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Topferol® contains cholecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones. Topferol® is used: To prevent vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D. With other medicine to treat certain bone conditions, such as thinning of the bone (osteoporosis). To treat vitamin D deficiency that has been confirmed by laboratory tests. How to use The tablets should be swallowed whole with water. You should take Topferol® preferably together with a large meal to help your body absorb the vitamin D. Use in adults The recommended dose for: Treatment of vitamin D deficiency: 50,000 IU/week (1 tablet) for 6-8 weeks, followed by maintenance therapy (1,400- 2,000 IU/day, such as 1 tablet a month.) Use in children and adolescents This high strength formulation is not recommended. Warnings and precautions Do not take Topferol®: If you are allergic to vitamin D3 or any of the other ingredients of this medicine. If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria). If you have kidney stones (renal calculi). If you have serious renal impairment. If you have high levels of vitamin D3 in your blood (hypervitaminosis D). If you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism). If you are pregnant. If you are under 18 years of age. If any of the above applies to you, talk to your doctor or pharmacist before taking Topferol®. Warnings and precautions Talk to your doctor or pharmacist before taking Topferol®: If you are undergoing treatment with certain medicines used to treat heart disorders (e.g, cardiac glycosides, such as digoxin). If you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D3 in the body). If you are taking medicines containing vitamin D3, or eating foods or milk enriched with vitamin D3. If you are likely to be exposed to a lot of sunshine whilst using Topferol®. If you take additional supplements containing calcium. Your doctor will monitor your blood levels of calcium to make sure they are not too high whilst you are using Topferol®. If you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine. Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects may include: Uncommon (may affect up to 1 in 100 people): Too much calcium in your blood (hypercalcaemia). Too much calcium in your urine (hypercalciuria). Rare (may affect up to 1 in 1,000 people): Skin rash. Itching. Hives. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Storage Information Topferol® tablets: Store below 30°C. Drug Interactions Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important if you are taking: Medicines that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethazide). When used at the same time as vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine. Medicines containing vitamin D3 or eating food rich in vitamin D3, such as, some types of vitamin D3-enriched milk. Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal disease). These medicines may interfere with the way your body process vitamin D3. The following medicines because they can interfere with the effect or the absorption of vitamin D3: Antiepileptic medicines (anticonvulsants), barbiturates. Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D3. Medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol). Certain medicines for weight loss that reduce the amount of fat your body absorbs (e.g. orlistat). Certain laxatives (such as liquid paraffin). Ingredients The active substance is cholecalciferol (Vitamin D3).
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