Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate
Chefaro Ireland DAC
N02AJ; N02AJ06
Paracetamol; Codeine phosphate hemihydrate
500 mg/12.8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Not marketed
2017-03-20
PACKAGE LEAFLET: INFORMATION FOR THE USER SOLPA-PLUS TABLETS paracetamol/codeine phosphate hemihydrate - 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. READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take 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. WHAT IS IN THIS LEAFLET 1. What Solpa-Plus Tablets is and what it is used for 2. What you need to know before you take Solpa-Plus Tablets 3. How to take Solpa-Plus Tablets 4. Possible side effects 5. How to store Solpa-Plus Tablets 6. Contents of the pack and other information 1. WHAT SOLPA-PLUS TABLETS IS AND WHAT IT IS USED FOR Solpa-Plus Tablets can be used in patients over 12 years of age for the short-term relief of moderate pain which requires stronger relief than other painkillers such as paracetamol, ibuprofen or aspirin alone. It can be used for headaches, migraine with or without warning signs (aura), dental pain (including pain after extraction), period pain, backache, muscle ache, neuralgia, pain in bones and joints arising from arthritis and rheumatism, strains and sprains, sciatica. The tablets co Přečtěte si celý dokument
Health℃Products℃Regulatory℃Authority 24℃May℃2023 CRN00D6QP Page℃1℃of℃9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpa-Plus℃Tablets℃Paracetamol℃500℃mg℃Codeine℃Phosphate℃Hemihydrate℃12.8℃mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each℃tablet℃contains℃500℃mg℃paracetamol℃and℃12.8℃mg℃codeine℃phosphate℃hemihydrate. Excipients℃with℃known℃effect:℃5.9℃mg℃lactose℃monohydrate℃per℃tablet.℃ For℃full℃list℃of℃excipients,℃see℃section℃6.1. 3 PHARMACEUTICAL FORM Film-coated℃tablet℃(tablets). Red℃film℃coated℃capsule℃shaped℃tablets,℃15.8℃mm℃x℃8.4℃mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solpa-Plus℃Tablets℃are℃recommended℃for℃the℃relief℃of℃acute℃moderate℃pain℃which℃requires℃stronger℃analgesia℃than℃paracetamol℃ or℃ibuprofen℃or℃aspirin℃alone.℃For℃the℃treatment℃of:℃dental℃pain℃(including℃pain℃after℃extraction),℃headache,℃migraine℃(with℃and℃ without℃aura),℃dysmenorrhea,℃backache,℃pain℃in℃bones℃and℃joints℃arising℃from℃arthritis℃and℃rheumatism,℃neuralgia,℃strains℃and℃ sprains,℃sciatica. The℃product℃is℃indicated for℃use℃in℃patients℃aged℃12℃years℃and℃older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Oral℃administration℃only. Adults: Two℃tablets℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at℃more℃than℃4℃–℃6℃hours'℃intervals. Adolescents 16 to 18 years of age: Two℃tablets℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at℃more℃than℃6℃hours'℃intervals. Not℃more℃than℃4℃doses℃(equivalent℃to℃Paracetamol℃4g℃and℃Codeine℃phosphate℃hemihydrate℃102.4℃mg)℃should℃be℃given℃in℃any℃ 24-hour℃period. Adolescents 12 to 15 years of age: One℃tablet℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at Přečtěte si celý dokument