Pierre Fabre Revitalose Ampoule Against Fatigue

Revitalose, a sugar-free oral solution sweetened with sorbitol, is an anti-asthenic medication containing amino acids, magnesium, and vitamin C.
It is recommended for temporary fatigue associated with intense physical exertion, overwork, and convalescence.

Composition of Revitalose Antiasthenic Ampoules

The active ingredients are as follows (per 5 ml ampoule):

AMPLOID A:

Magnesium Aspartate Dihydrate

0.200 g

L-Leucine

0.025 g

L-Lysine Monohydrochloride

0.200 g

L-Phenylalanine

0.010 g

L-Valine

0.010 g

Other ingredients are: Sorbitol, soluble orange flavor*, sodium methylparaben, sodium propylparaben, sodium acetate, glacial acetic acid, purified water. * Composition of the soluble orange flavor: orange and mandarin essential oils, ethyl butyrate, acetaldehyde, ethyl acetate, hexanol, dodecanol, linalyl acetate, ethanol

BULB

Sodium ascorbate

1.125 g

Quantity corresponding to ascorbic acid in

1.000 g

Other ingredients are: Methyl parahydroxybenzoate, propyl parahydroxybenzoate, propyl gallate, 96% v/v alcohol, glycerol, purified water.

Excipients with known effects are: sorbitol, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol.

Dosage of Revitalose Vitamin C 1000 mg Vials for Temporary Fatigue

It is important to always follow the dosage prescribed by your doctor.

The usual recommended dosage is 1 dose per day, preferably in the morning, dissolved in a glass of water.
One dose consists of one vial A and one vial B.

Regarding the duration of treatment: do not use for prolonged periods without prior medical advice.

In case of an overdose of Revitalose ampoules, consult a doctor.

Contraindications for Revitalose Anti-Fatigue Medicine

Contraindications for this medication include allergies to one of its ingredients, kidney stones when the vitamin C dose is greater than 1 g/day, or phenylketonuria due to the presence of phenylalanine.

Its use is not recommended for people with fructose intolerance.

If in doubt, do not hesitate to seek advice and guidance from your doctor or pharmacist.

Precautions for using Revitalose A+B oral ampoules

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per oral ampoule.

It is important to inform your doctor or pharmacist of any medication you are currently or recently taking, even if it is a non-prescription drug.

Revitalose and pregnancy

During pregnancy, Revitalose sugar-free oral solution sweetened with sorbitol should only be used on the advice of your doctor.
If you become pregnant during treatment, you must consult your doctor, as only they can determine the need to continue treatment.

Revitalose and breastfeeding

Breastfeeding is possible while using Revitalose.

Revitalose Side Effects

In case of overdose, high doses of vitamin C may cause various adverse effects, such as stomach pain, diarrhea, discomfort when urinating, or red urine due to the destruction of red blood cells in people with G6PD deficiency.

It is best not to use Revitalose late in the day, as vitamin C has a mild stimulant effect.
In people with diabetes, vitamin C may alter the response of blood and urine reagents.

Some of its components may cause allergic reactions (sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)).

Packaging: Box of 14 doses of two 5 ml ampoules

For iron deficiency patients, Pierre Fabre also offers Tardyferon 80 mg tablets.



LEAFLET
ANSM - Updated on: 01/12/2023
Name of the medicinal product
REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol
Box
Please read 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 after 15 days of treatment.
What is in this leaflet? 1. What is REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol, and what is it used for?
2. What you need to know before taking REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol?
3. How to take REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol?
4. Possible side effects?
5. How to store REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol?
6. Contents of the pack and other information.

1. WHAT IS REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol, AND WHAT IS IT USED FOR?
   Pharmacotherapeutic group: Digestive tract and metabolism – Tonics - ATC code: A13A
   REVITALOSE SUGAR-FREE, an oral solution sweetened with sorbitol, contains 6 active ingredients: 5 amino acids (magnesium aspartate dihydrate, L-leucine, L-lysine monohydrochloride, L-phenylalanine, and L-valine) and vitamin C (also known as ascorbic acid). These ingredients help combat fatigue.
   This medication is used to treat temporary fatigue that accompanies intense physical exertion, overwork, and convalescence.
   This medication is for adults and adolescents aged 15 and over.
   You should consult your doctor if you do not feel any improvement or if you feel worse after 15 days of treatment.
   2. WHAT YOU NEED TO KNOW BEFORE TAKING REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol?
   Do not take REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol:
   · if you are allergic to the active substances or any of the other ingredients of this medicine, listed in section 6.
   · if you suffer from kidney stones and are taking doses of vitamin C above 1 g per day.
   · if you have a hereditary disease that was detected at birth and called phenylketonuria, because this medicine contains phenylalanine.
   · if you have a disease characterized by iron overload (hemochromatosis, thalassemia) or if you are taking iron supplements.
   If you suffer from a hereditary disorder affecting your red blood cells (Glucose-6-Phosphate Dehydrogenase or G6PD deficiency) for vitamin C doses above 1 g per day.
   In children under 15 years of age.
   Warnings and precautions
   Talk to your doctor or pharmacist before taking REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol.
   If you have metabolic disorders, prolonged use of high-dose vitamin C may lead to hyperoxaluria (excretion of urine containing large amounts of calcium oxalate crystals), leading to the formation of calcium oxalate stones.
   You should avoid taking this medicine late in the day due to the mildly stimulating effect of vitamin C.
   You must follow the dosage instructions given the high dose of vitamin C.
   Children
   Not applicable.
   Other medicines and REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution
   · REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution containing vitamin C:
   o Can be used with caution with deferoxamine and deferiprone (medicines used particularly in diseases caused by iron or aluminum overload)
   o May decrease blood levels of cyclosporine (a medicine used to reduce the body's immune response), particularly when combined with vitamin E
   o May interfere with the following laboratory tests when vitamin C is taken at high doses (above 2 g/day): urine and blood glucose tests (diabetes dipstick tests) and creatinine.
   Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution with food and drink
   Not applicable.
   Pregnancy, breastfeeding, and fertility
   If you are pregnant or breastfeeding, or think you may be pregnant, ask your doctor or pharmacist before taking this medicine.
   You should avoid taking this medicine if you are pregnant or breastfeeding.

Driving and using machines
REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution has no or negligible influence on the ability to drive and use machines. REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol, contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), ethanol, and sodium.
· Sorbitol (E 420). This medicinal product contains 500 mg of sorbitol per dose, equivalent to 50 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
· Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217). This medicine may cause allergic reactions (possibly delayed).
· Ethanol. This medicine contains 27 mg of alcohol (ethanol) per dose. The amount in each dose of this medicine is equivalent to less than 1 ml of beer and 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effect. Sodium. This medicine contains 132.7 mg of sodium (the main component of cooking/table salt) per dose. This is equivalent to 6.6% of the recommended maximum daily intake of sodium for an adult. To be taken into account by patients controlling their sodium intake.
This medicine contains 10 mg of phenylalanine per dose, equivalent to 1 mg/ml. Phenylalanine can be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by the accumulation of phenylalanine that cannot be properly eliminated.
3. HOW TO TAKE REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Dosage
The recommended dose for adults and adolescents aged 15 years and over is 1 dose per day, taken with a glass of water, preferably in the morning. This medication contains vitamin C and therefore has a stimulating effect. It is therefore best not to take this medication late in the day.
One dose consists of one ampoule A and one ampoule B.
The maximum duration of treatment is 15 days.
A balanced diet allows you to cover your daily intake of vitamin C and amino acids.
Administration method
This medication is for oral use.
Dilute the contents of both ampoules in a glass of water before swallowing.
To open an ampoule, break both ends. To break the tip of the ampoule more easily, it is recommended to place it on the corner of a clean towel and gently bend it. The tip will break along the circular line.
Self-breakable ampoules may produce a crescent of glass when opened, i.e., a piece detaching from the tip. It is recommended not to open the ampoule over the glass.

To avoid collecting glass fragments, it is important to:

· Open the first tip outside the glass.

· Then turn the ampoule over, tilt it, and place the broken ampoule on top of the glass.

· Open the second tip in the same way, also outside the glass.

If you take more REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol than you should
Consult your doctor or pharmacist immediately.
At doses above 1 g/day of vitamin C, the following may occur:
· Digestive problems (abdominal pain, diarrhea)
· Urinary problems (kidney stones, kidney failure)
· Hemolysis (destruction of red blood cells, manifested in particular by a red color of the urine) if you have a hereditary red blood cell disease called Glucose-6-Phosphate Dehydrogenase or G6PD deficiency (an enzyme specific to red blood cells). If you forget to take REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution
Do not take a double dose to make up for a forgotten dose.
If you stop taking REVITALOSE SUGAR-FREE, sorbitol-sweetened 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.
Side effects may occur if you take high doses of vitamin C (more than 1 g per day): see "If you take more REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution than you should" in section 3, above.
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: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE REVITALOSE SUGAR-FREE, sorbitol-sweetened oral solution?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the packaging and oral ampoules. 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 medications via wastewater or household waste. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol, contains?

The active ingredients are:
AMPLOID A:
Magnesium aspartate dihydrate .............................................................................................. 0.200 g
L-Leucine .............................................................................................................................. 0.025 g
L-Lysine monohydrochloride .............................................................................................. 0.200 g
L-Phenylalanine ..................................................................................................................... 0.010 g
L-Valine ............................................................................................................................... 0.010 g
Per 5 ml ampoule
AMPLOID B:
Sodium ascorbate ............................................................................................................... 1.125 g
Amount corresponding in ascorbic acid to ..................................................................... 1.000 g
Per 5 ml ampoule
· Other ingredients are:
AMPLOID A:
Sorbitol, soluble orange flavor*, sodium methylparaben, sodium propylparaben, sodium acetate trihydrate, glacial acetic acid, purified water.
* Composition of soluble orange flavor: orange and mandarin essential oils, ethyl butyrate, acetaldehyde, ethyl acetate, hexanol, dodecanol, linalyl acetate, ethanol.
AMPLOID B:
Methylparaben, propylparaben, propyl gallate, alcohol 96% v/v, glycerol, purified water.
What is REVITALOSE SUGAR-FREE, oral solution sweetened with sorbitol and contents of the outer packaging?
This medicine is presented as an oral solution, 5 ml ampoule:
Ampoule A (amino acids): clear, colorless liquid
Ampoule B (ascorbic acid): slightly viscous, slightly yellow solution
Box of 2 x 7, 2 x 10, 2 x 12, 2 x 14, 2 x 15, and 2 x 20 ampoules (ampoules A and B).
Not all pack sizes may be marketed. Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
NEXTPHARMA S.A.S
17 ROUTE DE MEULAN
78520 LIMAY
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).
Health education advice:
This medicine is intended to relieve temporary fatigue. It is important to distinguish between normal physical fatigue, which occurs following significant exertion, for example, and asthenia, which is fatigue occurring without any exertion.
· Fatigue occurring following physical exertion is normal: rest is enough to make it disappear.
· Fatigue that does not respond to rest, or asthenia, is the feeling of being unable to exert yourself even before you have begun. This fatigue can be the result of overwork or illness.
Some medications can also cause unusual fatigue: reread the instructions for the medications you are taking and ask your pharmacist or doctor for advice. However, in many cases, no specific cause is found.
Fatigue can manifest itself through a wide variety of symptoms. This can include a general feeling of weakness. But sometimes symptoms can be associated with it, such as sleep disorders (insomnia, restless sleep, etc.), intellectual disorders (difficulty concentrating, memory, and attention), sexual disorders (decreased desire, etc.), and mood disorders (irritability, pessimism, sadness, demotivation, etc.).
You can reduce your fatigue by following the following advice as much as possible:
· Rest, relax, and look for the causes of your fatigue.
· Engage in regular, appropriate physical activity.
· Eat a balanced diet (especially avoiding alcohol, tobacco, and stimulants).
· Regain your sleep rhythm (regular bedtime and sufficient sleep).
Ask your pharmacist or doctor for advice in the following cases:
· No improvement after 15 days of treatment.
· Increased fatigue during treatment.
· Occurrence of new or unusual symptoms.