Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Ibuprofen
Reckitt Benckiser Ireland Ltd
M01AE; M01AE01
Ibuprofen
400 milligram(s)
Capsule, soft
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Marketed
2009-07-24
NUROFEN RAPID RELIEF MAXIMUM STRENGTH 400MG LIQUID CAPSULES Ibuprofen PACKAGE LEAFLET: INFORMATION FOR THE USER 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 OR NURSE 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to your doctor if you do not feel better or if you feel worse after 3 days. IN THIS LEAFLET: 1. What Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules are and what they are used for 2. Before you take Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules 3. How to take Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules 4. Possible side-effects 5. How to store Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules 6. Further Information 1. WHAT NUROFEN RAPID RELIEF MAXIMUM STRENGTH 400MG LIQUID CAPSULES ARE AND WHAT THEY ARE USED FOR? Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules contain ibuprofen which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling and high temperature. Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules are for the relief of HEADACHES, MIGRAINE, BACKACHE, PERIOD PAIN, DENTAL PAIN, NEURALGIA, MUSCULAR PAIN, RHEUMATIC PAIN, COLD AND FLU SYMPTOMS AND FEVER. 2. BEFORE YOU TAKE NUROFEN RAPID RELIEF MAXIMUM STRENGTH 400MG LIQUID CAPSULES: DO NOT TAKE NUROFEN RAPID RELIEF MAXIMUM STRENGTH 400MG LIQUID CAPSULES IF YOU: • are allergic (hypersensitive) to ibuprofen, aspirin, or any of the ingredients listed in Section 6. • have experienced shortness of breath, worsening of asthma, allergic rash or an itchy, ru Perskaitykite visą dokumentą
Health Products Regulatory Authority 22 May 2023 CRN00DDJT Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each liquid capsule contains 400mg ibuprofen. Excipients with known effect: Sorbitol 67.24 mg per capsule Ponceau 4R (E124), 1.25 mg per capsule For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule soft An oval shaped clear capsule with a translucent red gelatin shell, containing a clear liquid, printed with ‘NUROFEN’ in white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anti-inflammatory, analgesic and antipyretic for short term management of mild to moderate pain, fever and inflammation such as is associated with headache, dental pain, period pain, muscular strain, neuralgia, rheumatic pain and migraine and for the management of the symptoms of head colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short term use only. Do not chew. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days. Adults, the elderly and children over 12 years: 400mg taken with water up to three times a day as required. Leave at least four hours between doses with a maximum of 1200mg in any 24 hour period. If in adolescents this medicinal product is required for more than 3 days or if symptoms worsen a doctor should be consulted. Not for use by children under 12 years of age. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed (See Section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. 4.3 CONTRAINDICATIONS Known hypersensitivity to th Perskaitykite visą dokumentą