Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Ibuprofen
Galpharm Healthcare Limited
M01AE; M01AE01
Ibuprofen
400 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Not marketed
2013-11-29
1.3 PRODUCT INFORMATION. 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET. IBUPROFEN 400MG FILM-COATED TABLETS / MODULE 1.3.1 / FEBRUARY 2018 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS For adults and adolescents weighing from 40kg body weight (12 years and above) 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. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You must contact a doctor if you do not feel better or if you feel worse after 3 days with fever and 4 days with pain. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET _ _ 1. WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS. 3. HOW TO TAKE IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS. 4. POSSIBLE SIDE EFFECTS. 5. HOW TO STORE IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS. 6. CONTENTS OF THE PACK AND OTHER INFORMATION. 1. WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR. Ibuprofen Galpharm Max 400mg Film-coated Tablets contain ibuprofen, which belongs to a group of medicines Izlasiet visu dokumentu
Health Products Regulatory Authority 09 November 2018 CRN008L6Z Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Galpharm Max 400mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400mg Ibuprofen. Excipients with known effect: 80mg Lactose monohydrate per film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet White, capsule-shaped, biconvex, film-coated tablets with no markings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For short term symptomatic treatment of mild to moderate pain such as headache, dysmenorrhoea (period pain), dental pain, and fever and pain in the common cold. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short term use only: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults: 400mg, up to three times a day as required. Leave at least six hours between doses and do not take more than 1200mg in any 24 hour period. If this medicinal is required for more than 3 days in the case of fever or for more than 4 day for the treatment of pain, or if the symptoms do not improve or worsen the patient is advised to consult a doctor Adolescents ≥ 40 kg (12 years of age and above): 400mg, up to three times a day as required. Leave at least six hours between doses and do not take more than 1200mg in any 24 hour period. Health Products Regulatory Authority 09 November 2018 CRN008L6Z Page 2 of 17 If this medicinal product is required for more than 3 days or if symptoms worsen a doctor should be consulted. It is recommended that patients with a sensitive stomach take Ibuprofen Galpharm Max 400mg Film-coated Tablets with food. Special patient groups _Paediatric Population:_ Not recommended for adolescents weighing under 40 kg or children under 12 years of age. _Elderly:_ The elderly are at increased risk of serious consequences of adverse reactions. Izlasiet visu dokumentu