Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen; Codeine phosphate
Omega Pharma Ltd
N02AJ08
Ibuprofen; Codeine phosphate
200mg ; 12.8mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 10010100; GTIN: 5000347020339
SOLPADEINE MIGRAINE IBUPROFEN & CODEINE This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked. You should only take this product for a MAXIMUM OF 3 DAYS at a time. If you need to take it for longer than 3 days you should SEE YOUR DOCTOR OR PHARMACIST for advice. This medicine CONTAINS CODEINE which can CAUSE ADDICTION if you take it continuously for MORE THAN 3 DAYS. This can give you WITHDRAWAL SYMPTOMS from the medicine when you stop taking it. If you take this medicine for headaches for MORE THAN 3 DAYS it can MAKE THEM WORSE. PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Solpadeine Migraine Tablets carefully to get the best results from them. Keep this leaflet you may need to read it again. If you have any questions, or if there is anything you do not understand, ask your pharmacist. IN THIS LEAFLET: 1. What Solpadeine Migraine Tablets do 2. Check before you take Solpadeine Migraine Tablets 3. How to take Solpadeine Migraine Tablets 4. Possible side effects 5. How to store Solpadeine Migraine Tablets 6. Further information 1. WHAT SOLPADEINE MIGRAINE TABLETS DO Solpadeine Migraine Tablets can be used in patients OVER 12 YEARS of age for the SHORT‐TERM RELIEF OF MODERATE PAIN THAT IS NOT RELIEVED BY OTHER PAINKILLERS such as paracetamol or ibuprofen alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, rheumatic pain and sciatica. The active ingredients are ibuprofen and codeine, which are both painkillers. By working on your body in different ways, ibuprofen and codeine combine to relieve pain and ease stiffness. Ibuprofen belongs to a family of medicines called non‐steroidal anti‐inflammatory drugs (NSAIDs) which relieve pain and reduce inflammation. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in c Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpadeine Migraine Ibuprofen & Codeine Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen Ph Eur 200 mg Codeine Phosphate Hemihydrate Ph Eur 12.8 mg Excipients with known effect Each Tablet contains: 200mg of Cellactose 80 (which is a one-body compound consisting of lactose monohydrate (73-77%) and cellulose (23-27%). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, film-coated capsule-shaped tablets with a white core. Embossed with Solpaflex, C+ or Migraine OR plain on both the sides. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. For such conditions as soft tissue injuries, including sprains, strains and musculo- tendonitis, backache, non-serious arthritic and rheumatic conditions, neuralgia, migraine, headache, dental pain and dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). 1-2 tablets, up to three times a day as required, preferably with or after food. Leave at least four hours between doses and do not take more than 6 tablets in any 24 hour period. Paediatric population: Children and adolescents aged 12 – 18 years: 1 – 2 tablets, up to three times a day as required, preferably with or after food. Leave at least four hours between doses and do not take more than 6 tablets in any 24 hour period. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). Elderly: Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with particular caution in elderly patients who are prone to adverse e Baca dokumen lengkap