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Paracetamol, Guaifenesin, Phenylephrine Hydrochloride
Wrafton Laboratories Limited
N02BE51
Paracetamol, Guaifenesin, Phenylephrine Hydrochloride
250mg/100mg/5mg
Capsule, hard
Oral use
Pack sizes: 8 and 16 capsules.
GSL - General Sales List
Wrafton Laboratories Limited
Other analgesics and antipyretics & other cold combination preparations
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 mucous and provide relief from chesty coughs
Authorised
2015-04-14
Pack Copy Specification Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet Marketing Authorisation number PL 12063/0125 Version Number 1Paracetamol, Guaifenesin, Phenylephrine PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION YOU NEED TO KNOW. This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice. 1) WHAT IS THIS MEDICINE AND WHAT IS IT 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) IS THIS MEDICINE SUITABLE FOR YOU? DO NOT TAKE THIS MEDICINE IF YOU: • are ALLERGIC to paracetamol, guaifenesin, phenylephrine or any of the other ingredients • have a serious heart condition or cardiovascular disorder(s) • have high blood pressure (hypertension) • have diabetes • have an overactive thyroid • have glaucoma • have difficulty passing urine, an enlarged prostate or o 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg/100 mg/5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT MG/CAPSULE Paracetamol 250 Guaifenesin 100 Phenylephrine Hydrochloride 5 For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule). Light blue / purple 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 mucous and provide relief from chesty coughs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Swallow whole with water, do not chew. Adults, the elderly and children aged 12 years and over: Two capsules every four hours as required. Do not take more than 8 capsules (4 doses) in any 24 hour period. Do not give to children under 12 years old. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, guaifenesin or phenylephrine or any of the other ingredients. Hypertension (high blood pressure), hyperthyroidism, diabetes, serious heart disease, cardiovascular disorders or those patients receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (see Section 4.5). Those taking tricyclic anti-depressant drugs (see Section 4.5). Phaeochromocytoma Prostatic enlargement or urinary retention Use in patients with glaucoma, including closed angle glaucoma. Hepatic and renal impairment Use in patients who are currently receiving other sympathomimetic drugs 전체 문서 읽기