Package leaflet: Information for the Patient ...

1 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 further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this is in this leaflet1. What Colecalciferol Capsules are and what they are used for2.

2 What you need to know before you take Colecalciferol Capsules3. How to take Colecalciferol Capsules4. Possible side effects5. How to store Colecalciferol Capsules6. Contents of the pack and other information1. What Colecalciferol Capsules are and what they are used forColecalciferol Capsules contain the active ingredient colecalciferol. Colecalciferol is a form of vitamin D used in the initial treatment of clinically relevant vitamin D deficiency conditions in 20 000 IU Capsules contain the equivalent of 500 micrograms vitamin D3 which is involved in bone formation. The active ingredient, colecalciferol, is identical to the vitamin D3 that is found in the human of vitamin D may occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant).

3 2. What you need to know before you take Colecalciferol CapsulesDo not take Colecalciferol if you are allergic (hypersensitive) to colecalciferol or any of the other ingredients in the capsules (these are listed in section 6, Contents of the pack and other Information ) if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) if you suffer from pseudohypoparathyroidism (disorder of the parathyroid hormone balance) if you suffer from severe renal impairment if you have kidney stones (renal calculi) if you have high levels of vitamin D in your blood (hypervitaminosis D) if you already take other medicines containing vitamin D ( multivitamin preparations)Warnings and precautionsTalk to your doctor or pharmacist before taking Colecalciferol.

4 If you suffer from heart disease or narrowing of the arteries if you suffer from sarcoidosis (a multisystem chronic inflammatory condition which can affect your lungs, heart and kidneys), then there is a risk of increased conversion of vitamin D into its active form If you are taking medicines containing vitamin D, or eating foods or drinking milk enriched with vitamin D if your renal function is impaired if you have a tendency to form calcium-containing renal calculi. if you need additional calcium supplementation. Calcium supplements should be given only under close medical doctor may want you to have regular blood tests to check the amount of calcium in your treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum and renal calcium levels must be monitored and renal function checked via serum creatinine determination.

5 Such monitoring is particularly important in elderly patients and during concomitant treatment with cardiac glycosides or diuretics (see section Other medicines and Colecalciferol ). This also applies to patients who are particularly susceptible to the formation of kidney stones that contain pregnancy Colecalciferol should be taken only when strictly indicated and dosed only as it is absolutely necessary to correct the vitamin D and adolescentsThis product should not be used in young children and adolescents aged up to 18. Other medicines and ColecalciferolTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

6 This includes any medicines which you have bought without a must tell your doctor or pharmacist if you are taking any of the following medicines: medicines for epilepsy such as barbiturates or other anti-convulsants ( carbamazepine, phenobarbital, phenytoin, primidone) other vitamin D containing medicines including multi-vitamins cardiac glycosides for the treatment of cardiovascular disease ( digoxin, digitoxin) thiazide diuretics (water tablets) such as hydrochlorothiazide calcium supplements medicines to treat tuberculosis rifampicin, isoniazid medicines leading to fat malabsorption orlistat, cholestyramine, liquid paraffin medicines to treat fungal infections ketoconazole, itraconazole actinomycin (a medicine used to treat some forms of cancer) as it may interfere with the metabolism of vitamin D glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone).

7 Colecalciferol Capsules with food and drinkColecalciferol should preferably be taken together with food and drink. Pregnancy, breast-feeding and fertilityPregnancyDuring pregnancy Colecalciferol should be taken only when strictly indicated and dosed only as it is absolutely necessary to correct the vitamin D deficiency. Overdoses of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia (increased blood level of calcium) may lead to physical and mental disability as well as to congenital heart and eye diseases in the child. Breast-feedingVitamin D and its metabolites are excreted in human milk.

8 There have been no observed cases of overdose produced in this way among infants. This should, however, be borne in mind when administering additional vitamin D to the child. Treatment with high-dose vitamin D in breast-feeding women is not recommended. FertilityNormal endogenous levels of vitamin D are not expected to have any adverse effects on and using machinesColecalciferol should not affect your ability to drive or operate How to take Colecalciferol Capsules Always take this medicine exactly as your doctor or pharmacist has told you and as written on the label. Check with your doctor or pharmacist if you are not sure.

9 Recommended Dose and Dosage SchedulesAdults Initial treatment of clinically relevant vitamin D deficiency: Package leaflet : Information for the PatientColecalciferol 20 000 IU Capsules 1 capsule twice per week (equivalent to 40,000 IU/week) for 7 weeks (corresponding to a loading dose of 280,000 IU).Maintenance therapy with lower doses of vitamin D equivalent to 800 to 1000 IU daily may be considered one month after the end of initial treatment with Colecalciferol 20,000 IU Capsules. For this purpose other preparations are available. The doctor in charge shall decide on the individual dosage and the duration of in children and adolescentsColecalciferol 20,000 IU Capsules should not be used in infants or young children (under 12 years) as they may not be able to swallow the capsules and might choke.

10 Instead, it is advisable to use drops or dissolvable tablets. Due to the lack of data on posology the administration in adolescents between the ages of 12 18 years is not you have problems absorbing vitamin D, or have other conditions such as liver or kidney disease the dose may be different and will depend on your medical capsules should be swallowed whole with a glass of water, preferably with the main meal of the day. It is important not to exceed the prescribed you take more Colecalciferol Capsules than you shouldIf you accidentally take more capsules than you have been prescribed, contact your doctor or get medical advice immediately.