Colecalciferol Zentiva: detailed information

Patient information leaflet

Colecalciferolo Zentiva 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 pass it on 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 Zentiva is and what it is used for
What you need to know before taking Colecalciferolo Zentiva
How to take Colecalciferolo Zentiva
Possible side effects
How to store Colecalciferolo Zentiva
Contents of the pack and other information

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

Colecalciferolo Zentiva 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 Zentiva is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking Colecalciferolo Zentiva

Do not take Colecalciferolo Zentiva

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 suffer from severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo Zentiva.
Your doctor may recommend taking Colecalciferolo Zentiva for prevention of vitamin D deficiency in the following cases:

in newborns (especially premature infants) and infants,
during the last trimester of pregnancy,
during breastfeeding,
in elderly people,
if you have insufficient or ineffective exposure to sunlight,
if you follow a special diet (e.g. low in calcium, vegetarian diet),
if you have dark skin pigmentation,
if you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
liver diseases (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, coeliac disease).

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 fish 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 your vitamin D levels or calcium levels in blood and urine in the following cases:

if you need to take Colecalciferolo Zentiva for a long time and at high doses,
if you suffer or have suffered from kidney stones,
if you have kidney problems,
if you have heart problems,
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 suffer from 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 found to be high, your doctor will reduce the dose or stop treatment with Colecalciferolo Zentiva.

In general, if you have impaired kidney function, you will need periodic blood tests to monitor calcium and phosphate levels. If your calcium and phosphate levels are high, your doctor will reduce the dose or stop treatment with Colecalciferolo Zentiva.

Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Colecalciferolo Zentiva” may be required:

if you are taking antiepileptic medicines (anticonvulsants) (see section “Other medicines and Colecalciferolo Zentiva”) or barbiturates (used in anaesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Colecalciferolo Zentiva”);
if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Colecalciferolo Zentiva”);
if you are taking medicines for obesity such as orlistat (see section “Other medicines and Colecalciferolo Zentiva”);
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 Colecalciferolo Zentiva”);
if you suffer from gastrointestinal disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
if you suffer from extensive skin diseases;
if you have liver disease (hepatic insufficiency).

Other medicines and Colecalciferolo Zentiva
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 Zentiva:

medicines used to treat epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anaesthesia;
rifampicin (an antibiotic);
medicines to lower blood fats 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 forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole), medicines used to treat fungal infections.

Additionally, if you are taking 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;
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.

Colecalciferolo Zentiva with food, drinks and alcohol
Inform your doctor if you are taking other products already containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total intake of vitamin D 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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice 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 foetus (see section 3 “If you take more Colecalciferolo Zentiva than you should”).

Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when giving additional vitamin D to the infant.

Fertility
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.

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

3. How to take Colecalciferolo Zentiva

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.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Zentiva during meals.

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 for you and may subsequently prescribe a lower dose. Higher doses should be adjusted according to the desired 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).

Paediatric population (< 18 years)
Infants (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D) daily.
Treatment: The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 4 drops (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 D3).
Treatment: The doctor will determine the appropriate dose and may subsequently prescribe a lower dose.
The daily dose must not exceed 8 drops daily (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). The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops daily (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 vitamin D-deficient, a higher dose may be necessary (up to 2,000 IU daily – 8 drops).

Instructions for use
Follow these instructions to open the bottle and use the dropper:

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

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

If you stop taking Colecalciferolo Zentiva
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:
Uncommon (may affect up to 1 in 100 people)

high levels of calcium in the blood (hypercalcaemia, which may occur only in case of overdose or prolonged uncontrolled use leading to excessive accumulation of vitamin) and in the 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 through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colecalciferolo Zentiva

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. 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 Zentiva contains

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

Description of the appearance of Colecalciferolo Zentiva and contents of the pack
Colecalciferolo Zentiva is a clear, colourless or yellowish-green transparent solution, contained in an amber glass bottle closed with a child-resistant cap made of polypropylene.
It is available in packs containing 1 bottle of 10 ml and 1 glass dropper.

Marketing Authorization Holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/b - 20158 Milan, 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 (Milan) - Italy
VAMFARMA S.R.L. - Via Kennedy, 5 - 26833 - Comazzo (LO)

Patient Information Leaflet

Colecalciferolo Zentiva 25,000 IU 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 could 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:

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

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

Colecalciferolo Zentiva 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 support proper bone mineralization.
Colecalciferolo Zentiva is indicated for:

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

2. What you need to know before taking Colecalciferol Zentiva

Do not take Colecalciferol Zentiva

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 Colecalciferol Zentiva.
Your doctor may recommend taking Colecalciferol Zentiva for prevention of vitamin D deficiency:

in elderly patients,
in case of insufficient or ineffective sun exposure,
in case of a special diet (e.g. low in calcium, vegetarian diet),
in case of dark skin pigmentation,
in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), liver diseases (hepatic insufficiency),
if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs,
if you suffer from gastrointestinal disorders (intestinal malabsorption, cystic fibrosis, celiac disease).

Inform your doctor if you are already taking other products containing vitamin D, or if you consume large amounts of foods known to be rich in vitamin D (such as cod liver oil, fish, eggs), or foods or milk fortified with vitamin D, since vitamin D accumulates in the body and excessive intake 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 your vitamin D levels or calcium levels in blood and urine in the following cases:

if you need to take Colecalciferol Zentiva for a long time and at high doses,
if you have had or currently have 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 Zentiva.

In general, if you have impaired kidney function, you will need periodic blood tests to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colecalciferol Zentiva.
Inform your doctor in the following cases, as an increase in dosage above that indicated in section 3 “How to take Colecalciferol Zentiva” may be necessary:
if you are taking medications used to treat epilepsy (anticonvulsants) (see section “Other medicines and Colecalciferol Zentiva”) or barbiturates (used in anesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Colecalciferol Zentiva”);
if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Colecalciferol Zentiva”);
if you are taking medicines for obesity such as orlistat (see section “Other medicines and Colecalciferol Zentiva”);
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 Colecalciferol Zentiva”);
if you suffer from gastrointestinal disorders (intestinal malabsorption, cystic fibrosis);
if you have extensive skin diseases;
if you have liver disease (hepatic insufficiency).

Children and adolescents
Colecalciferol Zentiva 25,000 IU oral solution is not recommended in children and adolescents aged 0 to 18 years.

Other medicines and Colecalciferol Zentiva
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 Colecalciferol Zentiva:

medicines used to treat epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anesthesia;
rifampicin (an antibiotic);
medicines to lower blood lipids such as colestipol, cholestyramine;
medicines used to treat obesity (orlistat);
certain laxatives (such as liquid paraffin);
aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus;
corticosteroids, medicines used to treat inflammation;
actinomycin (a medicine used to treat certain forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole), medicines used to treat fungal infections.

Additionally, if you are taking the following medicines, inform your doctor, who will monitor you closely and carefully assess whether further 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 the blood less likely to clot.

Colecalciferol Zentiva with food, drink, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or if you are consuming vitamin D-enriched milk, so that the total intake of vitamin D 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, 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 Zentiva than you should”).
Colecalciferol Zentiva 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
Colecalciferol Zentiva 25,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower doses. This does not replace the need for 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
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.

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

3. How to take Colecalciferolo Zentiva

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 Zentiva 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 maintenance dose.

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

Pregnant women
The use of Colecalciferolo Zentiva 25,000 IU oral solution is not recommended during pregnancy.

If you take more Colecalciferolo Zentiva than you should
In case of accidental ingestion/overdose of Colecalciferolo Zentiva, 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 output (polyuria), constipation and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

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

If you stop treatment with Colecalciferolo Zentiva
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 side effects reported with vitamin D use 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 prolonged, uncontrolled use leading to excessive accumulation of vitamin D) and in the 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, hives.

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 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 Zentiva

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 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 Zentiva 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 ingredient is refined olive oil.

Description of the appearance of Colecalciferolo Zentiva and contents of the pack
Colecalciferolo Zentiva is a clear, colourless or yellowish-green transparent solution, contained in an amber glass container sealed with a cap made of polypropylene.
It is available in packs containing 1, 2 or 4 single-dose containers of 2.5 ml each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/b - 20158 Milan, 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 (Milan) - Italy
VAMFARMA S.R.L. - Via Kennedy, 5 - 26833 - Comazzo (LO), Italy

Patient information leaflet

Colecalciferolo Zentiva 50,000 IU 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Colecalciferolo Zentiva 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 Zentiva 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 Zentiva

Do not take Colecalciferolo Zentiva

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 suffer from severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo Zentiva.
Inform your doctor if you are already taking other products containing vitamin D, 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, since 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 or urine tests to monitor your vitamin D or calcium levels in the following cases:

if you need to take Colecalciferolo Zentiva for a long time and at high doses;
if you currently have or have previously 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 can affect the whole 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 stop treatment with Colecalciferolo Zentiva.

In general, if you have impaired kidney function, you will need periodic blood tests to monitor your calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colecalciferolo Zentiva.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Colecalciferolo Zentiva” may be required:

if you are taking antiepileptic medicines (anticonvulsants) (see section “Other medicines and Colecalciferolo Zentiva”) or barbiturates (used in anaesthesia);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Colecalciferolo Zentiva”);
if you are taking medicines to lower blood fats such as colestipol, cholestyramine (see section “Other medicines and Colecalciferolo Zentiva”);
if you are taking medicines for obesity such as orlistat (see section “Other medicines and Colecalciferolo Zentiva”);
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 Zentiva”);
if you suffer from gastrointestinal diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
if you suffer from extensive skin diseases;
if you have liver disease (hepatic insufficiency).

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

Other medicines and Colecalciferolo Zentiva
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 Zentiva:

medicines used to treat epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anaesthesia;
rifampicin (an antibiotic);
medicines to lower blood fats such as colestipol, cholestyramine;
medicines used to treat obesity (orlistat);
certain laxatives (such as liquid paraffin);
antacids containing aluminium, 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 forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole), medicines used to treat fungal infections.

Additionally, if you are taking any of the following medicines, inform your doctor, who will monitor you closely and carefully consider whether further 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 conditions;
magnesium-containing preparations;
warfarin, a medicine used to make the blood less prone to clotting.

Colecalciferolo Zentiva with food and drink 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 your 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 might 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 foetus (see section 3 “If you take more Colecalciferolo Zentiva than you should”).
Colecalciferolo Zentiva 50,000 IU 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 Zentiva 50,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower doses.
This does not replace the administration of vitamin D to 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
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.

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

3. How to take Colecalciferolo Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in doubt, 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 Zentiva during meals.

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

Paediatric population
The use of Colecalciferolo Zentiva 50,000 IU oral solution is not recommended in neonates, children and adolescents under 18 years of age.

Pregnant women
The use of Colecalciferolo Zentiva 50,000 IU oral solution is not recommended during pregnancy.

If you take more Colecalciferolo Zentiva than you should
In case of accidental ingestion/overdose of Colecalciferolo Zentiva, 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 such as: 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 Zentiva
Do not take a double dose to make up for the missed dose.

If you stop taking Colecalciferolo Zentiva
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 listed below:
Uncommon (may affect up to 1 in 100 people)

high levels of calcium in the blood (hypercalcemia, which may occur only in case of overdose or prolonged uncontrolled use leading to excessive accumulation of vitamin D) and in the 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, hives.

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 amount of urine excreted (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

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 the national reporting system at Colecalciferolo Zentiva_FI 10.000
clean.docx 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 Zentiva

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 packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. 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 Colecalciferol Zentiva contains

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

Description of the appearance of Colecalciferol Zentiva and contents of the pack
Colecalciferol Zentiva is a clear, colourless or slightly yellowish-green transparent 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 Authorisation Holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/b - 20158 Milan, 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 (Milan) - Italy
VAMFARMA S.R.L. - Via Kennedy, 5 - 26833 - Comazzo (LO)