Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
The Boots Company Plc
N02BE; N02BE51
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
1000/60/10 mg/30ml
Oral solution
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2003-12-18
E E ,-.. "' N 148mm --------------------------- ! DAY C OLD & FLU RELIEF ORAL SOLUTION PARACETAMOL 1000 MG/30 ML, PHOLCODINE 10 MG/30 ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60 MG/30 ML READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always tak e t h is m e dicin e e xactly as :d e scrib e d in t h is l e afl e t or as your doctor or I p h armacist h as told you. : e K ee p this l e afl e t, you may n ee d to r e ad it : again 1 e Ask your pharmacist if you n ee d mor e : information or advic e : e If you g e t any sid e e ff e cts, talk to your 1 doctor or p h armacist. T h is includ e s any : possibl e sid e eff e cts not listed in t h is l e afl e t. 1 S e e s e ction 4 : e You must talk to a doctor if you do not f ee l : b e tt e r or if you f ee l wors e : WHAT IS IN THIS LEAFLET: 1 1 .W h at Boots Day Cold & Flu R e li e f Oral : solution is and w h at it is us e d for 1 2.What you ne e d to know b e for e you us e : Boots Day Cold & Flu R e li e f Oral Solution : 3. How to us e Boots Day Cold & Flu R e li e f 1 Oral Solution : 4. Possibl e sid e e ff e cts 6.How to stor e Boots Day Cold & Flu R e li e f : Oral Solution : 6.Cont e nts of t he pack and ot he r information : 1. WHAT BOOTS DAY COLD & FLU 1 RELIEF ORAL SOLUTION IS AND 1 WHAT IT IS USED FOR 1 Boots Day Cold & Flu R e li e f Oral Solution : r e li e v e s t he symptoms of colds and flu : including ac he s and pains, f e v e r, a block e d or rnnny nos e and dry, tickly coug h s. :2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BOOTS DAY COLD & FLU 1 RELIEF ORAL SOLUTION 1 00 not take Boots Day Cold & Flu R e li e f Oral : solution: 1 e IF YOU ARE ALLERGIC to any of t h e ingr e di e nts : e IF YOU HAVE ANGINA : e IF YOU HAVE HIGH BLOOD PRESSURE 1 (including t h at du e to a tumour n e ar your : kidn e ys) 1 e IF YOU HAVE HEART OR BLOOD VESSEL : DISEASE : e IF YOU HAVE diab e t e s, an ov e ractiv e t h yroid, 1 glaucoma or hyp e r e xcitability : e IF YOU HAVE SEVERE kidn e y dis e as e , liv e Les hele dokumentet
Health Products Regulatory Authority 22 December 2020 CRN009S1W Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Day Cold & Flu Relief Oral Solution Paracetamol 1000mg/30mg Pholcodine 10mg/30ml Pseudoephedrine Hydrochloride 60mg/30ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients mg/30ml Paracetamol 1000 Pseudoephedrine hydrochloride 60 Pholcodine 10 Excipients: Ethanol 1.153g/30ml; Glucose 1.7g/30ml; Glycerol 13g/30ml; sucrose 5.4g/30ml and sodium 35mg/30ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear orange liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the symptoms of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Take during the day. Adults and children over 16 years: 30ml every four hours, up to a maximum of 4 doses in 24 hours if needed. Children under 16 years: Not to be given to children under 16 years of age. Elderly: There is no specific requirement for dosage reduction in the elderly. For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Avoid in patients with angina, cardiovascular disease, hypertension, hyperexcitability, diabetes, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, severe kidney disease or liver failure and in patients with chronic bronchitis and bronchiectasis. Use in patients who are currently receiving other sympathomimetic drugs. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Should be given with caution to patients with impaired kidney or liver function. The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations). Sympathomimetic-containing products should be given with great care in patients receiving phenothiazines or tricyclic antidepressants. Health Products Regulatory Authority 22 December 2020 CRN009S1W Page 2 of 6 Sympathomimetic Les hele dokumentet