Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenylephrine; Ibuprofen
McNeil Products Ltd
M01AE51
Phenylephrine; Ibuprofen
6.1mg ; 200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 3574661338385
SINUS PAIN RELIEF 200MG/6.1MG TABLETS 18-0056 D4D73QMJ2 _Ibuprofen & Phenylephrine Hydrochloride_ READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ■ 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 or pharmacist if your symptoms worsen or do not improve. 1 WHAT THIS MEDICINE IS FOR This medicine contains ibuprofen and phenylephrine hydrochloride. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) which work by changing how the body responds to pain, swelling and high temperature. Phenylephrine hydrochloride is a decongestant which shrinks the blood vessels in the nose and sinuses which opens the airways helping you to breathe more easily. This medicine is used to relieve the symptoms of cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses. 2 BEFORE YOU TAKE THE MEDICINE DO NOT TAKE THIS MEDICINE IF YOU: ■ are allergic to ibuprofen, phenylephrine hydrochloride, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching) ■ have or have had a stomach ulcer, perforation or bleeding ■ have kidney or heart failure or severe liver failure ■ have heart problems or high blood pressure (particularly due to a tumour near the kidney) ■ have diabetes ■ have prostate problems ■ have glaucoma (increased pressure in the eye) ■ have an overactive thyroid gland ■ are taking more than 75mg of aspirin a day ■ are taking Monoamine Oxidase inhibitor medicines (used for depression) or have taken them within the last 14 days ■ are pregnant or breast feeding. WARNINGS AND PRECAUTIONS Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exce Lestu allt skjalið
OBJECT 1 SUDAFED SINUS PAIN RELIEF 200MG/6.1MG TABLETS Summary of Product Characteristics Updated 11-Jun-2018 | McNeil Products Ltd 1. Name of the medicinal product Ibuprofen and Phenylephrine Hydrochloride 200mg/6.1mg Tablets Galpharm Pain Relief & Decongestant 200mg/6.1mg Tablets Sudafed Congestion & Headache Relief Dual Action 200mg/6.1mg Tablets Sudafed Sinus Pain Relief 200mg/6.1mg Tablets 2. Qualitative and quantitative composition Ibuprofen 200 mg Phenylephrine hydrochloride 6.1 mg Sucrose 31.66 mg per tablet Tartrazine 0.274 mg per tablet For full list of excipients, see Section 6.1. 3. Pharmaceutical form Film-coated tablets (Tablets) Green, round bi-convex sugar coated tablet. 4. Clinical particulars 4.1 Therapeutic indications For the relief of symptoms of cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses. 4.2 Posology and method of administration For oral administration and short-term use only. _Adults, the elderly and children between 12 and 18 years:_ Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If in children between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor. Two tablets every 8 hours, preferably with or after food. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period. _Not to be given to children under 12 years._ 4.3 Contraindications Hypersensitivity to ibuprofen, phenylephrine hydrochloride or any of the excipients in the product. Hypertension and severe coronary heart disease. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). Active or history of Lestu allt skjalið