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

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An average of 3 sachets per day. In practice, the daily dosage can be doubled at the beginning of the treatment Please report any adverse drug reactions suspected to be associated to the use of Smecta ® to the NPRA. The statistical analysis plan was based upon the assumption that the duration of the diarrhoea episode would be shorter than seven days for all patients, without any risk of data censure. It was therefore planned to compare mean diarrhoea durations using the Wilcoxon's test, which is perfectly adapted to this type of data. The definition of diarrhoea duration required that patients are followed after the first formed stool to confirm the end of the diarrhoea episode. This definition of recovery was selected to guarantee the clinical relevance of the primary criterion. Of note is that it was much more constraining than previous trials, which defined recovery as the first nonliquid stool. However, according to the definition of recovery used in the study, 35 patients showed diarrhoea duration longer than seven days. Since the protocol planned a seven-day followup, these patients were censored in statistical analyses. Nevertheless, a post hoc time to event analysis taking data censure into account was carried out. The Gehan-Wilcoxon test was preferred to the Logrank test because of the particular distribution of the events considered and the onset of censures during study followup. Indeed, the Gehan-Wilcoxon test is more adapted than the Logrank test to early events and late censures. Moreover the latter is based upon the assumption of proportional hazards, which is most probably not verified in this trial since the active treatment is supposed to shorten time to recovery without modifying the risk of recovery. Acute watery diarrhoea is self-resolving, even in the absence of treatment. The results of the Gehan-Wilcoxon test confirmed the effectiveness of diosmectite. These results are consistent with the primary analysis and confirm that diosmectite shortens time to recovery. Maintain food intake (preferably grilled meat and rice) during the bout of diarrhoea, excluding certain supplements and in particular, raw vegetables, fruit, green vegetables, spicy food and frozen foods and drinks. 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).

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.

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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. DRUG INTERACTIONS (summary) This drug may decrease the absorption of many drugs. A delay of at least 2 hours (or even 4 hours with antibiotics of the quinolone family) must be observed between taking this drug and that of other treatments. Ask your doctor or pharmacist. Smecta drug does not have any indication for pregnant and lactating women. Therefore, before using, you should consult your doctor to weigh the benefits and risks of the drug. When treating acute diarrhoea in children, administer Smecta with oral rehydration products to prevent Acute diarrhoea is one of the leading causes of morbidity worldwide [ 1]. The annual rate of diarrhoea among adults in Western Europe and the United States averages about one episode per person per year [ 2– 4]. Episodes are usually brief, not life-threatening and most often self-limited but symptoms can be disturbing and incapacitating. Urgency, loose stools, abdominal discomfort, and inconvenience such as loss of faecal continence make it an unpleasant and distressing condition. It is commonly recognized that these symptoms lead to substantial costs for society as it is estimated that half of the episodes are related to missed workdays [ 5, 6].

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication. NPRA has received a total of 9 reports with 12 adverse events suspected to be related to dioctahedral smectite/ diosmectite. Reported adverse events include rash, urticaria, angioedema and periorbital oedema. To date, no report related to lead poisoning following the use of Smecta ® has been reported to the NPRA 2. Composition of vanilla flavor : maltodextrin, sucrose, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soya lecithin (E322), vanilla fragrance.

Therefore, before using Smecta, the patient should make a list of the medicines you are using for the doctor or pharmacist. To ensure safety when using, you should not arbitrarily take the drug, stop or change the dosage without the permission of your doctor. WHAT IS SMECTA 3 g ORANGE-VANILLA, powder for oral suspension in sachets AND WHAT CASES IS IT USED FOR? The only dosage form of Smekta is a powder for the preparation of a suspension weighing 3 g. The composition of the drug in addition to the active substance includes: Also, not everyone knows how to drink Smecta, in what dosage. Instructions for use Smecta provides an answer to this question. The usual dosage for adults and adolescents is 3 sachets per day. It is necessary to observe the interval between taking the drug and eating about 1-2 hours.

It is important to list the medicines you are taking with your doctor before you intend to use Smecta to avoid drug interactions How much does Smecta medicine cost? If there is diarrhea due to food poisoning or poisoning of harmful substances, the toxins should be removed from the body immediately. Usually, Smecta is best taken before meals or in between meals (of course, if one is not prescribed a diet). But there are exceptions. So, for heartburn, medicine is best taken after a meal. Smecta is used for diarrhea, food and alcohol poisoning, relieving hangover, nausea, dyspepsia, vomitting, flatulence. Smecta adalah obat antidiare yang di produksi oleh Combiphar. Smecta mengandung Dioctahedral smectite yang diindikasikan untukmengobati gejala pada diare non spesifik. KeteranganYou should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist. Diosmectite (brand names Smecta, Smecdral) is a natural silicate of aluminium and magnesium used as an intestinal adsorbent in the treatment of several gastrointestinal diseases, including infectious and non-infectious acute and chronic diarrhoea, including irritable bowel syndrome diarrhea subtype. Other uses include: chronic diarrhea caused by radiation-induced, chemotherapy-induced, and HIV/AIDS-associated chronic diarrhea. [1] WARNING (Contents) Diarrhea that is accompanied by torpor, thirst, fever, or blood in the stool requires prompt medical attention. Similarly, diarrhea in the infant , accompanied by a weight loss of more than 5% (sign of dehydration), may require urgent care. Smecta is sold over the world in pharmacies. The manufacturer of the drug is the French pharmaceutical company “Bofour Ipsen Industry”. Smecta has analogues with similar indications. Usually they have the same active substance – dioctahedral smectite. These drugs include Neosmectin and Diosmectin. Other sorbents, for example, activated carbon, are indirect analogues. However, it should be understood that not all sorbents are as effective and selective in their action as Smecta. Indications for use, contraindications and side effects

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. 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.DIRECTIONS FOR USE AND DOSAGE (summary) This medication is taken preferably after meals for esophageal pain, between meals for other indications. It can be mixed with water or semi-liquid food. For babies, the contents of the sachet can be diluted in a 50 ml bottle. Taking this medication may decrease the absorption of other medicines ingested simultaneously. No medication should be taken at the same time as SMECTA 3 g ORANGE-VANILLA. In children and infants, acute diarrhea should be treated in combination with the early administration of oral rehydration solution (ORS) to prevent dehydration.