0

Drug SMECTA The active substance is Diosmectite 3 g  Symptomatic treatment of  acute diarrhea, chronic diarrhea in children and infants in addition to oral rehydration and in adults

No-Spa  Indicated for Colic biliary pain due to smooth muscle spasm

Diatabs treatment of acute and chronic diarrhea in nonspecific bowel diseases

NORMAGUT indications for maintenance of a well-functioning intestinal flora and a good intestinal health

1. IDENTIFYING THE MEDICATION

A) Name: SMECTA, powder for drinkable suspension in sachet.

B) Composition:

The active substance is Diosmectite: 3 g The other components are: Glucose monohydrate. Sodium saccharin, orange- vanilla flavour (containing saccharose)

C) Pharmaceutical form:

Powder for drinkable suspension Box containing 30 or 60 sachets

D) Pharmaco-therapeutics class:

Other intestinal adsorbents

E) Marketing Authorisation Holder/distributon IPSEN Pharma

65 quai Georges Gorse 92100 Boulogne- Billancout.

F) Manufacturer name and address: BEAUFOUR IPSEN Industrie

Rue Ethe Virton 28100 Dreux – France

SMECTA The active substance is Diosmectite 3 g

2. INDICATION:

– Symptomatic treatment of acute diarrhea in children and infants in addition to oral rehydration and in adults;

– Symptomatic treatment of chronic diarrhea;

– Symptomatic treatment of pain associated with oesogastroduodenal and colonic disease

3. CONTRA-INDICATION:

– Hypersensitivity to diosmectite or to one of the excipients

– Due to the presence of glucose and saccharose, this medication is contraindicated for patients who are fructose intolerant.

4. PRECAUTION AND WARNING:

If the problem does not disappear within 7 days, consult your doctor.

If the pain is associated with a high temperature or vomiting, consult your doctor immediately.

Smecta must be used with precaution if you have a history of severe constipation.

In children and infants, the treatment of acute diarrhea must be accompanied by the early administration of an oral rehydration solution (ORS) to avoid dehydration.

5. INTERACTION WITH MEDICATIONS AND OTHER INTERACTION:

This product’s absorbent properties may interfere with the absorption periods and/or rates of another substance. It is recommended that this medication is not taken with any other medication.

6. PREGNANCY AND LACTATION:

During pregnancy and breast feeding, you should always ask the advice of your doctor or pharmacist before taking any medication.

7. POSOLOGYAND METHOD OF ADMINISTRATION:

a) Dosage:

Treatment of acute diarrhea Children and infants:

– Up to one year: 2 sachets a day for 3 days, then 1 sachet a day

– One year and older: 4 sachets a day for 3 days, then 2 sachets a day.

Adults:

An average of 3 sachets a day. In practice, the daily dosage can be doubled at the beginning of the treatment.

Other indications:

In children and infants:

– Up to one year: 1 sachet a day

– Between 1 and 2 years: 1 to 2 sachets a day

– After 2 years: 2 to 3 sachets a day.

In adults:

An average of 3 sachets a day. b) Method of administration: Orally The content of the sachet must be mixed in suspension directly before use. Preferably to be taken:

– After meals, if oesophagite,

– Between meals, for other indications.

C) Overdose:

If you take too much Smecta, contact your doctor or pharmacist immediately

d) Forget to take one or more doses:

Do not take double dose to make up for the single dose you have forgotten to take.

8. ADVERSE EFFECTS

As with any active ingredient, this medication can cause more or less embarrassing effects in certain people.

– Constipation, usually resolving with the reduction of the dose, but in rare cases, it can lead to the treatment being stopped.

– Flatulence.

– Vomiting.

Whilst post-marketing experience, very rare cases of allergic reactions including urticaria rashes, pruritis and angio- oedema have been reported. Cases of constipation worsening have also been reported.

– Inform your doctor or pharmacist of any adverse or embarrassing event that is not included in this leaflet

9. PHARMACODYNAMIC PROPERTIES SMECTA

due to its structure in leaves and its high plastic viscosity, has a significant digestive mucous covering capacity.

SMECTA, by interacting with mucus glycoproteins, increases the mucous gel’s resistance to attack.

SMECTA, by acting on the digestive mucous barrier and its high fixation capacity, protects the digestive mucous. SMECTA is radio- transparent, does not colour stools and, at the usual doses, does not affect the physiological intestinal transit time.

The combined results of the 2 double blind randomised studies that compare the efficacy of SMECTA against placebo and which included 602 patients aged between 1 and 36 months, suffering from acute diarrhea, demonstrate a significant reduction in stool output emitted during the first 72 hours, in the group of patients treated by SMECTA, in addition to oral rehydration.

Given the structure of diosmectite, SMECTA is neither absorbed nor metabolised.

11. SHELF – LIFE: 3 years

12. SPECIAL STORAGE CONDITION: A dry place, below 25C

13. NATURE AND CONTENTS OF CONTAINER

Sachet (Kraft paper, Aluminum foil, Polyethylene) containing 3.760 g of powder for oral suspension

KEEP OUT OF REACH OF THE CHILDREN DO NOT EXCEED THE EXPIRY DATE THAT APPEARS ON THE OUTER CARTON.

Children and infants:

The content of the sachet may be mixed in a bottle of 50 ml of water to be given during the day, or mixed with a semi-liquid food, such as broth, compote, puree, baby food…

Adults:

The content of the sachet may be mixed with half a glass of water.

Read the insert leaflet carefully before use. For more information, please see a doctor.

Leave a Reply