NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
SARGENOR 1g / 5 ml oral solution
Arginine aspartate
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 of the 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 contact your doctor if you experience no improvement or feel less well after 15 days.
Do not use this medication for children.
What is in this leaflet?
1. What is SARGENOR 1 g / 5 ml, oral solution and in which cases it is used?
2. What should I tell you before taking SARGENOR 1 g / 5 ml, oral solution?
3. How to take SARGENOR 1 g / 5 ml, oral solution?
4. What are the possible side effects?
5. How to store SARGENOR 1 g / 5 ml, oral solution?
6. Package contents and other information.
1. WHAT IS SARGENOR 1 g / 5 ml, oral solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: A13A
This drug is indicated in the states of transient fatigue.
2. BEFORE YOU TAKE SARGENOR 1 g / 5 ml, oral solution?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Never take SARGENOR 1 g / 5 ml, oral solution:
· if you are allergic (hypersensitive) to arginine aspartate or to any of the other ingredients of this medication mentioned in section 6.
This medicine contains "Parahydroxybenzoate" and may cause allergic reactions.
Warnings and Precautions
The appearance of fatigue in children under 12, even if it seems transient, requires a medical consultation with your doctor.
Taking this medication does not mean that you do not respect the main rules of hygiene such as: regular physical activity, balanced diet (including avoidance of alcohol, tobacco, and / or stimulants), regular hours of sleep, rest.
The duration of the treatment is limited to 15 days.
If fatigue persists after 15 days or if fatigue is accompanied by unusual symptoms, take the advice of your doctor or pharmacist.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Other medicines and SARGENOR 1 g / 5 ml, oral solution
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine contains arginine aspartate. Other medicines contain it. Do not combine them, so as not to exceed my maximum recommended doses (see section 3, "Dosage"). |
Pregnancy and breast feeding
It is best not to use this medication during pregnancy and lactation. If you discover that you are pregnant, consult your doctor, alone can judge the need to continue treatment.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
List of excipients with known effect : sucrose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218).
3. HOW TO TAKE SARGENOR 1 g / 5 ml, oral solution?
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.
Dosage
Adult : 2 to 3 ampoules per day.
Children over 12 years : 1 to 2 ampoule (s) per day.
Method and route of administration
Oral use
The ampoules are to be taken diluted in a little water, preferably before the meals.
Duration of treatment
The duration of use is limited to 15 days
If you take more than 1 g / 5 ml SARGENOR, oral solution you should:
Immediately consult your doctor or pharmacist.
Arginine may cause diarrhea at high doses.
If you forget to take SARGENOR 1 g / 5 ml, oral solution:
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
The frequency of these side effects is indeterminate (can not be estimated from the available data).
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Arginine may cause gastrointestinal disturbances
· In high doses, it may lead to diarrhea
· Some skin reactions are reported.
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 SARGENOR 1 g / 5 ml, oral solution?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
No special storage conditions.
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 SARGENOR contains 1 g / 5 ml oral solution
· The active substance is:
Arginine aspartate .............................................. .................................................. .............. 1 g
For a 5 ml ampoule.
· The other ingredients are sucrose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), apricot flavor, caramel (E 150), purified water.
What is SARGENOR 1 g / 5 ml, oral solution and contents of the pack
This medicine is in the form of a drinkable solution in a 5 ml ampoule: box of 10, 20 or 40 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
MEDA PHARMA
40-44 WASHINGTON STREET
75008 PARIS
Marketing Authorization Operator
MYLAN MEDICAL SAS
40-44 Washington Street
75008 PARIS
Maker
MEDA MANUFACTURING
AVENUE JF KENNEDY
33700 MERIGNAC
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).