Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
GUAIFENESIN, LEVOMENTHOL
McNeil Products Limited
R05CA03
GUAIFENESIN, LEVOMENTHOL
SYRUP
GUAIFENESIN 100 milligram(s)/5 millilitre ; LEVOMENTHOL 1.1 milligram(s)/5 millilitre
OTC
COUGH AND COLD PREPARATIONS
Authorised
2006-08-10
■ This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5 ml, equivalent to 5 ml beer, 2 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast- feeding women, children and high-risk groups such as patients with liver disease or epilepsy. ■ Ponceau 4R (E124) may cause allergic reactions. ■ This medicinal product contains 16.42 mg sodium per 5 ml. To be taken into consideration by patients on a controlled sodium diet. 3 HOW TO TAKE THIS MEDICINE CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE TO TAKE. ■ For oral use only. ■ Do not use more than the stated dose shown. CHILDREN UNDER 12 YEARS This medicine is not recommended for children under 12 years old. ADULTS AND CHILDREN AGED 12 YEARS AND OVER 2 BEFORE TAKING THIS MEDICINE This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… ■ If you have ever had a BAD REACTION to any of the ingredients. ■ For a child under 12 years of age. If any of these apply to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING BENYLIN CHESTY COUGHS NON-DROWSY. TALK TO YOUR DOCTOR OR PHARMACIST… ■ If you suffer from LIVER or KIDNEY PROBLEMS. ■ If you have been told by your doctor that you have an intolerance to some sugars. ■ If you have had a COUGH for a few weeks that may be caused by ASTHMA, or a cough which brings up a lot of mucus (phlegm). ■ If you are taking ALCOHOL. If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING ■ Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast- Soma hati kamili
1 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1 NAME OF THE MEDICINAL PRODUCT BENYLIN Chesty Coughs (Non-drowsy) Benylin Mucus Cough 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of product contains 100 mg guaifenesin and 1.1 mg levomenthol. Also contains: Ethanol 0.2595ml/5ml Glucose 3492 mg/5ml Sucrose 999 mg/5ml Sodium 16.42 mg/5ml Ponceau 4R (E124) For full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Clear red syrup 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic relief of cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN AGED 12 YEARS AND OVER: Oral. Two 5 ml spoonfuls four times a day. CHILDREN UNDER 12 YEARS: This product is contraindicated in children under the age of 12 years (see section 4.3). THE ELDERLY: As for adults. 2 HEPATIC/RENAL DYSFUNCTION Experience with the use of this product suggests that normal adult dosage is appropriate for mild to moderate dysfunction. Caution should be exercised in severe hepatic and severe renal impairment. [See Pharmacokinetics]. Do not exceed the stated dose. Keep out of the reach and sight of children. 4.3 CONTRAINDICATIONS This product is contraindicated in individuals with known hypersensitivity to the product, or any of its components. Not to be used in children under the age of 12 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment, [See Pharmacokinetics]. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5ml dose, equivalent to approximately 5 ml beer, 2 ml wine per 5 Soma hati kamili