French pharmacy
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French pharmacy
Smectalia Anti Diarrheal 12 Sachets Caramel Cocoa Flavor on sale in our organic pharmacy
For warnings, precautions for use and contraindications, please consult the instructions for use.
Short-term treatment of acute diarrhea in adults and children over 15 years of age. This treatment is a complement to dietary measures.
What is diarrhea ?
It is defined by too frequent daily emissions of too abundant, liquid or pasty stools (weight greater than 300 g / d). In practice, we speak of diarrhea when there are more than three loose or watery stools per day.
Acute diarrhea usually lasts less than 8 to 10 days. It is preceded by normal transit and does not recur in the short term. Chronic diarrhea usually lasts for months or years. The onset of chronic diarrhea can be mistaken for acute diarrhea which is much more common.
1 sachet (3 g) then 1 sachet after each new non-molded saddle, without exceeding 6 sachets per day.
The maximum duration of treatment is 3 days.
Method of administration :
Preferably administer :
Diosmectite 3.00 g
For 1 sachet.
The other ingredients are :
Xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, caramel-cocoa flavor *, purified water.
* Composition of the caramel-cocoa flavor: mixture of natural and synthetic flavors, caramel coloring (E 150d), caramelized sugar syrup, propylene glycol, water, ethanol, caffeine.
Box of 12 sachets of oral suspension.
Be careful, the drug is not a product like any other. Read the instructions for the medication carefully before ordering it. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 18/11/2015
SMECTALIA 3 g, oral suspension in sachet
diosmectite
This is an authorized and controlled medication (see Identification No on the outer packaging):
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist beyond 3 days, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
· Do not use this medication for children.
What this leaflet contains:
1. What is SMECTALIA 3 g, oral suspension in sachets and in which cases it is used?
2. What should I know before taking SMECTALIA 3 g oral suspension in sachets ?
3. How to take SMECTALIA 3 g, oral suspension in sachet ?
4. What are the possible side effects?
5. How to store SMECTALIA 3 g, oral suspension in sachets ?
6. Additional information.
1. WHAT IS SMECTALIA 3 g, oral suspension in sachet AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE SMECTALIA 3 g, oral suspension in sachet?
List of information needed before taking the medication
Not applicable.
Never take SMECTALIA 3 g oral suspension in sachets in the following cases:
· If you are allergic (hypersensitive) to diosmectite or any of the other ingredients of SMECTALIA. You will find the list of components in section 6.
Precautions for use; special warnings
Warnings and Precautions
Do not try to manage the symptoms yourself and see your doctor promptly if:
· Diarrhea is accompanied by a high fever, chills or repeated vomiting;
· Your stools contain mucus and / or blood;
· Your diarrhea is accompanied by a sudden weight loss (more than 2 kg);
· Diarrhea occurs during or after antibiotic treatment;
· You present a vulnerable terrain: known heart valves disease, a treatment that diminishes your body's immune system (immunosuppressive or ongoing chemotherapy);
· You have recently traveled to a tropical country.
Do not continue diarrhea treatment yourself and see your doctor if:
· Your symptoms do not improve or worsen after two days of treatment.
· You are very thirsty, you are tired or you have dry tongue (sign of dehydration). It is imperative to QUICKLY CONSULT A DOCTOR.
· Diarrhea often recurs or you experience alternating episodes of diarrhea and constipation.
Take special precautions with SMECTALIA 3 g, oral suspension in sachet:
· SMECTALIA should be used with caution in patients with severe constipation.
This treatment is a complement to the following hygiene-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),
· Feed the time of diarrhea,
o excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,
o By favoring grilled meats, rice.
This medicine contains small amounts of ethanol (alcohol) of less than 100 mg per daily dose.
Interaction with other medicines
Other medicines and SMECTALIA 3 g, oral suspension in sachet:
You should take SMECTALIA intake from another medication to avoid decreasing the effectiveness of the other treatment.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
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.
Tell your doctor if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SMECTALIA 3 g, oral suspension in sachet contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.
3. HOW TO TAKE SMECTALIA 3 g, oral suspension in sachet?
Not applicable.
Medicine RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS.
The management of diarrhea in the elderly requires special attention . Indeed, diarrhea can cause significant water loss (dehydration) which can have serious consequences in the elderly.
Dosage
Start by taking 1 sachet (3 g) and then take 1 extra sachet after each new unmolded saddle, without exceeding 6 sachets per day.
Maximum dosage: 6 sachets per day. Do not exceed 3 days of treatment in the absence of medical advice.
Administration mode
This medication is used orally. It is ready for use.
To thin the suspension, knead the bag between the fingers before opening it.
The contents of the sachet can be swallowed pure or diluted in a little water before use.
Take this medication preferably at a distance from meals.
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 appear (blood, dehydration, ...), consult your doctor.
Symptoms and Instructions for Overdose
If you take more SMECTALIA 3 g, oral suspension in a sachet than you should : Consult your doctor or pharmacist immediately.
Instructions for omission of one or more doses
If you forget to take SMECTALIA 3 g, oral suspension in sachet:
Do not take a double dose to make up for a missed dose.
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.
The following side effects may occur:
· constipation, which usually disappears once the doses are decreased. This effect may lead in rare cases to stopping treatment.
· gases
· vomitings
· the aggravation of constipation.
In very rare cases, an allergy can occur. Allergy can be manifested by the following signs:
· of urticaria (sensation similar to a sting of nettles)
· buttons
· itches
· swelling of the face and throat (angioedema).
If you experience any of these signs, you should seek immediate medical attention.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 SMECTALIA 3 g, oral suspension in sachet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require special precautions for storage.
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.
Full list of active substances and excipients
What SMECTALIA contains 3 g, oral suspension in sachet:
The active substance is:
Diosmectite ................................................. .................................................. ........................ 3.00 g
For 1 sachet.
The other components are:
Xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, caramel-cocoa flavor *, purified water.
* Composition of caramel-cocoa flavor: blend of natural and synthetic flavors, caramel color (E 150d), caramelized sugar syrup, propylene glycol, water, ethanol, caffeine.
Pharmaceutical form and content
Aspect of SMECTALIA 3 g, oral suspension in sachet and contents of the pack
This medication is in the form of a drinkable suspension in a sachet.
This medicine is available in packs of 12 and 18 sachets.
Marketing Authorization Holder and Manufacturer
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
BEAUFOUR IPSEN INDUSTRIE
17-20 ETHE VIRTON STREET
28100 DREUX
OR
Pharmatis
AREA OF ACTIVITY IS N ° 1
60190 ESTREES SAINT DENIS
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.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Gastrointestinal tract
diosmectite
Powder for oral suspension is a generic of SMECTA orange-vanilla.
. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
SMECTALIA: powder for oral suspension (orange flavoring vanilla); box of 18 bags.
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SMECTALIA: oral suspension (caramel cocoa flavor); box of 12 bags.
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Laboratory Ipsen Pharma
| p sachet | p sachet | |
| diosmectite | 3 g | 3 g |
| Glucose | + | |
| Sucrose | + | |
| ethanol | + |
Usual dosage:
