3g of smectite 30s powder for oral suspension

The instruction for medical use of SMEKTA® medicine the Trade name of Smekta® the International unlicensed name Is not present the Dosage form Powder for preparation of suspension for intake Structure One bag (3 g) contains active agent - smectite dioctahedral (diosmektit) 3 g, excipients: sodium saccharin, glucose monohydrate, orange fragrance, vanilla fragrance the Description Powder from white till slightly beige color with the light orange smell appearing at suspension preparation. Pharmacotherapeutic group Digestive tract and metabolism. Antidiarrheal 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 the Drug Smekta® of natural origin, has the adsorbing effect. Dioctahedral smectite (diosmektit) – 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: For children and babies the contents of a sachet can be divorced in a small amount of water in a small bottle with a pacifier and are distributed on several receptions during the day or mixed with semi-fluid food (for example, broth, compote, puree, baby food). Adults: Contents of a bag can be divorced in half of glass of water. The recommended course of treatment: 3-7 days. Side effects the Following by-effects were revealed during the clinical trials conducted at adults and children. These by-effects in general were passing, insignificant and intensity and touched mainly a digestive tract. 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. 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 - glucose galactose malabsorption Medicinal interactions the Absorbing properties of drug can influence time and/or extent of absorption of other substances therefore Smekt is not recommended to accept Special instructions along with other drugs the Interval between reception of Smekty® 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 syndrome of the lowered absorption 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 does not influence the Overdose can lead to appearance of a heavy constipation or a bezoar. 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 or 30 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 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 of Pharm) in RK 050040 Almaty, Al-Farabi Ave., 45, office 2 Ph./fax: 8 (727) 2646448, 2646620, 2646715 E-mail address: pharmacovigilance.kazakhstan@ipsen.com