देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Caffeine; Paracetamol
Chefaro Ireland DAC
N02BE; N02BE51
Caffeine; Paracetamol
500/65 milligram(s)
Soluble tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2017-01-27
PACKAGE LEAFLET: INFORMATION FOR THE USER SOLPA-EXTRA 500MG/65MG SOLUBLE TABLETS PARACETAMOL/CAFFEINE READ ALL OF THIS LEAFLET CAREFULLY 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 you 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 Solpa-Extra Soluble Tablets is and what it is used for 2. What you need to know before you take Solpa-Extra Soluble Tablets 3. How to take Solpa-Extra Soluble Tablets 4. Possible side effects 5. How to store Solpa-Extra Soluble Tablets 6. Contents of the pack and other information 1. WHAT SOLPA-EXTRA SOLUBLE TABLETS IS AND WHAT IT IS USED FOR SOLPA-EXTRA SOLUBLE TABLETS contain two active ingredients. Paracetamol is a painkiller and also reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol. The dual action of the ingredients provides fast and effective pain relief from headache and migraine with or without warning signs (aura). They can also relieve backache, muscle and joint pain, toothache, period pain, neuralgia, sore throat and the fever, aches and pains of colds and flu. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPA-EXTRA SOLUBLE TABLETS DO NOT TAKE SOLPA-EXTRA SOLUBLE TABLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, caffeine or to any of the other ingredients (listed in Section 6) • if you are TAKING OTHER MEDICINES CONTAINING PARACETAMOL. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Solpa-Extra Soluble Tablets; • If you have LIVER or KIDNEY DISEASE , including ALCOHOLIC LIVER DISEASE पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 22 July 2022 CRN00C5FN Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpa-Extra 500 mg/65 mg Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500 mg and Caffeine 65 mg. Excipients with known effect: - 24 mmol (427 mg) sodium per tablet - 50 mg sorbitol per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablet. White bevel-edged scored tablets, 25 mm in diameter. The score line is not intended for breaking the tablet into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solpa-Extra 500 mg/65 mg Soluble Tablets are used for the treatment of mild to moderate pain, for example: headache including migraine (with and without aura), backache, toothache, muscle ache, neuralgia, joint pain, dysmenorrhea, sore throat, and for the relief of fever, aches and pains of colds and influenza. This product is indicated to be used in adults and adolescents 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Oral administration only. Adults (including the elderly) and adolescents16 years and over: Dissolve one to two tablets in at least half a tumbler of water every 4-6 hours. Do not exceed 4 doses, equivalent to 8 tablets (4000/520mg/24h). Elderly: It is recommended that frail or immobile patients should reduce the dose or frequency of dosing. Do not exceed 8 (4000/520mg) tablets in 24 hours. Adolescents 12-15 years of age: Dissolve one tablet in at least half a tumbler of water every 4-6 hours. Do not exceed 4 doses, equivalent to 4 tablets (2000/260mg/24h). The tablet will take up to 2 minutes to dissolve. Children aged less than 12 years: Not suitable for children under 12 years of age. _Renal impairment:_ Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum inte पूरा दस्तावेज़ पढ़ें