Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol, ascorbic acid, caffeine, chlorphenamine (chlorphenamine maleate)
STADA Arzneimittel AG
N02BA71
paracetamol, ascorbic acid, caffeine, chlorphenamine (chlorphenamine maleate)
200mg+ 150mg+ 25mg+ 2,5mg
capsules
(10/1x10/) in blister
OTC
Registered
2017-09-05
1 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Grippostad ® C capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 capsule, hard contains 200 mg paracetamol, 150 mg ascorbic acid, 25 mg caffeine, 2.5 mg chlorphenamine hydrogen maleate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Capsule top: yellow opaque Capsule bottom: white opaque, filled with white to yellowish powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of common cold-related concurrently occurring symptoms such as headache and pain in limbs, rhinitis and dry cough.Grippostad ® C reducesconcomitantly occurring fever or increased body temperature. Because of the fixed combination, doses of the single substances of Grippostad ® C cannot be adjusted individually in cases where one of the mentioned symptoms occurs predomi- nantly. In these cases medicinal products with different compositions should be preferred. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents aged 12 years and overtake 2 capsules three times a day. Patients with hepatic and/or renal impairment Dose must be reduced or dosing interval must be prolonged in patients with impaired he- patic or renal function and Gilbert's syndrome. Grippostad ® C must not be used with severe liver and/or kidney insufficiency (see section 4.3). METHOD AND DURATION OF ADMINISTRATION The capsules are swallowed with a sufficient amount of fluid. Grippostad ® C should not be used over long periods of time or at high dosages without 2 consulting a doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Severely impaired kidney function Children under 12 years of age Pregnancy Breast-feeding 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Grippostad ® C should only be used with special caution or after consulting a doctor with Impaired renal function Impaired hepatic function Gilbert's syndrome Read the complete document