Colecalciferol Teva: detailed information

Package leaflet: Information for the patient

Colecalciferolo Teva 50,000 IU/2.5 ml oral solution

colecalciferol (vitamin D)
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 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:

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

1. What COLECALCIFEROLO TEVA is and what it is used for

Colecalciferolo Teva 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 Teva 50,000 IU/2.5 ml oral solution is indicated for the treatment of
vitamin D deficiency in adults.

2. What you should know before taking Colecalciferol Teva

Do not take Colecalciferol Teva

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”);
if you are pregnant (see section “Pregnancy and breastfeeding”);
if the person taking this medicine is a child or adolescent under 18 years of age (see section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Teva.
Inform your doctor if you are already taking other products containing vitamin D, or if you consume many 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 Colecalciferol Teva 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 can affect the whole body and leads to the formation of nodules, or other granulomatous diseases. If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or stop treatment with Colecalciferol Teva.

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

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

Other medicines and Colecalciferol Teva
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 Teva:

medicines used to treat epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anaesthesia;
rifampicin (an antibiotic); medicines used to lower blood lipids 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 types 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 prone to clotting.

Colecalciferol Teva 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 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine if you are pregnant (see section 2 “Do not take Colecalciferol Teva”).
Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when giving additional vitamin D to the infant.
Fertility
The effect of high doses of vitamin D on fertility is unknown.

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

3. How to take Colecalciferolo Teva

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

Recommended dose:
Adults
1 single-dose container (50,000 IU) 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 administration of Colecalciferolo Teva is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnancy
The administration of Colecalciferolo Teva is not recommended during pregnancy.

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

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

If you stop taking Colecalciferolo Teva
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 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 case of overdose or prolonged and 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, passing 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 amount of urine excreted (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 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 Colecalciferol Teva

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.

6. Package contents and other information

What Colecalciferolo Teva 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 ingredient is refined olive oil.

Description of the appearance of Colecalciferolo Teva and contents of the pack
Colecalciferolo Teva is a clear, colourless or slightly yellowish-green transparent solution, contained in an amber glass container closed with a cap made of polypropylene 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 Authorisation Holder
TEVA B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

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

Patient information leaflet

Colecalciferolo Teva 10,000 IU/ml oral drops, solution, 25,000 IU/2.5 ml oral solution

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

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

Contents of this leaflet:

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

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

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

2. What you need to know before taking Colecalciferol Teva

Do not take Colecalciferol Teva

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 Colecalciferol Teva.
Your doctor may recommend taking Colecalciferol Teva as 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, 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, 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 or urine tests to monitor vitamin D levels or calcium levels in the following cases:

if you need to take Colecalciferol Teva 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 may 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 Colecalciferol Teva.

In general, you should not take Colecalciferol Teva if you have impaired kidney function (see section “Do not take Colecalciferol Teva”); however, if your doctor considers treatment with Colecalciferol Teva to be 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 Colecalciferol Teva.

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

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

Other medicines and Colecalciferol Teva
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 Teva:

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 aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus;
corticosteroids, medicines used to treat inflammation.

Additionally, if you are taking any of the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate 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 disorders;
magnesium-containing preparations;
warfarin, a medicine used to make blood less prone to clotting.

Colecalciferol Teva 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 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 are 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 Colecalciferol Teva than you should”).

Breastfeeding
Your doctor may prescribe this medicine during breastfeeding if needed. However, this does not replace the administration of vitamin D to the newborn.

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

3. How to take Colecalciferolo Teva

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

Colecalciferolo Teva 10,000 IU/ml oral drops, solution
The daily doses indicated below may also be taken once weekly by multiplying the daily dose by seven.

Neonates, Children and Adolescents (<18 years)
Prevention: The recommended dose is 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D).
Treatment: The recommended dose is 8–16 drops daily (equivalent to 2,000–4,000 IU of vitamin D) for 4–5 months.

Pregnant Women
The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D) during the last trimester.

Adults and Elderly
Prevention: The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D). In cases of high risk of deficiency, your doctor may decide whether to increase the dose up to 8 drops daily (equivalent to 2,000 IU of vitamin D).
Treatment: The recommended dose is 20–40 drops daily (equivalent to 5,000–10,000 IU of vitamin D) for 1–2 months.

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 solution;
Remove the dropper and return it to its protective cap;
Screw the bottle cap back on to close the bottle.

Colecalciferolo Teva 25,000 IU/2.5 ml oral solution
Neonates, Children and Adolescents (<18 years)
Prevention: The recommended dose is 1 single-dose container (equivalent to 25,000 IU of vitamin D) every 1–2 months.
Treatment: The recommended dose is 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a week for 16–24 weeks.

Pregnant Women
The recommended dose is 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a month during the last trimester.

Adults and Elderly
Prevention: The recommended dose is 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a month. In cases of high risk of deficiency, your doctor may decide whether to increase the dose to 2 single-dose containers (equivalent to 50,000 IU of vitamin D) once a month.
Treatment: The recommended dose is 2 single-dose containers (equivalent to 50,000 IU of vitamin D) once a week for 8–12 weeks.

If you take more Colecalciferolo Teva than you should
If you accidentally ingest or take an excessive dose of Colecalciferolo Teva, 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, intense 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 Teva
Do not take a double dose to make up for the missed dose.

If you stop taking Colecalciferolo Teva
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 side effects reported with vitamin D use are the following:

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 urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)
high levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria).

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colecalciferolo Teva

Store below 30 °C.
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 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 in the original packaging to protect the medicine from light.
Colecalciferolo Teva 10,000 IU/ml oral drops, solution
The shelf life of the medicine after first opening the bottle is 5 months (record the date of first
opening in the designated space on the carton).
After this period, any remaining medicine must be discarded.

6. Package contents and other information

What Colecalciferolo Teva contains
Colecalciferolo Teva 10,000 IU/ml oral drops, solution

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

Colecalciferolo Teva 25,000 IU/2.5 ml oral solution

The active substance is colecalciferol (vitamin D): one single-dose container containing 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 Teva and contents of the pack
Oral drops, solution
Colecalciferolo Teva is presented as a 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 with 1 dropper.
Oral solution:
Colecalciferolo Teva is presented as a solution contained in an amber glass container, closed with a polypropylene cap.
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 Authorization Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

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