SHORT PRODUCT INFORMATION: PURGYL 11% + 12.5% ​​Oral Solution. ACTIVE INGREDIENTS: In 200 ml (1 bottle); Tartaric Acid 22 g / Sodium bicarbonate 25 g. PHARMACOLOGICAL PROPERTIES: Pharmacotherapeutic group: Osmotic laxative ATC Code: A06AD21 It is a mixture of sodium bicarbonate, tartaric acid and sodium tartrate. Tartaric acid is used as a laxative salt. Since salts with laxative effect are not easily absorbed from the small intestines, they remain in the intestinal content, and the increased volume of body fluids and isotonic content has a stimulant effect on the intestinal wall, causing frequent peristaltic movements and accelerating the passage in the intestines. THERAPEUTIC INDICATIONS: It can be used to empty the bowel before surgical, radiological, proctoscopic or colonoscopic procedures. It may be useful in expelling parasites after antihelmentic treatment. It is used as a laxative. POSOLOGY / FREQUENCY AND DURATION OF APPLICATION: As a laxative; For children over 12 years old, half -1 spoon 3 times a day, 1-2 scales 3 times a day for adults. Before surgical, radiological, proctoscopic or colonoscopic procedures; For children over 12 years of age, 100-200 ml (half -1 bottle) is used at one time, and for adults 200-400 ml (1-2 full bottles) is used. For expulsion of parasites after antihelmentic treatment; For children over 12 years old, 100-200 ml (half – 1 bottle) is used at one time, for adults 200-400 ml (1-2 full bottles) is used. CONTRAINDICATIONS: Hypersensitivity to the active substances or to the excipients listed in section 6.1. All laxatives are contraindicated in acute abdominal pain, nausea, vomiting or undiagnosed abdominal pain, as in appendicitis. It should not be used in heart patients, chronic lung, kidney, liver patients, edema patients and those on a low sodium diet. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Causes systemic alkalosis when taken for a long time. Shortly after the drug is taken, it causes more stomach acid to be secreted. It makes the urine alkaline. It can cause the formation of kidney stones. PURGYL, because of the sucrose it contains; Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. It may cause allergic reactions (possibly delayed) due to the methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) it contains. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER MODES OF INTERACTION: Oral bicarbonate compounds can increase or decrease the degree and/or rate of absorption of many drugs with their effect on raising gastric pH. Alkalization of the urine results in increased renal clearance of acidic drugs such as salicylates. On the contrary, it can extend the half-life of some essential drugs, for example; Sodium bicarbonate increases lithium excretion. PREGNANCY CATEGORY C. LACTATION PERIOD: No effects on the breastfed child are anticipated. PURGYL should be used with caution during breastfeeding. PURGYL has no known effects on the ability to drive and use machines. UNDESIRED EFFECTS: Metabolism and nutrition disorders Very rare: Alkalosis, hypercalcemia and edema. Gastrointestinal disorders Rare: Abdominal bloating and flatulence. QUALITY AND CONTENT OF THE PACKAGING: In a 200 ml amber glass bottle with a white PE locking cap, with a 20 ml PP scale.
It is presented in a cardboard box. REPORTING SUSPICIOUS ADVERSE REACTIONS: Reporting suspected adverse reactions of drugs after authorization is of great importance.
Reporting allows continuous monitoring of the benefit/risk balance of the drug. Any suspected adverse reaction of healthcare professionals Turkish Pharmacovigilance Center
(TÜFAM) (www.titck.gov.tr; e-mail: [email protected]; tel: 0 800 314 00 08; fax: 0 312 218 35 99). LICENSE OWNER İstanbul İlaç Sanayi ve Ticaret A.Ş. Kartal / Istanbul
LICENSE NUMBER 77 / 36 Date of first license: 11.08.1965 SALES AND MARKETING: FARMAVIP ILAC VE KOZMETIK SANAYİ VE TİCARET A.Ş. Arabayatagi Mah. 2. Celik Sok. No:13/2 Yildirim/BURSA
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