Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
guaifenesin, butamirate (butamirate citrate)
TEVA Operations Poland Sp. z o.o
guaifenesin, butamirate (butamirate citrate)
100mg+4mg
tablets
OTC
1/4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT STOPTUSSIN TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Butamirate citrate 4.0 mg, guaifenesinum 100.0 mg in one tablet. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets Tablet of a round shape and white colour fitted with a halving groove. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dry, irritative, difficult to control cough of various aetiology; it is used for relief of cough before and after an operation. The preparation can be administered to adults and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage should be adjusted according to the patient’s body weight as follows: Up to 50 kg of body weight 1/2 tablet 4 times a day 50 kg – 70 kg 1 tablet 3 times a day 70 kg – 90 kg 1 1/2 tablets 3 times a day 90 kg and above 2 tablets 3 times a day The interval between the doses should be 4 – 6 hours. The preparation should be administered after meal. The tablets should be swallowed with a sufficient volume of liquid (water, tea, juice, etc.). 4.3 CONTRAINDICATIONS Hypersensitivity to guaifenesin, butamirate citrate or to any of the excipients of the product, myasthenia gravis, the first trimester of pregnancy, children below 12 years of age. 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE Patients should avoid alcoholic beverages during treatment. Stoptussin should not be used by patients with a productive cough and / or persistent or chronic cough associated with smoking, asthma, chronic bronchitis or emphysema. If the cough persists or worsens, the treatment should be reconsidered. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Guaifenesin increases the analgesic effect of paracetamol and acetylsalicylic acid; it also enhances both the inhibitory effect of alcohol, sedatives, hypnotics and general anaesthetics to CNS and the COMMENT [K1]: In UA text 1 1/2 tablets 4 times a day 2/4 muscle relaxant effect. Urinary determinations of vanillyl Read the complete document