Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
CAFFEINE, PARACETAMOL, CODEINE PHOSPHATE, HEMIHYDRATE
Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland
N02AJ06
CAFFEINE 30 mg PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 8 mg
HARD CAPSULE
CAFFEINE 30 mg PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 8 mg
OTC
ANALGESICS
Authorised
2006-09-22
Perrigo component code: Artwork reference nr: FOR APPROVAL • Approval needs to be given within AMS. Please verify this proof carefully concerning lay-out, size, texts and bar code. For the PMS colours please refer to the latest PMS coulour guide. After your approval on the above we can proceed to the next stage of your project. Graphic Design Solpadeine Capsules LF02111H 11027734 Ireland 148 x 420 mm Capsules - leaflet English CR07495 Aenova Vochezer N/A - 0 08/07/22 - - - - - - - - - - - - - - LF02111H - 03 - Cutter Black - - - - - - N/A 1x N/A 17405 N/A - - - - 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 capsules 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 capsules can be used in patie Baca dokumen lengkapnya
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Solpadeine capsules Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Gelatin capsules with a red, opaque cap and a white, opaque body plain on both 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 other analgesics such as 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 capsules up to four times daily as required to a 8 capsules 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 capsules every 6 hours. Do not exceed 4 doses, equivalent to 8 capsules. _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). _Adolescents aged 12 to 15 years of age _ 1 capsule every 6 hours. Do not exceed 4 doses, equivalent to 4 capsules. _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 Page 2 of 14 opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). _Elderly patients _ Experience Baca dokumen lengkapnya