Smecta 3 g powder for oral suspension
SMECTA 3 g powder for oral suspension
Smecta 3 g powder for oral suspension
Each sachet contains 3 g of diosmectite ( diosmectite * (DCF))
Excipients with known effect: glucose, sucrose, ethanol.
Dioctahedralsmectite (1.4 nm phyllite):
*This is a natural double silicate of aluminum and magnesium that differs from other silicates in its X-ray diffraction spectrum. Iron, magnesium and calcium partially replace aluminum in the octahedral layer of aluminum oxide.
For the full list of excipients, see point 6.1
Powder for oral suspension in sachets.
The medicinal product is a gray-white to ocher powder with a slight orange-like odor when the suspension is prepared.
- Treatment of acute diarrhea in children > 2 years of age together with oral rehydration solution, as well as in adults
- Symptomatic treatment of chronic functional diarrhea in adults
- Symptomatic treatment of pain associated with functional bowel disease in adults
For special warnings and precautions for use, see section 4.4. Treatment does not exclude the need for rehydration when required. The volume of rehydrate and the method of administration (oral or intravenous) is adapted to the age and condition of the patient and the severity of the diarrhea.
- Dosage and method of administration
In children from two years of age:
6 grams (2 sachets) per day
This dose may be doubled at the onset of an episode of acute diarrhea
Adults
- 9 grams (3 sachets) per day
- This dose may be doubled at the beginning of an episode of acute diarrhea
• Treatment for other indications
Adults
Average 9 grams (three sachets) daily.
Application method
Oral administration
The contents of the sachet should be suspended immediately before use.
Children
The contents of the sachet can be dissolved in a teat or bottle with 50 ml of water and given during the day or mixed well with semi-liquid food: porridge, stewed fruit, vegetable puree and baby food.
Adults:
The contents of the sachet can be dissolved in half a glass of water.
Hypersensitivity to the active substance or to any of the excipients listed in point 6.1.
Special warnings
They are required when patients with a history of severe chronic constipation are treated with diosmectite.
Pediatric population
In infants and children under 2 years of age, the use of Smecta should be avoided. The reference treatment for acute diarrhea is oral rehydration solution (ORS). In children, treatment of acute diarrhea with diosmectite should be carried out in combination with prior oral rehydration therapy to avoid dehydration. Long-term use of Smekta should be avoided.
In adults , rehydration therapy is not necessary except in special cases.
The duration of oral or intravenous rehydration therapy should be tailored to the nature (severity) of the disease, the age of the patient, and also to the clinical history of the disease.
Precautions for use
Smecta should not be taken by patients with rare hereditary problems such as fructose intolerance, malabsorption of glucose and galactose or deficiency of the sucrose-isomaltose complex enzyme.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.
- Interaction with other medicinal products and other forms of interaction
Since the absorption properties of this product may affect the rate and/or level of absorption of other substances, it is recommended that other drugs are not administered concurrently with Smecta.
Fertility
The effect on human fertility has not been studied.
Pregnancy
There is no or limited data (on the outcome of less than 300 cases of pregnancy) from the use of Smecta in pregnant women.
Animal studies are insufficient with regard to reproductive toxicity.
Account not recommended during pregnancy.
Breastfeeding
There is limited data on the use of Smecta during breastfeeding.
Smecta is not recommended during breastfeeding.
There is no influence on the ability to drive and use machines.
No studies have been conducted, but no effects are expected.
The most commonly reported adverse reaction during treatment is constipation, which occurs in approximately 7% of adults and approximately 1% of children. If constipation occurs, diosmectite should be discontinued and, if necessary, resumed at a lower dose. The table below lists adverse drug reactions from clinical trials and from post-marketing sources. Frequencies are defined according to the following rule: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000) to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Adverse drug reactions determined from clinical trials and from post-marketing sources
System-organ class | Frequency | Adverse reaction |
|---|---|---|
Gastrointestinal disorders | Frequent* | Constipation |
Disorders of the skin and subcutaneous tissue | Uncommon* | A rash |
Rare* | Urticaria | |
Unknowns | Angioedema, pruritus | |
Disorders of the immune system | Unknowns | Hypersensitivity |
* Estimated based on frequencies in clinical trials
Reporting of suspected adverse reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction by:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Phone: +35 928903417
website: www.bda.bg
Overdosage may result in severe constipation or bezoar.
- PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antidiarrheal adsorbents ; ATS code: А07ВС05
Clinical Pharmacology:
For diosmectite it has been confirmed that
- adsorbs gas in the intestines in adults
- restores normal mucosal permeability in a clinical study performed in children with gastroenteritis
Thanks to its sheet-like structure and its high plastic viscosity, Smectite has a powerful covering property of the gastrointestinal mucosa.
Toxico-pharmacological studies have shown that diosmectite:
- acts as a mucus stabilizer and cytoprotector of the gastrointestinal mucosa against aggressive agents such as hydrochloric acid, bile acids, salts and other irritants,
- demonstrates a high adsorption capacity against enterotoxins, bacteria and viruses,
- strengthens the barrier of the intestinal mucosa,
- diosmectite restores the defect in the epithelial barrier caused by the pro-inflammatory cytokine TNF-α (involved in several intestinal disorders: infectious diarrhea, inflammatory bowel disease and food allergy).
When taken, Smekta is limited to the luminal side of the epithelium (it is neither absorbed nor metabolized).
Diosmectite is excreted in the feces through the process of normal intestinal transit.
Non-clinical data indicate no specific hazard for humans, which data are based on conventional studies of acute and repeated toxicity and genotoxicity.
saccharin sodium,
Vanilla o in taste*,
Orange flavor**
* Vanilla flavor composition:
Maltodextrin, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soy lecithin (E322), vanilla flavor.
*Composition of the orange flavor
Maltodextrin, sucrose, acacia gum, mono- and diacetyl ester of tartaric acid and mono- and diglycerides of butyric acids (E472e), silicon dioxide (E551), orange flavor.
- Incompatibilities
Not known
- Expiry date
3 years
- Special storage conditions
There are no special storage conditions.
- Type and contents of packaging
Sachets (kraft paper, aluminum foil/PE) containing 3.760 g of powder for oral suspension.
Cardboard packs of 10, 30 and 60 sachets.
6.6 Special precautions for disposal and handling
Before discarding, the contents of the sachet must be mixed with water and poured out.
- HOLDER OF THE USE PERMIT
IPSEN Consumer HealthCare
65, quai Georges Gorse
92 100, Boulogne Billancourt
FRANCE
- USE AUTHORIZATION NUMBER(S).
20020513
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE USE AUTHORIZATION
Date of first authorisation: 20.06.2002
Date of last renewal: 21.12.2007
- TEXT UPDATE DATE: 06/2020
