NOTICE
ANSM - Last updated: 20/05/2016
Name of the medicinal product
LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet
Ascorbic acid
framed
Read this manual carefully because it contains important information.
· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
Review summary
In this notice :
1. WHAT IS LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet?
3. HOW TO TAKE LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
VITAMIN C
Therapeutic indications
This medication contains vitamin C.
It is indicated in the states of transient fatigue of the adult and the child of more than 15 years.
2. BEFORE YOU TAKE LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet:
· If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of LAROSCORBINE 1 g, effervescent tablet.
· In case of renal calculus
· In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Special warnings
· Due to the presence of sucrose (67 mg of sucrose per effervescent tablet), the use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency ( rare hereditary diseases).
Precautions for use
· Due to a slightly stimulating effect, it is advisable not to take vitamin C at the end of the day.
· This medicine contains 312 mg sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.
· 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).
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
This medication contains vitamin C.
Other medicines contain it. Do not combine them in order not to exceed the maximum recommended doses.
IF YOU TAKE OR HAVE RECENTLY TAKEN ANY OTHER MEDICINE, INCLUDING ANY DRUG, WITHOUT ORDER, TALK TO YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication will only be used during pregnancy if necessary only on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
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
List of excipients with known effect : aspartame, sodium, sucrose.
3. HOW TO TAKE LAROSCORBIN WITHOUT SUGAR 1 g, effervescent tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS
The dosage is 1 tablet per day.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
Method and route of administration
Oral use.
The tablet should be dissolved in a glass of water.
Duration of the treatment
The duration of treatment is limited to 1 month.
Symptoms and Instructions for Overdose
IN CASE OF OVERDOSAGE OR ACCIDENTAL INTOXICATION, IMMEDIATELY PREVENT A DOCTOR.
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, LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet is likely to have undesirable effects, although not everyone is subject to it.
At high doses above 1 g / day, possibility of:
· digestive disorders (heartburn, 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).
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 through 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 LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet after the expiry date stated on the box.
Storage conditions
For tube packaging (PP): "Store at a temperature not exceeding 25 ° C. Store in the well-closed tube, protected from light and moisture "in climatic zones I, II and III.
For tube (aluminum) packaging: "Store at a temperature not exceeding 30 ° C. Keep in the well-closed tube, protected from light and moisture "in climatic zones III and IV.
For heat-sealed film (Aluminum / PE) packaging: "Store at a temperature not exceeding 30 ° C. Store in the original package in order to protect from light and moisture in climatic zones III and IV.
If necessary, warnings against visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet?
The active substance is:
Ascorbic acid ................................................ .................................................. .......................... 1000 mg
For an effervescent tablet.
The other components are:
Sodium bicarbonate, anhydrous citric acid, anhydrous sodium carbonate, malic acid, isomalt, sodium chloride, aspartame, potassium acesulfame, orange flavor *, mandarin flavor, β-carotene 1% CWS / M.
* Orange flavor and β-carotene 1% CWS / M contain sucrose (approximately 67 mg of sucrose per effervescent tablet).
Pharmaceutical form and content
What is LAROSCORBINE WITHOUT SUGAR 1 g, effervescent tablet and contents of the pack?
This medication is in the form of effervescent tablets.
Tube of 10 or 15 tablets in box of 1 or 2 tubes.
1 effervescent tablet with heat-sealed film.
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
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
Maker
DELPHARM GAILLARD
33 STREET OF INDUSTRY
74240 GAILLARD
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 ANSM website (France).
Information for health professionals only
Not applicable.
Other
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.