Kraj: Armenia
Język: angielski
Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hydrotalcite
KRKA d.d.
A02AD04
hydrotalcite
500mg
tablets chewable
(20/2x10/) in blister, (60/6x10/) in blister
OTC
Registered
2018-11-27
1.3.1 Hydrotalcite SPC, Labeling and Package Leaflet AM SmPCPIL116083_1 14.08.2018 – Updated: 14.08.2018 Page 1 of 5 1. NAME OF THE MEDICINAL PRODUCT Rutacid 500 mg chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg hydrotalcite. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Tablets are round, white or almost white with beveled edges and with a slight peppermint odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rutacid tablets eliminate or relieve symptoms associated with excessive gastric acid secretion: - belching, heartburn, - burning pain in the stomach, - inflammation of the lining of the stomach (gastritis), which is a result of stress, improper diet, excessive consumption of alcohol or nonsteroidal anti-inflammatory drugs. Rutacid tablets promote the healing of gastric and duodenal ulcers and are also effective in the maintenance treatment of chronic ulcer disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The chewable tablets should not be swallowed whole but should be chewed thoroughly. _Adults _ The recommended dose is 1 to 2 tablets 3 to 4 times daily, usually one hour after a meal and at bedtime, or when the above-mentioned problems occur. _Elderly _ No dosage adjustment is required. _Patients with impaired renal function _ Patients with impaired renal function can take Rutacid only for a short time and at lower doses (see section 4.4). _Patients with impaired liver function _ No dosage adjustment is required. _Children _ The recommended dose for children aged 6 to 12 years is half the adult dose (½ to 1 tablet) taken 3 to 4 times daily, usually one hour after a meal and at bedtime, or when problems occur. Rutacid is not recommended for use in children under 6 years of age because its safety and efficacy have not been established. 1.3.1 Hydrotalcite SPC, Labeling and Package Leaflet AM SmPCPIL116083_1 14.08.2018 – Updated: 14.08.2018 Page 2 of 5 4.3 CONTRAINDICATIONS Hypersensitivity to the active su Przeczytaj cały dokument