SMECTALIA 3G ORAL SUSPENSION 12 BAGS

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SMECTALIA 3G ORAL SUSPENSION 12 BAGS

For warnings, precautions for use and cons-indications, see the instructions for use.


SMECTALIA Description 3G ORAL SUSPENSION 12 BAGS

Short-term treatment of acute diarrhea in adults and children over 15 years. This treatment is a complement dietary measures


SMECTALIA Council to use 3G ORAL SUSPENSION 12 BAGS

1 bag (3 g) and 1 bag after each unformed new saddle, without exceeding 6 sachets per day.
The maximum duration of treatment was 3 days.

Administration mode :
Oral
To thin the suspension, it is recommended to knead the bag between your fingers before opening.
The pouch contents can be swallowed pure or diluted in a little water before use.
Administer preferably:
· Between meals


SMECTALIA composition 3G ORAL SUSPENSION 12 BAGS

Diosmectite 3.00 g
1 Bag.

The other ingredients are:
Xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, caramel and cocoa flavor *, purified water.
* Composition of caramel and cocoa flavor: blend of natural and synthetic flavors, caramel color (E 150d), caramelized sugar syrup, propylene glycol, water, ethanol, caffeine.

SMECTALIA Introducing 3G ORAL SUSPENSION 12 BAGS


Box of 12 sachets of oral suspension.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist of current treatments to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance Reporting an or effect (s) Adverse (s) bound (s) use of a medicament

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.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 18/11/2015

Name of the medicinal product

SMECTALIA 3 g, oral suspension in sachet

diosmectite

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

Review summary

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?

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, oral suspension in sachet?

List of information needed before taking the medication

Not applicable.

Cons-indications

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

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

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?

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. 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.

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.

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.

Expiration date

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.

Storage conditions

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.

6. ADDITIONAL INFORMATION

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.

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 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.

Internet Information

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

Information for health professionals only

Not applicable.

Other

Not applicable.

Medicines for diarrhea Pharmacy Online: Order your medication to treat your discomfort

 

Diarrhea is a common disease. She reached the Transit and transforms the state of stools: they become loose or watery, sometimes uncontrollable If diarrhea, oral rehydration therapy is paramount.. In the elderly, such as infants, oral rehydration sachets are used to stop dehydration. Rehydration solution of the bags are available in pharmacies, even in tropical countries Sometimes it is necessary to prescribe an antibiotic treatment. There are also several categories of antidiarrheal adult intestinal transit retarders: they are based antidiarrheal loperamide. Some packages are sold without prescription. Than recommended by your doctor or pharmacist and do not continue the treatment for more than two days without medical advice.

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