NOTICE
ANSM - Last updated: 19/01/2017
Name of the medicinal product
SPASFON, suppository
framed
Read this leaflet carefully before you start using 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 SPASFON, suppository AND WHAT IT IS USED FOR?
2. WHAT TO DO ABOUT BEFORE USING SPASFON, suppository?
3. HOW TO USE SPASFON, suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SPASFON, suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS SPASFON, suppository AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTISPASMODICAL MUSCULOTROPE
Therapeutic indications
This medication is indicated for the treatment of spasmodic pain in the intestine, bile ducts, bladder and uterus.
2. WHAT TO DO ABOUT BEFORE USING SPASFON, suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use SPASFON, a suppository if you are allergic to any of the ingredients.
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 SPASFON, suppository:
Precautions for use
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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
Not applicable.
3. HOW TO USE SPASFON, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
3 suppositories per day.
Administration mode
Rectal route.
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 drugs, SPASFON, suppository is likely to have undesirable effects, although not everyone is subject to it:
· Mucocutaneous and allergic manifestations: rash, rarely urticaria, exceptionally angioedema, arterial hypotension, anaphylactic shock.
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 SPASFON, suppository?
Keep out of the reach and sight of children.
Expiration date
Do not use SPASFON, suppository after the expiry date stated on the carton.
Storage conditions
This medication should be stored away from heat.
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 does SPASFON contain, suppository?
The active substances are:
Phloroglucinol hydrate ................................................ .................................................. 0.1500 g
Corresponding amount of anhydrous phloroglucinol at ............................................ .............................. 0.11167 g
Trimethylphloroglucinol ................................................. .................................................. 0.1500 g
For a suppository.
The other components are:
Solid hemi-synthetic glycerides.
Pharmaceutical form and content
What is SPASFON, suppository and contents of the pack?
This medication is in the form of a suppository. Box of 10 or 100.
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
ACINO FRANCE SAS
76-78 AVENUE DU MIDI
63808 COURNON D'AUVERGNE CEDEX
exploiting
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
Maker
LAPHAL INDUSTRIES
AVENUE DE PROVENCE
13190 ALLAUCH
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.