देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol; Calcium gluconate; Nicotinic acid
Thornton & Ross Ltd
A11AA02
Colecalciferol; Calcium gluconate; Nicotinic acid
20microgram ; 200mg ; 20mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09120000; GTIN: 5011309863116 5011309863215
PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 558845 11402 Addition of reporting of side effects in line with MHRA requirements. MHRA approved. MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 12's/24's/48's 23646008 210mm x 148mm 4 13.02.2015 Process Black Keyline (Does not print) Crampex Tablets UK Custom Helvetica CRAMPEX TABLETS (cholecalciferol, calcium gluconate, nicotinic acid) IMPORTANT INFORMATION ABOUT CRAMPEX TABLETS • This medicine is for night time muscle cramp. • It can be taken by adults including the elderly. DO NOT TAKE…. • If you are pregnant. See section 2. • If you are under 18 years old. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • 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. 1. WHAT THE MEDICINE IS FOR Crampex Tablets contain calcium gluconate and cholecalciferol (vitamin D) 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 USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU HAVE…. • An ALLERGY to any of the ingredients listed in section 6. • An EXCESSIVE amount of CALCIUM IN YOUR BLOOD. • KIDNEY STONES, or have had kidney stones in the past. TALK TO YOUR DOCTOR IF YOU HAVE…. • Poor kidney function. 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 पूरा दस्तावेज़ पढ़ें
OBJECT 1 CRAMPEX TABLETS Summary of Product Characteristics Updated 03-Mar-2016 | Thornton & Ross Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Crampex Tablets. 2. Qualitative and quantitative composition Cholecalciferol Ph.Eur. 0.02 mg Calcium Gluconate Ph.Eur. 200 mg Nicotinic Acid Ph.Eur. 20 mg For full list of excipients see section 6.1 3. Pharmaceutical form Tablet. 4. Clinical particulars 4.1 Therapeutic indications For night muscle cramp. 4.2 Posology and method of administration Adults and the Elderly: One or two tablets with plenty of fluid, preferably before retiring. Attacks of cramp usually occur in bouts which last from a few days to several weeks. Often there are several weeks between each series of attacks. In such cases, it is advisable to take Crampex Tablets at night for a period and then discontinue when the anticipated duration of the attack has passed. Drink plenty of fluids whilst taking this product. The product should be used for a maximum of 4 weeks f पूरा दस्तावेज़ पढ़ें