In this manual :
1. WHAT IS MAALOX EASY SWEET, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAALOX SWEET BACTER, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol?
3. HOW TO TAKE MAALOX SWEET BACTER, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE MAALOX SWEET BACTER, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol?
6. ADDITIONAL INFORMATION
1. WHAT IS MAALOX SWEET BACTER, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol AND WHEN IS IT USED?
Pharmacotherapeutic class
Antacid.
This medicine is indicated in adults and children over 15 years of age for heartburn and acid reflux.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAALOX EASY SWEET, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take MAALOX SWEET BACTER WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol in case:
- history of allergy to any of the components of the tablet,
- serious kidney disease.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Be careful with MAALOX EASY SWEET, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol:
Special warnings
You should only use this medicine on the advice of your doctor:
- if your disorders are associated with weight loss,
- if you have difficulty swallowing or persistent abdominal discomfort,
- if you are experiencing digestive problems for the first time or if these problems have recently changed,
- if you have kidney disease (renal insufficiency) or if you are on dialysis, you should consult a doctor because MAALOX EASY SWEETENERS, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol contains aluminium and magnesium The accumulation of aluminum and magnesium can lead to serious neurological disease (encephalopathy).
This medicine contains sorbitol and maltitol. Its use is not recommended in patients with fructose intolerance (rare hereditary disease).
Precautions for use
If the intensity and/or frequency of symptoms persist without improvement or worsen after 10 days of treatment, do not increase the dose but consult your doctor or pharmacist.
If in doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions with other medicines
Taking or using other medicines
Do not take the antacid and another medicine at the same time.
The other medicine can be taken at a distance from the antacid (e.g. 2 hours before).
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This medicine contains antacids (aluminium hydroxide and magnesium hydroxide). Other medicines contain them. Do not combine them, so as not to exceed the maximum recommended doses (see instructions for use and dosage).
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Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
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Do not take this medicine without asking your doctor or pharmacist.
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Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
Breastfeeding
This medicine may be used during breastfeeding.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: sorbitol, maltitol.
3. HOW TO TAKE MAALOX SWEET BACTER WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage/Mode of administration/Frequency of administration/Duration of treatment
Oral use.
RESTRICTED TO ADULTS and children over 15 years of age.
- 1 to 2 tablets to be sucked or chewed at the time of heartburn or acid reflux.
- Maximum number of doses per day: 6 doses.
- Do not exceed 12 tablets per day.
- Duration of use is limited to 10 days
Symptoms and instructions in case of overdose
If you have taken more MAALOX SWEET BACTER WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol than you should have:
Consult your doctor or pharmacist.
Overdosage of oral magnesium does not usually lead to toxic reactions if the kidneys are functioning normally. However, magnesium intoxication may develop in cases of kidney failure.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAALOX® SWEET SWEETENERS WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol is likely to have undesirable effects, although not everyone is subject to them:
Possibility of:
- digestive disorders (diarrhea or constipation),
- decrease in blood phosphorus levels with prolonged use or high doses.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE MAALOX® SWEET BACTER WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol
Keep out of the reach and sight of children.
Do not use MAALOX SWEET TASTE FREE, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol after the expiry date stated on the box.
No special storage precautions.
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 MAALOX® EASY SWEETENING TABLET contain, sweetened with saccharin sodium, sorbitol and maltitol?
The active ingredients are:
Aluminium oxide hydrate ............................................................................................................... 400 mg
Amount corresponding to aluminium oxide ...................................................................................... 200 mg
Magnesium hydroxide ................................................................................................................. 400 mg
For one chewable tablet.
Other components are:
70% sorbitol (non-crystallisable), maltitol, 85% glycerol, sodium saccharin, lemon flavour, talc, magnesium stearate.
Pharmaceutical form and content
What is MAALOX SWEET BACTER WITHOUT SUGAR, chewable tablet sweetened with saccharin sodium, sorbitol and maltitol and what does it contain?
This medicine comes in the form of chewable tablets.
Box of 12, 20, 40, 60 or 80 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
SANOFI-AVENTIS S.P.A.
VIALE EUROPE, 11
21040 ORIGGIO (VA)
ITALY
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 ADVICE/EDUCATION
This medicine is intended to relieve your stomach pain.
Heartburn, heartburn and acid reflux may be due to changes in diet (acidic or spicy food, alcoholic drinks, etc.) or to certain medicines (aspirin, anti-inflammatory drugs, etc.). Do not hesitate to talk to your doctor or pharmacist.
In order to limit the appearance of symptoms, respect the following rules of hygiene as much as possible:
- avoid smoking and limit alcohol consumption,
- avoid eating a lot of fatty food,
- avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
- eat slowly,
- vary your diet,
- normalize your weight,
- avoid making any major effort immediately after a meal.
YOUR PHARMACIST, YOUR DOCTOR, KNOW WELL THE MEDICINES.
DO NOT HESITATE TO ASK THEM FOR DETAILS.
NEVER LEAVE A MEDICINE WITHIN THE REACH OF CHILDREN.
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