Страна: Малта
Език: английски
Източник: Medicines Authority
CODEINE PHOSPHATE, HEMIHYDRATE, CAFFEINE, PARACETAMOL
Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland
N02AJ06
CODEINE PHOSPHATE HEMIHYDRATE 8 mg CAFFEINE 30 mg PARACETAMOL 500 mg
EFFERVESCENT TABLET
CODEINE PHOSPHATE HEMIHYDRATE 8 mg CAFFEINE 30 mg PARACETAMOL 500 mg
OTC
ANALGESICS
Authorised
2006-04-18
PACKAGE LEAFLET: INFORMATION FOR THE USER SOLPADEINE SOLUBLE TABLETS Paracetamol 500mg, codeine phosphate hemihydrate 8mg and caffeine 30mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR Solpadeine soluble tablets contains the active substances paracetamol 500 mg and codeine phosphate hemihydrate 8 mg , which are both pain-relieving drugs, and caffeine 30 mg, a stimulant which acts to enhance the pain-relieving effects of paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Paracetamol also helps to reduce temperature when you have a fever. Codeine has some cough suppressant action. Solpadeine soluble tablets can be used in patients over 12 years of age for the short-term relief of acute, moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. This medicine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough and/or cold. Solpadeine soluble tablets provide effective relief from pain, including: • Headache, including mi Прочетете целия документ
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Solpadeine soluble tablets Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg. Excipient(s) with known effect: Sorbitol (E420) 50 mg per tablet Sodium 427 mg per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Effervescent tablet. Flat, white tablets, with bevelled edges, plain on one side, breakline on the other. The tablet can be divided into two equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Codeine-containing products are indicated in patients older than 12 years of age for the short-term treatment of acute, moderate pain which is not relieved by paracetamol or ibuprofen alone. Solpadeine is indicated in the management of symptoms of headache, including migraine, toothache, backache, common cold, influenza, menstrual pain, musculoskeletal pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ 1-2 tablets up to four times daily as required to a 8 tablets in 24 hours. The dose should not be repeated more frequently than every 4 hours. _Adolescents aged 16 to 18 years of age _ 1-2 tablets every 6 hours. Do not exceed 4 doses, equivalent to 8 tablets. _Adolescents aged 12 years to 18 years: _ This medicine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough and/or cold (see section 4.4). _ _ Page 2 of 13 _Adolescents aged 12 to 15 years of age _ 1 tablet every 6 hours. Do not exceed 4 doses, equivalent to 4 tablets. _Paediatric population _ _ _ _Children aged less than 12 years: _ This medicine is contraindicated in children below the age of 12 years for the symptomatic treatment of cough and/or cold (see section 4.3). Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to t Прочетете целия документ