Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Ibuprofen
PCO Manufacturing Ltd.
M01AE01
Ibuprofen
400 milligram(s)
Coated tablet
Product not subject to medical prescription
ibuprofen
Authorised
2017-08-04
_ _ _ _ EXPRESS MAXIMUM STRENGTH ibuprofen (as sodium dihydrate) PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Nurofen Express Maximum Strength 400 mg Tablets carefully to get the best results from it. – Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice – You must contact a doctor if your symptoms worsen or do not improve after 3 days. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Nurofen Express Maximum Strength 400 mg Tablets are and what they are used for 2. Before you take Nurofen Express Maximum Strength 400 mg Tablets 3. How to take Nurofen Express Maximum Strength 400 mg Tablets 4. Possible side effects 5. How to store Nurofen Express Maximum Strength 400 mg Tablets 6. Further information 1. WHAT NUROFEN EXPRESS MAXIMUM STRENGTH 400 MG TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient (which makes the medicine work) in Nurofen Express Maximum Strength 400 mg Tablets is ibuprofen 400 mg (as sodium dihydrate 512 mg). Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature. Nurofen Express Maximum Strength 400 mg Tablets are used for the relief of fever and mild to moderate pain such as: • headaches, period pain and dental pain • muscle pain and backache • symptoms of colds and flu, and high temperature (fever) 2. BEFORE YOU TAKE NUROFEN EXPRESS MAXIMUM STRENGTH 400 MG TABLETS DO NOT TAKE THESE TABLETS IF YOU: • are allergic (hypersensitive) to ibuprofen or any of the other ingredients (see Section 6: Further Information) • are allergic (hypersensitive) to aspirin or to other painkillers • have or ever had Přečtěte si celý dokument
Health Products Regulatory Authority 06 December 2023 CRN00DXSC Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Express Maximum Strength 400 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 400 mg (as sodium dihydrate) Excipients with known effect: Each tablet contains sucrose and sodium. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Coated Tablet. _Product imported from Lithuania:_ A white to off-white, biconvex, round, sugar coated tablet with an identifying logo in red on one face. 4 CLINICAL PARTICULARS As per PA0979/032/011 5 PHARMACOLOGICAL PROPERTIES As per PA0979/032/011 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Croscarmellose sodium (E468) Xylitol (E967) Microcrystalline cellulose (E460) Magnesium stearate (E572) Colloidal anhydrous silica (E551) Carmellose sodium (E466) Talc (E553b) Acacia spray dried (E414) Sucrose Titanium dioxide (E171) Macrogol 6000 powder Red print ink* *(containing: Shellac (E904), iron oxide red (E172), ammonium hydroxide (E257) and simethicone) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 06 December 2023 CRN00DXSC Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER The blisters are packed into cardboard cartons. Each pack may contain 12 or 24 tablets. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/430/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 4 th August 2017 10 DATE OF REVISI Přečtěte si celý dokument