SPAGULAX MUCILAGE PUR granulé en Sachets-dose

NOTICE

ANSM - Updated: 08/11/2017

Name of the drug

SPAGULAX MUCILAGE PUR, granules in sachet-dose

Ispaghul (seed coat)

Framed

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

You should always take this medicine carefully following the information given in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Contact your pharmacist for any advice or information.

· If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after 3 days.

What does this booklet contain ?

1. What is SPAGULAX MUCILAGE PUR, granules in sachet-dose and in which cases is it used?

2. What information should be known before taking SPAGULAX MUCILAGE PUR, granules in sachet-dose?

3. How to take SPAGULAX MUCILAGE PUR, granules in sachet-dose?

4. What are the possible side effects?

5. How to store SPAGULAX MUCILAGE PUR, granules in sachet-dose?

6. Contents of the pack and other information.

1. WHAT IS SPAGULAX MUCILAGE PURE, granules in sachet-dose AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: LEST LAXATIVE.

Herbal medicine indicated for the symptomatic treatment of constipation.

2. BEFORE YOU TAKE SPAGULAX MUCILAGE PUR, granules in sachet-dose?

If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.

Do not take SPAGULAX MUCILAGE PUR in the following cases:

· certain diseases of the esophagus,

· if you are allergic to the seed coat of ispaghul, or to any of the other ingredients of this medicine, mentioned in section 6,

· in the event of a sudden change in bowel function that has persisted for more than 2 weeks,

· rectal bleeding of unknown cause or in the absence of relief after taking another laxative,

· certain diseases of the intestine and colon, such as ulcerative colitis, Crohn's disease, intestinal obstruction,

· in the event of abdominal pain (stomach pains) or faecal impaction (blockage of fecal matter),

· if you have difficulty swallowing or throat problems.

Warnings and Precautions

Warnings

The use of this medicine is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).

Occasional constipation

It may be linked to a recent change in lifestyle (eg travel). The drug can be of help in short treatment. Any recent constipation unexplained by the change in lifestyle, any constipation accompanied by pain, fever, swelling of the belly should seek medical advice.

Chronic constipation (long-lasting constipation)

It can be linked to two causes:

· either a disease of the intestine which requires treatment by the doctor;

· or an imbalance in intestinal function due to eating habits and lifestyle.

The treatment includes, among other things:

· an increase in food intake of products of plant origin (green vegetables, raw vegetables, wholemeal bread, fruit, etc.);

· increased consumption of water and fruit juice;

· an increase in physical activities (sport, walking, etc.);

· rehabilitation of the defecation reflex;

· sometimes the addition of bran to food.

Precautions for use

In order to prevent the granules from stagnating in the esophagus, SPAGULAX MUCILAGE PUR must never be absorbed while lying down or dry (without liquid). In addition, a large amount of liquid should be swallowed with each dose (see section 3. HOW TO TAKE SPAGULAX MUCILAGE PURE, granules in sachet-dose).

In the event of alteration of colonic motricity and in subjects confined to bed, the intake of this medication must be cautious (risk of fecaloma).

When SPAGULAX MUCILAGE PUR is taken with insufficient liquid, it may cause throat or esophageal obstruction and lead to respiratory shock. Associated symptoms may be chest pain, vomiting, or difficulty swallowing or breathing.

If you have abdominal pain or irregular bowel movements, stop treatment and see your doctor.

In case of diabetes, take into account the amount of sugar, i.e. 3 g per sachet.

Children and adolescents

In children and adolescents, the treatment of constipation is based on lifestyle and dietetic measures: in particular the use of the right amount of water with infant milk powders, a diet rich in original products. vegetable, addition of fruit juice. The use of a laxative requires medical advice

Other medicines and SPAGULAX MUCILAGE PUR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The medicines mentioned below must be taken under medical supervision with SPAGULAX MUCILAGE PUR:

· minerals, vitamins, cardiac glycosides derived from coumarin, carbamazepine,

· medicines to treat diabetes,

· thyroid hormones.

This medication should be taken during the day, at least ½ hour or 1 hour before or after any other medication.

SPAGULAX MUCILAGE PURE with food, drink and alcohol

Not applicable.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Not applicable.

SPAGULAX MUCILAGE PUR, contains sucrose.

3. HOW TO TAKE SPAGULAX MUCILAGE PURE, granules in sachet-dose?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

Do not take SPAGULAX MUCILAGE PUR immediately before bedtime.

SPAGULAX MUCILAGE PUR should be taken at least ½ hour to 1 hour before taking other medicines.

Dosage

Adults

Usually the dosage is one sachet before or after each of the main meals.

Use in children and adolescents

It is not recommended to use SPAGULAX MUCILAGE PUR in children and adolescents under 18 years old.

The effect of SPAGULAX MUCILAGE PUR manifests itself on average within 12 to 24 hours after administration, at the start of treatment.

If you have the impression that the effect of SPAGULAX MUCILAGE PUR is too strong or too weak, talk to your doctor or pharmacist.

Administration mode

Oral route.

Divide the contents of the sachet into 3 doses (1 sachet = 3 teaspoons of 5 ml). Swallow the granules in each teaspoon without chewing them and with a sufficient amount of liquid (approximately 70 ml of water, milk, fruit juice or similar liquid). In total you will need to drink a large glass of liquid of at least 200 ml for one sachet.

In order to prevent the granules from stagnating in the esophagus, SPAGULAX MUCILAGE PUR must never be absorbed while lying down, or dry (without liquid).

Duration of treatment

The duration of treatment varies depending on the symptoms. If symptoms persist beyond 3 days of treatment, consult your doctor or pharmacist.

If you take more SPAGULAX MUCILAGE PUR than you should:

Overdose with the seed coat of ispaghul can cause abdominal discomfort and gas, or even intestinal obstruction.

Appropriate hydration should be ensured with symptomatic monitoring.

If you forget to take SPAGULAX MUCILAGE PUR:

Continue treatment, but do not take a double dose to make up for the dose you forgot to take.

If you stop taking SPAGULAX MUCILAGE PUR:

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Depending on the dose, certain disorders may appear such as:

· Bloating, flatulence.

· Cases of esophageal obstruction (bezoars), most often requiring endoscopy, have been reported in elderly people, some of whom had impaired esophageal motility (especially when SPAGULAX MUCILAGE PUR is swallowed in insufficient quantity water).

· Allergic reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylactic shock.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SPAGULAX MUCILAGE PURE, granules in sachet-dose?

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What SPAGULAX MUCILAGE PUR contains

· The active substance is:

Ispaghul ( Plantago ovata Forssk) (seed coat of) .................................... .................................... 7 g

For a 10 g sachet

The other ingredient is: sucrose.

What SPAGULAX MUCILAGE PUR looks like and contents of the pack

This medication is in the form of granules in a sachet-dose. Box of 20.

Marketing authorization holder

ALMIRALL SAS

LE BARJAC BUILDING

1 VICTOR BOULEVARD

75015 PARIS

Marketing authorization operator

ALMIRALL SAS

LE BARJAC BUILDING

1 VICTOR BOULEVARD

75015 PARIS

Maker

INDUSTRIAS FARMACEUTICAS ALMIRALL SA

CTRA NACIONAL II, KM 593

08740 SANT ANDREU DE LA BARCA

BARCELONA

SPAIN

Or

ROTTAPHARM LTD

DAMASTOWN INDUSTRIAL PARK

MULHUDDART

DUBLIN, 15

IRELAND

Names of the drug in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{month YYYY}.>

Other

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

FAMILY VIDAL

SPAGULAX pure mucilage