Colecalciferol Mylan

Patient Information Leaflet

COLECALCIFEROLO MYLAN 10,000 IU/ml oral drops, solution

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it 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:

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

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

COLECALCIFEROLO MYLAN 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 MYLAN is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO MYLAN

Do not take COLECALCIFEROLO MYLAN

• 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 a kidney disease (renal failure) (see section “Warnings and precautions”).

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

• in newborns (especially premature infants) and infants;
• during the last trimester of pregnancy;
• in breastfeeding women at the end of winter and in spring;
• in 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 deeply pigmented skin;
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), digestive 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 vitamin D-enriched 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 and urine tests to monitor your vitamin D levels or calcium levels in the following cases:

• if you need to take COLECALCIFEROLO MYLAN for a long time and at high doses;
• if you have had or currently have 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 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 MYLAN.

In general, you should not take COLECALCIFEROLO MYLAN if you have impaired kidney function (see section “Do not take COLECALCIFEROLO MYLAN”); however, if your doctor considers treatment with COLECALCIFEROLO MYLAN 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 stop treatment with COLECALCIFEROLO MYLAN.

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

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

Other medicines and COLECALCIFEROLO MYLAN
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 MYLAN:

• antiepileptic medicines, such as phenytoin, or barbiturates (used in anesthesia) (see section “Other medicines and COLECALCIFEROLO MYLAN”);
• rifampicin (an antibiotic);
• medicines to lower blood lipids such as colestipol, cholestyramine;
• medicines used to treat obesity (orlistat);
• laxatives;
• aluminum-containing antacids, 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 monitor you closely and carefully evaluate whether further tests are needed:

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

COLECALCIFEROLO MYLAN with food and drink 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 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, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, vitamin D should be taken with caution due to the risk of fetal malformations (teratogenic effects) (see also “If you take more COLECALCIFEROLO MYLAN than you should”). Your doctor will prescribe this medicine only if strictly necessary.

Breastfeeding
When necessary, your doctor may prescribe this medicine during breastfeeding. However, it does not replace vitamin D supplementation in the newborn.

Fertility
There are no data on the effect of this product on fertility.

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 MYLAN

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 MYLAN during meals.

Paediatric population (< 18 years)
Neonates (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 per day (equivalent to 1,000 IU of vitamin D).

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

Adults and Elderly
Prevention: The recommended dose is 3-4 drops daily (equivalent to 750-1,000 IU of vitamin D). In the presence of
multiple risk factors for vitamin D deficiency, according to the doctor's judgment, the dosage may be
increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D) daily. Your doctor will determine the appropriate dose and
may subsequently prescribe a lower dose. Higher doses should be adjusted according to
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 per day (equivalent
to 4,000 IU of vitamin D).

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

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

If you take more COLECALCIFEROLO MYLAN than you should
In case of accidental ingestion/overdose of COLECALCIFEROLO MYLAN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria) may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, dehydration, anorexia (loss of appetite), abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, a kidney disease called nephrocalcinosis, kidney stones, and in more severe cases, cardiac arrhythmia. Extreme hypercalcemia may lead to coma and death.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs and irreversible kidney damage.
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 MYLAN
Do not take a double dose to make up for the missed dose.

If you stop treatment with COLECALCIFEROLO MYLAN
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 (hypercalcaemia) and in the urine (hypercalciuria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://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 MYLAN

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

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

Description of the appearance of COLECALCIFEROLO MYLAN and contents of the pack
COLECALCIFEROLO MYLAN 10,000 IU/ml 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.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan

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

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

COLECALCIFEROLO MYLAN 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 MYLAN is indicated for:

• the prevention of vitamin D deficiency in adults, only 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 COLECALCIFEROLO MYLAN

Do not take COLECALCIFEROLO MYLAN

• 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 a kidney disease (renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO MYLAN.
Your doctor may recommend taking COLECALCIFEROLO MYLAN to prevent 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), digestive 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 vitamin D-fortified milk, 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 your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take COLECALCIFEROLO MYLAN 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 elevated, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO MYLAN.

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

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

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

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

Other medicines and COLECALCIFEROLO MYLAN
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 MYLAN:

• medicines used to treat epilepsy, such as phenytoin, or barbiturates (used in anesthesia) (see section “Other medicines and COLECALCIFEROLO MYLAN”);
• rifampicin (an antibiotic);
• medicines to lower blood lipids such as colestipol, cholestyramine;
• medicines used to treat obesity (orlistat);
• laxatives;
• aluminum-containing antacids, 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 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 conditions;
• magnesium-containing preparations;
• warfarin, a medicine used to thin the blood.

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

Pregnancy and breastfeeding
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 COLECALCIFEROLO MYLAN than you should”). COLECALCIFEROLO MYLAN 25,000 IU oral solution in single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
COLECALCIFEROLO MYLAN 25,000 IU oral solution in single-dose container is not recommended during breastfeeding.
When necessary, your doctor may prescribe this medicine during breastfeeding at lower doses.
This does not replace vitamin D supplementation in the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
There are no data on the effect of this product on fertility.

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

3. How to take COLECALCIFEROLO MYLAN

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 MYLAN 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 MYLAN 25,000 IU oral solution in single-dose containers is not
recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of COLECALCIFEROLO MYLAN 25,000 IU oral solution in single-dose containers is not
recommended during pregnancy.

If you take more COLECALCIFEROLO MYLAN than you should
If you accidentally ingest or take an excessive dose of COLECALCIFEROLO MYLAN, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased calcium levels in the blood (hypercalcemia) and in the urine (hypercalciuria) may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, dehydration, anorexia (loss of appetite), abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, a kidney disease called nephrocalcinosis, kidney stones, and in more severe cases, cardiac arrhythmia. Severe hypercalcemia can lead to coma and death.
Chronic excessive dosing may lead to deposition of calcium salts in blood vessels and organs and irreversible kidney damage.
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 MYLAN
Do not take a double dose to make up for the missed dose.

If you stop taking COLECALCIFEROLO MYLAN
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 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 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 http://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 MYLAN

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

6. Package contents and other information

What COLECALCIFEROLO MYLAN 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 MYLAN and package contents
COLECALCIFEROLO MYLAN is presented as 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
MYLAN S.p.A.
Via Vittor Pisani 20
20124 Milano

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

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Colecalciferolo Mylan 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 Mylan 50,000 IU/2.5 ml oral solution in single-dose container is indicated for the
treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking Colecalciferol Mylan

Do not take Colecalciferol Mylan

• 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 (hypercalcaemia) 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 Mylan.
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 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 or urine tests to monitor your vitamin D levels or calcium levels in the following cases:

• if you need to take Colecalciferol Mylan 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 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 found to be high, your doctor will reduce the dose or stop treatment with Colecalciferol Mylan.

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

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

Children and adolescents
Colecalciferol Mylan 50,000 IU oral solution in single-dose container is not recommended for children and adolescents aged between 0 and 18 years.

Other medicines and Colecalciferol Mylan
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 Mylan:

• 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 or cholestyramine;
• medicines used to treat obesity (orlistat);
• laxatives;
• 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 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;
• preparations containing high amounts of calcium;
• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• preparations containing magnesium;
• warfarin, a medicine used to make the blood less prone to clotting.

Colecalciferol Mylan 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 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, 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 Colecalciferol Mylan than you should”).
Colecalciferol Mylan 50,000 IU oral solution in single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
Colecalciferol Mylan 50,000 IU oral solution in single-dose container is not recommended during breastfeeding. When necessary, your doctor may prescribe this medicine 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 effect of this product on fertility.

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

3. How to take Colecalciferol Mylan

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

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

Paediatric population
The use of Colecalciferol Mylan 50,000 IU oral solution in single-dose containers is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of Colecalciferol Mylan 50,000 IU oral solution in single-dose containers is not recommended during pregnancy.

If you take more Colecalciferol Mylan than you should
In case of accidental ingestion/overdose of Colecalciferol Mylan, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria) may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, dehydration, anorexia (loss of appetite), abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, a kidney disease called nephrocalcinosis, kidney stones, and in more severe cases, cardiac arrhythmia. Extreme hypercalcaemia may lead to coma and death.
Chronic excessive dosing may lead to deposition of calcium salts in blood vessels and organs, and irreversible kidney damage.
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 Colecalciferol Mylan
Do not take a double dose to make up for the missed dose.

If you stop taking Colecalciferol Mylan
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 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) 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 calcium deposition 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 Colecalciferol Mylan

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

6. Package contents and other information

What Colecalciferol Mylan contains

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

Description of the appearance of Colecalciferol Mylan and contents of the pack
Colecalciferol Mylan 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
MYLAN S.p.A. – Via Vittor Pisani 20, 20124 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