Smectalia box of 18 bags orange-vanilla flavour

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.

• - Keep this leaflet, you may need to read it again.
• - This medicine is a SELF-MEDICATION speciality which can be used without consulting a doctor or being prescribed by a doctor.
• - If your symptoms persist, worsen or develop new ones, you should seek medical advice.

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:

• - Diarrhoea is accompanied by high fever, chills or repeated vomiting;
• - Your stools contain mucus and/or blood;
• - Your diarrhea is accompanied by sudden weight loss (more than 2kg);
• - The diarrhea occurs during or after an antibiotic treatment;
• - You present a vulnerable ground: known disease of the heart valves, treatment which decreases the immune defences of your body (immunosuppressive treatment or chemotherapy in progress).
• - You have recently travelled to a tropical country.

Do not continue the treatment against diarrhoea on your own and consult your doctor if:

• - Your symptoms do not improve or get worse 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 QUICKLY.
• - Diarrhea recurs frequently or you have alternating episodes of diarrhea and constipation.

Take special precautions with SMECTA:

• - 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).
• - SMECTA should be used with caution in patients with a history of severe constipation.

This treatment is a complement to the following hygienic and dietary rules:

• - Rehydrate yourself with abundant drinks, salted or sweetened, in order to compensate for the loss of liquid due to diarrhoea (the average daily water intake of an adult is 2 litres),
• - Feed yourself during the diarrhoea:

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 the treatment.

Inform 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.

Method of administration

• - This medicine 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 medicine preferably at a distance from meals.

Duration of treatment

The maximum duration of treatment is 3 days, if no medical advice is given.

If the symptoms do not improve or worsen after 2 days or if signs of seriousness appear (blood, dehydration, ...), 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:

• - constipation, which usually disappears once doses are decreased. In rare cases, this effect may lead to discontinuation of treatment.
• - gas
• - vomiting
• - worsening of constipation.

In very rare cases, an allergy may occur. Allergy may be manifested by the following signs:

• - hives (a sensation similar to a nettle sting)
• - Pimples
• - Itching
• - swelling of the face and throat (angioedema).

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