SPAGULAX poudre effervescente suspension buvable en Sachets-dose

NOTICE

ANSM - Updated on: 21/12/2015

Name of the medicinal product

SPAGULAX, effervescent powder for oral suspension in sachet dose

Ispaghul (seed coat of)

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 or pharmacist.

· This also applies to any side effects 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.

Review summary

What this leaflet contains:

1. What is SPAGULAX, an effervescent powder for oral suspension in a dose sachet and in which cases it is used?

2. What should I know before taking SPAGULAX, an effervescent powder for oral suspension in a dose sachet ?

3. How to take SPAGULAX, effervescent powder for oral suspension in a dose sachet ?

4. What are the possible side effects?

5. How to store SPAGULAX, effervescent powder for oral suspension in a dose sachet ?

6. Additional information.

1. WHAT IS SPAGULAX, an effervescent powder for oral suspension in a dose sachet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

LAXATIVE OF LEST

Therapeutic indications

Herbal medication indicated in the symptomatic treatment of constipation.

2. BEFORE YOU TAKE SPAGULAX, effervescent powder for oral suspension in a dose 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 SPAGULAX 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 medication mentioned in section 6,

· In case of abrupt change in intestinal function persisting for more than 2 weeks.

· Rectal bleeding of unknown cause or in the absence of an exemption after taking another laxative,

· certain diseases of the bowel and colon, such as rectocolitis, Crohn's disease, intestinal occlusion,

· in the case of abdominal pain (stomach pains) or fecal matter (fecal plug),

· If you have swallowing difficulties or throat problems.

.

Precautions for use; special warnings

Warnings and Precautions

Warnings

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

Occasional constipation

It may be related to a recent change in lifestyle (eg travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.

Chronic constipation (long-term constipation)

It can be linked to two causes:

· a bowel disease that requires a physician to take care of;

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

Treatment includes:

· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);

· increased consumption of water and fruit juices;

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

· rehabilitation of the defecation reflex;

· sometimes, adding sound to the diet.

Special cases of child and adolescent

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

Precautions for use

In case of impaired colonic drive and in patients confined to bed, caution should be exercised in taking this medication (risk of fecal impaction).

The contents of the sachet must be swallowed with sufficient water.

When SPAGULAX is taken with insufficient fluid, it may cause an obstruction of the throat or esophagus and result in respiratory shock. Associated symptoms can be chest pain, vomiting or difficulty swallowing or breathing.

In case of abdominal pain or irregular stools, stop treatment and consult your doctor.

This medicinal product contains 120 mg sodium per sachet-dose: take this into account in the following people with a strict sodium diet.

Interaction with other medicines

Other drugs and SPAGULAX:

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

The medicines mentioned below should be taken under medical supervision with SPAGULAX,

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

· Medicines for treating diabetes,

· Thyroid hormones

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

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 and lactation only 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 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

SPAGULAX contains sucrose, sodium and orange yellow S (E110).

3. HOW TO TAKE SPAGULAX, effervescent powder for oral suspension in a dose sachet?

Instructions for proper use

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Do not take SPAGULAX immediately before bedtime.

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

When preparing the oral suspension, avoid inhaling the powder.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

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

SPAGULAX is not recommended for use in children and adolescents under the age of 18 years.

The effect of Spagulax occurs on average within 12 to 24 hours after administration, at the start of treatment.

If you feel that the effect of SPAGULAX is too strong or too weak, talk to your doctor or pharmacist

Administration mode

Oral use.

Dilute the powder in a large glass of water. Shake and drink immediately the preparation.

Duration of treatment

The duration of treatment varies according to the symptomatology. If symptoms persist beyond 3 days of treatment, talk to your doctor or pharmacist

Symptoms and Instructions for Overdose

If you take more SPAGULAX than you should:

Overdose with the seed coat of ispaghul may cause abdominal discomfort and flatulence, or even intestinal occlusion.

Appropriate hydration should be ensured with symptomatic monitoring.

Instructions for omission of one or more doses

If you forget to take SPAGULAX:

Continue the treatment, but do not take a double dose to replace the 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.

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

· Bloating, flatulence.

· Cases of oesophageal obstruction (bezoars), most often requiring endoscopy, have been reported in elderly patients, some of whom have impaired oesophageal motor function (particularly when SPAGULAX is swallowed with insufficient amounts of oesophageal reflux, water).

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

· Due to the presence of orange yellow S (E110), there is a risk of allergic reactions.

Declaration of side effects

If you experience any side effects, talk to your doctor or 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 SPAGULAX, effervescent powder for oral suspension in a dose 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. The expiry date refers to the last day of that 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 does SPAGULAX contain?

The active substance is:

Ispaghul (seed coat of) ......................................... .................................................. ........ 2,1430 g

For a sachet-dose.

The other components are:

Anhydrous citric acid, sodium bicarbonate, sodium saccharin, mandarin dry flavoring, orange yellow S (E110), sucrose.

Pharmaceutical form and content

Aspect of SPAGULAX and contents of the pack

This medication is in the form of an effervescent powder for oral suspension. Box of 20 or 30 sachets-dosages.

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

ALMIRALL SA

RONDA GENERAL MITER, 151

08022 BARCELONA

SPAIN

exploiting

ALMIRALL SAS

1 BOULEVARD VICTOR

75015 PARIS

Maker

INDUSTRIAS FARMACEUTICAS ALMIRALL, SL

CTRA. NACIONAL II, KM 593

E-08740 SANT ANDREU DE LA BARCA

BARCELONA

SPAIN

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 revised is MM / 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 OF THE FAMILY

SPAGULAX