Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
COLECALCIFEROL ; CALCIUM CARBONATE ; NICOTINIC ACID
Thornton & Ross Limited
A12AX
COLECALCIFEROL ; CALCIUM CARBONATE ; NICOTINIC ACID
%v/v
Tablets
Product not subject to medical prescription
Calcium, combinations with vitamin D and/or other drugs
Marketed
1993-04-23
PACKAGE LEAFLET: INFORMATION FOR THE USER CRAMPEX TABLETS nicotinic acid 20mg calcium gluconate 200mg cholecalciferol 0.02mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Crampex Tablets carefully to get the best results from it. •● Keep this leaflet. You may need to read it again. •● Ask your pharmacist if you need any more information or advice. •● You must contact your doctor if your symptoms worsen or do not improve. •● If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Crampex Tablets are and what they are used for 2. Before you take Crampex Tablets 3. How to take Crampex Tablets 4. Possible side effects 5. How to store Crampex Tablets 6. Further information 1. WHAT CRAMPEX TABLETS ARE AND WHAT THEY ARE USED FOR Crampex Tablets contain calcium gluconate and cholecalciferol to increase calcium levels in the blood as low levels of calcium can contribute to muscle cramps. They also contain nicotinic acid to improve circulation. The tablets are for night time muscle cramp. 2. BEFORE YOU TAKE CRAMPEX TABLETS DO NOT TAKE THE MEDICINE IF YOU HAVE…. •● An ALLERGY to any of the ingredients listed in section 6. •● An EXCESSIVE amount of CALCIUM IN YOUR BLOOD. TAKE SPECIAL CARE WITH CRAMPEX TABLETS IF YOU HAVE…. •● Poor kidney function or have a tendency to form kidney stones. Treatment with Crampex should be kept as short as possible if this applies. •● High blood pressure. •● Liver problems. •● An ulcer in your digestive system (including your stomach). •● Diabetes. •● Gout. Talk to your doctor or pharmacist before taking Crampex Tablets. TAKING OTHER MEDICINES…. Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. •● If you are taking Dig Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crampex Tablets Cholecalciferol 0.02 mg Calcium Gluconate 200 mg Nicotinic Acid 20 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Flat, circular bevel-edged white tablets with the word ‘Crampex’ engraved on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For treatment of night muscle cramp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. Adults only (including elderly): 1 or 2 tablets before retiring. Children: Not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not use in patients with hypercalcaemia. Each tablet contains: Colecalciferol 20 micrograms Calcium Gluconate 200 mg Nicotinic Acid 20 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _4_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _0_ _4_ _3_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Duration of treatment should be minimised in patients with impaired renal function or a tendency to form kidney stones. Use with caution in patients with hypertension, a history of peptic ulcer disease, diabetes mellitus, gout or impaired liver function. Not recommended for use in children. Prolonged use is not recommended. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Use with caution in patients taking digitalis. 4.6 FERTILITY, PREGNANCY Lue koko asiakirja