NOTICE
ANSM - Last updated: 22/01/2014
Name of the medicinal product
SPASMOCALM 80 mg orodispersible tablet
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS SPASMOCALM 80 mg orodispersible tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE SPASMOCALM 80 mg orodispersible tablet?
3. HOW TO TAKE SPASMOCALM 80 mg orodispersible tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SPASMOCALM 80 mg orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS SPASMOCALM 80 mg orodispersible tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medication is an antispasmodic.
Therapeutic indications
It is indicated in the treatment of spasmodic pain of the intestine, bile ducts, bladder and uterus.
2. BEFORE YOU TAKE SPASMOCALM 80 mg orodispersible tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take SPASMOCALM 80 mg orodispersible tablet if:
· known allergy to phloroglucinol or any of the other ingredients of the product ( see Composition ),
· in the case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with SPASMOCALM 80 mg orodispersible tablet:
If you are intolerant to some sugars, contact your doctor before taking this medication, because of the presence of lactose.
This medicine contains a source of phenylalanine, it can be dangerous for patients with phenylketonuria.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction 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, even medicines obtained without a prescription.
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
The use of this medication should only be considered during pregnancy if necessary.
Administration of this medication is not recommended for nursing mothers.
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
List of excipients with known effect: aspartame, lactose.
3. HOW TO TAKE SPASMOCALM 80 mg orodispersible tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Mode of Administration / Dosage / Administration Frequency
Oral use.
In adults , the dosage is 2 tablets, to be taken at the time of the crisis, to be renewed in case of major spasms. The tablets are to be allowed to melt under the tongue for a quick effect or to dissolve in a glass of water before ingestion.
In children : 1 tablet twice a day, after dissolving in a glass of water.
If you feel that the effect of SPASMOCALM 80 mg orodispersible tablet is too strong or too weak, talk to your doctor or pharmacist.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, SPASMOCALM 80 mg orodispersible tablet is likely to have side effects, although not everyone is subject to it:
Some very rare cases of allergic reactions of the skin.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE SPASMOCALM 80 mg orodispersible tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use SPASMOCALM 80 mg orodispersible tablet after the expiry date which is stated on the carton or the platelets.
Storage conditions
Store at a temperature not exceeding + 30 ° C, away from moisture.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What SPASMOCALM 80 mg contains orodispersible tablet contains?
The active substance is:
Phloroglucinol ................................................. .................................................. ................................. 80 mg
For an orodispersible tablet.
The other components are:
Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, aspartame (E951).
Pharmaceutical form and content
What is SPASMOCALM 80 mg orodispersible tablet and contents of the pack?
This medication is in the form of orodispersible tablets. Box of 2, 6, 10, 12, 18, 20 or 30.
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
French Pharmaceutical Cooperation
Place Lucien-Auvert
77020 Melun Cedex
exploiting
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien Auvert
77020 MELUN CEDEX
Maker
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
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 approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.