Price of SPASFON, coated tablet

Pharmacotherapeutic group: MUSCULOTROPIC ANTISPASMODIC – ATC code: A03AX12 (A.: digestive system and metabolism) (G: genitourinary system)

SPASFON belongs to a class of medicines called antispasmodics. It works against spasms (contractions).

This medicine is indicated in the treatment of spasmodic pain of the intestine, biliary tract, bladder and uterus.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Never take SPASFON, coated tablet:
· if you are allergic to phloroglucinol, trimethylphloroglucinol or any of the other ingredients of this medicine (listed in section 6).

· if you are allergic to wheat, due to the presence of wheat starch.

Warnings and precautions
Talk to your doctor or pharmacist before using SPASFON, coated tablet .

Children and adolescents
Not applicable.

Other medicines and SPASFON, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

SPASFON, coated tablet with food and drink
Not applicable.

Pregnancy and breastfeeding
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.

Pregnancy

The use of this medicine should only be considered during pregnancy if necessary.

Breastfeeding

The administration of this medication is not recommended in breastfeeding women.

Driving vehicles and using machines
SPASFON has no or negligible influence on the ability to drive and use machines.

SPASFON, coated tablet contains lactose, sucrose and wheat starch:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains a very small amount of gluten (from wheat starch). It is considered to be ‘gluten-free’ and is therefore unlikely to cause problems if you have coeliac disease. One tablet contains no more than 2.4 micrograms of gluten. If you have a wheat allergy (different from coeliac disease) you should not take this medicine.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

SPASFON is a symptomatic treatment. The duration of treatment varies depending on the indication. If symptoms persist, consult your doctor.

Dosage

In adults :

Take 2 tablets per dose, three times a day, respecting a minimum interval of 2 hours between each dose without exceeding 6 tablets per 24 hours.

The tablets can be used as a follow-up to an initial treatment in injectable form, at a maximum dosage of 6 tablets per 24 hours.

Use in children
This presentation is not suitable for children under 6 years old.

In children over 6 years old: 1 tablet per dose, twice a day, respecting a minimum interval of 2 hours between each dose without exceeding 2 tablets per 24 hours.

In children over 6 years of age, it is important to ensure that the tablets can be swallowed, otherwise another form will be preferred.

Mode and route of administration

Oral route.

The tablets should be swallowed with a glass of water.

If you take more SPASFON, coated tablet than you should
Consult your doctor or pharmacist immediately.

If you forget to take SPASFON, coated tablet
Do not take a double dose to make up for a forgotten dose.

If you stop taking SPASFON, coated tablet
Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

In some cases an allergy may occur.

You will recognize the signs of an allergy:

by pimples and/or redness on the skin, itching,
by sudden swelling of the face and neck (Quincke’s edema),
· or by sudden discomfort due to a drop in blood pressure (anaphylactic shock).

At an undetermined frequency, the following may occur:

· a widespread red scaly rash with lumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

If you develop these symptoms, stop using this medicine and contact your GP or seek medical advice immediately.

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

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

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

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.

Store at a temperature not exceeding 30°C.

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

What SPASFON, coated tablet contains

· The active substances are:

Phloroglucinol hydrate………………………………………………………………………………………………….80,000 mg

Amount corresponding to anhydrous phloroglucinol……………………………………………………….. 62.233 mg

Trimethylphloroglucinol ………………………………………… ………………………………………….. ………80,000 mg

For a coated tablet.

· The other components are:

Lactose monohydrate, sucrose, polyvinyl acetate, wheat starch, stearic acid, magnesium stearate.

Coating : polyvinyl acetate, talc, sucrose, gum arabic, gelatin, titanium dioxide (E171), erythrosine (E127), carnauba wax.

What SPASFON, coated tablet looks like and contents of the pack

This medicine comes in the form of a coated tablet. Box of 20, 30 or 500.

Marketing Authorization Holder

TEVA HEALTH
100-110 GENERAL DE GAULLE ESPLANADE

92931 PARIS LA DEFENSE CEDEX

Marketing Authorization Operator

TEVA HEALTH
100-110 GENERAL DE GAULLE ESPLANADE

92931 PARIS LA DEFENSE CEDEX

Manufacturer

MACORS LABORATORIES
CAILLOTTES STREET

ZI PLAINE DES ISLES

89000 AUXERRE

Or

Galen LPS
98 rue bellocier

89100 SENS

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

Not applicable.

The last date this notice was revised is:

[to be completed later by the holder]

Others

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