NOTICE
ANSM - Updated: 09/09/2015
Name of the drug
UPSA BETA CITRATE 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin
Citrate betaine
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· This medicine is a specialty of AUTOMEDICATION that can be used without consultation or prescription of a doctor.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist after 7 days, consult a doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Summary notice
In this notice :
1. WHAT IS BETAINE UPSA CITRATE 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE BETAINE UPSA CITRATE 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin?
3. HOW TO TAKE BETAINE UPSA CITRATE 2 g MINT WITHOUT SUGAR, effervescent tablet sweetened with sodium saccharin?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETAINE UPSA CITRATE 2 g SUGAR MINT, effervescent tablet sweetened with sodium saccharin?
6. ADDITIONAL INFORMATION
1. WHAT IS BETAINE UPSA CITRATE 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
UPSA BETA CITRATE 2 g SUCKLESS MINT, effervescent tablet sweetened with sodium saccharin is a digestive medicine.
Therapeutic indications
This medicine is indicated for the treatment of dyspeptic disorders (slow digestion, bloating).
2. BEFORE YOU TAKE BETAINE UPSA CITRATE 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of CITRATE DE BETAINE UPSA 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin.
Precautions for use; special warnings
Be careful with BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin:
This medicine 450 mg of sodium per tablet. To be considered in patients controlling their sodium dietary intake.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Interactions with other drugs
Taking or using other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
It is best not to use this medication during pregnancy and lactation.
If you discover that you are pregnant, consult your doctor, only he can judge the need to continue treatment. In general, consult your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of BETAINE UPSA CITRATE 2 g SUGAR MINT, effervescent tablet sweetened with sodium saccharin:
Sodium (approximately 450 mg per tablet).
3. HOW TO TAKE BETAINE UPSA CITRATE 2 g MINT WITHOUT SUGAR, effervescent tablet sweetened with sodium saccharin?
Instructions for a good 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.
1 to 3 tablets a day.
If you have the impression that the effect of BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, Sparkling Sodium-sweetened tablet does not work as expected, consult your doctor or pharmacist.
Administration mode
Oral way.
Take the tablets before or after meals.
Dissolve the tablets in half a glass of water.
Duration of treatment
The duration of treatment is limited to 7 days. Beyond that, you must consult your doctor.
Symptoms and instructions in case of overdose
If you have taken more BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, Sparkling Acid-Stimulated Tablet that you should have:
Tell your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, BETAINE UPSA CITRATE 2 g MINT SUGAR-FREE, effervescent tablet sweetened with sodium saccharin is likely to have side effects, although not everyone is subject to it.
In some cases, an allergic reaction may occur. You can identify the signs of allergy: by pimples and / or itching and / or redness of the skin, or by sudden swelling of the face and neck.
If you notice any side effect and think it is related to this medicine, please tell your doctor or pharmacist.
5. HOW TO STORE BETAINE UPSA CITRATE 2 g SUGAR MINT, effervescent tablet sweetened with sodium saccharin?
Keep out of the reach and sight of children.
Expiration date
Do not use BETAINE UPSA CITRATE 2 g SUGAR MINT, effervescent tablet sweetened with sodium saccharine after the expiry date which is stated on the box. The expiry date refers to the last day of the month.
Storage conditions
Keep the tube tightly closed and protected from moisture.
Recap the tube immediately after use.
The action of the desiccant cartridge contained in the stopper promotes the preservation of the tablets. The accidental absorption of its contents is not dangerous, the product being devoid of toxicity.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does BETAINE UPSA CITRATE contain 2 g MINT WITHOUT SUGAR, effervescent tablet sweetened with sodium saccharin?
The active substance is :
Citrate betaine ............................................... .................................................. ................................. 2 g
For a tablet.
The other components are :
Sodium bicarbonate, anhydrous citric acid, mannitol, sodium benzoate, sodium saccharin, macrogol 6000, mint flavor (menthone, isomenthone, methyl acetate, neomenthol, menthol, maltodextrin, modified starch E1450, E1518 glyceryl triacetate).
Pharmaceutical form and content
What is BETAINE UPSA CITRATE 2 g SUGAR MINT, effervescent tablet sweetened with sodium saccharin and contents of the pack?
This medication comes in the form of an effervescent tablet. Box of 2 tubes of 10 effervescent tablets.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
exploiting
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
979 AVENUE DES PYRENEES
47520 THE PASSAGE
or
UPSA SAS
304, AVENUE OF DOCTOR JEAN BRU
47000 AGEN
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
HEALTH EDUCATION ADVICE
If you are regularly subject to dyspeptic disorders (slow digestion, bloating), then it is recommended:
· To have a varied and balanced diet.
· Avoid meals too rich in fat and / or too rich, soft drinks.
· Eat in peace, if possible at fixed times.
· Drink enough water in the day.
· Avoid the practice of a major effort just after meals.
· Avoid as far as possible stress and anxiety.
· Observe a good general lifestyle: adequate sleep, exercise.
· Avoid sedentary life.
· Limit alcohol consumption.
· Remove the tobacco.
YOUR PHARMACIST, YOUR DOCTOR, KNOW THE MEDICINES.
DO NOT HESITATE TO REQUEST PRECISIONS.
NEVER LEAVE A MEDICINAL DRINK WITH CHILDREN.