NOTICE
ANSM - Updated: 27/10/2017
Name of the drug
SPORTENINE chewable tablet
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
What does this booklet contain ?
1. What is SPORTENINE Chewable Tablet and in which cases is it used?
2. What information do you need to know before taking SPORTENINE chewable tablets?
3. How to take SPORTENINE chewable tablet?
4. What are the possible side effects?
5. How to store SPORTENINE chewable tablets?
6. Contents of the package and other information.
1. WHAT IS SPORTENINE chewable tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Homeopathic medicine
SPORTENINE chewable tablet is a homeopathic medicine traditionally used in case of cramps, body aches, muscle fatigue, during sports efforts or physical overwork.
2. BEFORE YOU TAKE SPORTENINE chewable tablets?
Do not take SPORTENINE chewable tablets:
· In children under 6 years of age because of the risk of a false route related to the pharmaceutical form
· If you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 1.6 g of glucose per tablet which must be taken into account in the daily ration in case of low sugar diet or diabetes.
The use of this drug is not recommended in patients with glucose and galactose malabsorption syndrome.
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
children
Not applicable.
Other medicines and SPORTENINE chewable tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SPORTENINE chewable tablet with food and drinks
Take tablets away from meals.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
SPORTENINE chewable tablet contains glucose and lactose.
3. HOW TO TAKE SPORTENINE, chewable tablet?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
SPORTENINE chewable tablet is all the more effective as you accompany it with a healthy lifestyle and preventive measures. So warm-ups before and stretching after your workouts contribute to better preparation and recovery.
Dosage
· Before the muscular effort: 1 chewable tablet the day before or just before the test.
· During the muscular effort: 1 chewable tablet every hour.
· After the muscular effort: 1 chewable tablet, to renew every hour until improvement.
Do not exceed 10 tablets a day.
Administration mode
Oral way.
Duration of the treatment
The duration of treatment is 3 days maximum.
If you take more SPORTENINE chewable tablets than you should
Immediately consult your doctor or pharmacist.
If you forget to take SPORTENINE chewable tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking SPORTENINE chewable tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE SPORTENINE chewable tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
There are no special precautions for storage.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What SPORTENINE contains chewable tablet
· The active substances are:
Arnica montana 9 CH ............................................................................................. .... 6,67 mg
Sarcolacticum acidum 3 CH ....................................................................................... .6.67 mg
Zincum oxydatum 3 CH ............................................................................................. .6.67 mg
For a chewable tablet.
· The other components are:
Glucose monohydrate, lactose monohydrate, magnesium stearate, citric acid monohydrate, natural lemon flavor.
What SPORTENINE chewable tablet looks like and contents of the pack
This medicine is in the form of chewable tablets. It is packaged in a box containing 22 or 33 tablets.
Marketing Authorization Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
Operator of the marketing authorization
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date 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).