Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcitriol
Atnahs Pharma UK Ltd
A11CC04
Calcitriol
250nanogram
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5000471005912
Rocaltrol-PIL-UK-1405-0.25,0.50-cap PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UK ROCALTROL ® 0.25 MICROGRAM CAPSULES ROCHE ROCALTROL ® 0.5 MICROGRAM CAPSULES Calcitriol 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rocaltrol is and what it is used for 2. What you need to know before you take Rocaltrol 3. How to take Rocaltrol 4. Possible side effects 5. How to store Rocaltrol 6. Contents of the pack and other information 1. WHAT ROCALTROL IS AND WHAT IT IS USED FOR Rocaltrol contains a medicine called calcitriol. This belongs to a group of medicines called ‘vitamin D metabolites’. Rocaltrol is used to treat the following: Bone disease in people with kidney problems (renal osteodystrophy). Weakening of the bones in women after the menopause (change of life). This is also known as post- menopausal osteoporosis. Rocaltrol works by making your body absorb more calcium from your diet. This helps to form healthy bones and reduce bone damage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROCALTROL DO NOT TAKE ROCALTROL: IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: Calcitriol or any of the other ingredients of this medicine (listed in section 6). Other ‘vitamin D metabolite’ medicines (used to treat bone disease). These include alfacalcidol and colecalciferol. Do not take Rocaltrol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rocaltrol. DO NOT TAKE ROCALTROL IF: You have high levels of calcium in your blood (hyper Przeczytaj cały dokument
OBJECT 1 ROCALTROL 0.25MCG CAPSULES Summary of Product Characteristics Updated 07-Jul-2014 | Roche Products Limited 1. Name of the medicinal product Rocaltrol 0.25 microgram Capsules. Rocaltrol 0.5 microgram Capsules. 2. Qualitative and quantitative composition Each capsule contains either 0.25 or 0.5 microgram of calcitriol. For excipients, see 6.1. 3. Pharmaceutical form Soft capsules. 0.25 microgram: One length brown-orange to red-orange opaque and the other white to grey-yellow or grey-orange opaque. 0.5 microgram: Both lengths brown-orange to red-orange opaque. 4. Clinical particulars 4.1 Therapeutic indications Rocaltrol is indicated for the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy. Rocaltrol is also indicated for the treatment of established post-menopausal osteoporosis. 4.2 Posology and method of administration The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia. The effectiveness of treatment depends in part on an adequate daily intake of calcium, which should be augmented by dietary changes or supplements if necessary. The capsules should be swallowed with a little water. _ADULTS_ _RENAL OSTEODYSTROPHY_ The initial daily dose is 0.25 mcg of Rocaltrol. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient. If no satisfactory response in the biochemical parameters and clinical manifestations of the disease is observed within 2 - 4 weeks, the daily dosage may be increased by 0.25 mcg at 2 - 4 week intervals. During this period, serum calcium levels should be determined at least twice weekly. Should the serum calcium levels rise to 1 mg/100ml (250 µmol/l) above normal (9 to 11 mg/100 ml or 2250 2750 µmol/l), or serum creatinine rises to > 120 µmol/l, treatment with Rocaltrol should be stopped immediately until normocalcaemia ensues. Most patients respond to between 0.5 mcg and 1.0 mcg daily. See s Przeczytaj cały dokument