In this manual :
1. WHAT IS BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING BETAINE CITRATE UPSA 2 g MINT WITHOUT SUGAR, effervescent tablet sweetened with sodium saccharin?
3. HOW TO TAKE BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin?
6. ADDITIONAL INFORMATION
1. WHAT IS BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin is a digestive medicine.
This medicine is indicated in the treatment of dyspeptic disorders (slow digestion, bloating).
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin?
List of information needed before taking the medicine
Not applicable.
Do not take BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients contained in BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin.
Precautions for use; special warnings
Be careful with BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin:
This medicine 450 mg of sodium per tablet. To be taken into account in patients controlling their dietary sodium intake.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Lactation
It is preferable not to use this medicine during pregnancy and breastfeeding.
If you discover that you are pregnant, consult your doctor, only he/she can judge the need to continue the treatment. In general, it is advisable to ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with saccharin sodium:
Sodium (approximately 450 mg per tablet).
3. HOW TO TAKE BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin: Sodium (approximately 450 mg per 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.
1 to 3 tablets per day.
If you feel that the effect of BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin is not what you expected, consult your doctor or pharmacist.
How to take it
Take by mouth.
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. After that, you should consult your doctor.
Symptoms and instructions in case of overdose
If you have taken more BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with saccharin sodium than you should have:
Tell your doctor or pharmacist.
Instructions in case of missed doses
If you forget to take BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, 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 side effects
Like all medicines, BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin is likely to have undesirable effects, although not everyone is susceptible.
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 experience any side effects that you think may be related to this medicine, please tell your doctor or pharmacist.
5. HOW TO USE BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin
Keep out of the reach and sight of children.
Do not use BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with saccharin sodium after the expiry date stated on the box. The expiry date refers to the last day of the month.
Keep the tube tightly closed and away from moisture.
Recap the tube immediately after use.
The action of the desiccant cartridge contained in the cap helps to preserve the tablets. Accidental absorption of its contents is not dangerous, as the product is non-toxic.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of 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 BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin, contain?
The active substance is:
Betaine citrate ................................................................................................................................... 2 g
For one tablet.
The other components are:
Sodium bicarbonate, citric acid anhydrous, mannitol, sodium benzoate, saccharin sodium, macrogol 6000, mint flavour (menthone, isomenthone, methyl acetate, neomenthol, menthol, maltodextrin, E1450 modified starch, E1518 glyceryl triacetate ).
Pharmaceutical form and contents
What is BETAINE CITRATE UPSA 2 g SUGAR-FREE MINT, effervescent tablet sweetened with sodium saccharin and what does it contain?
This medicine is in the form of an effervescent tablet. Box of 2 tubes of 10 effervescent tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BRISTOL-MYERS SQUIBB
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
FRANCE
Operator
UPSA CONSEIL
3 RUE JOSEPH MONIER - B.P. 325
92506 RUEIL-MALMAISON CEDEX
FRANCE
Manufacturer
BRISTOL-MYERS SQUIBB
304 AVENUE DU DOCTEUR JEAN BRU
47000 AGEN
FRANCE
or
BRISTOL-MYERS SQUIBB
979 AVENUE DES PYRENEES
47520 LE PASSAGE
FRANCE
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
If you are regularly subject to dyspeptic disorders (slow digestion, bloating), it is recommended
- To have a varied and balanced diet.
- Avoid meals that are too rich in fat and/or too large, and avoid carbonated drinks.
- Eat calmly, if possible at fixed times.
- Drink enough water during the day.
- Avoid strenuous exercise immediately after meals.
- Avoid stress and anxiety as much as possible.
- Observe a good general lifestyle: sufficient sleep, physical exercise.
- Avoid a sedentary lifestyle.
- Limit alcohol consumption.
- Stop smoking.
YOUR PHARMACIST AND YOUR DOCTOR KNOW THE MEDICINES WELL.
DO NOT HESITATE TO ASK THEM FOR DETAILS.
NEVER LEAVE MEDICATION WITHIN THE REACH OF CHILDREN.
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