Country: Malta
Tungumál: enska
Heimild: Medicines Authority
IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Products Limited
R05X
IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
FILM-COATED TABLET
IBUPROFEN 200 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 30 milligram(s)
OTC
COUGH AND COLD PREPARATIONS
Authorised
2017-08-22
PAGE 1 OF 10 PACKAGE LEAFLET PAGE 2 OF 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUDAFED SINUS PRESSURE & PAIN 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 Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets is and what it is used for 2. What you need to know before you take Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets 3. How to take Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets 4. Possible side effects 5. How to store Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT SUDAFED SINUS PRESSURE & PAIN 200 MG/30 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Sudafed Sinus Pressure & Pain 200 mg/30 mg tablets 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. Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets is used for the symptomatic treatment of nasal congestion in head colds together with head Lestu allt skjalið
PAGE 1 OF 18 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 18 1 . NAME OF THE MEDICINAL PRODUCT Sudafed Sinus Pressure & Pain 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 (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. This product 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 _ This product is contraindicated in paediatric patients below 15 years of age (see section 4.3). Method of administration PAGE 3 OF 18 For oral use. The tablets should be swallowed who Lestu allt skjalið