Colecalciferol Mylan Italia

Package leaflet: Information for the patient

Colecalciferolo Mylan Italia 10,000 IU, soft capsules, 25,000 IU, soft capsules

colecalciferol (vitamin D3)
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 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:

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

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

Colecalciferolo Mylan Italia contains the active substance colecalciferol, better known as Vitamin D3.
Colecalciferol regulates the absorption and metabolism of calcium, as well as the incorporation of calcium
into bone tissue. Colecalciferolo Mylan Italia is indicated for:
Prevention and treatment of vitamin D deficiency in adults.
For the prevention of vitamin D deficiency, Colecalciferolo Mylan Italia 25,000 IU is
used in adults only when therapeutic adherence cannot be achieved with daily administration of low-dose colecalciferol.

2. What you should know before taking Colecalciferolo Mylan Italia

Do not take Colecalciferolo Mylan Italia

• if you are allergic to colecalciferol (vitamin D3) or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)
• if you have high levels of vitamin D in the body (hypervitaminosis D)
• if you have kidney disease (severe renal impairment) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo Mylan Italia, especially:
if you need to take Colecalciferolo Mylan Italia for a long period and at high doses.
if you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or diuretics). In this case, your blood and urine calcium levels should be checked.
if you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
if you suffer from a chronic inflammatory disease that can affect any organ, called sarcoidosis.
if you have impaired kidney function, as vitamin D levels in the body may be altered.
if you are prone to developing calcium-containing kidney stones.
if you have severe renal failure: in this case, other forms of vitamin D should be used.
if you take this medicine for long-term treatment, especially if you are elderly. In this case, your doctor will monitor your urinary calcium levels and kidney function. If necessary, your doctor may reduce the dose.
if you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).
Inform your doctor if you have any of the following conditions, as you may require an increased dosage as indicated in section 3 “How to take Colecalciferolo Mylan Italia”:
if you are obese.
if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis).
if you suffer from liver disease (hepatic insufficiency).
Children
Colecalciferolo Mylan Italia must not be given to neonates or children under 18 years of age.
Other medicines and Colecalciferolo Mylan Italia
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 or increase the effect of Colecalciferolo Mylan Italia:
other medicines containing vitamin D.
Medicines used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, pyrimidone, etc.
Medicines to lower blood lipids such as colestipol, cholestyramine, orlistat, and laxatives (e.g. liquid paraffin).
Medicines containing aluminium or magnesium (such as antacids), used to treat excess stomach acid that may reflux into the oesophagus.
Thiazide diuretics, medicines used to treat high blood pressure, which increase urine production.
Digitalis, a medicine used to treat certain heart disorders.
Medicines used to treat tuberculosis, such as rifampicin or isoniazid.
Imidazole antifungal agents (e.g. ketoconazole), medicines used to inhibit the growth of fungal organisms.
Actinomycin, a medicine used to treat cancer.
Glucocorticoids, medicines used to treat inflammation.
Warfarin, a medicine used to thin the blood.
Heart medicines (cardiac glycosides), as you will need to be monitored by a doctor, possibly undergo an ECG, and have your calcium levels checked.
Colecalciferolo Mylan Italia with food, drinks and alcohol
Inform your doctor if you are taking other medicines containing vitamin D, vitamin D-fortified foods, or if you consume vitamin D-enriched milk, so that your total vitamin D intake can be taken into account and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Colecalciferolo Mylan Italia must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with vitamin D at lower doses.
Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly necessary, due to the risk of harmful effects on the foetus (see section 3: “If you take more Colecalciferolo Mylan Italia”).
However, since vitamin D deficiency is harmful to both the foetus and the mother, if necessary, your doctor may prescribe low-dose vitamin D during pregnancy.
Breastfeeding
If necessary, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not replace the need for vitamin D supplementation in the newborn.
Driving and using machines
Colecalciferolo Mylan Italia has no effect on the ability to drive vehicles or operate machinery.

3. How to take Colecalciferolo Mylan Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and duration of treatment must be determined by your doctor according to your
health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take Colecalciferolo Mylan Italia with meals.

Colecalciferolo Mylan Italia 10,000 IU soft capsules
Adults and elderly
Prevention:
The recommended dose is 1 capsule every 2 weeks (equivalent to 20,000 IU of vitamin D3 per month).
If you are at high risk of vitamin D deficiency, your doctor will assess whether the dose should be
increased up to 1 capsule once a week (equivalent to 10,000 IU of vitamin D3).
Treatment:
The recommended dose is 2 capsules once a week (equivalent to 20,000 IU of vitamin D3 per week)
for 1–3 months. Your doctor will determine the most appropriate dose for you and may subsequently
prescribe lower doses.
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend
on vitamin D levels and response to treatment. Your doctor will determine the most suitable dose based
on your response to therapy. Higher doses must be adjusted according to the desired serum levels of
25-hydroxycolecalciferol (25(OH)D), severity of the disease, and response to treatment.
Long-term treatment:
If long-term treatment is required, especially in elderly patients, your doctor will monitor urinary calcium
excretion and renal function. If necessary, your doctor may reduce the dose.

Colecalciferolo Mylan Italia 25,000 IU soft capsules
Adults and elderly
Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
If you are at high risk of vitamin D deficiency, your doctor will assess whether the dose should be
increased up to 2 capsules (equivalent to 50,000 IU of vitamin D3) once a month.
Your doctor will determine the most appropriate dose for you and may subsequently prescribe lower doses.
Treatment:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3 per week) once a week
for 4–12 weeks. Your doctor will determine the most appropriate dose for you and may subsequently
prescribe lower doses.
During long-term treatment with high doses, urinary calcium excretion and renal function should be
monitored, especially in elderly patients. Dose reduction or discontinuation of treatment is recommended
if urinary calcium excretion exceeds 7.5 mmol/24 hours (300 mg/24 hours).
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend
on vitamin D levels and response to treatment. Your doctor will determine the most suitable dose based
on your response to therapy.
Higher doses must be adjusted according to the desired serum levels of 25-hydroxycolecalciferol
(25(OH)D), severity of the disease, and response to treatment.

If you take more Colecalciferolo Mylan Italia than you should
In case of accidental ingestion/overdose of Colecalciferolo Mylan Italia, inform your doctor immediately
or go to the nearest hospital. Overdose may lead to increased levels of calcium in the blood and urine,
with symptoms including: headache, loss of appetite, diarrhoea, constipation, abdominal pain, muscle
weakness, nausea, vomiting, thirst or excessive thirst (polydipsia), increased urine production (polyuria),
muscle and joint pain, bone pain, calcium deposits in the kidney (nephrocalcinosis), kidney stones,
irregular heartbeat (in severe cases), dehydration, fatigue, mental disturbances, and renal failure.
In the most severe cases, coma and death may occur.
Chronic, excessive overdoses may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause severe harm to the fetus
and newborn.

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

If you stop taking Colecalciferolo Mylan Italia
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects reported with vitamin D use are as follows:

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, gas from the intestine (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium deposits in the kidneys (nephrocalcinosis), increased urine production (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, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://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 Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 25 °C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What Colecalciferolo Mylan Italia contains
Colecalciferolo Mylan Italia 10 000 IU soft capsules

• The active substance is colecalciferol (vitamin D3). Each soft capsule contains: 0.250 mg colecalciferol equivalent to 10 000 IU vitamin D3.
• The other components are:
• Capsule contents: refined olive oil, butyl hydroxytoluene (E321).
• Capsule shell: glycerol (E422), titanium dioxide (E171), succinated gelatin and Allura red (E129).

Colecalciferolo Mylan Italia 25 000 IU soft capsules

• The active substance is colecalciferol (vitamin D3). Each soft capsule contains: 0.625 mg colecalciferol equivalent to 25 000 IU vitamin D3.
• The other components are:
• Capsule contents: refined olive oil, butyl hydroxytoluene (E321).
• Capsule shell: glycerol (E422), titanium dioxide (E171), succinated gelatin and Allura red (E129).

Description of the appearance of Colecalciferolo Mylan Italia and package contents
Colecalciferolo Mylan Italia 10 000 IU soft capsules
The pack contains 2, 4, 8, 10 capsules in a thermoformed blister made of PVC/PVDC and aluminium.
Colecalciferolo Mylan Italia 25 000 IU soft capsules
The pack contains 1, 2, 4, 8 capsules in a thermoformed blister made of PVC/PVDC and aluminium, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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