Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Ibuprofen
Pinewood Laboratories Ltd
M01AE; M01AE01
Ibuprofen
200 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Propionic acid derivatives; ibuprofen
Not marketed
1980-12-22
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN PINEWOOD 200 MG FILM-COATED TABLETS IBUPROFEN PINEWOOD 400 MG FILM-COATED TABLETS IBUPROFEN 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen Pinewood tablets are and what they are used for 2. What you need to know before you take Ibuprofen Pinewood tablets 3. How to take Ibuprofen Pinewood tablets 4. Possible side effects 5. How to store Ibuprofen Pinewood tablets 6. Contents of the pack and other information 1. WHAT IBUPROFEN PINEWOOD TABLETS ARE AND WHAT THEY ARE USED FOR Ibuprofen Pinewood tablets contain the active ingredient ibuprofen which is a non-steroidal anti-inflammatory drug (NSAID). They are used for the treatment of mild to moderate pain and inflammation associated with the following conditions: • post-operative pain • toothache • period pain • soft tissue injury (muscles and ligaments) • stiffness and pain in the back and muscles • types of arthritis e.g. rheumatoid, osteoarthritis 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN PINEWOOD TABLETS DO NOT TAKE IBUPROFEN PINEWOOD TABLETS: • if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) • if you previously experienced stomach bleeding or perforation after taking ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) • if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past Baca dokumen lengkapnya
Health Products Regulatory Authority 12 January 2023 CRN00D8HW Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Pinewood 200 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of Ibuprofen. Excipient(s) with known effect Each tablet contains 0.546 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet (Tablet). Pink, circular, film-coated tablets with the markings ‘IBU 200’ on one side and plain on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibuprofen Pinewood tablets are indicated in the management of various arthroses such as rheumatoid arthritis including Stills disease and osteoarthritis, fibrositis, and ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of the tendon, joint capsules and ligaments. Ibuprofen Pinewood tablets are also indicated for the treatment of mild to moderate pain (such as dysmenorrhoea, dental and post-operative pain). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For oral administration. In general, NSAIDS should only be used when an anti-inflammatory effect is required. NSAIDs should be used with particular caution in the elderly who are more prone to adverse events. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (_see section 4.4, Special warnings and precautions for _ _use). _Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Adults: The usual dose is 1200 to 1600 mg daily in divided doses. Some patients may be maintained on 600-1200 mg daily. The maximum daily dose should not exceed 2400 mg. Elderly: The recommended adult dose is appropriate. No specific dosage modifications are required unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Care should be taken in elderly Baca dokumen lengkapnya