NOTICE
ANSM - Last updated: 06/05/2015
Name of the medicinal product
SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet
diosmectite
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Review summary
What this leaflet contains:
1. What is SMECTA 3 g STRAWBERRY , powder for oral suspension in sachets and in which cases is it used?
2. What should be known before taking SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet ?
3. How to take SMECTA 3 g STRAWBERRY , powder for oral suspension in sachet ?
4. What are the possible side effects?
5. How to store SMECTA 3 g STRAWBERRY , powder for oral suspension in sachets ?
6. Additional information.
1. WHAT IS SMECTA 3 g STRAWBERRY, powder for oral suspension in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
OTHER INTESTINAL ADSORBENTS
Therapeutic indications
This medicinal product is indicated:
· in the symptomatic treatment of acute diarrhea in children and infants in addition to oral rehydration, and in adults,
· in the symptomatic treatment of chronic diarrhea,
· in the symptomatic treatment of pain related to oesogastroduodenal and colonic affections.
2. BEFORE YOU TAKE SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet:
· if you are allergic (hypersensitive) to diosmectite or to any of the other ingredients of this medication.
Precautions for use; special warnings
Warnings and Precautions
If the disorders do not go away within 7 days, consult your doctor.
If pain is associated with fever or vomiting, consult your doctor immediately.
Smecta 3g STRAWBERRY should be used with caution in patients with a history of severe constipation.
In children and infants, acute diarrhea should be treated in combination with the early administration of oral rehydration solution (ORS) to prevent dehydration.
This treatment is a complement to dietetic rules:
· rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (the adult's average daily water intake is 2 liters),
· feeding the diarrhea time, excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,
· favoring grilled meats, rice.
The use of this medication is not recommended in patients with glucose and galactose malabsorption syndrome.
Interaction with other medicines
Other drugs and SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription; talk to your doctor or pharmacist.
As a precaution, this medication and other medicines should not be taken at the same time.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
ASK FOR YOUR PHYSICIAN OR PHARMACIST BEFORE USING A MEDICINE.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet contains glucose.
3. HOW TO TAKE SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Treatment of acute diarrhea
In infants and children:
· Before 1 year: 2 sachets per day for 3 days then 1 sachet per day.
· After 1 year: 4 sachets per day for 3 days then 2 sachets per day.
In adults:
On average 3 sachets per day. In practice, the dosage can be doubled at the start of treatment.
Further information
In infants and children:
· Before 1 year: 1 sachet per day.
· Between 1 and 2 years: 1 to 2 sachets per day.
· After 2 years: 2 to 3 sachets per day.
In adults:
On average 3 sachets per day.
Method and route of administration
Oral use.
The contents of the sachet must be suspended just before use.
In children and infants:
The contents of the sachet can be diluted in a bottle of 50 ml of water to distribute during the day, or mixed with semi-liquid food: porridge, compote, puree, "petit-pot" ...
In adults:
The contents of the sachet can be diluted in half a glass of water
Frequency and Timing of Medication
Preferably:
· after meals in the esophagites,
· away from meals in other directions.
Duration of treatment
Not applicable.
Symptoms and Instructions for Overdose
If you take more SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet:
Do not take a double dose to make up for the single dose that you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· constipation, usually leading to reduction of dosage but in rare cases may lead to discontinuation of treatment,
· flatulence,
· vomiting.
During the marketing, very rare cases of allergic manifestations including urticaria, rash, pruritus and angioedema have been reported. Cases of aggravation of constipation have also been reported.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use SMECTA 3 g STRAWBERRY , powder for oral suspension after the expiry date which is stated on the carton and the sachet.
The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What SMECTA contains 3 g STRAWBERRY, powder for oral suspension in sachet
The active substance is:
Diosmectite ................................................. .................................................. ........................ 3.00 g
For a sachet.
The other components are:
Glucose monohydrate, sodium saccharin, strawberry flavor *.
* Composition of the strawberry aroma : maltodextrin, propylene glycol, gum arabic, blend of natural and synthetic aromas.
Pharmaceutical form and content
Aspect of SMECTA 3 g STRAWBERRY, powder for oral suspension in sachet and contents of the pack
This medicinal product is in powder form for oral suspension in sachets.
Boxes of 10, 12, 18, 30 or 60 sachets.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Marketing Authorization Holder and Manufacturer
Holder
IPSEN PHARMA
65, quai Georges Gorse
92100 BOULOGNE BILLANCOURT
exploiting
IPSEN PHARMA
65, quai Georges Gorse
92100 BOULOGNE BILLANCOURT
Maker
BEAUFOUR IPSEN industry
STREET VIRTON
28100 DREUX
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.>
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
