Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Paracetamol; Phenylephrine hydrochloride; Guaifenesin
Reckitt Benckiser Ireland Ltd
N02BE; N02BE51
Paracetamol; Phenylephrine hydrochloride; Guaifenesin
500 mg/6.1 mg/100 milligram(s)
Capsule, hard
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2010-08-06
PATIENT INFORMATION LEAFLET LEMSIP MULTI RELIEF CAPSULES PARACETAMOL 500MG PHENYLEPHRINE HYDROCHLORIDE 6.1MG GUAIFENESIN 100MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Lemsip Multi-Relief Cold & Flu Capsules carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact your doctor if your symptoms worsen or do not improve after 3 days. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Lemsip Multi-Relief Capsules are and what they are used for 2. What you need to know before you take Lemsip Multi Relief Capsules 3. How to take Lemsip Multi Relief Capsules 4. Possible side effects 5. How to store Lemsip Multi Relief Capsules 6. Contents of the pack and other information 1. WHAT LEMSIP MULTI RELIEF CAPSULES ARE AND WHAT THEY ARE USED FOR Capsule for oral use. This medicine is a combination of active ingredients which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains, sore throats, headache, nasal congestion, lowering of temperature and chesty cough. Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains, including headache and can also reduce a fever (antipyretic. Guaifenesin (expectorant) allows you to cough up phlegm when suffering from a chesty cough. Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing pressure which may cause a headache. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP MULTI RELIEF CAPSULES DO NOT TAKE LEMSIP MULTI RELIEF CAPSULES IF: You are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any Lugege kogu dokumenti
Health Products Regulatory Authority 02 November 2021 CRN00CJS9 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lemsip Multirelief capsules Paracetamol 500mg Phenylephrine hydrochloride 6.1mg Guaifenesin 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains paracetamol 500mg, phenylephrine hydrochloride 6.1mg and guaifenesin 100mg For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Capsules with a red cap and green body, printed ‘Lemsip’ on the cap in white ink, containing white, free flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms of cold and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or worsen. Posology: Adults, elderly and children (aged16 years and over): Two capsules every 4-6 hours as required. Do not take more than 8 capsules (4 doses) in 24 hours. DO NOT GIVE TO CHILDREN UNDER 16 YEARS OF AGE. Elderly Population: No dosage adjustment is considered necessary in the elderly. Method of Administration For oral administration. Swallow whole with water. Do not chew. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the active substances or any of the excipients listed in section 6.1. Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOI). Concomitant use of other sympathomimetic decongestants. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use with caution in patients with Raynaud's Phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-ci Lugege kogu dokumenti