देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Phenylephrine hydrochloride; Guaifenesin
The Boots Company Plc
N02BE51
Paracetamol; Phenylephrine hydrochloride; Guaifenesin
500mg ; 6.1mg ; 100mg
Oral capsule
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 5045094741366
PACKAGE LEAFLET: INFORMATION FOR THE USER ULTRA COLD & FLU RELIEF ALL IN ONE CAPSULES (Paracetamol, Guaifenesin, Phenylephrine Hydrochloride) 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 have 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 don’t feel better or feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR THIS MEDICINE CONTAINS: • PARACETAMOL which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever • GUAIFENESIN which is an expectorant to help loosen phlegm • PHENYLEPHRINE which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily. These capsules are used for the relief of the symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills and feverishness (high temperature). They can also loosen stubborn mucus (phlegm) and provide relief from chesty coughs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE DO NOT TAKE THIS MEDICINE IF YOU: • are ALLERGIC to paracetamol, guaifenesin, phenylephrine or any of the other ingredients (listed in section 6) • have a serious heart condition or cardiovascular disorder(s) • have high blood pressure (hypertension) • have an overactive thyroid • have glaucoma, including closed angle पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Ultra Cold and Flu Relief All in One Capsules, hard Morrisons All in One Max Strength Cold & Flu Capsules, hard Tesco Health Max Strength All-In-One Cold & Flu Relief Capsules _ _ _ _ Olbas Max Strength All-In-One Cold and Flu Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT MG/CAPSULE Paracetamol 500 Guaifenesin 100 Phenylephrine hydrochloride 6.1 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (Capsules) Dark blue/dark green hard gelatin capsules containing the drug product, an off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms associated with colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills, lowering of temperature, and to loosen stubborn mucus and provide relief from chesty coughs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Swallow whole with water. Do not chew. For all indications: Adults, the elderly and children aged 16 years and over: Two capsules every 4 to 6 hours when necessary to a maximum of 8 capsules (4 doses) in 24 hours. Dosage should not be continued for longer than 3 days without consulting a doctor. Children under 16 years: Do not give to children under 16 years old. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and /or any of the ingredients. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5). Use in patients with glaucoma or urinary retention. Use in patients who are currently receiving other sympathomimetic drugs. Phaeochromocytoma. Closed angle glaucoma. Avoid in patients with prostatic enlargement. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The physician or pharmacist should पूरा दस्तावेज़ पढ़ें