NOTICE
ANSM - Last updated: 30/06/2017
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 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 VITAMIN SARGENOR, an effervescent tablet and in which cases it is used?
2. What do you need to know before taking SARGENOR A VITAMIN C, an effervescent tablet?
3. How to take SARGENOR WITH VITAMIN C, effervescent tablet?
4. What are the possible side effects?
5. How to store SARGENOR WITH VITAMIN C, effervescent tablet?
6. Package contents and other information.
1. WHAT IS SARGENOR WITH VITAMIN C, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: - ATC code: A13A
This medicine contains an amino acid (arginine aspartate) and vitamin C.
It is indicated in the states of transient fatigue of the adult (from 15 years).
2. BEFORE YOU TAKE SARGENOR WITH VITAMIN C, effervescent tablet?
Never take SARGENOR WITH VITAMIN C, effervescent tablet:
· if you are allergic to any of the ingredients of this medication listed in section 6.
· If you have a kidney stone (oxalo-calcium).
· If you have phenylketonuria (hereditary disease detected at birth) because of the presence of aspartame.
Take special care with SARGENOR A VITAMIN C, effervescent tablet:
· Due to a slightly stimulating effect, it is advisable not to take this medication at the end of the day.
· This medication contains 109 mg sodium per effervescent tablet: take this into account in people on a strict salt-restricted diet.
· If your fatigue increases or persists after 1 month of treatment or if it is accompanied by unusual symptoms ( see Health Education Tips ), consult your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking SARGENOR A VITAMIN C, an effervescent tablet .
children
Not applicable.
Other medicines and SARGENOR A VITAMIN C, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medication contains arginine aspartate and vitamin C. Other medicines contain it. Do not combine them, in order not to exceed the maximum recommended doses (see Instructions for use and dosage).
SARGENOR WITH VITAMIN C, effervescent tablet with food and drinks.
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.
Driving and using machines
Not applicable.
SARGENOR A VITAMIN C, effervescent tablet contains:
Aspartam (source of phenylalanine) (E 951), sodium (109 mg per tablet).
3. HOW TO TAKE SARGENOR WITH VITAMIN C, effervescent tablet?
RESERVED FOR ADULTS (from 15 years)
Dosage
· Either an effervescent tablet in the morning and one at noon.
· Either two effervescent tablets in the morning or at noon in a single dose.
· Do not exceed 2 effervescent tablets per day.
· Dissolve the effervescent tablets in a glass of water before drinking.
Duration of the treatment
The duration of use is limited 1 month
If you take more SARGENOR WITH VITAMIN C, effervescent tablet than you should:
· In doses above 1 g / day in vitamin C possibility of:
o digestive disorders (heartburn, diarrhea),
o urinary disorders (formation of kidney stones),
· Vitamin C may interfere with the following biological tests in doses above 2 g / day in vitamin C: blood and urine creatinine and glucose (glucose oxidase).
· In doses greater than 3 g / day in vitamin C, risk of hemolysis (destruction of red blood cells) in glucose 6 phosphate dehydrogenase (specific enzymes of red blood cells).
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Arginine may cause gastrointestinal disturbances. In large doses, it may cause diarrhea.
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 WITH VITAMIN C, effervescent tablet?
Keep this medicine out of the reach and sight of children.
No special storage conditions.
Do not throw any medication into drains or household waste. 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 A LA VITAMIN C contains, effervescent tablet
· The active substances are:
Arginine aspartate .............................................. .................................................. .......... 1.5 g
Ascorbic acid ................................................ .................................................. ............ 0.5 g
For an effervescent tablet.
Anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, sodium citrate dihydrate, anhydrous colloidal silica, aspartame, sodium saccharin, beet red (E 162), riboflavin sodium phosphate, maltodextrin, lemon flavoring.
What is SARGENOR A VITAMIN C, effervescent tablet and contents of the pack
This medication is in the form of an effervescent tablet. Box of 10, 20 or 40.
Marketing Authorization Holder
MEDA PHARMA
40-44 WASHINGTON STREET
75008 PARIS
Marketing Authorization Operator
MEDA PHARMA
40-44 WASHINGTON STREET
75008 PARIS
Maker
HERMES PHARMA GES. MBH
ALLGAU 36
9400 WOLFSBERG
AUSTRIA
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
SANITARY EDUCATION COUNCILS
This medication is intended to alleviate a temporary state of fatigue.
It is necessary to distinguish normal physical fatigue occurring as a result of a major effort for example and asthenia which is fatigue outside of any effort.
· Fatigue arising from physical exertion is normal: rest is enough to make it disappear.
· Fatigue that does not give in to rest or asthenia is the feeling of not being able to provide an effort before it even began. This fatigue can be the consequence of overwork, of a disease.
Some medications may also cause unusual fatigue: read the package leaflet for medications you are taking and ask for advice from your pharmacist or doctor.
But in many cases no precise cause is found.
Fatigue can be manifested by very variable symptoms.
This can be a general impression of weakness.
But sometimes symptoms can associate with it such as sleep disorders (insomnia, restless sleep ...), intellectuals (difficulties of concentration, memory and attention ...), sexual (decreased desire). .), character (irritability, pessimism, sadness, demotivation ...) ...
You can reduce your fatigue by respecting as much as possible the following tips:
· Rest, relax, look for the reasons for your fatigue,
· Practice regular and appropriate physical activity.
· Have a balanced diet (especially avoid alcohol, tobacco, stimulants).
· Find your sleeping rhythm (regular bedtime and sufficient sleeping time).
Seek advice from your pharmacist or doctor in the following cases:
· No improvement after 1 month of treatment.
· Increased feeling of fatigue during treatment.
Occurrence of new symptoms or unusual symptoms.