NOTICE
ANSM - Updated: 12/12/2017
Name of the drug
MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE
400 mg / 400 mg SUGAR FREE chewable tablet
sweetened with sodium saccharine, sorbitol and maltitol
Aluminum hydroxide / magnesium hydroxide.
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 10 days.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol and in which cases is it used?
2. What you need to know before taking MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
3. How to take MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
4. What are the possible side effects?
5. How to store MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
6. Contents of the package and other information.
1. WHAT IS MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol AND WHAT CASES IT IS USED?
Anti-acid - A: digestive system and metabolism.
MAALOX MALE OF STOMACH. This medicine belongs to the antacid family. They act by neutralizing the acidity of the stomach.
This medicine is used to relieve heartburn and acid reflux.
It is reserved for adults and teenagers from the age of 15.
2. BEFORE YOU TAKE MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol:
· If you are allergic (hypersensitive) to any of the active ingredients (aluminum hydroxide or magnesium hydroxide) or any of the other ingredients of this medicine. You will find the list of components in section 6.
· If you have severe kidney disease (severe kidney failure).
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and precautions
Before taking MAALOX MAUX D'ESTOMAC you must consult your doctor:
· If your troubles are associated with weight loss,
· If you have difficulty swallowing or persistent abdominal discomfort,
· If you suffer from digestive disorders for the first time or if these disorders have recently changed,
· If you have kidney disease (kidney failure) or if you are on dialysis, you should consult a doctor because MAALOX MAUX D'ESTOMAC contains aluminum and magnesium. The accumulation of aluminum and magnesium can lead to a serious neurological disease (encephalopathy).
This medication may cause or worsen constipation in at-risk patients such as the renally impaired and the elderly.
Prolonged use of this drug should be avoided in patients with renal impairment.
Medical advice is recommended for prolonged use or if you have a risk of lack of phosphorus (eg low phosphorus diet).
This medicine contains sorbitol and maltitol. Its use is not recommended in patients with fructose intolerance (rare hereditary disease).
children
Not applicable
Other medicines and MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol
MAALOX MAUX D'ESTOMAC interacts with other drugs taken orally. Do not take MAALOX MAUX D'ESTOMAC and another medicine at the same time, and take at least 2 hours between taking them.
Some medications may be influenced by magnesium hydroxide or affect the effectiveness of magnesium hydroxide. Tell your doctor or pharmacist if you are already taking:
· Salicylates.
This medicine contains antacids (aluminum hydroxide and magnesium hydroxide). Other medicines contain it. Do not combine them, so as not to exceed the recommended maximum doses (see instructions for use and dosage). |
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol with food and beverages
Not applicable.
Pregnancy, lactation and fertility
Pregnancy
This medicine will only be used during pregnancy on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
The use of this medicine is possible during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol contains sorbitol (E420) and maltitol.
3. HOW TO TAKE MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
Dosage
· The usual dose is 1 to 2 tablets to suck or chew at the time of heartburn or acid reflux.
· You must not exceed 6 shots per day (6 to 12 tablets per day)
Duration of the treatment
The duration of use is limited to 10 days. |
If symptoms worsen or persist after 10 days of treatment, do not increase the dose but consult your doctor or pharmacist.
Method and route of administration
Oral way.
This medicine is reserved for adults and adolescents from 15 years old.
If you take more MAALOX MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol that you should have:
Immediately consult your doctor or pharmacist.
Oral overdosage of magnesium does not, in general, lead to toxic reactions in normal kidney function. Magnesium intoxication can, however, develop in kidney failure.
If you forget to take MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol:
Not applicable.
If you stop taking MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, MAALOX MAUX D'ESTOMAC can cause side effects, although not everybody gets them.
Adverse effects may occur at the frequencies defined below:
Very rare (may affect up to 1 in 10,000 people)
· hypermagnesemia. This has been observed after prolonged administration to patients with renal insufficiency
Not known frequency (frequency can not be estimated from available data)
· diarrhea or constipation,
· abdominal pain,
· decrease in the amount of phosphorus in the blood if you use this medicine for a long time or at high doses,
· increase in the amount of aluminum in the blood,
· allergic reaction :
o pimples and / or redness on the skin,
o urticaria,
o abrupt swelling of the face and neck may cause difficulty breathing (Quincke's edema),
o sudden discomfort with significant drop in blood pressure (anaphylactic shock).
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE MAALOX MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of this month.
Shelf life after opening the vial: 6 months.
This medicine does not require any special storage precautions.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What MAALOX MAALOX contains STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol
· the active substances are:
Aluminum hydroxide .............................................. .................................................. ... 400 mg
Equivalent to aluminum oxide ............................................ .......................................... 200 mg
Magnesium hydroxide ............................................... ............................................... 400 mg
For a chewable tablet.
· The other ingredients are: liquid sorbitol (non-crystallizable) (E420), maltitol, 85 percent glycerol, sodium saccharin, lemon flavor *, talc, magnesium stearate.
* Composition of the lemon aroma: Gum arabic (E414), aromatic extract (lemon oil and natural citral), butylhydroxyanisol (E320), purified water.
See section 2.
What MAALOX MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 400 mg / 400 mg SUGAR FREE, chewable tablet sweetened with sodium saccharin, sorbitol and maltitol and package contents
This medicine comes in the form of chewable tablets.
Box of 12, 20, 40, 60 or 80 tablets in platelets.
Box of 40 tablets in a bottle.
Not all presentations may be marketed.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Operator of the marketing authorization
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI SPA
VIALE EUROPA, 11
21040 ORIGGIO (VA)
ITALY
Or
SANOFI SPA
SS 17 KM 22
67019 SCOPPITO (AQ)
ITALY
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
HEALTH EDUCATION ADVICE
This medicine is intended to relieve your stomach upset.
Heartburn, acid reflux can be due to changes in diet (acidic or spicy food, alcoholic beverages ...) or taking certain drugs (aspirin, anti-inflammatory ...). Do not hesitate to talk to your doctor or pharmacist.
In order to limit the appearance of symptoms, respect as much as possible, the following hygiene rules:
· avoid heavy meals and high fat,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· vary your diet,
· normalize your weight and exercise,
· avoid the practice of a major effort just after the meal,
· avoid smoking and limit alcohol consumption.
YOUR PHARMACIST, YOUR DOCTOR, KNOW THE MEDICINES.
DO NOT HESITATE TO REQUEST PRECISIONS
NEVER LEAVE A MEDICINAL DRINK FOR CHILDREN.