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Indications :
- Symptomatic treatment of acute diarrhea in children and infants as a complement to oral rehydration and in adults.
- Symptomatic treatment of chronic diarrhea.
- Symptomatic treatment of pain related to oesogastroduodenal and colonic disorders.
Name of the medicinal product
SMECTA 3 g, powder for drinkable suspension in sachet
Diosmectite
Box
Please read this leaflet carefully before taking this medicine. It contains important information about your treatment.
If you have any other questions or doubts, ask your doctor or pharmacist for more information.
Contents of the leaflet
In this leaflet :
1. WHAT IS SMECTA 3 g, powder for drinkable suspension in sachet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING SMECTA 3 g, powder for drinkable suspension in sachet
3. HOW TO TAKE SMECTA 3 g, powder for drinkable suspension in sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SMECTA 3 g, powder for drinkable suspension in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS SMECTA 3 g, powder for oral suspension in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine contains an active substance, diosmectite, which acts to protect the digestive tract.
Therapeutic indications
This medicine is used to treat short-term diarrhoea (acute diarrhoea) in adults and children over the age of 15.
This treatment is a complement to dietary measures.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING SMECTALIA 3 g, powder for drinkable suspension in sachet?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Contraindications
Never take SMECTA:
If you are allergic (hypersensitive) to diosmectite or any of the other components contained in SMECTALIA. For a list of ingredients, see section 6.
Precautions for use; special warnings
Be careful with SMECTA:
Do not try to manage the symptoms yourself and consult your doctor promptly, if:
Do not continue the treatment against diarrhoea on your own and consult your doctor if:
Take special precautions with SMECTA:
This treatment is a complement to the following hygienic and dietary rules:
o by excluding certain foods and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as iced foods or drinks,
o give preference to grilled meats and rice.
Interactions with other medications
Taking other medications
You should space out SMECTA from another medicine to avoid decreasing the effectiveness of the other treatment.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he/she can decide whether it is necessary to continue treatment.
Tell your doctor if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of SMECTA:
This medicinal product contains glucose and sucrose (see also 'Be careful with SMECTA)
3. HOW TO TAKE SMECTA 3 g, powder for oral suspension in sachet
Instructions for proper use
Not applicable.
Posology, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
For adults and children over 15 years of age.
The management of diarrhoea in the elderly requires special attention. Indeed, diarrhoea can lead to significant water loss (dehydration) which can have serious consequences in the elderly.
Posology
Start by taking 1 sachet (3 g) and then take 1 additional sachet after each new unformed stool, without exceeding 6 sachets per day.
Maximum dosage: 6 sachets per day. Do not exceed 3 days of treatment without medical advice. |
Method of administration
Duration of treatment
The maximum duration of treatment is 3 days, in the absence of medical advice.
If symptoms do not improve or worsen after 2 days or if signs of severity (blood, dehydration, ...) appear, consult your doctor.
Symptoms and instructions in case of overdose
If you have taken more SMECTA than you should have:
Consult your doctor or pharmacist immediately.
Instructions in case of missed doses
If you forget to take SMECTA:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, SMECTA may have side effects, although not everyone is susceptible.
The following effects may occur:
In very rare cases, an allergy may occur. Allergy may be manifested by the following signs:
If you experience any of these signs, you should seek medical attention immediately.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE SMECTA 3 g, powder for drinkable suspension in sachet?
Keep out of the reach and sight of children.
Expiry date
Do not use SMECTA after the expiry date stated on the box and sachet. The expiry date refers to the last day of the month.
Conditions of storage
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does SMECTA contain?
The active substance is:
Diosmectite ........................................................................................................................................... 3 g
For one sachet.
The other components are:
Glucose monohydrate, sodium saccharin, orange-vanilla flavouring (containing in particular sucrose).
Pharmaceutical form and content
What is SMECTA and what does it contain?
This medicine comes in the form of a powder for drinkable suspension in a sachet. Box of 18 sachets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
Operator
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
Manufacturer
BEAUFOUR IPSEN INDUSTRIE
RUE ETHE VIRTON
28100 DREUX
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