Presentation - How to use - Composition

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

The majority of acute diarrhoeas are infectious: they result from infection of the intestines by viruses (the most frequent cause in France) or bacteria.
These transient diarrhoeas usually regress spontaneously or after symptomatic treatment in less than 2 or 3 days, without recurring in the short term.
Acute diarrhea is very common: on average, we all have an episode of acute diarrhea every year. Most of these episodes are brief, lasting less than 24 hours.

Description of Smecta Anti Diarrhea 18 Sachets Strawberry Flavor

The drug Smecta 3G POWDER FOR BUVABLE SUSPENSION Strawberry 18 sachets is indicated :

in the symptomatic treatment of acute diarrhea in children and infants, as a complement to oral rehydration, and in adults,
in the symptomatic treatment of chronic diarrhea, and in the symptomatic treatment of pain associated with esogastroduodenal and colonic disorders.

An effective remedy for restoring intestinal balance

Smecta Powder for Drinkable Suspension is your ally against episodes of diarrhoea. With its strawberry formula, this powder acts quickly to absorb the toxins and bacteria responsible for diarrhoea, helping to restore intestinal balance and relieve unpleasant symptoms. Don't let diarrhoea disrupt your daily routine. Choose Smecta and regain optimal intestinal comfort.

A practical, delicious solution for the whole family

With its convenient sachets and delicious strawberry taste, Smecta Powder for Drinkable Suspension is easy to take, even for the youngest members of the family. Give your family fast, effective relief from episodes of diarrhoea, while pleasing them with its appetizing fruity flavour. With Smecta, curing diarrhoea becomes an enjoyable experience for everyone.

The confidence of a treatment recommended by health professionals

Smecta is a trusted choice for the treatment of diarrhoea, recommended by health professionals for years. Its formula based on diosmectite, a natural mineral, offers a protective action on the intestinal mucosa, reducing the intensity and duration of diarrhoea episodes. Rely on Smecta to restore intestinal comfort quickly and safely.

Directions for use Smecta Anti Diarrhéique 18 Sachets Strawberry Flavor

Treatment of acute diarrhea
Infants and children:

Before 1 year: 2 sachets a day for 3 days, then 1 sachet a day.
After 1 year: 4 sachets a day for 3 days, then 2 sachets a day.

Adults:

An average of 3 sachets a day. In practice, the dosage may be doubled at the start of treatment.

Other indications

Infants and children:

Before age 1: 1 sachet per day.
Between 1 and 2 years: 1 to 2 sachets per day.
After 2 years: 2 to 3 sachets per day.

Adults:

On average 3 sachets per day.

Composition

Diosmectite, maltodextrin, propylene glycol, gum arabic, blend of natural and synthetic flavors.

Precautions for use

Never take this medicine if you are allergic (hypersensitive) to diosmectite or any of the other ingredients.

Warnings

If symptoms do not disappear within 7 days, consult your doctor.
If pain is associated with fever or vomiting, consult your doctor immediately.
Smecta 3 g Strawberry should be used with caution in patients with a history of severe constipation.
In children and infants, treatment of acute diarrhoea should be combined with early administration of oral rehydration solution (ORS) to avoid dehydration.

Packaging

Box of 18 sachets.

Warning: this 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.

How long does it take to feel the effects of Smecta?

The effects of Smecta are generally felt quickly, often within the first few hours after taking it.

Is Smecta suitable for children?

Yes, Smecta is suitable for children and can be used under adult supervision.

How many sachets of Smecta can I take in a day?

We recommend that you follow the instructions of your healthcare professional or pharmacist to determine the appropriate dosage according to age and severity of symptoms.

Are there any precautions I should take before taking Smecta?

It is important to read the instructions carefully and consult a healthcare professional if you have any doubts about taking Smecta, especially if you are pregnant or breast-feeding.

Can Smecta be taken with other medications?

Smecta should be taken at a distance from other medications to avoid potential interactions. Consult your pharmacist or doctor for further information.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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.

Vidal file

VIDAL OF THE FAMILY

SMECTA FRESH

Gastrointestinal tract

diosmectite

This medication 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)

SMECTA STRAWBERRY: powder for oral suspension (strawberry flavor); box of 12 bags.
-

Laboratory Ipsen Pharma

COMPOSITION ^(summary)

	p sachet
diosmectite	3 g
Glucose	+

INDICATIONS ^(summary)

This medication is a digestive dressing .
It is used in the symptomatic treatment of acute diarrhea, in addition to dietary measures, chronic diarrhea and pain in the esophagus, stomach, duodenum or colon.

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 is taken preferably after meals for esophageal pain, between meals for other indications. It can be mixed with water or semi-liquid food. For babies, the contents of the sachet can be diluted in a 50 ml bottle.

Usual dosage:

In the treatment of acute diarrhea:

Adult: 6 sachets per day the first days, then 3 sachets per day.
Children over 1 year: 4 sachets per day for 3 days, then 2 sachets per day.
Children under 1 year: 2 sachets per day for 3 days, then 1 sachet per day.

In the treatment of chronic diarrhea and digestive pain:

Adult: 1 sachet, 3 times a day.
Children from 2 to 15 years: 1 sachet, 2 or 3 times a day.
Children from 1 to 2 years: 1 or 2 sachets per day.
Children under 1 year: 1 sachet per day.

TIPS ^(summary)

Diarrhea can cause dehydration, especially in children or the elderly. This loss of water by the body must be compensated by 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.
A balanced diet, slow chewing, elimination of difficult-to-digest foods and alcoholic beverages often help to alleviate symptoms due to acid upwelling or stomach inflammation .

POSSIBLE ADVERSE EFFECTS ^(summary)

Common: constipation requiring a decrease in dosage.
Rarely: 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 may occur when liquid stool emissions are repeated throughout 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.

duodenum
A part of the intestine into which food from the stomach penetrates.

inflammation
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.

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.

symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.

symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.

Pharmacist's advice

used for :

digestive comfort, child, transit disorders, acute diarrhea

Smecta Anti Diarrhea 18 Sachets Strawberry Flavor

Description of Smecta Anti Diarrhea 18 Sachets Strawberry Flavor

An effective remedy for restoring intestinal balance

A practical, delicious solution for the whole family

The confidence of a treatment recommended by health professionals

Directions for use Smecta Anti Diarrhéique 18 Sachets Strawberry Flavor

Composition

Precautions for use

Packaging

How long does it take to feel the effects of Smecta?

Is Smecta suitable for children?

How many sachets of Smecta can I take in a day?

Are there any precautions I should take before taking Smecta?

Can Smecta be taken with other medications?

VIDAL OF THE FAMILY

SMECTA FRESH

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

Smecta Anti Diarrhea 18 Sachets Strawberry Flavor

Description of Smecta Anti Diarrhea 18 Sachets Strawberry Flavor

An effective remedy for restoring intestinal balance

A practical, delicious solution for the whole family

The confidence of a treatment recommended by health professionals

Directions for use Smecta Anti Diarrhéique 18 Sachets Strawberry Flavor

Composition

Precautions for use

Packaging

How long does it take to feel the effects of Smecta?

Is Smecta suitable for children?

How many sachets of Smecta can I take in a day?

Are there any precautions I should take before taking Smecta?

Can Smecta be taken with other medications?

VIDAL OF THE FAMILY SMECTA FRESH

Our doctors of pharmacy advise you

Advice from our naturopaths

VIDAL OF THE FAMILY

SMECTA FRESH