NOTICE
ANSM - Last updated: 28/09/2011
Name of the medicinal product
VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame
Vitamin C
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
3. HOW TO TAKE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
6. ADDITIONAL INFORMATION
1. WHAT VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
VITAMIN C
(A: digestive system and metabolism)
Therapeutic indications
This medication is indicated in the states of transient fatigue of the adult (from 15 years).
2. BEFORE YOU TAKE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame in the following cases:
· in the event of a history of allergy to any of the components of the tablet, in particular orange yellow S (E110),
· kidney stone,
· phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame,
· if you are on a fructose-free diet, due to the presence of sorbitol.
This medication MUST NOT BE GENERALLY USED IN association with KAYEXALATE unless directed to do so by your doctor.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame:
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
If fatigue persists after 10 days of treatment or if fatigue is accompanied by unusual symptoms : TAKE ADVICE OF YOUR DOCTOR.
Due to the presence of orange yellow S (E110), this medication can cause allergic reactions or even asthma, especially in people allergic to aspirin
Use this medication only with caution (precautions for use)
Due to a slightly stimulating effect, it is advisable not to take vitamin C at the end of the day.
Taking this medication does not mean that you do not respect the main rules of hygiene such as: regular physical activity, balanced diet (including avoidance of alcohol, tobacco, and / or stimulants), regular hours of sleep, rest.
In diabetics, vitamin C can alter the results of blood or urine tests.
The physiological requirements of vitamins are normally ensured by a varied dietary intake.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IN PARTICULAR KAYEXALATE (due to the presence of sorbitol), IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER PROCESSING IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
This medicine contains vitamin C. Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses ( see directions for use and dosage ). |
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
Do not take this medicine without consulting your doctor or pharmacist. |
This medication will only be used during pregnancy on the advice of your doctor. The use of vitamin C should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Excipients with a known effect : aspartam, orange yellow S (E110), sorbitol.
3. HOW TO TAKE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Do not use this medication in children (less than 15 years of age) |
Dosage
RESERVED FOR THE ADULT (from 15 years).
1 to 2 tablets per day.
Method and route of administration
Oral use.
The tablets are chewable.
Duration of treatment
The duration of use is limited to 10 days. |
Symptoms and Instructions for Overdose
If you take more VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame you should not have:
At doses above 1 g / day in vitamin C, possibility of:
· digestive disorders (gastric burns, diarrhea),
· urinary disorders (formation of kidney stones).
In doses greater than 2 g / day in vitamin C, ascorbic acid may interfere with the following biological tests: blood and urine creatine and glucose (glucose oxidase).
In doses above 3 g / day in vitamin C, risk of haemolysis (destruction of red blood cells) in glucose 6 phosphate dehydrogenase (specific enzymes of red blood cells).
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, VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame is likely to have undesirable effects, although not everyone is subject to it.
At high doses above 1 g / day, possibility of:
· digestive disorders (stomach burns, diarrhea),
· urinary disorders (discomfort with the emission of urine or red coloring of the urine),
· hemolysis (destruction of red blood cells) in glucose 6 phosphate dehydrogenase deficient (lack of an enzyme of red blood cells),
· because of the presence of sorbitol, this medication can cause diarrhea and abdominal pain.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame?
Keep out of the reach and sight of children.
Expiration date
Do not use VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does VITASCORBOL WITHOUT SUGAR BUFFER 500 mg contain, chewable tablet sweetened with sorbitol and aspartame?
The active substances are :
Ascorbic acid ................................................ .................................................. 200,000 mg
Sodium ascorbate ............................................... .................................................. 337.500 mg
Quantities corresponding to vitamin C ............................................. ............................................. 500,000 mg
For a tablet.
The other components are :
Sorbitol, anhydrous colloidal silica, magnesium stearate, lemon flavoring *, aspartam, orange-yellow amber lacquer S.
* Composition of lemon flavor : essential oils and fractionation products of essential oils of lemon and orange, citral, gum arabic, colloidal silica.
Pharmaceutical form and content
What is VITASCORBOL WITHOUT SUGAR BUFFER 500 mg, chewable tablet sweetened with sorbitol and aspartame and contents of the pack?
This medication is in the form of a chewable tablet. Box of 1 or 2 bottles of 12 tablets.
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
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
HAUPT PHARMA LIVRON
1, RUE COMTE DE SINARD
25250 LIVRON
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 approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.