国家: 以色列
语言: 英文
来源: Ministry of Health
ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL
GSK CONSUMER HEALTHCARE, ISRAEL LTD
N02BE51
CAPLETS
PARACETAMOL 250 MG; ACETYLSALICYLIC ACID 250 MG; CAFFEINE 65 MG
PER OS
Not required
GSK CONSUMER HEALTHCARE SARL, SWITZERLAND
PARACETAMOL, COMBINATIONS EXCL. PSYCHOLEPTICS
For temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual descomfort and pain accompanied by fever.
2019-11-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription Excedrin caplets, 250 mg/250 mg/65 mg Active ingredients and their amounts: Each caplet contains: Acetylsalicylic acid 250 mg Paracetamol 250 mg Caffeine 65 mg For a list of inactive ingredients and allergens - see section 6. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Take the preparation according to the instructions in section 3 - How should you use the medicine. Consult the pharmacist if you need more information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 5 days of pain treatment or after 3 days of treatment of pain accompanied by fever (see section 3 - How should you use the medicine). 1. What is the medicine intended for? The medicine is intended for temporary relief of headaches, mild to moderate pain related to migraines, pain of menstrual discomfort and pain accompanied by fever. Therapeutic class: Acetylsalicylic acid - non-steroidal anti-inflammatory drug (NSAIDs) Paracetamol - analgesic and antipyretic Caffeine - xanthine alkaloid, central nervous system stimulant 2. Before using the medicine Do not use this medicine if: You are sensitive (allergic) to the active ingredients or to any of the additional components the medicine contains (see section 6). Symptoms of an allergic reaction may include: Asthma, wheezing or shortness of breath, skin rash or hives, swelling of the face or tongue, runny nose. If you are unsure, ask your doctor or pharmacist. You had an allergic reaction in the past to other medicines used to treat pain, inflammation or fever , such as diclofenac or ibuprofen. You have a stomach or intestinal ulcer , or if you have a history of peptic ulceration . You have observed blood in the stool or black stool (symptoms of bleeding or pe 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Excedrin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One caplets contains 250 mg acetylsalicylic acid, 250 mg paracetamol and 65 mg caffeine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Caplets. White, oblong-shaped, caplet with the letter “E” debossed on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual discomfort and pain accompanied by fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY FOR HEADACHE, PAIN OF MENSTRUAL DISCOMFORT AND PAIN ACCOMPANIED BY FEVER: Adults and Adolescents above 12 years: The usual recommended dosage is 2 caplets every 6 hours. Pain relief may be felt within 15 minutes of administration the dose. FOR MIGRAINE HEADACHE: Adults- 2 caplets. If Excedrin is taken for migraine headache, and there is no improvement or there is an exacerbation after the first dose, reconsider the treatment. Do not use Excedrin for Migraine headache more than 24 hours Intake should be limited for 8 caplets in 24 hours. Intake period should be limited for up to 5 days for pain relief and up to 3 days for pain accompanied by fever. Drink a full glass of water with each dose. Do not score or crush the capsule. Do not lie down for 15-30 minutes after administration the capsule. Children and adolescents Excedrin is not indicated for children and adolescents under 12 years old. Elderly Based on general medical considerations, caution should be exercised in the elderly, particularly in elderly patients with low bodyweight. 4.3 CONTRAINDICATIONS • Hypersensitivity to acetylsalicylic acid, paracetamol, caffeine or to any of the excipients listed in section 6.1. Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs such as diclofenac or ibuprofen. • Active gastric or intestinal ulcer, gast 阅读完整的文件