Colecalciferol Ipsopharma: detailed information

Package leaflet: Information for the patient

COLECALCIFEROLO IPSO PHARMA 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, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What COLECALCIFEROLO IPSO PHARMA is and what it is used for
What you need to know before taking COLECALCIFEROLO IPSO PHARMA
How to take COLECALCIFEROLO IPSO PHARMA
Possible side effects
How to store COLECALCIFEROLO IPSO PHARMA
Contents of the pack and other information

1. What COLECALCIFEROLO IPSO PHARMA is and what it is used for

COLECALCIFEROLO IPSO PHARMA 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 bone mineralization.
COLECALCIFEROLO IPSO PHARMA is indicated for the prevention and treatment of
vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO IPSO PHARMA

Do not take COLECALCIFEROLO IPSO PHARMA

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 suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
if you have a kidney disease (renal insufficiency) (see section “Warnings and precautions”).

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

in newborns (especially if premature) and infants,
during the last trimester of pregnancy,
in breastfeeding women at the end of winter and in spring,
in the elderly,
in case of insufficient sun exposure, particularly in children and adolescents,
in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
in case of dark skin pigmentation,
in case of extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
gastrointestinal disorders or liver diseases (hepatic insufficiency),
in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines. Inform your doctor if you are already taking other products containing vitamin D, vitamin D-fortified foods or milk, as vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important not to exceed the recommended dose.

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 COLECALCIFEROLO IPSO PHARMA for a long time and at high doses,
if you have or have had kidney stones,
if you have kidney problems,
if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics),
if you have sarcoidosis, an inflammatory disease that can affect the whole body and leads to nodule formation, or other granulomatous diseases. If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO IPSO PHARMA.

In general, you should not take COLECALCIFEROLO IPSO PHARMA if you have impaired kidney function (see section “Do not take COLECALCIFEROLO IPSO PHARMA”); however, if your doctor considers treatment with COLECALCIFEROLO IPSO PHARMA absolutely necessary, periodic tests to monitor calcium and phosphate levels in blood will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO IPSO PHARMA.

Inform your doctor in the following cases, as higher doses than those indicated in section 3. “How to take COLECALCIFEROLO IPSO PHARMA” may be needed:

if you are taking medicines used to treat epilepsy (anticonvulsants) (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”) or barbiturates (used in anesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you are taking medicines to lower blood fats such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you are taking medicines for obesity treatment such as orlistat (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
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 IPSO PHARMA”);
if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis);
if you have a liver disease (hepatic insufficiency).

Other medicines and COLECALCIFEROLO IPSO PHARMA
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 they may reduce the effect of COLECALCIFEROLO IPSO PHARMA:

medicines used to treat epilepsy (anticonvulsants) or barbiturates, medicines used in anesthesia,
rifampicin (an antibiotic),
medicines to lower blood fats such as colestipol, cholestyramine,
medicines used to treat obesity (orlistat),
antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus,
corticosteroids, medicines used to treat inflammation.

Moreover, if you are taking any of the following medicines, inform your doctor, who will closely monitor you and carefully evaluate whether additional tests are needed:

thiazide diuretics, medicines used to treat high blood pressure by increasing urine production,
digitalis, medicines used to treat certain heart disorders,
magnesium-containing preparations,
warfarin, a medicine used to make blood less likely to clot.

COLECALCIFEROLO IPSO PHARMA with food, drinks and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or if you are 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 and breastfeeding
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
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3. “If you take more COLECALCIFEROLO IPSO PHARMA than you should”).
Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. This does not replace vitamin D supplementation in the newborn.

Driving and using machines
There are no data available on the effects of this product on the ability to drive vehicles or use machinery.

3. How to take COLECALCIFEROLO IPSO PHARMA

Paediatric population (< 18 years)
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 physician'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 third 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 physician'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
Follow these steps to open the bottle and use the dropper:

Press and unscrew the bottle cap simultaneously;
Remove the cap;
Unscrew the protective cap covering the dropper;
Screw the dropper onto the bottle and draw up the required amount;
Remove the dropper and return it to the protective cap;
Screw the bottle cap back on to close the bottle.

If you take more COLECALCIFEROLO IPSO PHARMA than you should
If you accidentally ingest or take an excessive dose of COLECALCIFEROLO IPSO PHARMA, 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 urine output (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.

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

If you stop taking COLECALCIFEROLO IPSO PHARMA
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 side effects reported with vitamin D use are as follows:

allergic reactions
weakness, loss of appetite (anorexia), thirst
drowsiness, confusion
headache
constipation, gas (flatulence), stomach pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth
skin rash, itching, hives
excessive calcium deposition in the kidneys (nephrocalcinosis), increased amount of urine excreted (polyuria), intense thirst (polydipsia), kidney disease (renal failure)
high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please 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 IPSO PHARMA

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 discarded.

6. Package contents and other information

What COLECALCIFEROLO IPSO PHARMA contains

The active substance is colecalciferol (vitamin D): 10 ml of solution contain 2.5 mg (equivalent to 100,000 IU) of colecalciferol. 1 drop contains: 250 IU of vitamin D.
The other component is refined olive oil.

Description of the appearance of COLECALCIFEROLO IPSO PHARMA and contents of the
packaging
COLECALCIFEROLO IPSO PHARMA is a solution contained in an amber glass bottle, closed with a child-resistant cap made of polypropylene.
It is available in a pack containing 1 bottle of 10 ml and 1 dropper.
It is possible that not all pack sizes are marketed.

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

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 (Milan) - Italy
Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Package leaflet: information for the patient

COLECALCIFEROLO IPSO PHARMA 25,000 IU/2.5 ml oral 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, 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What COLECALCIFEROLO IPSO PHARMA is and what it is used for
What you need to know before taking COLECALCIFEROLO IPSO PHARMA
How to take COLECALCIFEROLO IPSO PHARMA
Possible side effects
How to store COLECALCIFEROLO IPSO PHARMA
Package contents and other information

1. What COLECALCIFEROLO IPSO PHARMA is and what it is used for

COLECALCIFEROLO IPSO PHARMA 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 bone mineralization.
COLECALCIFEROLO IPSO PHARMA 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 colecalciferol;
treatment of vitamin D deficiency in adults (age over 18 years).

2. What you need to know before taking COLECALCIFEROLO IPSO PHARMA

Do not take COLECALCIFEROLO IPSO PHARMA

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 suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
if you have a kidney disease (renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO IPSO PHARMA.
Your doctor may recommend taking COLECALCIFEROLO IPSO PHARMA as prevention of vitamin D
deficiency:

in elderly people,
in case of insufficient sun exposure,
in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
in case of deeply pigmented skin,
in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
gastrointestinal disorders or liver diseases (hepatic insufficiency),
in patients being treated with antiepileptic drugs or undergoing long-term treatment with certain anti-inflammatory medicines. Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, as vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.

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 IPSO PHARMA for a long time and at high doses,
if you have or have had kidney stones,
if you have kidney problems,
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 have sarcoidosis, an inflammatory disease that can affect the entire body and leads to nodule formation, or other granulomatous diseases. If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO IPSO PHARMA.

In general, you should not take COLECALCIFEROLO IPSO PHARMA if you have impaired kidney function (see section “Do not take COLECALCIFEROLO IPSO PHARMA”); however, if your doctor considers treatment with COLECALCIFEROLO IPSO PHARMA 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 IPSO PHARMA.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take COLECALCIFEROLO IPSO PHARMA” may be needed:

if you are taking medicines used to treat epilepsy (anticonvulsants) (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”) or barbiturates (used in anesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you are taking medicines for obesity such as orlistat (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and COLECALCIFEROLO IPSO PHARMA”);
if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis);
if you have a liver disease (hepatic insufficiency).

Children and adolescents
COLECALCIFEROLO IPSO PHARMA 25,000 IU oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and COLECALCIFEROLO IPSO PHARMA
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 they may reduce the effect of COLECALCIFEROLO IPSO PHARMA:

medicines used to treat epilepsy (anticonvulsants) or barbiturates, medicines used in anesthesia,
rifampicin (an antibiotic),
medicines to lower blood lipids such as colestipol, cholestyramine,
medicines used to treat obesity (orlistat),
antacids containing aluminum, medicines used to treat excessive stomach acid that may rise into the esophagus,
corticosteroids, medicines used to treat inflammation.

Additionally, if you are taking any of the following medicines, inform your doctor, who will closely monitor you and carefully assess whether further tests are needed:

thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
digitalis, a medicine used to treat certain heart conditions;
magnesium-containing preparations;
warfarin, a medicine used to make blood less likely to clot.

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

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

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe vitamin D only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3 “If you take more COLECALCIFEROLO IPSO PHARMA than you should”).
COLECALCIFEROLO IPSO PHARMA 25,000 IU oral solution 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 IPSO PHARMA 25,000 IU 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 present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Driving and using machines
There are no data available on the effects of this product on the ability to drive vehicles or use machinery.

3. How to take COLECALCIFEROLO IPSO PHARMA

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 maintenance dose.

Paediatric population
The use of COLECALCIFEROLO IPSO PHARMA 25,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of COLECALCIFEROLO IPSO PHARMA 25,000 IU oral solution is not recommended during pregnancy.

If you take more COLECALCIFEROLO IPSO PHARMA than you should
In case of accidental ingestion or overdose of COLECALCIFEROLO IPSO PHARMA, 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 urine output (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.

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

If you stop treatment with COLECALCIFEROLO IPSO PHARMA
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 will experience them.
The side effects reported with vitamin D use are as follows:

allergic reactions
weakness, loss of appetite (anorexia), thirst
drowsiness, confusion
headache
constipation, gas (flatulence), stomach pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth
skin rash, itching, urticaria
excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)
high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may also report side effects directly through 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 IPSO PHARMA

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 used. This will help protect the environment.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.

6. Pack contents and other information

What COLECALCIFEROLO IPSO PHARMA 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 IPSO PHARMA and pack contents
COLECALCIFEROLO IPSO PHARMA is a solution contained in an amber glass container, closed with a cap made of polypropylene.
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
Ipso Pharma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

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 (Milan) - Italy
Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Patient information leaflet

Colecalciferolo Ipso Pharma 50,000 IU/2.5 ml oral 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, 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Colecalciferolo Ipso Pharma is and what it is used for
What you need to know before taking Colecalciferolo Ipso Pharma
How to take Colecalciferolo Ipso Pharma
Possible side effects
How to store Colecalciferolo Ipso Pharma
Package contents and other information

1. What Colecalciferolo Ipso Pharma is and what it is used for

Colecalciferolo Ipso Pharma 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 bone mineralization.
Colecalciferolo Ipso Pharma 50,000 IU/2.5 ml oral solution is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you should know before taking Colecalciferol Ipso Pharma

Do not take Colecalciferol Ipso Pharma

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 have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
if you have severe kidney disease (renal failure) (see section “Warnings and precautions”);

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Ipso Pharma.
Inform your doctor if you are already taking other products containing vitamin D, or if you consume large amounts of foods known to be sources of vitamin D (such as cod liver oil, fish, and eggs), or vitamin D–fortified foods or milk, because vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.
Your doctor may prescribe periodic blood tests to monitor vitamin D levels or blood and urine calcium levels in the following cases:

if you need to take Colecalciferol Ipso Pharma for a long time and at high doses;
if you have or have had kidney stones;
if you have kidney problems;
if you have heart problems;
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 have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation, or other granulomatous diseases. If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or stop treatment with Colecalciferol Ipso Pharma.

In general, you should not take Colecalciferol Ipso Pharma if you have impaired kidney function (see section “Do not take Colecalciferol Ipso Pharma”); however, if your doctor considers treatment with Colecalciferol Ipso Pharma 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 Colecalciferol Ipso Pharma.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Colecalciferol Ipso Pharma” may be needed:

if you are taking antiepileptic medicines (anticonvulsants) (see section “Other medicines and Colecalciferol Ipso Pharma”) or barbiturates (used in anaesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Colecalciferol Ipso Pharma”);
if you are taking lipid-lowering medicines such as colestipol, cholestyramine (see section “Other medicines and Colecalciferol Ipso Pharma”);
if you are taking medicines for obesity such as orlistat (see section “Other medicines and Colecalciferol Ipso Pharma”);
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 Colecalciferol Ipso Pharma”);
if you have digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
if you have liver problems (hepatic insufficiency);
if you are obese.

Children and adolescents
Colecalciferol Ipso Pharma 50,000 IU oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Colecalciferol Ipso Pharma
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 they may reduce the effect of Colecalciferol Ipso Pharma:

antiepileptic medicines (anticonvulsants such as phenytoin) or barbiturates, medicines used in anaesthesia;
rifampicin (an antibiotic);
lipid-lowering medicines such as colestipol, cholestyramine;
medicines used to treat obesity (orlistat);
certain laxatives (such as liquid paraffin);
aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
corticosteroids, medicines used to treat inflammation;
actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole), medicines used to treat fungal diseases.

Additionally, if you are taking the following medicines, inform your doctor, who will monitor you closely and carefully evaluate whether additional tests are needed:

thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
calcium-containing preparations;
digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
magnesium-containing preparations;
warfarin, a medicine used to make blood less likely to clot.

Colecalciferol Ipso Pharma with food and 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 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
During the first 6 months of pregnancy, your doctor will prescribe vitamin D only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3 “If you take more Colecalciferol Ipso Pharma than you should”).
Colecalciferol Ipso Pharma 50,000 IU oral solution 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
Colecalciferol Ipso Pharma 50,000 IU 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 present in breast milk. This should be taken into account when administering additional vitamin D to the infant.
Fertility
The impact of high doses of vitamin D on fertility is unknown.

Driving and using machines
No data are available on the effects of this product on the ability to drive vehicles or operate machinery.

3. How to take Colecalciferolo Ipso Pharma

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 based on your health status.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Ipso Pharma during meals. The single-dose container should be used for a single administration, ensuring that the entire dose is taken.
The recommended dose is:
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 for you and may subsequently prescribe a lower dose.
Paediatric population
The use of Colecalciferolo Ipso Pharma 50,000 IU oral solution is not recommended in neonates, children, and
adolescents under 18 years of age.
Pregnant women
The use of Colecalciferolo Ipso Pharma 50,000 IU oral solution is not recommended during pregnancy.
If you take more Colecalciferolo Ipso Pharma than you should
If you accidentally ingest or take an excessive dose of Colecalciferolo Ipso Pharma, 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 symptoms including: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to deposits of calcium salts 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.
If you forget to take Colecalciferolo Ipso Pharma
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Colecalciferolo Ipso Pharma
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 will experience them.
The side effects reported with the use of vitamin D are as follows:
Uncommon (may affect up to 1 in 100 people)

high levels of calcium in the blood (hypercalcemia, which may occur only in cases of overdose or following prolonged and uncontrolled use leading to excessive accumulation of vitamin) and in urine (hypercalciuria)

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

allergic reactions
weakness (asthenia), loss of appetite (anorexia), thirst
drowsiness, confusion
constipation, gas (flatulence), stomach pain, nausea, diarrhoea
skin rash, itching, urticaria

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

headache
vomiting, metallic taste (dysgeusia), dry mouth
excessive deposition of calcium in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)

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 Ipso Pharma

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 medicines 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.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What Colecalciferolo Ipso Pharma contains

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

Description of the appearance of Colecalciferolo Ipso Pharma and contents of the pack
Colecalciferolo Ipso Pharma is a clear, colourless or slightly yellowish-green transparent solution, contained in an amber glass container closed with a polipropylene cap and an inner seal made of polyethylene.
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
Ipso Pharma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

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 (Milan) - Italy
Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy