Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
R05X
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
200/30 milligram(s)
Film-coated tablet
Product not subject to medical prescription
OTHER COLD PREPARATIONS
Marketed
2016-01-29
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NON-DROWSY SUDAPRO HEAD COLD 200 MG/30 MG FILM-COATED TABLETS Ibuprofen/Pseudoephedrine hydrochloride For adults and adolescents from 15 years and older 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. See section 4. - You must talk to a doctor if symptoms worsen, or if this medicine is required for more than 4 days (adults) or 3 days (adolescents), respectively. WHAT IS IN THIS LEAFLET: 1. What Non-Drowsy Sudapro Head Cold is and what it is used for 2. What you need to know before you take Non-Drowsy Sudapro Head Cold 3. How to take Non-Drowsy Sudapro Head Cold 4. Possible side effects 5. How to store Non-Drowsy Sudapro Head Cold 6. Contents of the pack and other information 1. WHAT NON-DROWSY SUDAPRO HEAD COLD IS AND WHAT IT IS USED FOR Non-Drowsy Sudapro Head Cold contains two active substances: ibuprofen and pseudoephedrine hydrochloride. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and high temperature. Pseudoephedrine hydrochloride belongs to a group of active substances called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion. Non-Drowsy Sudapro Head Cold is used for the symptomatic treatment of nasal congestion in head colds together with headache and/or fever, in adults and adolescents aged 15 years and older. 2 You should only take this combination product if you have a blocked nose with headache or fever. If you have only one of these symptoms you should talk to your pharmacist or doctor about using eith Preberite celoten dokument
Health Products Regulatory Authority 27 February 2019 CRN008JPV Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Non-Drowsy Sudapro Head Cold 200mg / 30mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height: approx. 5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of nasal congestion associated with acute rhinosinusitis suspected to be of viral origin with headache and/or fever. Non-Drowsy Sudapro Head Cold is indicated in adults and adolescents aged 15 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 15 years and older: _ 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 6 hours if necessary. For more intense symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6 hours if necessary, to a maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride). The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) must not be exceeded. For short-term use. THE PATIENT SHOULD CONSULT A DOCTOR IF SYMPTOMS WORSEN. THE MAXIMUM DURATION OF TREATMENT IS 4 DAYS FOR ADULTS AND 3 DAYS FOR ADOLESCENTS AGED 15 YEARS AND OLDER. In situations where the symptoms predominantly consist of either pain/fever or nasal congestion, administration of single entity products is to be preferred. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _Paediatric population _ Non-Drowsy Sudapro Head Cold is contraindicated in paediatric patients below 15 years of age (see section 4.3). Method of adminis Preberite celoten dokument