NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
SPASFON LYOC 160 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 160 mg, oral lyophilisate and in which cases it is used?
2. What should I tell you before taking SPASFON LYOC 160 mg oral lyophilisate?
3. How to take SPASFON LYOC 160 mg oral lyophilisate?
4. What are the possible side effects?
5. How to store SPASFON LYOC 160 mg oral lyophilisate?
6. Package contents and other information.
1. WHAT IS SPASFON LYOC 160 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 LYOC 160 mg belongs to a class of medications called antispasmodics. It acts against spasms (contractions).
This medicine is indicated in adults for the treatment of spasmodic pain in the intestine, biliary tract, bladder and uterus.
2. BEFORE YOU TAKE SPASFON LYOC 160 mg oral lyophilisate?
Do not take SPASFON LYOC 160 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 160 mg oral lyophilisate .
Children and Youth
Not applicable.
Other medicines and SPASFON LYOC 160 mg oral lyophilisate
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SPASFON LYOC 160 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
The use of SPASFON LYOC 160 mg is not recommended in breast-feeding women.
Driving and using machines
SPASFON has no or negligible effect on the ability to drive and use machines .
SPASFON LYOC 160 mg oral lyophilisate contains
Not applicable.
3. HOW TO TAKE SPASFON LYOC 160 mg oral lyophilisate?
Always take this medication exactly as prescribed in this leaflet or as directed 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 symptoms persist, consult your doctor.
Reserved for adults only.
Dosage
Take 1 oral lyophilisate at the time of the crisis. Repeat in case of severe spasms within a minimum interval of 2 hours between each intake without exceeding 3 oral lyophilisates per day.
Use in children
This dosage is not suitable for the child.
Method and route of administration
Oral use.
Oral lyophilisates should be dissolved in a glass of water or allowed to melt under the tongue for a quick effect.
If you take more SPASFON LYOC 160 mg oral lyophilisate than you should:
Immediately consult your doctor or pharmacist.
If you forget to take SPASFON LYOC 160 mg oral lyophilisate:
Do not take a double dose to make up for the missed dose
If you stop taking SPASFON LYOC 160 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 160 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.
No special precautions for storage.
Do not use if you notice any visible signs of product degradation.
The surface of lyophilisates may not be smooth, but sometimes bumpy. This irregular appearance does not affect the quality and effectiveness of the product.
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 160 mg contains, oral lyophilisate
· The active substance is:
Phloroglucinol dihydrate ................................................ ................................................ 160,000 mg
Corresponding amount of anhydrous phloroglucinol at ............................................ 124.466 mg
For an oral lyophilisate.
· The other components are:
Mannitol, dextran 70, sucralose, macrogol hydroxystearate 15.
What SPASFON LYOC 160 mg oral lyophilisate contains and contents of the pack
SPASFON LYOC 160 mg is in the form of oral lyophilisates white to creamy white and round. Oral lyophilisates are tablets that dissolve easily in water or saliva.
The oral lyophilisates are presented under platelets. In some countries, these platelets may be overwrapped in a sachet.
SPASFON LYOC 160 mg is presented in a box of 5 or 10 oral lyophilisates.
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).