In this manual :
1. WHAT IS GURONSAN, effervescent tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING GURONSAN, effervescent tablet
3. HOW DO I TAKE GURONSAN, effervescent tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE GURONSAN, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS GURONSAN, effervescent tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
FOR ANTIASTHENIC USE
(A: Digestive system and metabolism)
This medicine is recommended in the case of temporary fatigue in adults (over 15 years of age).
2. WHAT YOU SHOULD KNOW BEFORE TAKING GURONSAN, effervescent tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Do not take GURONSAN effervescent tablet in the following cases:
- history of allergy to any component of the tablet,
- oxalocalcic renal lithiasis (kidney stones) when using high doses of vitamin C, greater than 1 g.
This medicine should NOT be used in combination with enoxacin, unless your doctor advises otherwise.
IF IN DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care with GURONSAN, effervescent tablet:
Special Warnings
This medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
This medicine contains sodium. This medicine contains 616 mg of sodium per tablet. To be taken into account in patients controlling their dietary sodium intake.
Vitamin C should be used with caution in cases of Glucose-6-Phosphate Dehydrogenase deficiency (hereditary red blood cell disease), as high doses of vitamin C, i.e. more than 1 g/day in adults, may cause haemolysis (destruction of red blood cells). It is important to respect the dosage and to take into account the intake of ascorbic acid by other medicines.
Precautions for use
Because of the possibility of insomnia, it is preferable to avoid taking this medicine after 4 p.m.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medication including one 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 and lactation
The use of this medicine should generally be avoided during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
The use of this medicine should be avoided during breast-feeding.
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
The attention of sportsmen and women is drawn to the fact that this medicine contains an active ingredient (caffeine) which may cause a positive reaction in tests carried out during anti-doping controls.
Effects on the ability to drive vehicles or use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of GURONSAN Effervescent Tablets: Sodium (616 mg/tablet), sucrose (see section "Take care with GURONSAN effervescent tablet".
3. HOW TO TAKE GURONSAN 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 (over 15 years).
The tablets should be dissolved in a glass of water.
2 tablets per day, 1 in the morning and 1 at noon.
Avoid taking after 4 p.m.
Duration of treatment limited to 4 weeks.
Mode and route of administration
Oral route
Duration of treatment
DO NOT USE FOR MORE THAN 4 WEEKS
Symptoms and instructions in case of overdose
If you have taken more GURONSAN effervescent tablets than you should have:
A possible overdose may cause acute hemolysis in some people (G6PD deficient). If you have taken more GURONSAN effervescent tablets than you should, contact a doctor or pharmacist.
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, GURONSAN, effervescent tablet is likely to have undesirable effects, although not everyone is subject to them:
- possible insomnia, nervousness (see Precautions for use).
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 STORE GURONSAN, effervescent tablet?
Keep out of the reach and sight of children.
Do not use GURONSAN effervescent tablets after the expiry date stated on the outer packaging.
Store below 25°C and protect from moisture.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does GURONSAN effervescent tablet contain?
The active ingredients are
Glucuronamide ................................................................................................................................. 400 mg
Ascorbic acid ............................................................................................................................. 500 mg
Caffeine ............................................................................................................................................. 50 mg
For one effervescent tablet.
Other components are:
Sodium bicarbonate, monosodium fumarate, sodium polymetaphosphate, sodium cyclamate, sodium saccharin, sucrose, macrogol 6000, gin-fizz flavour*.
*Composition of gin-fizz flavouring: deterpenated lemon essential oil, juniper berry essential oil, maltodextrin, gum arabic.
Pharmaceutical form and content
What is GURONSAN effervescent tablet and what does it contain?
This medicine is presented as an effervescent tablet. Box of 1 or 2 tubes of 15 effervescent tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
MSD FRANCE
34, AVENUE LEONARD DE VINCI
92400 COURBEVOIE
Operator
MSD FRANCE
34, AVENUE LEONARD DE VINCI
92400 COURBEVOIE
Manufacturer
UNITHER INDUSTRIES
ZONE INDUSTRIELLE LE MALCOURLET
03800 GANNAT
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.
Not applicable.
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