NOTICE
ANSM - Updated: 12/12/2017
Name of the drug
MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet
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 do not feel better or if you feel worse.
What does this booklet contain ?
1. What is MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet and in which cases is it used?
2. What you need to know before taking MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
3. How to take MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
4. What are the possible side effects?
5. How to store MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
6. Contents of the package and other information.
1. WHAT IS MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachets AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Anti-acid, ATC code: A02AD01
(A: digestive system and metabolism).
MAALOX MAUX D'ESTOMAC contains aluminum hydroxide and magnesium hydroxide. 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 HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
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 460 mg / 400 mg, oral suspension in sachet:
· if you are allergic to aluminum hydroxide or magnesium hydroxide or to any of the other ingredients of this medicine, listed 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
Talk to your doctor or pharmacist before taking MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet :
· if your troubles are associated with weight loss,
· if you have difficulty swallowing or persistent abdominal discomfort,
· if you have 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 sucrose and sorbitol. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency.
This medicine contains 3.15 g of sucrose per sachet which should be taken into account in the daily ration in case of low sugar diet or diabetes.
children
Not applicable.
Other medicines and MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet
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 ). |
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
MAALOX STOMACH MALE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet with food and drink
Not applicable.
Pregnancy and breast feeding
This medicine will only be used during pregnancy on the advice of your doctor.
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 HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet contains sucrose and sorbitol (E420).
3. HOW TO TAKE MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
Oral way.
This medicine is reserved for adults and adolescents from 15 years old.
Dosage
The usual dose is 1 to 2 sachets per dose at the time of heartburn or acid reflux.
You must not exceed 6 shots per day (6 to 12 bags).
Administration mode
Thoroughly mix the bag before opening.
Absorb the suspension as it is without diluting it.
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.
If you take more than MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet that you should have
Consult your doctor or your 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 HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet
Not applicable.
If you stop taking MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse effects can 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 STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet?
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.
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's in MAALOX STOMACH MALE HYDROXIDE ALUMINUM / MAGNESIUM HYDROXIDE 460 mg / 400 mg, oral suspension in sachet
· Active substances are:
Aluminum hydroxide .............................................. .................................................. ... 460 mg
Equivalent to aluminum oxide ............................................ .......................................... 230 mg
Magnesium hydroxide ............................................... ............................................... 400 mg
For a sachet of oral suspension.
· The other ingredients are: 64% sucrose syrup, liquid sorbitol (non-crystallizable) (E420), xanthan gum, guar gum, sodium chloride, lemon-green lemon flavor *.
* Composition of the lemon-lime aroma: lemon essential oil, vitamin E, lemon-terpene essential oil, grapefruit essential oil, distilled lime essential oil, orange essential oil, coconut oil, citral.
See section 2.
What is MAALOX STOMACH MALE HYDROXIDE ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 460mg / 400mg, oral suspension in sachet and contents of the pack
This medication is in the form of an oral suspension in sachets.
Box of 10, 20, 30 or 50 sachets.
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
A. NATTERMANN & CIE GMBH
NATTERMANN ALLEE 1
50829 COLOGNE
GERMANY
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
{MM / YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
COUNCIL OF HEALTH EDUCATION:
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.