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SMECTA GO x 8 bags

Code :

36500

Brand:

SMECTA

Manufacturer :

IPSEN


Last retail price: 8.69 лв
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SMECTA GO x 8 bags

SmectaGo® (SmectaGo )

Ready-to-drink suspension in sachets containing diosmectite

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This leaflet has been prepared to help you use this medicine correctly. If you have any further questions, ask your doctor or pharmacist.

Keep this leaflet because 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 taking SmectaGo®

3. How to take SmectaGo®

4. Possible side effects of SmectaGo®

5. How to store SmectaGo®

6. Contents of the pack and other information

  1. What is SmectaGo® and what is it 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 of age . 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 in SmectaGo is diosmectite. Diosmectite is a natural clay that helps stop and treat diarrhea and relieve stomach pain. It has been shown to:

  • binds to toxins and microorganisms (bacteria and viruses) and helps remove them from the body;
  • protects the gastrointestinal tract and helps repair gastrointestinal damage with its natural coating properties.

The efficacy of diosmectite has been proven through clinical studies.

  1. 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 pack and further 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, chills, or repeated vomiting;
  • you have signs of dehydration (if you experience extreme thirst, dry tongue, fatigue or persistent loss of appetite);
  • your stool contains blood or mucus;
  • diarrhea is accompanied by sudden weight loss;
  • 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 recurs, or you experience alternating bouts of diarrhea and constipation.

                                 

Take special precautions with SmectaGo

  • SmectaGo should be used with caution by 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 compensate for fluids lost from diarrhea and to prevent dehydration.

Children should eat regularly while diarrhea persists. It is recommended to eat small, frequent portions of mixed foods (e.g. rice, eggs, meat, cooked fruits and vegetables).

If your child experiences behavioral changes, if diarrhea symptoms do not improve or worsen, or if there is frequent or persistent vomiting, contact your doctor.

  • In adults with acute diarrhea, SmectaGo is an adjunct treatment to water rehydration to compensate for fluids lost from diarrhea. While diarrhea continues, regular food intake should be maintained. It is recommended to consume fruit juices or small portions of light foods without fatty, heavy, spicy, stimulating ingredients.

Treatment of diarrhoea in elderly or frail patients requires special attention, as diarrhoea can lead to significant fluid loss (dehydration), which can have serious consequences.

Warnings for chronic diarrhea or stomach pain

Prolonged or repeated use of SmectaGo is not recommended. In case of 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 medications 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 breastfeeding women, but it is recommended to consult your doctor before taking SmectaGo®.

  1. How to take SmectaGo

Method of administration:

This medical device is taken orally and is ready to drink. The contents of the sachet can be swallowed directly.

Shake the sachet before opening it.

Each sachet is used only once after opening.

Recommended dosage

  • Acute diarrhea

Age

Dose

Children (8 to 15 years old 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 stool, up to 6 sachets per day

How long to take SmectaGo® for acute diarrhea?

You can use SmectaGo for up to 3 days . If diarrhea lasts longer than 3 days, consult your doctor.

  • Chronic diarrhea or stomach pain:

Age

Dose

Adults (only)

Up to 3 sachets per day (1 in the morning, 1 at noon, 1 in the evening), if necessary.

How long should SmectaGo be taken for chronic diarrhea or stomach pain?

You can only use this medical device for up to 2 weeks without seeking medical advice. Prolonged or repeated use of SmectaGo is not recommended.

If you forget to take SmectaGo

If you forget to take a dose, take it after your next loose stool (bowel movement). Do not exceed the recommended daily dose.

  1. Possible side effects

The most common adverse reaction during treatment is constipation . If constipation occurs, treatment should be discontinued and, if necessary, restarted at a lower daily dose. Some other less common adverse reactions 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 listed in this leaflet, or if any of the side effects persist for a long time, tell your doctor or pharmacist.

  1. How to store SmectaGo®

Keep out of the reach of children.

SmectaGo should not be used after the expiry date stated on the packaging. There are no special storage conditions for this medical device.

6. Contents of the pack and other information

The main ingredient in SmectaGow 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

Designations:

CE 0426

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