciferolo ABC”);
• 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 Colecalciferolo ABC”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colecalciferolo ABC”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis or mucoviscidosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Other medicines and Colecalciferolo ABC
Inform 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 your doctor may decide to perform additional tests:

• 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 Colecalciferolo ABC:

• 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 species of Streptomyces bacteria;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms (e.g. ketoconazole).

Colecalciferolo ABC with food, beverages and alcohol
Inform your doctor if you are taking other products already containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If necessary, your doctor will prescribe vitamin D at low doses during the last trimester of pregnancy.
Colecalciferolo ABC 10,000 IU/ml oral drops, solution may be taken during the last trimester of pregnancy (see section 3 “How to take Colecalciferolo ABC”).
Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. This does not replace 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 Colecalciferolo ABC on the ability to drive vehicles or operate machinery. However, you should be aware that drowsiness may occur as a rare side effect of treatment with Colecalciferolo ABC.

3. How to take Colecalciferolo ABC

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 Colecalciferolo ABC 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 vitamin D deficient, a higher dose may be required (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 must be adjusted according to serum levels of
25-hydroxycolecalciferol (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
Follow the instructions below to open the bottle and use the dropper:

1. press and unscrew the cap of the bottle simultaneously;
2. remove the cap;
3. unscrew the protective cap of the dropper;
4. screw the dropper onto the bottle and draw up the contents;
5. remove the dropper and place it back into the protective cap;
6. screw the bottle cap back on to close the bottle.

If you take more Colecalciferolo ABC than you should
In case of accidental ingestion or overdose of Colecalciferolo ABC, 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 urine production (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 Colecalciferolo ABC
Do not take a double dose to make up for the missed dose.

If you stop taking Colecalciferolo ABC
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 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 (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)
• loss of 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 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 Colecalciferolo ABC

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 in use. This will help protect the environment.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.
The shelf life 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 disposed of.

6. Package contents and other information

What Colecalciferolo ABC contains
The active substance is colecalciferol (vitamin D ).
2.5 mg (equivalent to 100,000 IU) of colecalciferol are contained in 10 ml of solution.
Each drop contains: 250 IU of vitamin D .
The other component is refined olive oil.

Description of the appearance of Colecalciferolo ABC and package contents
Colecalciferolo ABC is a clear, colourless or slightly yellowish-green transparent solution, contained in an amber glass bottle closed with a child-resistant cap made of polypropylene with an inner polyethylene lining.
It is available in a pack containing one 10 ml bottle and one glass dropper.

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (MI) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Package leaflet: information for the patient

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

colecalciferol (vitamin D )
Equivalent medicine
Please read all of this leaflet carefully before you take 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 they have the same symptoms as you, 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 Colecalciferolo ABC is and what it is used for
2. What you need to know before taking Colecalciferolo ABC
3. How to take Colecalciferolo ABC
4. Possible side effects
5. How to store Colecalciferolo ABC
6. Contents of the pack and other information

1. What Colecalciferolo ABC is and what it is used for

Colecalciferolo ABC contains cholecalciferol, better known as vitamin D. The main function
of vitamin D is to ensure adequate calcium absorption in the intestine and to promote proper
bone mineralization.
Colecalciferolo ABC 25,000 IU/2.5 ml oral solution in single-dose container is indicated for:

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

2. What you need to know before taking Colecalciferolo ABC

Do not take Colecalciferolo ABC

• 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 the blood (hypercalcemia) or in the urine (hypercalciuria);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo ABC.
Your doctor may recommend taking Colecalciferolo ABC 25,000 IU/2.5 ml oral solution in single-dose container as prevention of vitamin D deficiency:

• in the elderly;
• in case of insufficient or ineffective sun exposure;
• in case of special diets or eating patterns (e.g. low in calcium, vegetarian, etc.);
• in case of deeply pigmented skin;
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy);
• in case of liver diseases (hepatic insufficiency);
• in case of gastrointestinal disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis, celiac disease);
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs.

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 Colecalciferolo ABC 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 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, or other granulomatous diseases;
• 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 Colecalciferolo ABC.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colecalciferolo ABC with food, drinks, and alcohol”).
Do not take Colecalciferolo ABC if you have significant reduction in kidney function (see section “Do not take Colecalciferolo ABC”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with Colecalciferolo ABC 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 Colecalciferolo ABC.
Inform your doctor in the following cases, as dose adjustments may be needed compared to those indicated in section 3 “How to take Colecalciferolo ABC”:

• if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering drugs (such as colestipol, cholestyramine), or orlistat (used to treat obesity) (see section “Other medicines and Colecalciferolo ABC”);
• 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 Colecalciferolo ABC”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colecalciferolo ABC”);
• if you are obese;
• if you have intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis or mucoviscidosis) or have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

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

Other medicines and Colecalciferolo ABC
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 keep you under close monitoring 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 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 effect of Colecalciferolo ABC:

• 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 (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, capable of inhibiting fungal growth (e.g. ketoconazole).

Colecalciferolo ABC with food, drinks, and alcohol
Inform your doctor if you are taking other products already containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total vitamin D intake can be taken into account 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
Colecalciferolo ABC 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 fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
Colecalciferolo ABC 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 during breastfeeding at lower doses. This does not replace 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 Colecalciferolo ABC on the ability to drive vehicles or use machinery.
However, it should be noted that drowsiness may occur as a side effect of treatment with Colecalciferolo ABC, although this is rare.

3. How to take Colecalciferolo ABC

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 status.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo ABC during meals. The single-dose
container should be used for a single administration, making sure to take the entire dose.
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 and may subsequently prescribe a lower dose.
Use in children and adolescents
The use of Colecalciferolo ABC 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 Colecalciferolo ABC 25,000 IU/2.5 ml oral solution in single-dose containers is not recommended
during pregnancy.
If you take more Colecalciferolo ABC than you should
In case of accidental ingestion/overdose of Colecalciferolo ABC, 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 urine production (polyuria),
constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Taking an excessive dose 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 Colecalciferolo ABC
Do not take a double dose to make up for the missed dose.
If you stop taking Colecalciferolo ABC
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, grouped 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)
• loss of 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 calcium deposition in the kidneys (nephrocalcinosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at 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 Colecalciferolo ABC

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 that you no longer use. This will help protect the environment.
Store below 30°C.
Store in the original packaging to protect the medicine from light.

6. Package contents and other information

What Colecalciferolo ABC contains
The active substance is colecalciferol (vitamin D).
One single-dose container with 2.5 ml of solution contains 0.625 mg (equivalent to 25,000 IU) of
colecalciferol.
The other component is refined olive oil.

Description of the appearance of Colecalciferolo ABC and contents of the pack
Colecalciferolo ABC 25,000 IU/2.5 ml oral solution in single-dose container is a clear, colourless or slightly yellowish-green transparent solution, contained in an amber glass container closed with a cap made of polypropylene with an inner seal of polyethylene.
It is available in packs of 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC) - Italy
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (MI) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Patient Information Leaflet

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

colecalciferol (vitamin D)
Equivalent medicine
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 may 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 Colecalciferolo ABC is and what it is used for
2. What you need to know before taking Colecalciferolo ABC
3. How to take Colecalciferolo ABC
4. Possible side effects
5. How to store Colecalciferolo ABC
6. Contents of the pack and other information

1. What Colecalciferolo ABC is and what it is used for

Colecalciferolo ABC contains colecalciferol, better known as vitamin D. The main function
of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper
mineralization of bones.
Colecalciferolo ABC 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 Colecalciferolo ABC

Do not take Colecalciferolo ABC

• 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 high levels of vitamin D in your blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo ABC.
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 Colecalciferolo ABC at high doses;
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics);
• if you suffer from sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation, or other granulomatous diseases;
• 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 Colecalciferolo ABC.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colecalciferolo ABC with food, beverages, and alcohol”).
You must not take Colecalciferolo ABC if you have significantly reduced kidney function (see section “Do not take Colecalciferolo ABC”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers treatment with Colecalciferolo ABC 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 Colecalciferolo ABC.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take Colecalciferolo ABC” 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 medicines (such as colestipol, cholestyramine), or orlistat (used to treat obesity) (see section “Other medicines and Colecalciferolo ABC”);
• 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 Colecalciferolo ABC”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colecalciferolo ABC”);
• 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 if you have undergone bariatric surgery;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents
Colecalciferolo ABC 50,000 IU/2.5 ml oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Colecalciferolo ABC
Inform 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 close monitoring and additional tests may be required:

• digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
• 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 Colecalciferolo ABC:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some 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 Streptomyces species;
• antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

Colecalciferolo ABC 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 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Colecalciferolo ABC 50,000 IU/2.5 ml single-dose oral solution 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
Colecalciferolo ABC 50,000 IU/2.5 ml single-dose oral solution is not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D at lower doses during breastfeeding.
This does not replace 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 Colecalciferolo ABC on the ability to drive vehicles or operate machinery.
However, drowsiness may occur as a rare side effect of treatment with Colecalciferolo ABC, and this should be taken into account.

3. How to take Colecalciferolo ABC

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 Colecalciferolo ABC during meals.
The single-dose container must be used for a single administration only, making sure to take the entire dose.

Adults and elderly
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 and may subsequently prescribe a lower dose.

Use in children and adolescents
The use of Colecalciferolo ABC 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 Colecalciferolo ABC 50,000 IU/2.5 ml oral solution in single-dose containers is not recommended during pregnancy.

If you take more Colecalciferolo ABC than you should
In case of accidental ingestion/overdose of Colecalciferolo ABC, 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 the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive intake 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 Colecalciferolo ABC
Do not take a double dose to make up for the missed dose.

If you stop treatment with Colecalciferolo ABC
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 everybody gets 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 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 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 Colecalciferolo ABC

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 30°C.
Store in the original packaging to protect the medicine from light.

6. Package contents and other information

What Colecalciferolo ABC contains
The active substance is colecalciferol (vitamin D).
One single-dose container with 2.5 ml of solution contains 1.25 mg (equivalent to 50,000 IU) of colecalciferol.
The other component is refined olive oil.

Description of the appearance of Colecalciferolo ABC and contents of the package
Colecalciferolo ABC 50,000 IU/2.5 ml oral solution in single-dose container is a clear, colourless or yellowish-green transparent solution, contained in an amber glass container closed with a polipropylene cap with an inner polyethylene lining.
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 Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (MI) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy