NOTICE
ANSM - Updated: 02/10/2017
Name of the drug
STIMOL 1 g / 10 ml, oral solution in ampoule
Citrulline malate
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.
What does this booklet contain ?
1. What is STIMOL 1 g / 10 ml oral solution in ampoule and in which cases is it used?
2. What information do you need to know before taking STIMOL 1 g / 10 ml, oral solution in ampoule ?
3. How to take STIMOL 1 g / 10 ml, oral solution in ampoule ?
4. What are the possible side effects?
5. How to store STIMOL 1 g / 10 ml, oral solution in ampoule ?
6. Contents of the package and other information.
1. WHAT IS STIMOL 1 g / 10 ml, oral solution in ampoule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTIASTHENIC VIEW (A: Digestive system and metabolism)
- ATC code: A13.
This medicine is indicated in the states of fatigue passenger.
2. BEFORE YOU TAKE STIMOL 1 g / 10 ml, oral solution in ampoule?
Do not take STIMOL 1 g / 10 ml, oral solution in ampoule in the following case:
· if you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
· In the case of low sodium diet, take into account in the daily ration the presence of 30 mg of sodium per ampoule.
· Due to the acidic pH, the ampoules should always be diluted in a glass of water.
Talk to your doctor or pharmacist before taking STIMOL 1 g / 10 ml, oral solution in ampoule .
children
Not applicable.
Other medicines and STIMOL 1 g / 10 ml, oral solution in ampoule
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
STIMOL 1 g / 10 ml, oral solution in ampoule with food and drink
Not applicable.
Pregnancy and breast feeding
The use of this medication should usually be avoided during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
The use of this medicine should be avoided during breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
Driving and using machines
Not applicable.
STIMOL 1 g / 10 ml, oral solution in ampoule contains sodium.
3. HOW TO TAKE STIMOL 1 g / 10 ml, oral solution in ampoule?
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD.
Adult :
3 ampoules a day, spreading them throughout the day.
Child :
2 ampoules a day, spreading them throughout the day.
Method and route of administration
Oral way
Dilute the ampoules in a glass of water.
Duration of treatment
Do not use more than 4 weeks.
If you take more STIMOL 1 g / 10 ml, oral solution in ampoule than you should
Possible overdose may result in aggravation of adverse effects (gastrointestinal disorders).
If you forget to take STIMOL 1 g / 10 ml, oral solution in ampoule
Not applicable.
If you stop taking STIMOL 1 g / 10 ml, oral solution in ampoule
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Rare: slight heartburn at the beginning of treatment.
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 STIMOL 1 g / 10 ml, oral solution in ampoule?
Keep this medicine out of the sight and reach of children.
No special conditions of conservation.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month .
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 STIMOL contains 1 g / 10 ml, oral solution in ampoule
· The active substance is :
Citrulline malate ............................................... .................................................. ....................... 1.00 g
For a 10 ml ampoule.
· The other components are :
Natural aroma of orange sangria, 30% sodium hydroxide solution (m / m), purified water.
What STIMOL 1 g / 10 ml oral solution in ampoule and contents of the pack
Marketing Authorization Holder
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
Operator of the marketing authorization
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
Maker
BIOCODEX
1 AVENUE BLAISE PASCAL
60000 BEAUVAIS
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
Not applicable.