REVITALOSE 14 Drinkable ampoules Asthenia

NOTICE

ANSM - Updated on: 09/06/2017

Name of the medicinal product

REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol

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 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 contact your doctor if you experience no improvement or feel less well after 15 days of treatment.

What is in this leaflet?

1. What is REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol and in which cases it is used?

2. What should I know before taking REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

3. How to take REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

4. What are the possible side effects?

5. How to store REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

6. Package contents and other information.

1. WHAT IS REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: Digestive tract and metabolism - Tonics - ATC code: A13A

REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol contains 6 active substances: 5 amino acids (magnesium aspartate dihydrate, L-Leucine, L-Lysine monohydrochloride, L-phenylalanine and L-Valine) and vitamin C ascorbic). These substances help fight fatigue.

This medication is used to treat the transient fatigue states that accompany intense physical exertions, states of overwork and convalescence.

This medicine is reserved for adults and adolescents from the age of 15 years.

You should contact your doctor if you experience no improvement or feel less well after 15 days of treatment.

2. BEFORE YOU TAKE REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Never take REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol:

· If you are allergic to any of the active ingredients (Magnesium Aspartate dihydrate, L-Leucine, L-Lysine Monohydrochloride, L-Phenylalanine, L-Valine or Vitamin C) or any of the other ingredients of this medication mentioned in heading 6.

· If you are suffering from kidney stones and are taking doses of vitamin C greater than 1 g / day.

· If you have a hereditary disease that has been detected at birth and is called phenylketonuria, because this drug contains phenylalanine.

· If you have a disease caused by iron overload (hemochromatosis) or if you are taking iron supplements.

· If you have an inherited disorder affecting the red blood cells (glucose-6-phosphate dehydrogenase deficiency) and you are taking doses of vitamin C greater than 1 g / day.

· In children under 15 years of age.

Warnings and Precautions

· Prolonged use of vitamin C at high doses can lead to hyperoxaluria (excretion of urine containing a large amount of calcium oxalate crystals).

· You should avoid taking this medication at the end of the day because of the slightly stimulating effect of vitamin C.

You must follow the dosage, because of the high dose of vitamin C.

Talk to your doctor or pharmacist before taking REVITALOSE WITHOUT SUGAR, a sorbitol-sweetened oral solution.

children

Not applicable.

Other medicines and REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol

· REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol contains ascorbic acid:

o may interfere with the following biological tests when taken at high doses (greater than 2 g / day): urine and blood tests.

o can be used with caution with deferoxamine (a drug used especially in diseases caused by iron or aluminum overload)

· REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol contains magnesium salts which can reduce the absorption of:

o tetracyclines (antibiotics). An interval of 3 hours must be observed between the two outlets.

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol with food and drink

Not applicable.

Pregnancy and breast feeding

You should not use REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol during pregnancy.

You may breast-feed while taking this medication.

Do not take excessive doses to avoid unwanted side effects for you or your child.

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

REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol has no known effect on the ability to drive and use machines.

REVITALOSE WITHOUT SUGAR, sorbitol-sweetened oral solution contains sorbitol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E 216), sodium methyl paraben (E 219), sodium propyl parahydroxybenzoate (E 217) ethanol, sodium.

· Sorbitol. The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).

· Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium methyl parahydroxybenzoate (E 219), soda propyl parahydroxybenzoate (E 217). This medication may cause allergic reactions (possibly delayed).

· Ethanol. This medication contains small amounts of ethanol (alcohol), less than 100 mg per dose.

· Sodium. This medicine contains 5.72 mmol (or 132.7 mg) of sodium per dose. To be taken into account in patients controlling their sodium dietary intake.

3. HOW TO TAKE REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

Adults and teenagers from 15 years:

The recommended dose is 1 dose per day, dissolved in a glass of water, preferably in the morning.

One dose is composed of a bulb A and B.

Administration mode

This medication is used orally.

To break the tip of the bulb more easily, it is recommended to place it in the corner of a clean towel and exert a slight flexion. The point will break according to the circular line. The self-breaking bulbs can generate a glass crescent, that is to say a piece detaching itself from the point. To avoid collecting glass debris it is important to:

§ to open the first point out of his glass.

§ then turn the bulb, tilt it, place the broken bulb over the glass.

§ open the second point also out of the glass.

Mix the contents of the 2 ampoules in a glass of water before swallowing.

Frequency of Administration

You should take this medication preferably in the morning.

Indeed, this medicine contains vitamin C and can therefore have a slight stimulating effect. It is therefore best not to take this medication at the end of the day.

The maximum duration of treatment will be 15 days.

A balanced diet can cover the daily intake of vitamin C, Amino Acids.

If you take more REVITALOSE WITHOUT SUGAR, sorbitol sweetened oral solution you should not have

Immediately consult your doctor or pharmacist.

Some side effects may occur. You will find them in section 4. What are the possible side effects?

If you forget to take REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol

Do not take a double dose to make up for the single dose you have forgotten to take.

If you stop taking REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following side effects may occur if you take high doses of vitamin C (greater than 1 g / day):

§ frequent (may affect up to 1 in 10 people): digestive disorders such as abdominal pain,

§ uncommon (likely to affect up to 1 in 100 people): diarrhea,

§ rare (likely to affect up to 1 in 1000 people): urinary disorders (formation of kidney stones)

§ (the frequency can not be estimated from the available data): red urine coloration is linked to destruction of red blood cells (hemolysis) in patients with inherited red blood cell disease (also known as glucose deficiency -6-phosphate dehydrogenase).

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 REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the packaging and drinkable ampoules. The expiry date refers to the last day of the month.

No special precautions for storage.

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 is REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol

· The active substances are:

BULB 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

For a 5 ml ampoule

BULB B:

Sodium ascorbate ............................................... .................................................. .......... 1.125 g

Amount corresponding to ascorbic acid at ............................................ ......................... 1,000 g

For a 5 ml ampoule

· The other components are:

BULB A :

Sorbitol, soluble orange flavor *, sodium methyl parahydroxybenzoate, soda propyl parahydroxybenzoate, sodium acetate, glacial acetic acid, purified water.

* Soluble orange aroma composition : essential oils of orange and mandarin, ethyl butyrate, acetaldehyde, ethyl acetate, hexanol, dodecanol, linalyl acetate, ethanol.

BULB B :

Methyl parahydroxybenzoate, propyl parahydroxybenzoate, propyl gallate, 96% v / v alcohol , glycerol, purified water.

What is REVITALOSE WITHOUT SUGAR, oral solution sweetened with sorbitol and contents of the pack

This medication is in the form of a drinkable solution, 5 ml ampoule, box of 7, 10, 12, 14, 15 and 20 twin vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Marketing Authorization Operator

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Maker

NEXTPHARMA SAS

17 ROUTE DE MEULAN

78520 LIMAY

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]

<{MM / YYYY}> <{YYYY month}.>

Other

Detailed information on this medicine is available on the ANSM website (France).

Health 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 may be associated with it such as sleep disorders (insomnia, restless sleep ...), intellectuals (difficulties of concentration, memory and attention ...), sexual (decreasing 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 15 days of treatment.

· Increased feeling of fatigue during treatment.

· Occurrence of new symptoms or unusual symptoms.

VIDAL OF THE FAMILY

Revitalose