NOTICE
ANSM - Updated on : 03/01/2024
Name of the medicinal product
ALGINATE DE SODIUM/BICARBONATE DE SODIUM BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with sodium saccharin
Sodium alginate/sodium bicarbonate
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 7 days.
What does this leaflet contain?
1. What is SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, drinkable suspension in sachet sweetened with sodium saccharin and what is it used for?
2. What information should I know before taking SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet édulcorée à la saccharine sodique?
3. How to take SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, Oral suspension in sachet sweetened with sodium saccharin?
4. What are the possible side effects?
5. How to store ALGINATE DE SODIUM/BICARBONATE DE SODIUM BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet édulcorée à la saccharine sodique?
6. Package contents and other information.
1. WHAT IS SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, drinkable suspension in sachet sweetened with sodium saccharin AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Other drugs for peptic ulcer and gastro-sophageal reflux disease (G.S.R.), ATC code: A02BX.
SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL is indicated for heartburn, acid reflux (pyrosis) and heartburn.
These symptoms may occur, for example, after meals or during pregnancy, or in cases of inflammation of the esophagus.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, oral suspension in sachet sweetened with sodium saccharin?
Never take SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, drinkable suspension in sachet sweetened with sodium saccharin.
- If you are allergic to any of the active ingredients or to any of the other components of this medicine listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before taking SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL.
If symptoms do not improve within seven days, the clinical situation should be reconsidered.
The maximum recommended daily dose (8 sachets) of this medicine contains 1112 mg sodium. This is equivalent to 56% of the recommended maximum daily intake of sodium.
Talk to your doctor or pharmacist if you need more than 2 sachets daily for a prolonged period, especially if you are on a low-salt (sodium) diet.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and teenagers
Not applicable.
Other medicinal products and SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with sodium saccharin
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
As a precaution, it is advisable to take ALGINATE DE SODIUM/BICARBONATE DE SODIUM BIOGARAN CONSEIL 2 hours after another medicine.
ALGINATE DE SODIUM/BICARBONATE DE SODIUM BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet édulcorée à la saccharine sodique with food and drink.
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This medicine may be used during pregnancy and while breast-feeding.
Driving vehicles and using machines
This medicine has no or only a negligible effect on the ability to drive vehicles and use machines.
SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with saccharin sodium contains sodium, sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).
This medicine contains 139 mg sodium (main component of table salt) per sachet. This is equivalent to 7% of the maximum recommended daily allowance of sodium for an adult.
This medicine contains "parahydroxybenzoates" and may cause allergic reactions (possibly delayed).
3. HOW TO TAKE SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with sodium saccharin?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults, including the elderly, and children over 12 : 1 sachet 3 times a day, after the 3 main meals and possibly at bedtime.
This dosage may be doubled in cases of severe reflux or sophageal inflammation.
Children under 12 only on medical advice.
Elderly people No dose adjustment is required for this population.
Patients with hepatic impairment no dose adjustment is required.
Patients with renal impairment Caution is required in the case of a strict salt-free diet.
Method and route of administration
Oral administration.
Knead sachet well before opening.
Frequency of administration
Take after meals.
Duration of treatment
If symptoms do not improve after seven days, the clinical situation should be reconsidered.
If you have taken more SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, oral suspension in sachet sweetened with sodium saccharin than you should have
You may feel bloated. This is unlikely to have any adverse effects on your health, but you should consult your doctor or pharmacist.
If you forget to take SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, oral suspension in sachet sweetened with sodium saccharin
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ALGINATE DE SODIUM/BICARBONATE DE SODIUM BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet édulcorée à la saccharine sodique :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Very rare (less than 1 in 10,000 patients): an allergic reaction to the components may occur. Symptoms may include rash, itching, difficulty breathing, dizziness or swelling of the face, lips, tongue or throat.
If any of these symptoms or other side effects occur, stop treatment immediately and consult your doctor.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https: //signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with sodium saccharin?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and sachet. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What is contained in BIOGARAN CONSEIL SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet sweetened with sodium saccharin?
- The active ingredients are:
Sodium alginate......................................................................................................... 500 mg
Sodium bicarbonate................................................................................................... 267 mg
For one 10 ml sachet.
- The other components are :
Calcium carbonate, carbomer 974P, saccharin sodium, peppermint essential oil, sodium hydroxide (for pH adjustment), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), purified water.
What is SODIUM ALGINATE/BICARBONATE BIOGARAN CONSEIL 500 mg/267 mg, suspension buvable en sachet sweetened with sodium saccharin, and what does it contain?
This medicine takes the form of a white to dark beige oral suspension sachet.
Box of 12 or 24 sachets of 10 ml.
Marketing authorization holder
biogaran
15, boulevard charles de gaulle
92700 colombes
Marketing authorization holder
biogaran
15, boulevard charles de gaulle
92700 colombes
Manufacturer
UNITHER LIQUID MANUFACTURING
1-3 ALLEE DE LA NESTE
Z.I EN SIGAL
31770 COLOMIERS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH EDUCATION ADVICE
This medicine is intended to relieve stomach ache.
Heartburn and acid reflux can be caused by changes in diet (acidic or spicy foods, alcoholic beverages) or by certain medications (aspirin, anti-inflammatory drugs). Talk to your doctor or pharmacist.
To limit the onset of symptoms, observe the following hygiene rules wherever possible:
- avoid smoking and limit alcohol consumption,
- avoid heavy, high-fat meals,
- eat slowly,
- avoid certain foods such as chocolate, spices, peppers, citrus juices and soft drinks,
- vary your diet,
- normalize your weight,
- avoid strenuous exercise immediately after a meal.