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Arginine Veyron oral solution is indicated for the adjunctive treatment of digestive problems from the age of 15, as well as for temporary fatigue from the age of 6, as well as for congenital hyperammonemia due to urea cycle deficiency in children from 1 month to 15 years of age.
Composition of Arginine Veyron
Its active ingredient is L(+) arginine hydrochloride at a dosage of 16.4000 g (corresponding quantity of L(+) arginine: 13.5562 g) per 100 g of oral solution.
The other ingredients in its formula are: caramel flavoring (containing alcohol), methyl parahydroxybenzoate (E 218), 67% (w/w) sucrose solution, saccharin, and purified water.
Dosage of Arginine Veyron Oral Solution in a Bottle
Arginine Veyron oral solution should be swallowed with a little water.
In cases of dyspepsia, the generally recommended dosage for adults and adolescents over 15 years of age is 1 to 2 teaspoons before the 3 main meals, or at times of symptoms.
In cases of asthenia, the dosage for adults and children over 6 years of age is 1 teaspoon, 2 to 3 times a day.
The duration of treatment should not exceed 4 weeks without medical advice.
Regarding congenital hyperammonemia, the dosage depends on your child's weight. In all cases, it is necessary to follow your doctor's instructions.
Contraindications for Arginine Veyron Syrup
You should not use this medication if you are allergic to any of its ingredients.
Arginine Veyron oral solution should be used with caution in cases of bile duct obstruction or severe liver disease.
If you have diabetes or are on a low-sugar (hypocarbohydrate) diet, it is important to take into account the sucrose content of the oral solution: 0.75 g per teaspoon.
If you experience diarrhea or abdominal pain, you should discontinue treatment and consult your doctor.
Regarding pregnancy and breastfeeding, you should always seek medical advice before using any medication.
Finally, the list of excipients that is necessary for safe use in certain patients is as follows: Sucrose (0.75 g per teaspoon) - Methyl parahydroxybenzoate (E 218).
Arginine Veyron: what are the side effects?
This medication may, at an unknown frequency, cause: an allergic reaction; diarrhea; and abdominal pain.
Packaging: 250 ml bottle.
Pierre Fabre Laboratories also offers Revitalose anti-fatigue ampoules. They contain magnesium and vitamin C.
LEAFLET
ANSM - Updated on: 01/02/2023
Name of the medicinal product
ARGININE VEYRON, oral solution in bottle
Arginine hydrochloride
Box
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You must always take this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may 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 includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is ARGININE VEYRON, oral solution in a bottle and what is it used for?
2. What you need to know before taking ARGININE VEYRON, oral solution in a bottle?
3. How to take ARGININE VEYRON, oral solution in a bottle?
4. Possible side effects?
5. How to store ARGININE VEYRON, oral solution in a bottle?
6. Contents of the pack and other information.
1. WHAT IS ARGININE VEYRON, oral solution in a bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: CHOLAGOGUE-CHOLERETIC, HYPOAMMONIAMANT, ANTIASTHENIC – ATC code: A: Digestive system and metabolism
This medicine contains the active substance L(+) Arginine hydrochloride. It is indicated for:
· Adjunctive treatment of digestive problems in adults
· Treatment of temporary fatigue in adults and children over 6 years of age.
· Congenital hyperammonemia due to urea cycle deficiency in infants, children, and adults.
2. WHAT YOU NEED TO KNOW BEFORE TAKING ARGININE VEYRON, oral solution in a bottle?
Do not take ARGININE VEYRON, oral solution in a bottle:
If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
· Talk to your doctor or pharmacist before taking ARGININE VEYRON, oral solution in a bottle.
· USE THIS MEDICINE WITH CAUTION in cases of bile duct obstruction or severe liver disease. In case of diarrhea or abdominal pain, stop treatment and CONSULT YOUR DOCTOR.
Children and adolescents
Not applicable.
Other medicines and Arginine Veyron, oral solution in a bottle
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Arginine Veyron, oral solution in a bottle with food, drink, and alcohol
Not applicable.
Pregnancy, breastfeeding
This medicine is not recommended if you are pregnant or if you are of childbearing age without using contraception.
If you are breastfeeding, avoid using this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
Arginine Veyron, oral solution in a bottle contains
· 0.8 g of sucrose per teaspoon (5 ml). This should be taken into account by patients with diabetes mellitus. May be harmful to teeth.
· If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
· methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).
· 23 mg of ethanol per teaspoon (5 ml). The amount per teaspoon in this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine is not likely to cause any noticeable effects.
3. HOW TO TAKE ARGININE VEYRON, oral solution in a bottle?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure. Dosage
Use in adults
Indigestion:
1 to 2 teaspoons before the 3 main meals or at times of discomfort.
Temporary fatigue:
1 teaspoon, 2 to 3 times a day.
The duration of treatment should not exceed 4 weeks.
Congenital hyperammonemia:
The dosage is based on weight.
Use in children over 6 years of age
Temporary fatigue:
1 teaspoon, 2 to 3 times a day.
The duration of treatment should not exceed 4 weeks.
Use in children and infants
Congenital hyperammonemia: The dosage is based on your child's weight.
It is necessary to follow your doctor's instructions.
Method of administration
Oral administration.
Swallow with a little water.
For infants, dilute in water or in a bottle. Duration of treatment
For temporary fatigue, DO NOT USE FOR MORE THAN 4 WEEKS WITHOUT MEDICAL ADVICE.
If you take more Arginine Veyron oral solution than you should
Risk of diarrhea at high doses.
Consult your doctor or pharmacist immediately.
If you forget to take Arginine Veyron oral solution
Not applicable.
If you stop taking Arginine Veyron oral solution
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. Their frequency is not known (it cannot be established based on the available data):
· Allergic reaction (hypersensitivity)
· Diarrhea, abdominal pain.
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 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.signalement-sante.gouv.fr.
By reporting side effects, you help provide more information on the safety of this medicine.
5. HOW TO STORE ARGININE VEYRON, oral solution in a bottle?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ARGININE VEYRON, oral solution in a bottle, contains
· The active substance is:
L(+) arginine hydrochloride............................................................................................. 16.4000 g
Corresponding quantity in L(+) arginine............................................................................. 13.5562 g
Per 100 g of oral solution
One teaspoon (i.e., 5 ml of oral solution) contains 0.9184 g of L(+) arginine hydrochloride.
The other ingredients are: Caramel flavoring (containing ethanol*), methyl parahydroxybenzoate (E 218), 67% sucrose solution (m/m), saccharin, purified water.
* See section 2 "ARGININE VEYRON contains".
What ARGININE VEYRON, oral solution in a bottle, looks like and contents of the outer packaging
This medicine is presented as an oral solution (brown homogeneous liquid): 250 ml bottle. Marketing Authorization Holder
Pierre Fabre Médicament
Les Cauquillous
81500 Lavaur
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
RUE DU LYCEE
ZONE INDUSTRIELLE DE CUIRY
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed later by the holder]
Other
Detailed information on this medicinal product is available on the ANSM website (France).