In this manual :
1. WHAT IS SUGAR-FREE LAROSCORBINE 1 g, effervescent tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet
3. HOW DO I TAKE LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS SUGAR-FREE LAROSCORBINE 1 g, effervescent tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
VITAMIN C
This medicine contains vitamin C.
It is indicated for the temporary fatigue of adults and children over 15 years of age.
2. WHAT YOU SHOULD KNOW BEFORE TAKING LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet
List of information needed before taking the medicine
Not applicable.
Do not take LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet:
- If you are allergic (hypersensitive) to the active substance or to any of the other ingredients contained in LAROSCORBINE 1 g, effervescent tablet.
- In case of kidney stones
- In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with LAROSCORBINE SUGAR-FREE 1 g, effervescent tablets:
Special warnings
- Due to the presence of sucrose (67 mg of sucrose per effervescent tablet) this medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
Precautions for use
- Because of a slightly stimulating effect, it is advisable not to take vitamin C at the end of the day.
- This medicine contains 312 mg of sodium per tablet. To be taken into account in patients controlling their dietary sodium intake.
- When taken in high doses (more than 2 g/day), ascorbic acid may interfere with the following biological tests: creatinine and glucose measurements, blood and urine tests (glucose oxidase test for diabetes).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
This medicine contains vitamin C.
Other medicines contain it. Do not combine them so as not to exceed the maximum recommended doses.
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICATION, INCLUDING MEDICATION OBTAINED WITHOUT A PRESCRIPTION, TALK TO YOUR DOCTOR OR PHARMACIST.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medicine should only be used during pregnancy if necessary on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
The use of vitamin C should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: aspartam, sodium, sucrose.
3. HOW TO TAKE LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS OF AGE
The dosage is 1 tablet per day.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Method of administration
Oral administration.
The tablet should be dissolved in a glass of water.
Duration of treatment
The duration of treatment is limited to 1 month.
Symptoms and instructions in case of overdose
IN CASE OF OVERDOSE OR ACCIDENTAL POISONING, SEEK MEDICAL ATTENTION IMMEDIATELY.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet is likely to have undesirable effects, although not everyone is subject to them.
At high doses above 1 g/day, possibility of:
- digestive disorders (heartburn, diarrhea),
- urinary disorders (discomfort in the emission of urine or red coloration of urine),
- haemolysis (destruction of red blood cells) in subjects with glucose 6 phosphate dehydrogenase deficiency (lack of an enzyme in red blood cells).
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet
Keep out of the reach and sight of children.
Do not use LAROSCORBINE SUGAR-FREE 1 g, effervescent tablet after the expiry date stated on the box.
For tube packaging (PP): "Store at a temperature not exceeding 25°C. Store in the tube carefully closed, protected from light and moisture" in climate zones I, II and III.
For tube packaging (aluminium): "Store at a temperature not exceeding 30°C. Store in the tube tightly closed, protected from light and moisture" in climate zones III and IV.
For heat-sealed film packaging (Aluminium/PE): "Store at a temperature not exceeding 30°C. Store in the original packaging, protected from light and moisture" in climate zones III and IV.
If necessary, warnings against certain visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does LAROSCORBINE SWEET 1 g, effervescent tablet contain?
The active substance is:
Ascorbic acid ............................................................................................................................ 1000 mg
For one effervescent tablet.
The other components are:
Sodium bicarbonate, citric acid anhydrous, sodium carbonate anhydrous, malic acid, isomalt, sodium chloride, aspartam, acesulfame potassium, orange flavour*, tangerine flavour, β-carotene 1% CWS/M.
*Orange flavour and β-carotene 1% CWS/M contain sucrose (approximately 67 mg sucrose per effervescent tablet).
Pharmaceutical form and content
What is LAROSCORBINE SWEET 1 g, effervescent tablet and what does it contain?
This medicine is presented in the form of effervescent tablets.
Tube of 10 or 15 tablets in boxes of 1 or 2 tubes.
1 effervescent tablet in a heat-sealed film.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAYER FAMILY HEALTH
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Operator
BAYER SANTE FAMILIALE
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Manufacturer
BAYER SANTE FAMILIALE
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE
This medicine is intended to alleviate a temporary state of fatigue.
It is important to distinguish between normal physical fatigue, which occurs after a major effort, for example, and asthenia, which is fatigue without any effort.
- Fatigue following physical effort is normal: rest is enough to make it disappear.
- Fatigue that does not give way to rest or asthenia is the feeling of not being able to make an effort before it has even begun. This fatigue can be the result of overwork or illness.
Certain medications can also cause unusual fatigue: read the instructions for the medications you are taking and ask your pharmacist or doctor for advice. But in many cases, no specific cause can be found.
Fatigue can manifest itself in a variety of symptoms. It can be a general feeling of weakness. But sometimes symptoms can be associated with it such as sleep disorders (insomnia, restless sleep...), intellectual (difficulties of concentration, memory and attention...), sexual (decrease of desire...), character (irritability, pessimism, sadness, demotivation...)..
You can reduce your fatigue by following these tips as much as possible:
- Rest, relax, look for the reasons for your fatigue,
- Practise a regular and adapted physical activity.
- Eat a balanced diet (in particular, avoid alcohol, tobacco and stimulants).
- Get back into your sleep rhythm (regular bedtime and sufficient sleep time).
Ask your pharmacist or doctor for advice in the following cases:
- No improvement after 1 month of treatment.
- Increase in the feeling of tiredness during treatment.
- New or unusual symptoms occur.
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