Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Guaifenesin
J M Loveridge Ltd
n/a
Guaifenesin
Not applicable
No Controlled Drug Status
Valid as a prescribable product
BNF: 03090200
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MG POWDER FOR ORAL SOLUTION 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 do not feel better or if you feel worse after 5 days. The name of your medicine is PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MG POWDER FOR ORAL SOLUTION. It will be referred to as PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE throughout the remainder of the leaflet. WHAT IS IN THIS LEAFLET 1. What Perrigo Paracetamol/Guaifenesin/Phenylephrine is and what it is used for 2. What you need to know before you take Perrigo Paracetamol/Guaifenesin/Phenylephrine 3. How to take Perrigo Paracetamol/Guaifenesin/Phenylephrine 4. Possible side effects 5. How to store Perrigo Paracetamol/Guaifenesin/Phenylephrine 6. Contents of the pack and other information 1. WHAT PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE 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 sachets are used for the short term symptomatic relief of colds and flu including aches and pains, headache, blocked nose and sore throat, chills and fever, and for relief from chesty coughs. You must talk to a doctor if you do not feel better or if you feel wor Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perrigo Paracetamol/Guaifenesin/Phenylephrine Hydrochloride 500mg/200mg/10mg powder for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT MG/SACHET Paracetamol 500 Guaifenesin 200 Phenylephrine hydrochloride 10 Excipient(s) with known effect Sucrose 2077 mg Aspartame (E951) 12 mg Sodium citrate (E331) 500 mg (contains 117.3 mg sodium) Sodium cyclamate (E952) 100 mg (contains 11.5 mg sodium) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Sachets containing the drug product, an off-white powder with a characteristic citrus/menthol odour. The reconstituted solution is opalescent yellow with a characteristic citrus/menthol odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term symptomatic relief of colds and flu including aches and pains, headache, blocked nose and sore throat, chills and fever, and for relief from chesty coughs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, the elderly and children aged 12 years and over: One sachet every four hours as required. Do not exceed 4 sachets (4 doses) in any 24 hour period. Do not give to children under 12 years old. Seek medical advice if symptoms persist for more than 5 days. Method of administration For oral use after dissolving the contents of the sachet in a standard mug of hot, but not boiling water (250 ml). Allow to cool to a drinkable temperature. Drink all of the solution within 1½ hours. 4.3 CONTRAINDICATIONS • Hypersensitivity to paracetamol, guaifenesin, phenylephrine hydrochloride or to any of the excipients listed in section 6.1 • Pregnancy and breastfeeding • Hepatic or severe renal impairment • Heart disease and cardiovascular disorders, including severe haemolytic anaemia • Hypertension • Hyperthyroidism • Diabetes • Phaeochromocytoma • Those taking tricyclic antidepressants (see section 4.5) • Those currently taking other paracetamol-containing products (se Pročitajte cijeli dokument