NOTICE
ANSM - Updated on : 17/04/2024
Product name
VIATRIS SODIUM ALGINATE/SODIUM BICARBONATE500 mg/267 mg, Oral suspension in sachet
Sodiumalginate/sodium bicarbonate
Cover
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 nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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.
What does this leaflet contain?
1. What is VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet and what is it used for?
2. What do I need to know before taking VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet?
3. How to take VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet?
4. What are the possible side effects?
5. How to store VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet?
6. Package contents and other information.
1. WHAT IS VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: other drugs for peptic ulcer and gastro-sophageal reflux disease (G.S.R.) - ATC code: A02BX.
This medicine is indicated for the treatment of gastro-sophageal reflux disease (G.R.D.), characterized by heartburn (pyrosis), acid reflux and heartburn.
2. WHAT YOU SHOULD KNOW BEFORE TAKING VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet?
Never take VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet:
- if you are allergic to any of the active ingredients or to any of the other ingredients listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
This medicine contains calcium. Each sachet contains 160 mg calcium carbonate. Precautions should be taken in patients suffering from, or who have suffered from, severe kidney disease.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and teenagers
Not applicable.
Other medicinal products and VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet
As a precaution, it is advisable to take ALGINATE DE SODIUM/BICARBONATE DE SODIUM VIATRIS 2 hours after another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet with food, drink and alcohol.
Not applicable.
Pregnancy and breast-feeding
VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet may be used during pregnancy and lactation.
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.
Driving and using machines
This medicine has no or only a negligible effect on the ability to drive vehicles and use machines.
VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet contains sodium, methyl parahydroxybenzoate and propyl parahydroxybenzoate.
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.
Talk to your doctor or pharmacist if you require 3 or more sachets of this medicine daily for a prolonged period, especially if you are on a low-salt (sodium) diet.
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
3. HOW TO TAKE VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet?
Dosage
1 sachet 3 times daily after the 3 main meals and possibly at bedtime. This dosage may be doubled in cases of severe reflux or inflammation of the esophagus.
Method and route of administration
This product is to be taken orally. Knead sachet well before opening.
Frequency and timing of administration
This medicine should be taken after meals.
If you have taken more VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet, than you should have done
You may feel bloated. This is unlikely to affect your health, but if symptoms persist, consult your doctor or pharmacist.
If you forget to take VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Very rare (less than one 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, pharmacist or nurse. 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 Centres Régionaux de Pharmacovigilance - 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 VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, Oral suspension in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and/or sachet after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg oral suspension sachet contains
- The active ingredients are :
sodium alginate........................................................................................................... 500.00 mg
sodium bicarbonate..................................................................................................... 267.00 mg
per 10 mL sachet.
- The other components are :
calcium carbonate, carbomer (974P), sodium saccharin, sodium methyl parahydroxybenzoate (E218), sodium propyl parahydroxybenzoate (E216), peppermint essential oil, sodium hydroxide, purified water.
What is VIATRIS SODIUM ALGINATE/BICARBONATE 500 mg/267 mg, drinkable suspension in sachet, and what does it contain?
This medicine takes the form of a whitish, viscous oral suspension in sachet.
Boxes of 10, 12, 16, 18, 20, 24 or 30 sachets.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
UNITHER LIQUID MANUFACTURING
1-3 ALLEE DE LA NESTE
Z.I. D'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: stomach aches
Antacid alone
This medicine is designed to relieve stomach ache.
Heartburn and acid reflux can be caused by dietary changes (acidic or spicy foods, alcoholic beverages, etc.) or by certain medications (aspirin, anti-inflammatories, etc.). Talk to your doctor or pharmacist.
To limit the onset of symptoms, observe the following hygiene rules as far as 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.