Spasmocalm 80mg 20 orodispersible tablets

In this manual :

1. WHAT IS SPASMOCALM 80 mg, orodispersible tablet AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING SPASMOCALM 80 mg, orodispersible tablet

3. HOW DO I TAKE SPASMOCALM 80 mg, orodispersible tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE SPASMOCALM 80 mg, orodispersible tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS SPASMOCALM 80 mg, orodispersible tablet AND WHAT IS IT USED FOR?

This medicine is an antispasmodic.

It is indicated for the treatment of spasmodic pain of the intestine, biliary tract, bladder and uterus.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SPASMOCALM 80 mg, orodispersible tablet

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Never take SPASMOCALM 80 mg, orodispersible tablet in the following cases:

- known allergy to phloroglucinol or any of the other components of the product(see Composition),

- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Be careful with SPASMOCALM 80 mg, orodispersible tablet:

If you have an intolerance to certain sugars, contact your doctor before taking this medicine, because of the presence of lactose.

This medicine contains a source of phenylalanine and may be harmful to patients with phenylketonuria.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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Pregnancy and lactation

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

The use of this medicine is not recommended for women who are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medication.

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List of excipients with a notable effect:aspartam, lactose.

3. HOW TO TAKE SPASMOCALM 80 mg, orodispersible tablet

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Method of administration / Dosage / Frequency of administration

Oral use.

In adultsIn adults, the dosage is 2 tablets, to be taken at the time of the crisis, to be repeated in case of severe spasms. The tablets should be left to melt under the tongue for a rapid effect or dissolved in a glass of water before ingestion.

In childrenTake 1 tablet twice a day, dissolved in a glass of water.

If you feel that the effect of SPASMOCALM 80 mg, orodispersible tablet is too strong or too weak, consult your doctor or pharmacist.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, SPASMOCALM 80 mg, orodispersible tablet is likely to have side effects, although not everyone is susceptible:

Some very rare cases of allergic skin reactions.

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 SPASMOCALM 80 mg, orodispersible tablet

Keep out of the reach and sight of children.

Do not use SPASMOCALM 80 mg, orodispersible tablet after the expiry date stated on the box or blister.

Store at a temperature not exceeding +30°C, protected from moisture.

Medicines should not be disposed of down the drain or in the household garbage. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does SPASMOCALM 80 mg, orodispersible tablet contain?

The active substance is:

Phloroglucinol .................................................................................................................................... 80 mg

For one orodispersible tablet.

The other components are:

Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, aspartam (E951).

What is SPASMOCALM 80 mg, orodispersible tablet and what does it contain?

This medicine comes in the form of orodispersible tablets. Boxes of 2, 6, 10, 12, 18, 20 or 30.

Holder

Coopération Pharmaceutique Française

Place Lucien-Auvert

77020 Melun Cedex

Operator

COOPERATION PHARMACEUTIQUE FRANCAISE

Place Lucien Auvert

77020 MELUN CEDEX

Manufacturer

LABORATOIRES OPODEX INDUSTRIE

34/46 avenue du Vieux Chemin de Saint Denis

BP 32

92392 VILLENEUVE LA GARENNE CEDEX

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The last date on which this package insert was approved was {date}.

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Detailed information on this medicinal product is available on the Afssaps website (France).