NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
MAALOX REFLUX SODIUM ALGINATE / SODIUM MICROWAVE BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with saccharin sodium
Sodium alginate / Sodium bicarbonate
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
This is an authorized and controlled medication (see Identification No on the outer packaging):
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist beyond 7 days, if they worsen or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
· Do not use this medication for children.
Review summary
What this leaflet contains:
1. What is MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg SUGAR-FREE, oral suspension sachet, sweetened with saccharin sodium and in which cases is it used?
2. What should I know before taking MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension sachet, sweetened with saccharin sodium ?
3. How to take MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension sachet, sweetened with saccharin sodium ?
4. What are the possible side effects?
5. How to store MAALOX REFLUX SODIUM ALGINATE / SODIUM MICROWAVE BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension sachet, sweetened with saccharin sodium ?
6. Additional information.
1. WHAT MAALOX REFLUX SODIUM ALGINATE / SODIUM MICROWAVE BICARBONATE 500 mg / 267 mg SUGAR-FREE, oral suspension in sachets, sweetened with sodium saccharin AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
OTHER MEDICINAL PRODUCTS FOR PEPTIC ULCER AND GASTRO-ESOPHAGEAL REFLUX (GERD).
Therapeutic indications
MAALOX REFLUX SODIUM ALGINATE / SODIUM MINT BICARBONATE is indicated in heartburn, acid reflux or referral (heartburn) and heartburn.
These symptoms may, for example, occur after meals or during pregnancy, or during inflammation of the esophagus.
2. BEFORE YOU TAKE MAALOX REFLUX SODIUM ALGINATE / SODIUM MICHAEL BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with saccharin sodium?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachets, sweetened with sodium saccharin:
If you are allergic to any of the ingredients, skin irritations and breathing difficulties have been reported.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Warnings and Precautions
DO NOT LEAVE THIS MEDICINE FOR THE REACH AND SIGHT OF CHILDREN.
This treatment may be less effective if you have a low gastric acidity.
This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions.
Please consult your doctor before taking this medication if you have been asked to follow a diet low in sodium especially if you suffer from heart failure.
This medicine contains sodium. This medicine contains 6 mmol (or 138 mg) of sodium per sachet. To be taken into account in patients controlling their sodium dietary intake.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Other medicines and MAALOX REFLUX SODIUM ALGINATE / SODIUM MICHAEL BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with saccharin sodium
Antacids can decrease the effect of many other drugs. As a precaution, take 2 hours between the antacid and another medication.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication may be used during pregnancy or while breastfeeding, if necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE MENTHE 500 mg / 267 mg SUGAR-FREE, oral saccharine suspension, sodium saccharin sweetener contains sodium, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
3. HOW TO TAKE MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with saccharin sodium?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults, including elderly, and children over 12 years: 1 sachet 3 times a day, after the 3 main meals and possibly the evening at bedtime.
This dosage may be doubled in severe oesophageal reflux or inflammation.
Method and route of administration
Oral use.
Mix well before opening.
Frequency of Administration
This medication should be taken after meals.
Duration of treatment
In the absence of symptom improvement after seven days, the clinical situation should be reconsidered.
Symptoms and Instructions for Overdose
If you take more MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension sachet, sweetened with saccharin sodium you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension sachet, sweetened with saccharin sodium:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· possible constipation,
· in case of prolonged use, risk of an increase in calcium in the blood.
· Allergic reactions (urticaria, difficulty breathing).
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with saccharin sodium?
Keep out of sight and reach of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month .
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is contained in MAALOX REFLUX SODIUM ALGINATE / SODIUM MENTHE BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with sodium saccharin
The active substances are:
Sodium alginate ............................................... .................................................. .............. 500 mg
Sodium bicarbonate ............................................... .................................................. 267 mg
For a bag of 10 ml.
The other components are:
Calcium carbonate, 974P carbomer, sodium saccharine, peppermint essential oil, sodium hydroxide, sodium methyl parahydroxybenzoate (E218), sodium propyl parahydroxybenzoate (E216), purified water.
Pharmaceutical form and content
Aspect of MAALOX REFLUX SODIUM ALGINATE / SODIUM MICRO BICARBONATE 500 mg / 267 mg WITHOUT SUGAR, oral suspension in sachet, sweetened with sodium saccharin and contents of the pack
This medication is in the form of a whitish, viscous drinkable suspension in a sachet.
Box of 12 or 24 sachets of 10 ml.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Marketing Authorization Holder and Manufacturer
Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
UNITHER LIQUID MANUFACTURING
1-3 ALLEE OF THE NESTE
ZI D'EN SIGAL
31770 COLOMIERS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.>
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
HEALTH EDUCATION COUNCIL
This medication is intended to relieve your stomach ache.
Burns, heartburn, acid reflux may be due to changes in food (acidic or spicy foods, alcoholic beverages ...) or to certain medications (aspirin, anti-inflammatory drugs ...). Do not hesitate to talk to your doctor or pharmacist.
In order to limit the onset of symptoms, respect the following hygiene rules as much as possible:
· avoid tobacco and limit alcohol consumption,
· avoid abundant and high-fat meals,
· eat slowly,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· vary your diet,
· normalize your weight,
· avoid exertion after the meal.