NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
SPASFON LYOC 80 mg oral lyophilisate
phloroglucinol
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is SPASFON LYOC 80 mg oral lyophilisate and in which cases it is used?
2. What should I tell you before taking SPASFON LYOC 80 mg oral lyophilisate?
3. How to take SPASFON LYOC 80 mg oral lyophilisate?
4. What are the possible side effects?
5. How to store SPASFON LYOC 80 mg oral lyophilisate?
6. Package contents and other information.
1. WHAT IS SPASFON LYOC 80 mg oral lyophilisate AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTISPASMODIQUE MUSCULOTROPE, ATC code: A03AX12 (A: digestive system and metabolism) (G: genitourinary system)
SPASFON belongs to a class of medications called antispasmodics. It acts against spasms (contractions).
This medication is indicated for the treatment of spasmodic pain in the intestine, bile ducts, bladder and uterus.
2. BEFORE YOU TAKE SPASFON LYOC 80 mg oral lyophilisate?
Do not take SPASFON LYOC 80 mg oral lyophilisate:
· if you are allergic to phloroglucinol or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using SPASFON LYOC 80 mg oral lyophilisate .
Children and Youth
Not applicable.
Other medicines and SPASFON LYOC 80 mg oral lyophilisate
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SPASFON LYOC 80 mg, oral lyophilisate with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of this medication should only be considered during pregnancy if necessary.
feeding
Administration of this medication is not recommended for nursing mothers.
Driving and using machines
SPASFON has no or negligible effect on the ability to drive and use machines.
SPASFON LYOC 80 mg oral lyophilisate contains
Not applicable.
3. HOW TO TAKE SPASFON LYOC 80 mg oral lyophilisate?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Spasfon is a symptomatic treatment. The duration of treatment varies according to the indication. If the symptoms persist, consult your doctor.
Dosage
In the adult
Take 2 oral lyophilisates at the time of the crisis. Renew in case of severe spasms, respecting a minimum interval of 2 hours between each catch without exceeding 6 oral lyophilisates per 24 hours.
Use in children
In children over 2 years, take 1 oral lyophilisate, at the time of the crisis. Renew in case of severe spasms, respecting a minimum interval of 2 hours between each catch without exceeding 2 oral lyophilisates per 24 hours.
Method and route of administration
Oral use.
In adults: oral lyophilisates are to be dissolved in a glass of water or to melt under the tongue for a quick effect.
In children: oral lyophilisates are to be dissolved in a glass of water.
If you take more SPASFON LYOC 80 mg oral lyophilisate than you should have
Immediately consult your doctor or pharmacist.
If you forget to take SPASFON LYOC 80 mg oral lyophilisate
Do not take a double dose to make up for the missed dose .
If you stop taking SPASFON LYOC 80 mg, oral lyophilisate
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may 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 a sudden swelling of the face and neck (Quincke's edema),
· or a sudden discomfort due to a fall in blood pressure (anaphylactic shock).
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SPASFON LYOC 80 mg oral lyophilisate?
Keep this medicine out of the reach and sight of children.
Do not use this medication after the expiry date indicated on the box. The expiry date refers to the last day of that month.
Plates (PVC / Aluminum): Keep away from heat and moisture.
PVC / Aluminum packs (aluminum): to be stored at a temperature not exceeding 30 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SPASFON LYOC 80 mg contains, oral lyophilisate
· The active substance is:
Phloroglucinol hydrate ................................................ ................................................. 80 , 00 mg
Corresponding amount of anhydrous phloroglucinol ............................................. ............ 62.25 mg
For an oral lyophilisate.
· The other components are:
Dextran 70, mannitol.
What is SPASFON LYOC 80 mg oral lyophilisate and contents of the pack
This medication is in the form of an oral lyophilisate. Box of 10, 16 or 20.
Marketing Authorization Holder
TEVA HEALTH
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Marketing Authorization Operator
TEVA HEALTH
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Maker
GALIEN LPS
22 RUE EDME LABORDE
NEVERS SAINT ELOI ACTIVITY PARK
58000 NEVERS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).