Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Guaifenesin; Levomenthol; Diphenhydramine hydrochloride
McNeil Products Ltd
R05FB
Guaifenesin; Levomenthol; Diphenhydramine hydrochloride
20mg/1ml ; 220microgram/1ml ; 2.8mg/1ml
Oral solution
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 03090200; GTIN: 3574660496970
SPECIAL WARNINGS ABOUT THIS MEDICINE ■ This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink. SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS This medicine contains sucrose and liquid glucose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. Contains 1 g sucrose and 3.5 g glucose per 5 ml. This should be taken into account in patients with diabetes mellitus. 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. This should be taken into account by patients on a controlled sodium diet. 3 HOW TO TAKE THIS MEDICINE CHECK THE TABLE OVERLEAF TO SEE HOW MUCH MEDICINE TO TAKE. ■ For oral use only. ■ Do not use more than the stated dose shown overleaf. CHILDREN UNDER 12 YEARS Do not use in children under 12 years. 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. ■ If you are taking, or have taken in the last two weeks, DRUGS FOR DEPRESSION known as Monoamine Oxidase Inhibitors (MAOIs). ■ 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 MUCUS COUGH NIGHT. TALK TO YOUR DOCTOR OR PHARMACIST… ■ If you suffer from LIVER or KIDNEY PROBLEMS. ■ If you have PROSTATE PROBLEMS (diffi culty with passing water or needing to pass water often). ■ If you have NARROW-ANGLE GLAUCOMA (increased pressure Pročitajte cijeli dokument
OBJECT 1 BENYLIN MUCUS COUGH NIGHT Summary of Product Characteristics Updated 19-Jan-2012 | McNeil Products Ltd 1. Name of the medicinal product Benylin Dual Action Night Cough & Congestion Benylin Mucus Cough Night 2. Qualitative and quantitative composition Each 5 ml contains Diphenhydramine hydrochloride 14 mg, Guaifenesin 100 mg and Levomenthol 1.1 mg. For a full list of excipients, see section 6.1. 3. Pharmaceutical form A clear red syrup with no insoluble matter. 4. Clinical particulars 4.1 Therapeutic indications For the night time relief of cough, associated congestive symptoms and aiding restful sleep. 4.2 Posology and method of administration For oral use. ADULTS AND CHILDREN AGED 12 YEARS AND OVER: Patients may start with two 5 ml spoonfuls at bedtime followed by two 5 ml spoonfuls every 6 hours. Or two 5 ml spoonfuls four times a day. Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24 hours. CHILDREN UNDER 12 YEARS: This medicine is contraindicated in children under the age of 12 years (see section 4.3). ELDERLY (OVER 65 YEARS): As for adults. Do not exceed the stated dose. Keep out of the reach and sight of children. 4.3 Contraindications Known hypersensitivity to the product or any of its constituents. This product should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks. Not to be used in children under the age of 12 years. 4.4 Special warnings and precautions for use This product should be not used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. Subjects with moderate to severe renal or hepatic dysfunction or urinary retention should exercise caution when using this product (see section 5.2). This product contains diphenhydramine and should be used with caution in patients with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Avoid alcoholic drink. The l Pročitajte cijeli dokument