Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Acetylsalicylic acid; Paracetamol; Caffeine
Haleon Ireland Limited
N02BE; N02BE51
Acetylsalicylic acid; Paracetamol; Caffeine
250/250/65 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2010-06-04
PACKAGE LEAFLET: INFORMATION FOR THE USER EXCEDRIN film coated tablets Aspirin 250 mg, Paracetamol 250 mg and Caffeine 65 mg 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 has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must talk to a doctor if you do not feel better or your symptoms worsen or do not improve after 3 days for migraine and 4 days for headache. • 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. What is in this leaflet: 1. What EXCEDRIN is and what it is used for 2. What you need to know before you take EXCEDRIN 3. How to take EXCEDRIN 4. Possible side effects 5. How to store EXCEDRIN 6. Contents of the pack and other information 1. What EXCEDRIN is and what it is used for Each tablet of EXCEDRIN contains three active substances: acetylsalicylic acid (aspirin), paracetamol and caffeine. • Acetylsalicylic acid (aspirin) and paracetamol reduce pain and fever, and acetylsalicylic acid (aspirin) also reduces inflammation. • Caffeine is a mild stimulant and increases the effect of acetylsalicylic acid (aspirin) and paracetamol. EXCEDRIN is used for the acute treatment of headache and migraine attacks (symptoms such as headache, nausea, sensitivity to light and sound and functional disability) with or without aura. 2. What you need to know before you take EXCEDRIN Do not take EXCEDRIN if you: • are allergic (hypersensitive) to acetylsalicylic acid (aspirin), paracetamol, caffeine or any of the other ingredients of EXCEDRIN listed in section 6. • have ever had an allergic reaction to other medicines used to treat pain, inflammation or fever, such as acetylsalicylic acid and salicylates, or any other anti-inflammatory medicines known as NSAIDs Belgenin tamamını okuyun
Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Excedrin 250 mg/ 250 mg/ 65 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 250 mg acetylsalicylic acid (aspirin), 250 mg paracetamol and 65 mg caffeine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, oblong-shaped, film-coated tablet with the letter “E” debossed on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Excedrin is indicated in adults for the acute treatment of headache and of migraine attacks with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults (18 years and older) FORHEADACHE: The usual recommended dosage is 1 tablet; an additional tablet can be taken, with 4 to 6 hours between doses. In case of more intense pain, it is possible to take 2 tablets. If needed, additional 2 tablets can be taken, with 4 to 6 hours between doses. Excedrin is intended for episodic use, up to 4 days for headache. FORMIGRAINE: Take 2 tablets when symptoms appear. If needed additional 2 tablets can be taken, with 4 to 6 hours between doses. Excedrin is intended for episodic use, up to 3 days for migraine. For both headache and migraine, intake must be limited to 6 tablets in 24 hours. The medicinal product must not be used for a longer period or at a higher dosage without first consulting a doctor. (see section 4.4). Drink a full glass of water with each dose. Children and adolescents (under 18 years ofage) Safety and efficacy of Excedrin in children and adolescents have not been evaluated. Use of Excedrin in children and adolescents is therefore not recommended (see section 4.4). Elderly Based on general medical considerations, caution should be exercised in the elderly, particularly in elderly patients with low body weight. Hepatic and renalimpairment The effect of hepatic or renal disease on the pharmacokinetics of Excedrin has not been evaluat Belgenin tamamını okuyun