NOTICE
ANSM - Updated: 18/10/2018
Name of the drug
GURONSAN, effervescent tablet
Glucuronamide / ascorbic acid / caffeine
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 15 days.
What does this booklet contain ?
1. What is GURONSAN, effervescent tablet and when is it used?
2. What information do you need to know before taking GURONSAN, effervescent tablet?
3. How to take GURONSAN, effervescent tablet?
4. What are the possible side effects?
5. How to store GURONSAN, effervescent tablet?
6. Contents of the package and other information.
1. WHAT GURONSAN, Effervescent tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic class: A targeted antiasthenic. (A: Digestive system and metabolism) - ATC code: A13 TONICS.
This drug is recommended in the states of tired passenger of the adult (more than 15 years).
You should talk to your doctor if you do not feel better or if you feel worse after 15 days.
2. WHAT YOU NEED TO KNOW BEFORE TAKING GURONSAN, an effervescent tablet?
If your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take GURONSAN, effervescent tablet:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· if you have a history of renal calculus (kidney calcium oxaliasis) when using high doses of vitamin C, greater than 1 g.
This medicine SHOULD NOT BE USED unless otherwise directed by your doctor in combination with enoxacin.
IF IN DOUBT, YOU MUST ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking GURONSAN, an effervescent tablet.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
The maximum recommended daily dose of this medicine is 1232 mg of sodium (the main component of cooking salt / table). This equates to 61.6% of the maximum recommended daily sodium intake for an adult. Talk to your doctor or pharmacist if you need to take GURONSAN daily for a long time, especially if you have to follow a low salt (sodium) diet.
Vitamin C should be used with caution in cases of Glucose-6-Phosphate Dehydrogenase (hereditary red blood cell) deficiency, as high doses of vitamin C, ie greater than 1 g / day can cause hemolysis (destruction of red blood cells). It is important to adhere to the dosages and to consider vitamin C intake with other medications.
Due to the possibility of onset of insomnia, it is best to avoid taking this medicine after 16 hours.
Talk to your doctor or pharmacist before taking GURONSAN, an effervescent tablet.
Children and adolescents
Not applicable.
Other medicines and GURONSAN, effervescent tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including: enoxacin, ciprofloxacin, norfloxacin (antibiotics), stiripentol (antiepileptic) or deferoxamine (used in iron overload or aluminum intoxication).
GURONSAN, effervescent tablet with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medication should generally be avoided during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
The use of this medicine should be avoided during breastfeeding.
Driving and using machines
Not applicable.
GURONSAN, effervescent tablet contains sodium (616 mg / tablet) and sucrose
3. HOW TO TAKE GURONSAN, effervescent tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
RESERVED FOR ADULTS (over 15 years).
The recommended dose is 2 tablets daily, 1 in the morning and 1 at noon.
Avoid taking after 16 hours.
Administration mode
Oral way
The tablets are to dissolve in a glass of water
Duration of treatment
The duration of treatment should not exceed 2 weeks.
If you take more GURONSAN, effervescent tablet than you should
Vitamin C overdosage may cause some people with G6PD deficiency (an enzyme specific for red blood cells) to have acute hemolysis (destruction of red blood cells). If you take more GURONSAN, effervescent tablet than needed, contact your doctor or pharmacist.
An overdose of GURONSAN, an effervescent tablet, may cause the following symptoms, which may be related to the presence of caffeine: headaches, visual disturbances, anxiety, excitement, insomnia, cardiac arrhythmias, and even in severe cases confusion or transient psychosis, If you take more GURONSAN, effervescent tablet than necessary, contact your doctor or pharmacist.
Vitamin C and / or caffeine intake from other sources should be taken into account.
If you forget to take GURONSAN, effervescent tablet:
Not applicable.
If you stop taking GURONSAN, effervescent tablet:
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known (can not be estimated from the available data):
· Agitation, sleep disorders, hallucinations,
· Palpitations, fast heart rate (tachycardia),
· Headache.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacy. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE GURONSAN, effervescent tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of this month.
Store at a temperature below 25 ° C and protected from light.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What GURONSAN contains, effervescent tablet
· The active substances are:
Glucuronamide ................................................. .................................................. ........... 400 mg
Ascorbic acid................................................ .................................................. ........ 500 mg
Caffeine................................................. .................................................. ........................ 50 mg
For an effervescent tablet
· The other components are:
Sodium bicarbonate, monosodium fumarate, sodium polymetaphosphate, sodium cyclamate, saccharin sodium, sucrose, macrogol 6000, gin-fizz * flavor.
* Composition of the gin-fizz aroma: essential oil of lemon, essential oil of juniper berries, maltodextrin, gum arabic.
What GURONSAN, effervescent tablet looks like and contents of the pack
This medicine comes in the form of an effervescent tablet. Box of 1 or 2 tubes of 15 effervescent tablets.
Marketing Authorization Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
Operator of the marketing authorization
BAYER HEALTHCARE SAS
33 INDUSTRY STREET
74240 GAILLARD
Maker
UNITHER INDUSTRIES
INDUSTRIAL ZONE MALCOURLET
03800 GANNAT
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
This medication is intended to alleviate a state of temporary fatigue.
It is necessary to distinguish the normal physical fatigue occurring after a major effort for example and asthenia which is a fatigue out of all effort.
· Fatigue following physical exertion is normal: rest is enough to make it disappear.
· The fatigue that does not give way to rest, or asthenia, is the feeling of not being able to provide an effort even before having started it. This fatigue may be the result of overwork or illness.
Some medicines may also cause unusual tiredness: read the package leaflet for the medicines you are taking and ask your pharmacist or doctor for advice.
But in many cases, no specific cause is found.
Fatigue can manifest itself in very variable symptoms.
This can be a general impression of weakness.
But sometimes symptoms can be associated as sleep disorders (insomnia, restless sleep ...), intellectual (difficulties of concentration, memory and attention ...), sexual (decreased desire .. .), character (irritability, pessimism, sadness, demotivation ...).
You can reduce your fatigue by respecting as much as possible the following tips:
· Rest, relax, look for reasons for your tiredness;
· Practice regular and appropriate physical activity;
· Have a balanced diet.
Find your sleep pattern (regular bedtime and enough sleep).
Ask your pharmacist or doctor for advice if:
· No improvement after 2 weeks of treatment.
· Increased feeling of fatigue during treatment
· New symptoms or unusual symptoms