Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
Haleon Ireland Limited
M01AE; M01AE51
Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE
200 mg/30 milligram(s)
Capsule, soft
Propionic acid derivatives; ibuprofen, combinations
Not marketed
2016-03-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ADVIL COLD & FLU RELIEF SOFT CAPSULES IBUPROFEN 200 MG / PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ADVIL COLD & FLU RELIEF BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Advil Cold & Flu Relief is available without prescription. Always take Advil Cold & Flu Relief 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 you do not feel better or if you feel worse after 5 days. WHAT IS IN THIS LEAFLET 1. What Advil Cold & Flu Relief is and what it is used for 2. What you need to know before you take Advil Cold & Flu Relief 3. How to take Advil Cold & Flu Relief 4. Possible side effects 5. How to store Advil Cold & Flu Relief 6. Contents of the pack and other information 1. WHAT ADVIL COLD & FLU RELIEF IS AND WHAT IT IS USED FOR WHAT ADVIL COLD & FLU RELIEF IS Advil Cold & Flu Relief contains two active substances, ibuprofen and pseudoephedrine. • Ibuprofen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs). It helps to reduce pain and lower a high temperature (fever). • Pseudoephedrine belongs to a group of medicines called ‘vasoconstrictors’. It helps to clear the nasal passages and eases nasal congestion. WHAT ADVIL COLD & FLU RELIEF IS USED FOR Advil Cold & Flu Relief is used to treat symptoms of the common cold and flu, including headache, high temperature (fever), sore throat, aches and pains, blocked nose, in adults and young people aged 12 and over. Only use this medicine if you have a blocked nose together with the symptoms listed above such as headache and high temperature. Do not use if you only have one of the symptoms listed above. 2. Izlasiet visu dokumentu
Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Advil Cold & Flu Relief Soft Capsules Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES MG/CAPSULE Ibuprofen 200 Pseudoephedrine Hydrochloride 30 Excipients with known effect: Sorbitol (E 420), soya lecithin. 3 PHARMACEUTICAL FORM Soft capsules (capsules). A clear, oval, soft-gelatin capsule filled with a clear liquid and printed with 200/30 in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Advil Cold & Flu Relief is indicated for the relief of symptoms of the common cold and flu such as headache, fever, sore throat, minor aches and pain when associated with blocked nose (nasal congestion) and sinuses (sinusitis) in adults and adolescents over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. This combination product should be used where both, the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are required. If one symptom (either nasal congestion or headache and/or fever) predominates, single-agent therapy is preferable. Posology Adults, older people and adolescents over 12 years of age: Take 1 capsule every 4-6 hours to a maximum of 6 capsules in any 24 hour period. In case of more intense symptoms, 2 capsules (400 mg ibuprofen/60 mg pseudoephedrine hydrochloride) may be taken at a time. The dose can be repeated, if necessary, at six-hour intervals without exceeding a maximum daily dose of 6 capsules (1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). The lowest effective dose should be used for the shortest duration necessary to relieve the symptoms (see section 4.4). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Maximum duration of treatment is 5 days unles Izlasiet visu dokumentu