Presentation - How to use - Composition

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description of Smectalia Anti Diarrhéique 18 Sachets Orange Vanilla Flavor

Smectalia Anti Diarrhea is indicated for the treatment of short-termdiarrhea (acute diarrhea) in adults and children over 15 years of age. It contains the active substance diosmectite, which protects the digestive tract.

Causes of diarrhea

Tourista is the common name for "travelers' diarrhea". It's an infectious diarrhea, most often benign, which can affect you during a stay where hygiene conditions are not always respected. Tourista is generally caused by food-borne bacteria.
Acute gastroenteritis is an inflammation of the mucous membrane of the digestive tract, causing diarrhea and, frequently, abdominal pain and vomiting. It's a very common condition.
Stress-induced diarrhea: The link between stress and diarrhea is well known: stress accelerates transit through the intestine and colon, and a stressful episode can be responsible for diarrhea.
Food-induced diarrhea: Acute diarrhea can also be food-induced: poisoning by contaminated food or allergy. Many foods can cause diarrhea if contaminated: pastries, ready-made meals, raw or cooked shellfish, unpasteurized dairy products, roast or rotisserie chicken, raw beef, etc.

Directions for use

Oral use.
The contents of the sachet should be suspended just before use, for example in half a glass of water.
Best taken between meals.
Dosage :
1 sachet (3 g) then 1 sachet after each new unformed bowel movement, up to a maximum of 6 sachets per day.
The maximum duration of treatment is 3 days.

Composition

The active substance is diosmectin (3 grams per sachet).
The other components are Glucose monohydrate, sodium saccharin, orange-vanilla flavoring (containing sucrose).

Diosmectite . 3 g
For one sachet.
Notable excipients: glucose, saccharose.

Glucose monohydrate, saccharin sodium, orange* flavor, vanilla** flavor.

*Composition of orange flavor: maltodextrin, saccharose, gum arabic (E414), mono- and diacetyltartaric ester of mono- and diglycerides of fatty acids (E472e), sillicon dioxide (E551), orange fragrance.

**Composition of vanilla flavor: maltodextrin, sucrose, glyceryl triacetate (E1518), sillicon dioxide (E551), ethyl alcohol, soy lecthin (E322), vanilla flavor.

Precautions for use

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking Smectalia Diarrhée Aiguë 18 Sachets.
Never take Smectalia Anti Diarrhea 18 Sachets Orange Vanilla Flavor:

If you are allergic (hypersensitive) to diosmectite or any of the other ingredients in SMECTALIA.

Do not try to manage the symptoms yourself, and consult your doctor promptly, if :

Diarrhea is accompanied by high fever, chills or repeated vomiting,
Your stools contain mucus and/or blood,
Your diarrhea is accompanied by sudden weight loss (over 2kg),
Diarrhea occurs during or after antibiotic treatment,
You have a vulnerable immune system: known heart valve disease, treatment that reduces your body's immune defenses (immunosuppressive therapy or ongoing chemotherapy),
You have recently travelled to a tropical country:

Do not continue your diarrhea treatment on your own, and consult your doctor if :

Your symptoms do not improve or worsen after two days of treatment,
You feel very thirsty, tired or have a dry tongue (a sign of dehydration).

It is imperative that you SEEK MEDICAL CARE AS SOON AS POSSIBLE.

Diarrhea recurs frequently or you notice alternating episodes of diarrhea and constipation.

Take special precautions:

Contains 2 sugars (glucose and sucrose). Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
SMECTALIA should be used with caution in patients with a history of severe constipation.
This treatment complements the following hygienic and dietary rules:
Rehydrate with plenty of salty or sweet drinks, to compensate for fluid losses due to diarrhea (the average daily water intake for adults is 2 liters).
Feed yourself during diarrhea:

Exclude certain foods, especially raw vegetables, fruit, green vegetables, spicy dishes and iced foods and drinks.
Give preference to grilled meats and rice.

Taking other medications:
Smectalia Acute Diarrhea 18 Sachets should be taken at intervals from other medications to avoid reducing the effectiveness of the other treatment. If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist on our online pharmacy.

Pregnancy and breast-feeding:

Do not use during pregnancy except on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue.
Inform your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medication.

Important information about certain ingredients.
This medicine contains glucose and sucrose.

Presentation

Box of 18 sachets.

Warning: this medicine is not a product like any other. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 30/07/2010

Name of the medicinal product

SMECTALIA 3 g powder for oral suspension in sachet

diosmectite

framed

Read this leaflet carefully before you start taking this medicine. It contains important information about your treatment.

· Keep this leaflet, you may need to read it again.

· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.

· The persistence of the symptoms, the aggravation or the appearance of new disorders require to take a medical opinion.

If you have any further questions, ask your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS SMECTALIA 3 g, powder for oral suspension in sachets AND WHAT CASES IS IT USED FOR?

2. BEFORE YOU TAKE SMECTALIA 3 g, powder for oral suspension in sachet?

3. HOW TO TAKE SMECTALIA 3 g powder for oral suspension in sachet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE SMECTALIA 3 g powder for oral suspension in sachet?

6. ADDITIONAL INFORMATION

1. WHAT IS SMECTALIA 3 g, powder for oral suspension in sachets AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group

This medication contains an active substance, diosmectite, which acts by protecting the digestive tract.

Therapeutic indications

This medication is used to treat short-term diarrhea (acute diarrhea) in adults and children over 15 years of age.

This treatment is a complement to dietary measures.

2. BEFORE YOU TAKE SMECTALIA 3 g, 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 SMECTALIA:

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

Take special care with SMECTALIA:

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 brutal weight loss (+2kg);

· Diarrhea occurs during or after antibiotic treatment;

· You present a vulnerable terrain: known disease of heart valves, a treatment that decreases the immune defenses of your organism (immunosuppressive treatment or chemotherapy in progress).

· 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:

· This medicine contains 2 sugars (glucose and sucrose). Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).

· 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 diarrhea time:

o excluding certain foods and particularly raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,

o favoring grilled meats, rice.

Interaction with other medicines

Taking other medicines

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

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.

Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of SMECTALIA:

This medicine contains glucose and sucrose ( see also "Take special care with SMECTALIA )

3. HOW TO TAKE SMECTALIA 3 g 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

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.

· Prepare the mixture just before use. Pour the contents of the sachet into half a glass of water and mix.

· 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 than you should:

Immediately consult your doctor or pharmacist.

Instructions for omission of one or more doses

If you forget to take SMECTALIA:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, SMECTALIA is likely to have side effects, although not everybody gets them.

The following 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.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE SMECTALIA 3 g powder for oral suspension in sachet?

Keep out of the reach and sight of children.

Expiration date

Do not use SMECTALIA after the expiry date which is stated on the carton and 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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does SMECTALIA contain?

The active substance is:

Diosmectite ................................................. .................................................. ........................................ 3 g

For a sachet.

The other components are:

Glucose monohydrate, saccharin sodium, orange-vanilla flavoring (containing sucrose in particular).

Pharmaceutical form and content

What is SMECTALIA and contents of the pack?

This medicinal product is in powder form for oral suspension in sachets. Box of 18 bags.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

IPSEN PHARMA

65, QUAI GEORGES GORSE

92100 BOULOGNE-BILLANCOURT

exploiting

IPSEN PHARMA

65, QUAI GEORGES GORSE

92100 BOULOGNE-BILLANCOURT

Maker

BEAUFOUR IPSEN INDUSTRIE

STREET VIRTON

28100 DREUX

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 leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

Vidal file

VIDAL OF THE FAMILY

SMECTALIA

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

PRESENTATIONS ^(summary)

SMECTALIA: powder for oral suspension (orange flavoring vanilla); box of 18 bags.
-

SMECTALIA: oral suspension (caramel cocoa flavor); box of 12 bags.
-

Laboratory Ipsen Pharma

COMPOSITION ^(summary)

	p sachet	p sachet
diosmectite	3 g	3 g
Glucose	+
Sucrose	+
ethanol		+

INDICATIONS ^(summary)

This medication is a digestive dressing .
It is used in the short-term treatment of acute diarrhea, in addition to dietary measures.

WARNING ^(Contents)

Precautions are necessary if there is a history of severe chronic constipation.
Diarrhea accompanied by numbness, thirst, fever, or blood in the stool requires prompt medical attention.

DRUG INTERACTIONS ^(summary)

This drug may decrease the absorption of many drugs. A delay of at least 2 hours (or even 4 hours with antibiotics of the quinolone family) must be observed between taking this drug and that of other treatments. Ask your doctor or pharmacist.

PREGNANCY AND BREAST-FEEDING ^(summary)

Substances contained in this medication are poorly absorbed. However, do not use it prolonged during pregnancy or breastfeeding without the advice of your doctor or pharmacist.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

This medication should be taken preferably at a distance from meals.
Powder for oral suspension: the contents of the sachet must be mixed with half a glass of water or a semi-liquid food.
Oral Suspension: the sachet must be kneaded between the fingers before opening; its content can be swallowed pure or diluted in a little water.

Usual dosage:

Adult and adolescents over 15 years of age: start with 1 sachet, then 1 additional sachet after each liquid stool, not to exceed 6 sachets per day and 3 days of treatment; If the symptoms persist, consult a doctor.

TIPS ^(summary)

This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Diarrhea can cause dehydration, especially in the elderly. This loss of water by the body must be compensated by rehydration solutions or abundant drinks (salted broth, sugary drinks) because it can cause fatigue, discomfort or confusion of ideas.
Diarrhea diet is based on a light diet, based on:

banana, potato, soup or mashed potatoes;
pasta, rice or tapioca, cooked water, rice;
apple or quince sauce, quince or blueberry jelly;
biscuits or sweet.

Should be avoided: raw fruit juices and fruit, vegetables rich in fiber, meats, eggs, dairy products and iced drinks.

POSSIBLE ADVERSE EFFECTS ^(summary)

Common: constipation, requiring a decrease in dosage or more rarely cessation of treatment.
Uncommon: bloating, vomiting.
Allergic reaction .

GLOSSARY ^(summary)

antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.

antibiotics
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .

diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally, stools are pasty, but the emission of liquid or barely formed stools, without pain or particular associated disorder, is not pathological. Diarrhea can occur when liquid stool emissions are repeated during the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.

digestive dressing
Medication that protects the digestive tract by lining the mucosa with a protective film and decreasing the acidity of the stomach. This type of medication may interfere with the absorption of other drugs.

Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.

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Pharmacist's advice

used for :

transit disorders, acute diarrhea

Smectalia Anti Diarrhea 18 Sachets Orange Vanilla Flavor

Description of Smectalia Anti Diarrhéique 18 Sachets Orange Vanilla Flavor

Directions for use

Composition

Precautions for use

Presentation

VIDAL OF THE FAMILY

SMECTALIA

PRESENTATIONS ^(summary)

COMPOSITION ^(summary)

INDICATIONS ^(summary)

WARNING ^(Contents)

DRUG INTERACTIONS ^(summary)

PREGNANCY AND BREAST-FEEDING ^(summary)

DIRECTIONS FOR USE AND DOSAGE ^(summary)

TIPS ^(summary)

POSSIBLE ADVERSE EFFECTS ^(summary)

GLOSSARY ^(summary)

Our doctors of pharmacy advise you

Advice from our naturopaths

Smectalia Anti Diarrhea 18 Sachets Orange Vanilla Flavor

Description of Smectalia Anti Diarrhéique 18 Sachets Orange Vanilla Flavor

Directions for use

Composition

Precautions for use

Presentation

VIDAL OF THE FAMILY SMECTALIA

Our doctors of pharmacy advise you

Advice from our naturopaths

VIDAL OF THE FAMILY

SMECTALIA