Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
PCO Manufacturing Ltd.
M01AE; M01AE51
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
200 mg/30 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen, combinations
Authorised
2014-11-24
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NUROFEN ® COLD & FLU FILM-COATED TABLETS ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg 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 Cold & Flu Film-Coated Tablets carefully to get the best results from them. – 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-effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Nurofen Cold & Flu Film-Coated Tablets are and what they are used for 2. Before you take Nurofen Cold & Flu Film-Coated Tablets 3. How to take Nurofen Cold & Flu Film-Coated Tablets 4. Possible side effects 5. How to store Nurofen Cold & Flu Film-Coated Tablets 6. Further information 1. WHAT NUROFEN COLD & FLU FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Nurofen Cold & Flu Film-Coated Tablets contain two active ingredients which work together to relieve the major symptoms of cold & flu: ibuprofen relieves pain, reduces inflammation and lowers temperature, whilst Pseudoephedrine Hydrochloride is an effective decongestant to ease nasal and sinus congestion. Nurofen Cold and Flu Film-Coated Tablets rapidly relieves the headaches, aches and the pain and fever commonly associated with colds and flu and eases blocked noses, sinuses and the pain of sore throats. 2. BEFORE YOU TAKE NUROFEN COLD & FLU FILM-COATED TABLETS DO NOT TAKE NUROFEN COLD & FLU FILM-COATED TABLETS IF YOU: – are allergic to ibuprofen, pseudoephedrine hydrochloride, or any of the ingredients of Nurofen Cold & Flu Film-Coated Tablets listed in Section 6. – have experienced shortness of breath, worsening of asthma, allergic rash or an itchy, runny nose or swelling of the lips, face, tongu Прочитајте комплетан документ
Health Products Regulatory Authority 25 November 2021 CRN00CMVD Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Cold & Flu film-coated tablets Ibuprofen 200mg Pseudoephedrine hydrochloride 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients Quantity Ibuprofen 200 mg Pseudoephedrine Hydrochloride 30 mg Excipient with known effect: Sunset yellow (E110) For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet _Product imported from Greece and Poland:_ Yellow, circular, biconvex, tablets printed in black with an identifying motif. 4 CLINICAL PARTICULARS As per PA 0979/033/001 5 PHARMACOLOGICAL PROPERTIES As per PA 0979/033/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Product imported from Greece Core: Tricalcium Phosphate Microcrystalline Cellulose Povidone Croscarmellose Sodium Magnesium stearate Film Coating: Hypromellose Talc Opaspray yellow M-1F-6168 or Mastercoat Yellow FA 0156 Black printing Ink: Black iron oxide (E172) Propylene glycol N-butyl alcohol Dehydrated ethanol Isopropyl alcohol Shellac glaze Product imported from Poland Core: Health Products Regulatory Authority 25 November 2021 CRN00CMVD Page 2 of 3 Calcium phosphate Microcrystalline cellulose Povidone Croscarmellose sodium Magnesium stearate Film coating: Hypromellose Talc Opaspray yellow M-1F-6168 or Mastercoat Yellow FA 0156 containing: Titanium dioxide (E171) Sunset yellow (E110) Quinoline yellow (E104) Printing ink: Iron oxide black (E172) Propylene glycol Shellac 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. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER A pack consisting of a blister containing 12 tablets. One or two blisters packed in a cardboard carton (12 or 24 table Прочитајте комплетан документ