Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
R05CA10
GUAIFENESIN 100 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 300 mg/5ml
ORAL SOLUTION
GUAIFENESIN 100 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 300 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2007-06-12
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adult Meltus Chesty Coughs with Congestion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Guaiphenesin 100mg/5ml Pseudoephedrine hydrochloride 30mg/5ml 3 PHARMACEUTICAL FORM Oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefit from a combination of a nasal decongestant and an expectorant. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral ADULTS AND CHILDREN AGED 12 YEARS AND OVER: Two 5ml spoonsful three times a day. THE ELDERLY: No specific studies have been carried out on the elderly, but similar products have been widely used in older people. However it may be advisable to monitor renal and hepatic function, and if there is serious impairment then caution should be exercised. 4.3 CONTRA-INDICATIONS The product is contraindicated in patients who have previously shown tolerance to pseudoephedrine or guaiphenesin. It is also contraindicated in persons currently being treated with monoamine oxidase inhibitors, and also within two weeks of stopping such treatment. It is also contraindicated in persons with severe hypertension or severe coronary artery disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Although pseudoephedrine has virtually no presser effect in patients with normal blood pressure, Adult Meltus Chesty Coughs with Congestion should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose of linctus on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic সম্পূর্ণ নথি পড়ুন