NOTICE
ANSM - Updated on: 21/04/2015
Name of the medicinal product
ARGININE VEYRON, oral solution in vial
Arginine Hydrochloride
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 talk to your doctor if you do not feel better or feel less well.
Review summary
In this notice :
1. WHAT ARGININE VEYRON, drinkable solution in a vial AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE ARGININE VEYRON, oral solution in a vial?
3. HOW TO TAKE ARGININE VEYRON, oral solution in a vial?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARGININE VEYRON, oral solution in vial?
6. ADDITIONAL INFORMATION
1. WHAT ARGININE VEYRON, drinkable solution in a vial AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
Choleretic-cholagogue.
HYPOAMMONIEMIANT.
ANTI-asthenic.
(A: Digestive System and Metabolism).
Therapeutic indications
This medication is recommended:
· in supportive treatment of difficult digestions and transient fatigue states,
· in congenital hyperammonemia due to deficiency of the urea cycle.
2. BEFORE YOU TAKE ARGININE VEYRON, oral solution in a vial?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take ARGININE VEYRON, oral solution in vial:
If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Warnings and Precautions
USE THIS MEDICINE WITH CAUTION in cases of obstruction of the bile ducts or severe liver disease.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
In case of diarrhea or abdominal pain, stop treatment and CONSULT YOUR DOCTOR.
This medicine contains methyl parahydroxybenzoate (E 218) and may cause allergic reactions.
This medication contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Talk to your doctor or pharmacist before taking ARGININE VEYRON, oral solution in a vial.
Interaction with other medicines
Other medicines and ARGININE VEYRON, drinkable solution in vial
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
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.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
ARGININE VEYRON, oral solution in vial contains
Sucrose, methyl parahydroxybenzoate (E 218) and ethanol.
3. HOW TO TAKE ARGININE VEYRON, oral solution in a vial?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Swallow with a little water.
Dyspepsia:
Adult: 1 to 2 teaspoons, before the 3 main meals or at the time of the troubles.
Asthenia:
Adult and child over 6 years: 1 teaspoon, 2 to 3 times a day.
The duration of treatment should not exceed 4 weeks.
Congenital hyperammonemias: the dosage depends on the weight of your child.
It is necessary to follow the directions of your doctor.
Administration mode
Oral use.
Duration of treatment
In the context of asthenia, DO NOT USE MORE THAN 4 WEEKS WITHOUT MEDICAL ADVICE.
Symptoms and Instructions for Overdose
If you take more ARGININE VEYRON, oral solution in a vial than you should:
Risk of diarrhea at high doses.
Immediately consult your doctor or pharmacist.
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, this medicine may cause side effects, although not everybody gets them.
· Risk of high dose diarrhea.
Declaration of side effects
If you notice any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed 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 ARGININE VEYRON, oral solution in vial?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month .
Storage conditions
This medicine does not require any special storage precautions.
If necessary, warnings against visible signs of deterioration
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. ADDITIONAL INFORMATION
Full list of active substances and excipients
What ARGININE VEYRON contains, oral solution in vial
• The active substance is:
L (+) - arginine hydrochloride ........................................... .................................................. 16.4000 g
Corresponding amount of L (+) arginine .......................................... .............................................. 13.5562 g
For 100 g oral solution.
• Other ingredients are: Caramel flavoring (containing alcohol), methyl parahydroxybenzoate (E 218), 67% (m / m) sucrose solution, saccharin, purified water.
Pharmaceutical form and content
Aspect of ARGININE VEYRON, oral solution in bottle and contents of the pack
This medication is in the form of a drinkable solution; 250 ml bottle.
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
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE BILLANCOURT
exploiting
PIERRE FABRE MEDICAMENT
45 place Abel Gance
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
RUE DU LYCEE
INDUSTRIAL ZONE OF CUIRY
45500 GIEN
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 revised is {MM / YYYY}.
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.