Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
Lexon (UK) Ltd
M01AB05
Diclofenac sodium
100mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
5. HOW TO STORE VOLTAROL SUPPOSITORIES EXPIRY DATE Do not use this medicine after the expiry date shown on the carton or Suppository label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do. STORAGE • KEEP OUT OF THE SIGHT AND REACH OF CHILDREN • Do not store above 30°C • Protect from heat IMPORTANT Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you. 6. FURTHER INFORMATION WHAT VOLTAROL SUPPOSITORIES CONTAINS Each suppository contains 100mg of diclofenac sodium as the active ingredient. Voltarol Suppositories also has the following inactive ingredient: suppository mass 5. WHAT VOLTAROL SUPPOSITORIES LOOKS LIKE AND CONTENTS OF THE PACK Voltarol Suppositories are a white to yellowish, torpedo-shaped, with smooth surface and slightly fatty odour and are sealed in a composite foil. Voltarol Suppositories comes in foil packs of 10 Suppositories. MANUFACTURER AND LICENCE HOLDER This medicine is manufactured by Novartis Pharma S.A.S., 8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil Malmaison, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you. PL 15184/1089 Voltarol is a registered trademark of সম্পূর্ণ নথি পড়ুন
1. NAME OF THE MEDICINAL PRODUCT Voltarol ® Suppositories 100mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium). Each suppository contains 100mg diclofenac sodium Ph.Eur. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS _ _ _Adults and Elderly_: Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery._ _ _ _ _Children_: Not indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Not to be taken by mouth, as per rectal administration only. The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools. ADULTS: 75-150mg daily, in divided doses. 100mg suppositories may also be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with 25mg or 50mg tablets or suppositories up to the maximum dose of 150mg per day. SPECIAL POPULATIONS ELDERLY Although the pharmacokinetics of Voltarol are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also se সম্পূর্ণ নথি পড়ুন