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?
Pharmacotherapeutic class
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
List of information needed before taking the medicine
Not applicable.
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.
Precautions for use; special warnings
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.
Interactions with other medicines
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.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:aspartam, lactose.
3. HOW TO TAKE SPASMOCALM 80 mg, orodispersible tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
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.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of 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.
If necessary, warnings against certain visible signs of deterioration
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
Full list of active ingredients and excipients
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).
Pharmaceutical form and content
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.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
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
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the Afssaps website (France).
Information for healthcare professionals only
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