Country: Malta
Language: English
Source: Medicines Authority
CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN
Omega Pharma Limited 1st Floor, 32 Vauxhall Bridge Road, London SW1V 2SA, United Kingdom
M01AE51
CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg
FILM-COATED TABLET
CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2006-10-26
FRONT BACK LEADING EDGE LEADING EDGE TRAILING EDGE TRAILING EDGE OTC.LT.012 becoming pregnant; however tell your doctor before taking this medicine if you have problems becoming pregnant. DO NOT TAKE Solpadeine Migraine if you are PREGNANT. DO NOT TAKE Solpadeine Migraine while you are BREASTFEEDING. Codeine and morphine passes into breast milk. DRIVING AND USING MACHINES This medicine can affect your ability to drive as it may make you SLEEPY or DIZZY. DO NOT DRIVE while taking this medicine UNTIL YOU KNOW HOW IT AFFECTS YOU. It is an OFFENCE to drive if this medicine affects your ability to drive. However, you would NOT be committing an offence if: • The medicine has been taken to treat a MEDICAL or DENTAL problem and • You have taken it ACCORDING TO THE INFORMATION PROVIDED with the medicine and • It was not affecting your ability to drive safely. TALK TO YOUR DOCTOR or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Details regarding a NEW DRIVING OFFENCE concerning driving after drugs have been taken IN THE UK may be found here: www.gov.uk/drug-driving-law 3. How to take Solpadeine Migraine This product is intended for short term use only. You should take the lowest effective dose for the shortest time necessary to relieve your symptoms. Adults and children aged 12 years and over: SWALLOW 1 OR 2 TABLETS WITH WATER, EVERY 4 TO 6 HOURS AS NEEDED. • Leave AT LEAST 4 HOURS BETWEEN DOSES. • Do not take more than 6 TABLETS IN 24 HOURS. • Do not take MORE THAN THE RECOMMENDED DOSE. • This medicine should not be taken for more than 3 DAYS. If the pain does not improve after 3 days, TALK TO YOUR DOCTOR for advice. • Solpadeine Migraine should not be taken by children BELOW THE AGE OF 12 years, due to the risk of severe breathing problems. POSSIBLE WITHDRAWAL EFFECTS This medicine contains codeine and can cause addiction if you take it continuously for MORE THAN 3 DAYS. When you stop taking it you may get WITHDRAWAL SYMPTOMS. You should TALK TO YOUR DOCTOR Read the complete document
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Solpaflex tablets Cuprofen PLUS Solpadeine Migraine Ibuprofen & Codeine Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen PhEur 200 mg Codeine Phosphate Hemihydrate PhEur 12.8 mg 3. PHARMACEUTICAL FORM White film-coated capsule-shaped tablets. 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. 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. Page 2 of 14 Leave at least four hours between doses and do not take more than 6 tablets in any 24 hour period. Children aged less than12 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 events. Route of Administration: For oral administration and short-term use only. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers sh Read the complete document