NOTICE
ANSM - Last updated: 19/06/2017
Name of the medicinal product
MAALOX STOMACH HOMES ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE 525mg / 600 mg, drinkable suspension in vial
Aluminum hydroxide, magnesium hydroxide
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 10 days.
What is in this leaflet?
1. What is MAALOX STOMACH, oral suspension in a vial and in which cases is it used?
2. What should I know before taking MAALOX MALES OF STOMACH, oral suspension in a vial?
3. How to take MAALOX STOMACH MALTS, oral suspension in a vial?
4. What are the possible side effects?
5. How do I keep MAALOX STOMACH, oral suspension in a vial?
6. Package contents and other information.
1. WHAT MAALOX STOMACH MALTS, oral suspension in a vial AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: Anti-acid, ATC code: A02AD01
(A: digestive system and metabolism).
MAALOX STOMACH MALTS, oral suspension in vial contains aluminum hydroxide and magnesium hydroxide. This medication belongs to the antacid family. They act by neutralizing the acidity of the stomach.
This medication is used to relieve heartburn and acid reflux. It is reserved for adults and teenagers from the age of 15 years.
2. BEFORE YOU TAKE MAALOX STOMACH MALTS, drinkable suspension in a bottle?
Do not take MAALOX STOMACH MALT, oral suspension in a vial:
· if you are allergic to aluminum hydroxide or magnesium hydroxide or any of the other ingredients of this medication mentioned in section 6.
· if you have a 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 before taking MAALOX STOMACH:
· if your disorders are associated with weight loss,
· if you have difficulty swallowing or persistent abdominal discomfort,
· if you are suffering from digestive problems for the first time or if these disorders have recently changed,
· if you have kidney disease (kidney failure) or if you are dialysed because MAALOX STOMACH MALNES contains aluminum and magnesium. Accumulation of aluminum and magnesium can lead to severe neurological disease (encephalopathy).
This medication can cause or aggravate constipation in patients at risk such as kidney failure and the elderly.
Prolonged use of this medication should be avoided in patients with impaired renal function.
Medical advice is recommended for prolonged use or if you are at risk of phosphorus deficiency (eg low phosphorus diet).
This medicine contains sorbitol (E420). Its use is discouraged in patients with fructose intolerance (rare hereditary disease).
children
Not applicable.
Other medicines and MAALOX STOMACH MAL, oral suspension in vial
MAALOX STOMACH MALTS, oral suspension in a vial interacts with other medications taken orally. Do not take MAALOX STOMACH and other medicines at the same time and take at least 2 hours to take them.
This medicine contains antacids (aluminum hydroxide and magnesium hydroxide). Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses (see instructions for use and dosage). |
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MAALOX STOMACH MALTS, oral suspension in a vial with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor.
Use of this medication is possible during breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
MAALOX STOMACH MALTS, oral suspension in vial contains sorbitol (E420).
3. HOW TO TAKE MAALOX STOMACH, oral suspension in a vial?
Oral use.
This medication is reserved for adults and adolescents from the age of 15 years.
Dosage
The usual dose is 1 tablespoon at the time of heartburn or acid lifts, without exceeding 6 tablespoons per day.
Duration of treatment
The duration of use is limited to 10 days. |
If the symptoms worsen or persist after 10 days of treatment, do not increase the dose but take the advice of your doctor or pharmacist.
If you take more MAALOX STOMACH MALS than you should have
Consult your doctor or pharmacist.
Overdosage of magnesium by the oral route does not generally lead to toxic reactions in normal kidney function. Magnesium poisoning, however, can develop in patients with renal insufficiency.
If you forget to take MAALOX MALES OF STOMACH
Not applicable.
If you stop taking MAALOX MALES OF STOMACH
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
· diarrhea or constipation,
· decrease in the amount of phosphorus in the blood if you use this drug for a long time or at high doses,
· increase in the amount of magnesium or aluminum in the blood,
· allergic reaction :
o pimples and / or redness on the skin,
o urticaria,
o abrupt swelling of the face and neck, which may cause difficulty breathing (angioedema)
o malaise with severe drop in blood pressure (anaphylactic shock).
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 STOMACH, oral suspension in a vial?
Keep this medicine out of the reach and sight 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 that month.
Store at a temperature not exceeding 25 ° C.
After first opening the vial, the medication should not be stored for more than 6 months.
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. PACKAGE CONTENTS AND OTHER INFORMATION
What MAALOX MALES OF STOMACH contains, drinkable suspension in a vial
· The active substances are:
Magnesium hydroxide ............................................... .................................................. 4.00 g
Magnesium hydroxide ............................................... .................................................. 3.50 g
For 100 ml
· The other components are:
Concentrated hydrochloric acid, citric acid monohydrate, peppermint essential oil, Mannitol, domiphene bromide, sodium saccharin, liquid (non crystallizable) sorbitol (E420), purified water.
What is MAALOX STOMACH MAL, oral suspension in bottle and contents of the pack
This medication is in the form of a drinkable suspension.
Bottle of 250 ml or 500 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RAPSAIL
94250 GENTILLY
If you have any questions about this product or if you would like to report an adverse reaction, please see the "Our Medicines" section on sanofi.fr or contact us by phone:
Patient Information: N ° green 0800 222 555
Call from abroad: +33 1 57 63 23 23
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RAPSAIL
94250 GENTILLY
Maker
THE NIGEN PHARMA
35 CAGE MILL OF THE CAGE
92230 GENNEVILLIERS
Or
SANOFI SPA
VIALE EUROPE 11
21040 ORIGGIO (VA)
ITALY
Or
AVENTIS PHARMA SPECIALTIES
20 AVENUE RAYMOND ARON
92160 ANTONY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
To be completed later by the holder.
Other
SOME TIPS FOR YOUR TREATMENT
This medication is intended to relieve your stomach ache.
Burns and acid refluxes can be due to changes in the diet (acidic or spicy foods, alcoholic beverages ...) or to certain medications (aspirin, anti-inflammatories ...). 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 abundant and high-fat meals,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· vary your diet,
· normalize your weight and exercise,
· avoid the practice of an important effort just after the meal,
· avoid tobacco and limit alcohol consumption.
YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM.
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.