Keep out of reach of children.
Read the directions carefully before use.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Diosmectite …………………….. 3 g
Excipients q.s …………… 1 tablet
Powder for oral suspension.
Product description: A light brownish-yellow, fine powder with an aromatic odour.
Box of 24 sachets x 3.8 g
Pharmacotherapeutic group: Other intestinal adsorbents. ATC code: A07BC05.
Diosmectite has been shown in clinical pharmacology:
- Adsorbs intestinal gas in adults.
- Restores normal permeability of the mucosa during a clinical study in children with gastroenteritis.
By its structure in layers and high plastic viscosity, diosmectite has a significant covering power of the digestive mucosa.
The combined results of 2 randomized double-blind studies comparing the efficacy of diosmectite versus placebo and including 602 patients aged 1 to 36 months with acute diarrhea show a significant reduction in the flow of stool emitted during the first 72 hours in diosmectite group in addition to oral rehydration.
Due to diosmectite's structure, diosmectite remains on the luminal side of the digestive epithelium. It is neither absorbed nor metabolized.
Diosmectite is eliminated in the stool according to the natural process of intestinal transit.
No studies on the effects on the ability to drive and use machines have been performed. However, the expected effect is none or negligible.
Pregnancy
There are no data or limited data (fewer than 300 pregnancies) on the use of diosmectite in pregnant women.
Studies in animals are insufficient to conclude on reproductive toxicity.
Diosmectite is not recommended during pregnancy.
Breast-feeding
There is limited data on the use of diosmectite during breast-feeding.
Diosmectite is not recommended during breastfeeding.
Fertility
The effect on human fertility has not been studied.
Since the adsorbent properties of this product may interfere with the absorption rate and/or extent of another substance, it is recommended that any other medication be administered away from diosmectite (more than 2 hours, if possible).
The most common side effect reported during treatment is constipation, which occurs in approximately 7% of adults and 1% of children. If constipation occurs, treatment with diosmectite should be discontinued, and reintroduced if necessary at a lower dose.
Adverse reactions reported during clinical studies and post-marketing follow-up are listed below. The frequency is defined according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); not known (cannot be estimated from the available data).
Undesirable effects reported during clinical studies and post-marketing follow-up:
Gastrointestinal disorders
Common*: constipation. Uncommon*: vomiting.
Skin and subcutaneous tissue disorders
Uncommon*: eruption. Rare*: urticaria. Not known: angioedema, pruritus.
Immune system disorders
Not known: hypersensitivity.
* Frequency estimated from the incidence rates observed during clinical studies.
Please inform your doctor of all undesirable effects upon drug administration.
An overdose can lead to severe constipation or bezoar.
Store in dry places, not exceeding 30°C, protect from light.
Treatment of acute diarrhea in children over 2 years of age in addition to oral rehydration and in adults.
Symptomatic treatment of chronic diarrhea in adults.
Symptomatic treatment of pain associated to gastrointestinal diseases in adults.
METHOD OF ADMINISTRATION
Oral use.
The contents of the sachet should be suspended just before use.
In children, the contents of the sachet can be diluted with 50 ml of water to be distributed during the day, or mixed with a semi-liquid food, such as broth, compote, puree, baby food, etc.
In adults, the contents of the sachet can be diluted in half a glass of water.
POSOLOGY
Treatment of acute diarrhea
Children aged > 2 years: 4 sachets/day for 3 days, then 2 sachets/day for 4 days.
Adults: An average of 3 sachets/day for 7 days. In practice, the daily dosage can be doubled at the start of treatment.
Other indications
Adults: An average of 9 g (3 sachets) per day.
Or as directed by the physician.
CONTRAINDICATIONS
Hypersensitivity to diosmectite or to any of the excipients of the drug.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Diosmectite should be used with caution in patients with a history of severe chronic constipation.
In infants and children under 2 years of age, the use of diosmectite should be avoided. The standard treatment for acute diarrhea is oral rehydration solution (ORS).
In children over 2 years of age, the treatment of acute diarrhea should be accompanied by an early administration of an oral rehydration solution (ORS) to avoid dehydration.
Chronic use of diosmectite should be avoided.
In adults, rehydration should not be skipped during the treatment if this is considered to be necessary.
The extent of rehydration by oral or intravenous rehydration solution should be adjusted according to the intensity of diarrhea, the age and the particularities of the patient.
The patient should be informed to:
- Rehydrate with plenty of salty or sweet fluids to compensate for the loss of the fluid due to diarrhea (the average daily intake of water for an adult is 2 liters);
- Maintain a normal food intake during diarrhea:
+ by excluding certain intakes and particularly raw vegetables, fruits, green vegetables, spicy dishes as well as frozen foods or drinks;
+ by favoring grilled meats and rice.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially “sodium-free”.
Patients with rare hereditary problems of galactose intolerance, e.g. galactosaemia, or glucose-galactose malabsorption should not take this medicine.
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