Smecta*60 Sachets. A New Step in Treating Diarrhoea -Powder for Oral Suspension.

Product Information

Children and infants: The content of the sachet may be mixed in a bottle of 50ml of water to be given during the day, or mixed with a semi-liquid food, such as broth, compote, puree, baby food… The drug Smecta that contains the active ingredient Dioctahedral smectite has a layered structure and a high mucus. This active ingredient is used to coat and protect the digestive mucosa. Composition of vanilla flavor : maltodextrin, sucrose, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soya lecithin (E322), vanilla fragrance. SmectaGo ® is a ready to drink liquid preparation to be taken orally. The content of the sachet can be swallowed directly. Treatment for acute diarrhoea

Other ingredients are: glucose, saccharin sodium, vanilla flavoring (maltodextrin, sucrose, glycerol triacetate, colloidal anhydrous silica, ethyl alcohol, soy lecithin, vanilla flavoring) and orange flavoring (maltodextrin, monohydrate, -and diglyceride diacetyltartaric acid esters, colloidal anhydrous silica, orange oils). How to take Smecta Appearance of cases with hypersensitivity reactions including symptoms such as rash, urticaria, pruritus, angioedema. The trial was performed in a homogeneous Tunisian population with positive stool culture in 26% of the patients. These figures are consistent with those reported in the literature and previously in Tunisia [ 4, 6, 23, 25]. Of note is that most patients had a recent episode of acute diarrhoea, similar in both groups (median time from first watery stool to treatment onset = 1 [0–3] day from the 1st watery stool to inclusion (NS)), with at least one associated symptom such as nausea, abdominal pain, or anal irritation in >90% of the patients and a median number of six stools per day before treatment onset. Hence, it can be extrapolated that if the primary endpoint variable had been measured from the time of onset of diarrhoea, instead of from the first intake of study drug, the difference between the two groups would still have been the same, that is, 15.2 hours. Moreover, this pattern of diarrhoea is in accordance with the definition of acute diarrhoea in developed countries [ 4, 25, 26]. Therefore, it can be estimated that results of the present study can be extrapolated to western countries. The endpoints most frequently used in trials regarding antidiarrhoeal drugs in children and adults are stool volume and time from treatment onset to last liquid or first formed stool [ 12, 14, 26, 27]. Except in chronic diarrhoea, trials performed in adults rarely use stool volume as an endpoint. The clinical effect of diosmectite as an antidiarrhoeal agent in adults has been assessed mainly by the measurement of time to transit normalization [ 6, 26]. The definition of recovery chosen is again more stringent since it is based not only on the achievement of a normal stool but also by its following a nonwatery stool, thereby reflecting an actual cessation of the acute diarrhoea episode. The ingredients in the drug are very benign, only work for the digestive tract, so they do not adversely affect the mother and the fetus.

QUESTIONS & ANSWERS

Cumulative percentages of recovered patients per 12h period. Recovery was the first formed stool followed by a nonwatery stool (primary endpoint). Diosmectite (6g three times a day) or placebo in the treatment of acute diarrhoea in adults. When applying Smecta for children one should use the following instructions for the preparation of the drug. Smecta must be dissolved in 50 ml of warm water. If the child refuses to take Smecta, then it can be mixed with mashed potatoes, cereal, milk mixture, fruit juice or fruit juice. Continue feeding during diarrhea, excluding certain foods, especially raw vegetables and fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,

Before using Smecta Sachet Powder, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below. The drug is a pharmaceutical product produced by the French company Beaufour Ipsen Industrie. The drug is not only indicated for the treatment of diarrhea but also helps to improve the pain caused by diseases of the esophagus, stomach and intestines. Currently, the drug has been imported and widely distributed in Vietnam. Smecta ® (dioctahedral smectite) is an edible natural clay used for the symptomatic treatment of diarrhoea. If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4. With regards to the primary endpoint, statistical analysis was based on Wilcoxon's test in the intention-to-treat (ITT) population. The ITT population included randomized patients having taken the study drug at least once together with a primary endpoint that was assessable. Per-protocol (PP) population included ITT patients without major protocol deviations as defined after a blind review. PP analyses were supportive only. To assess robustness of the results, it was decided to perform post hoc analyses of primary efficacy data in ITT and PP populations using the “time to event” Gehan-Wilcoxon test, which takes into account censored data and their specific distributions with early events and late censures. Secondary efficacy analyses were conducted in the ITT population.

Patients attended the study centres three times: at screening (patients included in the study began treatment at once), at midstudy (day 4 or 5 after inclusion), and for a concluding examination (day 8 or 9 after inclusion). In children and infants: The contents of the sachet can be diluted in a bottle of 50 ml of water to be distributed during the day, or mixed with semi-liquid food: boiled, compote, puree, small -pot ", etc. Sample size determination was based on the hypothesis that time to recovery was significantly shorter under diosmectite than under placebo (one-sided hypothesis). From previous studies, the expected difference of the primary efficacy criterion between diosmectite and placebo was 24 hours, with an estimated standard deviation (SD) of 61.7 hours. With an alpha risk of 5% and a beta risk of 20%, the number of patients to be included per group was 140 to obtain 104 “assessable” patients per group, that is, for which the primary outcome could be assessed. The average dosage is 3 sachets per day. Depending on diarrhoea severity, the daily dose can be doubled (6 sachets) at the start of the treatment. Diosmectite ................................................. .................................................. ................ 3,000 g