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3g of smectite 10s powder for oral suspension with strawberry flavor




The instruction for medical use of SMEKTA® medicine Trade name СМЕКТА® the International unlicensed name Is not present the Dosage form Powder for preparation of suspension for intake with taste of strawberry Structure One bag (3 g) contains active agent – smectite dioctahedral (diosmektit) 3 g, excipients: glucose monohydrate, sodium saccharin, strawberry fragrance the Description Powder from white till slightly beige color with a light strawberry smell Pharmacotherapeutic group the Digestive tract and a metabolism. Antidiarrheal, intestinal anti-inflammatory/antimicrobial drugs. Intestinal adsorbents. Other intestinal adsorbents. The ATX A07BC05 Code Diosmektit the Pharmacological Pharmacokinetics Dioctahedral Smectite properties it is not absorbed from digestive tract, removed in an invariable look. The pharmacodynamics (diosmektit) Dioctahedral smectite – double silicate of aluminum and magnesium. Diosmektit, thanks to the foliaceous structure and the increased plastic viscosity, has the considerable enveloping property mucous a digestive tract. Diosmektit stabilizes a mucous barrier, forms polyvalent bonds with slime glycoproteins, increases amount of slime, improves its gastroprotektorny properties (concerning negative effect of ions of hydrogen of hydrochloric acid, bilious salts, viruses, microorganisms and their toxins). Diosmektit is X-ray transparent substance, does not paint kcal, and at therapeutic doses does not change time of physiological intestinal transit. Indications – acute diarrhea at children (in a complex with oral rehydration) and at adults are chronic diarrhea – symptomatic treatment of the pain associated with disorders of a gastro intestinal path the Route of administration and doses Treatment of acute diarrhea Children – till 1 year: on 2 bags a day within 3 days, then 1 bag a day, – is more senior than 1 year: on 4 bags a day within 3 days, then on 2 bags a day. Adults On average 3 bags a day. In practice at the beginning of a course of treatment (during the first 3 days) the daily dose can be doubled. Other indications Children: Till 1 year: 1 bag a day From 1 year to 2 years: 1-2 bags a day Are more senior than 2 years: 2-3 bags a day Adults: On average 3 bags a day. Route of administration Inside. Contents of a bag have to be dissolved just before the use. Preferable time of reception – between meals, in an esophagitis – after a meal. Children: Contents of a bag are dissolved in a children’s small bottle (50 ml) and distributed on several receptions during the day or mixed with any semi-fluid product (porridge, puree, compote, baby food). Adults: Contents of a bag are dissolved in ½ glasses of water. The recommended course of treatment: 3-7 days. Side effects the Frequency of by-effects was classified as follows: often (≥ 1/100, & lt, 1/10), infrequently (≥ 1/1,000, & lt, 1/100). Gastrointestinal disorders: Often: the constipation which is usually stopping with decrease in a dosage, but in rare instances leading to the treatment termination. Infrequently: meteorism, vomiting. During the post-registration period there were messages about reactions of hypersensitivity (frequency is not known) – urticaria, rash, an itching and vascular hypostasis. Also it was reported about cases of aggravation of a constipation. Contraindications – hypersensitivity to drug components – it is contraindicated to persons with glucose galactose malabsorption Medicinal interactions Reduces the speed and/or extent of absorption of at the same time accepted medicines Special instructions the Interval between reception СМЕКТА® and other medicines has to make 1-2 hours. With care to apply at the patients inclined to a chronic heavy constipation. At children the treatment of acute diarrhea has to be carried out in combination with early intake of solution for oral rehydration to avoid dehydration. At adult patients the SMEKTA® drug treatment does not exempt from rehydration if that is necessary. Rehydration volume has to be calculated by solution for oral or intravenous rehydration depending on intensity of diarrhea, age and features of the patient. The patient has to be informed on need: • to use plentiful drink, salty or sweet to offset loss of liquid owing to diarrhea (daily average norm of water for the adult – 2 liters), • to support food during diarrhea: – excepting some products and, in particular, crude vegetables and fruit, fruit, green vegetables, hot dishes and also the frozen food and drinks, – to give preference to the meat roasted on a grill and rice. This medicine contains glucose. It is not recommended to apply at patients with a sprue of glucose and a galactose. Considering pregnancy and the period of a lactation that drug is not soaked up in digestive tract, it can be applied during pregnancy and a lactation if necessary. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Overdose Symptoms does not influence: strengthening of side effects Treatment: symptomatic the Form of release and packing place Powder for preparation of suspension for intake in bags from the paper laminated by aluminum foil and polyethylene. On 10 bags together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! A period of storage 3 years not to apply after expiry date Prescription status Without prescription the Producer BOFUR IPSEN Indastri, France 28100 DREUX, France the Owner of the registration certificate of IPSEN of Pharm, France the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: Representative office of JSC IPSEN PHARMA (IPSEN FARMA) in RK 050040 Almaty, Bayzakov St., 280, BC Almaty Towers, the Northern tower, the 13th floor Ph./fax: 8 (727) 2646448, 2646620, 2646715 E-mail address:

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