SMECTA GO x 8 bags
SmectaGo® (SmectaGo )
Ready-to-drink suspension in a sachet containing diosmectite
Read the leaflet carefully before you start taking this product because it contains important information for you. A leaflet has been prepared to help you use this product correctly. If you have any other questions, ask your doctor or pharmacist.
Keep this leaflet as you may need to read it again.
What this leaflet contains
1. What SmectaGo® is and what it is used for
2. What you need to know before you take SmectaGo®
3. How to take SmectaGo®
4. Possible side effects of SmectaGo®
5. How to store SmectaGo®
6. Contents of the package and additional information
- What SmectaGo® is and what it is used for
SmectaGo is a medical device – a ready-to-drink suspension in a sachet as a single dose for oral administration.
SmectaGo is intended for:
• treatment of acute diarrhea in adults and children over 8 years old . In children, treatment of acute diarrhea should be accompanied by oral rehydration solution to prevent dehydration
• treatment of chronic diarrhea or stomach pain in adults.
The main ingredient of SmectaGo is diosmectite. Diosmectite is a natural clay that helps stop and treat diarrhea and relieve stomach pain. It has been proven that he:
- binds to toxins and microorganisms (bacteria and viruses) and helps to remove them from the body;
- protects the gastrointestinal tract and helps to restore gastrointestinal damage with its natural coating properties.
The effectiveness of diosmectite has been proven by clinical studies.
- What you need to know before taking SmectaGo®
Do not take SmectaGo :
- if you are allergic to diosmectite or any of the other ingredients (see Section 6: "Contents of the package and additional information" );
- in children under 8 years of age with acute diarrhea;
- in children with chronic diarrhea or stomach pain.
Special warnings and precautions for this medical device
Do not try to treat the symptoms yourself and consult your doctor immediately if:
- diarrhea is accompanied by high fever, fever or repeated vomiting;
- you have signs of dehydration (if you feel very thirsty, dry tongue, lethargy or persistent loss of appetite);
- your stool contains blood or mucus;
- diarrhea is accompanied by a sudden loss of body weight;
- diarrhea occurs during or after antibiotic treatment;
- you have an established immunodeficiency or are currently undergoing treatment that suppresses the body's immune system (with immunosuppressants or cancer treatment);
- you have recently returned from a trip to a tropical country.
Do not continue to treat diarrhea and consult your doctor if:
- Symptoms do not improve or worsen after the recommended duration of treatment (see Section 3: "How to take SmectaGo") .
- Diarrhea often comes back, or you experience alternating bouts of diarrhea and constipation.
Take special precautions with SmectaGo
- SmectaGo should be used with caution in patients who have had acute constipation;
- SmectaGo contains small amounts of ethanol (ethyl alcohol), less than 100 mg per daily dose.
Warnings for patients with acute diarrhea
- In children, SmectaGo should be used together with an oral rehydration solution (ORS) to replace fluids lost from diarrhea and to prevent dehydration.
Children should take regular meals as long as the diarrhea continues. It is recommended to take frequent small portions of mixed foods (eg rice, eggs, meat, cooked fruits and vegetables).
If the child experiences changes in behavior, if the diarrhea symptoms do not improve or get worse, or if there is frequent or persistent vomiting, see your doctor.
- In adults with acute diarrhoea, SmectaGo is an adjunctive treatment to rehydration with water to replace fluids lost from diarrhoea. As long as the diarrhea continues, regular food should be taken. It is recommended to take fruit juices or small portions of light foods without fatty, heavy, spicy, stimulating ingredients.
Treatment of diarrhea in elderly or frail patients requires special attention, as diarrhea can lead to significant fluid loss (dehydration), which can have serious consequences.
Warnings for chronic diarrhea or stomach pain
Long-term or repeated use of SmectaGo is not recommended. For chronic diarrhea or stomach pain, if symptoms persist for more than two weeks, consult your doctor to determine the root cause before treatment can continue.
Other medicines and SmectaGo
Do not take SmectaGo at the same time as other oral medications, so as not to reduce the effectiveness of the other treatment. It is recommended to have an interval of 2 hours between taking other medicines and SmectaGo.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines or medical devices, including those obtained without a prescription.
Pregnancy and breastfeeding
SmectaGo® can be used by pregnant and lactating women, but it is recommended to consult your doctor before taking SmectaGo®.
- How to take SmectaGo
Method of reception:
This medicinal product is taken orally and is ready to drink. The contents of the sachet can be swallowed straight.
Rub the sachet before opening.
Each sachet is used only once after opening.
Recommended dosage
- Acute diarrhea
Age | Dose |
Children (from 8 to 15 years inclusive) | 2 sachets initially, then 1 sachet after each loose stool, up to 4 sachets per day Oral rehydration solution (ORS) should be taken to replace fluids lost from diarrhea and prevent dehydration. |
Adults and children over 15 years old | 2 sachets initially, then 1 sachet after each loose bowel movement, up to 6 sachets per day |
How long is SmectaGo® taken for acute diarrhea? | You can use SmectaGo for up to 3 days . If the diarrhea lasts more than 3 days, consult your doctor. |
- Chronic diarrhea or stomach pain:
Age | Dose |
Adults (only) | Up to 3 sachets per day (1 morning, 1 lunch, 1 evening) as needed. |
How long to take SmectaGo for chronic diarrhea or stomach pain | You can use this medical device for only up to 2 weeks without seeking medical advice. Long-term or repeated use of SmectaGo is not recommended. |
If you forget to take SmectaGo
If you forget to take a dose, take it after the next loose stool (bowel). Do not exceed the recommended daily dose.
- Possible side effects
The most common side effect during treatment is constipation . If constipation occurs, the treatment should be stopped and, if necessary, restarted with a smaller daily dose. Some other less common side effects are rash, urticaria (hives), pruritus (itching), and angioedema (an allergic reaction that causes swelling of the skin, lips, throat, and tongue).
If you notice any side effects not described in this leaflet, or if any of the side effects last longer, tell your doctor or pharmacist.
- How to store SmectaGo®
Keep out of the reach of children.
SmectaGo should not be used after the expiry date stated on the package. There are no special storage conditions for this medical device.
6. Contents of the package and other information
The main ingredient in SmectaGo is diosmectite, 3 g per sachet.
The other ingredients are: caramel and cocoa flavoring*, xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, purified water.
*Composition of caramel and cocoa flavoring: mixture of natural and synthetic flavorings, caramel coloring E 150d, caramelized sugar syrup, propylene glycol E1520, water, ethanol, caffeine.
Manufacturer:
Ipsen Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
France
Phone: +33 (0)1 58 33 00 00
Last edited: November 2018
Markings:
CE 0426
