Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
phenylephrine hydrochloride 10 mg, paracetamol 600 mg
Beecham Group PLC
N02BE51
phenylephrine hydrochloride, paracetamol
powder for oral solution
Authorised
2006-02-23
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Beechams Cold & Flu Hot Lemon carefully to get the best results 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 Cold & Flu does 2. Check before you take Beechams Cold & Flu 3. How to take Beechams Cold & Flu 4. Possible side effects 5. How to store Beechams Cold & Flu 6. Further information 1. WHAT BEECHAMS COLD & FLU DOES BEECHAMS COLD & FLU 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. The medicine contains two 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. This product also contains 40 mg ascorbic acid (vitamin C). 2. CHECK BEFORE YOU TAKE BEECHAMS COLD & FLU DO NOT TAKE BEECHAMS COLD & FLU: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, phenylephrine hydrochloride or to any of the other ingredients (listed in Section 6) • if you have KIDNEY or LIVER PROBLEMS, OVERACTIVE THYROID, DIABETES, HIGH BLOOD PRESSURE or HEART OR CIRCULATION 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 WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS. DO NOT TAKE WITH ANY OTHER FLU, COLD OR DECONGESTANT Baca dokumen lengkap
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1) NAME OF THE MEDICINAL PRODUCT Beechams Hot Lemon or Beechams Warmers Lemon or Beechams Cold & Flu Hot Lemon 2) QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituents mg / 6g powder Paracetamol 600.00 Phenylephrine Hydrochloride 10.00 3) PHARMACEUTICAL FORM Powder 4) CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The relief of symptoms of influenza, feverishness, chills and feverish 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 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 six sachets per 24 hours. Do not take continuously for more than 7 days without medical advice. Not to be given to children under 12 years, of age except on medical advice. Page 2 of 7 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents. Concomitant use of other sympathomimetic decongestants Phaeochromocytoma Closed angle glaucoma Hypertensive patients or those taking or have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5). Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care is advised in the admi Baca dokumen lengkap