מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL, ASCORBIC ACID
GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
N02BE51
PHENYLEPHRINE HYDROCHLORIDE 10 mg PARACETAMOL 1000 mg ASCORBIC ACID 40 mg
POWDER FOR ORAL SOLUTION
PHENYLEPHRINE HYDROCHLORIDE 10 mg PARACETAMOL 1000 mg ASCORBIC ACID 40 mg
OTC
ANALGESICS
Withdrawn
2006-02-23
_HOT LEMON_ _Paracetamol, Phenylephrine, Vitamin C_ P L E A S E R E AD RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Beechams Flu Plus Hot Lemon carefully to get the best re sults from it. • Keep this leaflet you may need to read it again. • If you have any questions, or if there is anything you do not understand, ask your pharmacist. IN THIS LEAFLET: 1. What Beechams Flu Plus does 2. Check before you take Beechams Flu Plus 3. How to take Beechams Flu Plus 4. Possible side effects 5. How to store Beechams Flu Plus 6. Further information 1. What Beechams Flu Plus does BEECHAMS FLU PLUS IS USED FOR THE SHORT TERM RELIEF OF THE SYMPTOMS OF FLU, COLDS AND CHILLS. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh and sore throat. This medi cine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Phenylephrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Ascorbic acid (vitamin C) is a common ingredient of cold and flu products. It is included to help replace vitamin C which may be lost in the initial stages of colds and flu. 2. Check before you take Beechams Flu Plus DO NOT TAKE BEECHAMS FLU PLUS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, phenylephrine hydrochloride, ascorbic acid or any of the other ingredients (listed in Section 6) • if you have KIDNEY or LIVER PROBLEMS, OVERACTIVE THYROID, DIABETES, HIGH BLOOD PRESSURE or HEART DISEASE • if you have PHAEOCHROMOCYTOMA or GLAUCOMA • if you are taking TRICYCLIC ANTIDEPRESSANTS (e.g. imipramine or amitriptyline) or if you are taking or have taken within the last two weeks MONOAMINE OXIDASE INHIBITORS (MAOIs) (e.g. moclobemide) prescribed for DEPRESSION • if you are taking BETA BLOCKERS. DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE. DO NOT TAKE WITH קרא את המסמך השלם
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1) NAME OF THE MEDICINAL PRODUCT Beechams Flu Plus Hot Lemon 2) QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE CONSTITUANTS MG / 6.427 G POWDER Paracetamol 1000.00 Ascorbic Acid 40.00 Phenylephrine Hydrochloride 10.00 3) PHARMACEUTICAL FORM Powder 4) CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term symptomatic relief of symptoms of influenza, feverishness, chills and colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Directions for use Empty contents of sachet into a beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired. Recommended Dose and Dosage Schedule Adults (including elderly) and children aged 12 years and over: One sachet to be taken every four to six hours as necessary. Do not exceed four sachets per 24 hours. Not to be given to children under 12 years of age, except on medical advice. The product should not be used continuously for more than seven days without medical advice. Page 2 of 9 4.3 CONTRAINDICATIONS Known hypersensitivity to paracetamol or any of the other constituents. Concomitant use of other sympathomimetic decongestants Phaeochromocytoma Closed angle glaucoma Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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-cirrhotic alcoholic liver disease. Medical advice should be sought before taking this product in patients with these conditions: An enlargement of the prostate gland Occulusive Vascular disease (e.g. Raynaud’s Phen קרא את המסמך השלם