NOTICE
ANSM - Last updated: 08/06/2017
Name of the medicinal product
VITASCORBOL 1 g, effervescent tablet
Ascorbic acid
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the instructions 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 your 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 afterwards.
What is in this leaflet?
1. What is VITASCORBOL 1 g, effervescent tablet and in which cases it is used?
2. What should I know before taking VITASCORBOL 1g, effervescent tablet?
3. How to take VITASCORBOL 1 g, effervescent tablet?
4. What are the possible side effects?
5. How to store VITASCORBOL 1 g, effervescent tablet?
6. Package contents and other information.
1. WHAT VITASCORBOL 1 g, effervescent tablet AND IN WHAT CASES IS IT USED?
NON - ASSOCIATED ASCORBIC ACID (VIT C).
This medicine is indicated in the states of transient fatigue of the adult and the child of more than 15 years.
2. BEFORE YOU TAKE VITASCORBOL 1 g, effervescent tablet?
Never take VITASCORBOL 1 g, effervescent tablet in the following cases:
· Hypersensitivity to any of the components.
· Kidney stone.
IN CASE OF DOUBT IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Take special care with VITASCORBOL 1 g, effervescent tablet:
Special warnings
Due to the presence of sucrose, this drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Precautions for use
Due to a slightly stimulating effect, it is advisable not to take vitamin C at the end of the day.
The physiological requirements of vitamins are normally ensured by a varied dietary intake.
This medicine contains 283 mg of sodium per tablet: take it into account in people on a strict diet low in salt.
This medication contains an azo agent (yellow orange S (E110)) and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Taking or using other medicines
When taken at high doses (more than 2 g / day), ascorbic acid may interfere with the following biological tests: creatinine and glucose, blood and urine (glucose oxidase).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult the doctor as he alone can judge the need to continue.
The use of vitamin C should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
List of excipients with known effect:
Sodium, sucrose, orange yellow S (E 110).
3. HOW TO TAKE VITASCORBOL 1 g, effervescent tablet?
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS.
One effervescent tablet per day.
Administration mode
Oral use.
The tablet should be dissolved in half a glass of water.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
At high doses above 1 g / day, possibility of:
· digestive disorders (burning of the stomach, diarrhea),
· urinary disorders (discomfort with the emission of urine or red coloring of the urine),
· hemolysis (destruction of red blood cells) in subjects deficient in glucose 6 phosphate dehydrogenase (deficiency in an enzyme of red blood cells).
Due to the presence of orange yellow S (E 110), risk of allergic reaction.
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 VITASCORBOL 1 g, effervescent tablet?
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 outer packaging after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C. and away from moisture.
Do not throw any medicines into drains or rubbish. 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 VITASCORBOL contains 1 g, tablet
· The active substance is:
Ascorbic acid (vitamin C) ............................................ .................................................. 1,000 g
For an effervescent tablet
· The other components are:
Sodium bicarbonate, anhydrous citric acid, sucrose, sodium saccharin, polyethylene glycol 6000, sodium benzoate, orange flavor *, orange yellow S (E110).
* Composition of the orange flavor : essential oils of orange (citral - limonene - linalol - decanal) - concentrated orange juice - maltodextrin.
What is VITASCORBOL 1 g, tablet and contents of the pack
This medication is in the form of effervescent tablets. Box of 10, 20 or 30.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
LA FRANCE
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
LA FRANCE
Maker
DELPHARM GAILLARD
33 STREET OF INDUSTRY
74240 GAILLARD
LA FRANCE
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:
July 2016
Other
Detailed information on this medicine is available on the ANSM website (France).
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 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 1 month of treatment.
· Increased feeling of fatigue during treatment.
· Occurrence of new symptoms or unusual symptoms.