Ref. number: 1334
Do not take SMECTA:
if you are allergic to diosmectit or any of the other ingredients of this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Smecta:
If your doctor has told you that you have an intolerance to some sugars in the case of a history of severe constipation.
In infants and children under 2 years of age: Smecta should not be used
For children over 2 years of age: Smecta should be used only for the treatment of acute diarrhea in combination with early administration of oral rehydration solution (RDP).
Prolonged use of Smecta should be avoided.
Talk to your doctor
- If the disorders due to acute diarrhea do not disappear within 3 days.
- If the pain is accompanied by fever or vomiting.
This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per dose.
Children and adolescents
SmectA should only be used in children over 2 years of age for the treatment of acute diarrhea. In children, acute diarrhea should be treated concomitantly with early administration of oral rehydration solution (ODP) to avoid dehydration.
Additional nutrition rules:
Provide rehydration with multiple salty or sugary drinks to compensate for diarrhea fluid loss (average daily water intake in adults should be 2 liters);
Continue eating while diarrhea continues, but with the exception of certain foods, especially raw vegetables and fruits, green vegetables, spicy foods, and frozen foods or beverages;
Grilled meat and rice are preferred
Other medicines and SMECTA
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The adsorption properties of this product may affect the rate of absorption of other substances. Therefore, no other medicines should be used together with diosmectitis. An interval of 2 hours is recommended between taking Smecta and another medicine.
Pregnancy, breastfeeding and fertility
Smecta is not recommended during pregnancy and lactation. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
No studies on the ability to drive and use machines have been performed, but no effects are expected.
SMECTA contains glucose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
SMECTA contains 0.679 g glucose per dose. This should be borne in mind in patients with diabetes mellitus.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects, which are usually mild and do not last long, include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Nettle fever (itchy rash)
Frequency not known (cannot be estimated from available data)
Symptoms of an allergic reaction such as skin redness, itching, swelling, difficulty breathing, nausea or seizures.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of damage to the sachet.
The draft does not require any special storage conditions.
Do not dispose of medicines in sewage or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
Marketing Authorization Holder
IPSEN PHARMA, FRANCE
Beaufour Ipsen Industrie, France
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Treatment of acute diarrhea
For children 2 years of age and older: the recommended dose is 6 g per day, which is equivalent to 2 sachets per day.
This dose may double at the beginning of an episode of acute diarrhea.
The recommended dose is 9 g per day, which corresponds to 3 sachets per day. In practice, the daily dose may be doubled at the beginning of treatment.
The average recommended dose is 9 g per day, which corresponds to 3 sachets per day.
Method and route of administration
Just before use, the contents of the sachet must be mixed with liquid to form a suspension.
In children: the contents of the sachet may be mixed with water in a 50 ml bottle and administered at intervals during the day or mixed with semi-liquid food such as broth, compote, puree, baby food.
In adults: the contents of the sachet can be mixed with half a glass of water.
Always take this medicine exactly as prescribed or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
If you take more SMECTA than you should
Taking too much Smecta can cause constipation. Constipation usually disappears when treatment is stopped or the dose is reduced
If you forget to take SMECTA
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What the SMECTA contains
The active substance is diosmectitis
The other ingredients are: glucose monohydrate, saccharin sodium, orange flavor *, vanilla taste **
* Orange flavor composition: maltodextrin, sucrose, acacia (E414), esters of mono- and diacetyl tartaric acid with fatty acid mono- and diglycerides (E472e), silica (E551), orange aroma.
** Vanilla flavor composition: maltodextrin, sucrose, glyceryl triacetate (E1518), silica (E551), ethyl alcohol, soya lecithin (E322), vanilla flavor.