NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate
Arginine aspartate
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. What is SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with sodium saccharin and sodium cyclamate and in which cases it is used?
2. What should I know before taking SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with sodium saccharin and sodium cyclamate ?
3. How to take SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
4. What are the possible side effects?
5. How to store SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
6. Additional information.
1. WHAT IS SOGGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with sodium saccharin and sodium cyclamate AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
TONIC
(A: Digestive System and Metabolism).
Therapeutic indications
This medicine is indicated in the states of transient fatigue of the adult and the child of more than 12 years.
2. BEFORE YOU TAKE SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take SARGENOR WITHOUT SUGAR 1 g, chewable tablet with sodium saccharin and sodium cyclamate in the following cases:
· Allergic (hypersensitivity) to arginine aspartate or any of the other ingredients mentioned in "Additional Information".
Precautions for use; special warnings
Take special care with SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate:
· The appearance of fatigue in children under 12, even if it seems transient, requires a consultation with your doctor.
· If fatigue persists after 4 weeks of treatment or if fatigue is accompanied by unusual symptoms, consult your doctor or pharmacist.
Interaction with other medicines
Taking or using other medicines:
This medicine contains arginine aspartate. Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses (see section "If you take more than 1 g SARGENOR WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium and sodium cyclamate you should not have" ).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
Instructions for proper use
This medication should not be used without medical advice in children under 12 years of age.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adult: 2 to 3 tablets per day.
Children over 12 years: 1 to 2 tablets per day.
The tablets are chewable, preferably before meals.
Route of Administration
Oral use.
Duration of the treatment
The duration of treatment is limited to 4 weeks.
Symptoms and Instructions for Overdose
If you take more than 1 g SARGENOR WITHOUT SUGAR, chewable tablet sweetened with sodium saccharin and sodium cyclamate you should:
In case of accidental overdose, digestive disorders such as diarrhea, abdominal pain or bloating may occur. In this case, stop treatment and contact a doctor.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate is likely to have undesirable effects, although not everyone is subject to it:
· Allergic reactions (possibly delayed).
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 through 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 WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the outer packaging.
Storage conditions
Not applicable.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does SARGENOR WITHOUT SUGAR contain 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate?
The active substance is :
Arginine aspartate .............................................. .................................................. ................................ 1 g
For a chewable tablet.
The other components are :
Mannitol, anhydrous citric acid, orange flavoring, sodium saccharin, sodium cyclamate, magnesium stearate, talc.
Pharmaceutical form and content
What is SARGENOR WITHOUT SUGAR 1 g, chewable tablet sweetened with saccharin sodium and sodium cyclamate and contents of the outer carton?
This medication is in the form of a chewable tablet, in a 20, 40 or 60 chewable tablet.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MEDA PHARMA
40-44 WASHINGTON STREET
75008 PARIS
exploiting
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.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.