NOTICE
ANSM - Updated on : 01/07/2023
Product name
MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet
Aluminium hydroxide / Magnesium hydroxide
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- Contact your doctor if you do not feel better or feel worse after 10 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet and what is it used for?
2. What do I need to know before taking MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet?
3. How to take MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet?
4. What are the possible side effects?
5. How to store MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet?
6. Package contents and other information.
1. WHAT IS MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antacids,ATCcode: A02AD01.
(A: digestive system and metabolism).
MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet. This medicine belongs to the family of antacids. They act by neutralizing stomach acidity.
This medicine is used to relieve heartburn and acid reflux.
It is intended for adults and adolescents aged 15 and over.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING MAALOX MAUX DESTOMAC SALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet?
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Never take MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet:
- If you are allergic (hypersensitive) to any of the active ingredients (aluminium hydroxide or magnesium hydroxide) or to any of the other ingredients of this medicine. See section 6 for a list of ingredients.
- If you have severe kidney disease (severe renal failure).
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Before taking MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet you should consult your doctor:
- If your symptoms are associated with weight loss,
- If you have difficulty swallowing or persistent abdominal discomfort,
- If you suffer from digestive problems for the first time, or if these problems have recently changed,
- If you have kidney disease (renal failure) or if you are on dialysis, you should consult a doctor as MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet contains aluminium and magnesium. Accumulation of aluminum and magnesium can lead to serious neurological disease (encephalopathy).
This medicine may cause or aggravate constipation in patients at risk, such as renal failure patients and the elderly.
Prolonged use of this drug should be avoided in patients with impaired renal function.
Medical advice is recommended in case of prolonged use or if you are at risk of phosphorus deficiency (e.g. low phosphorus diet).
Children
Not applicable
Other medicinal products and MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet
MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet interacts with other oral medications. Antacids and other drugs should not be taken at the same time.
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This medicine contains antacids (aluminum hydroxide and magnesium hydroxide). Other drugs contain them. Do not combine them, so as not to exceed the maximum recommended doses (see "Dosage").
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Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription from the following list, assome medicines may be influenced by MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, comprimé à croquer or may affect the efficacy of MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, comprimé à croquer.
In particular:
- Drugs used to treat :
o The heart, such as digitalis, quinidine, metoprolol, latenolol and propranolol.
o Anemia, such as iron salts.
o Ulcers and gastric acidity, such as ranitidine or cimetidine (H2-receptor antagonists).
o Malaria, such as chloroquine.
o Bone diseases, such as bisphosphonates.
o Certain allergic, inflammatory or abnormal immune reactions, such as glucocorticoids or fexofenadine.
o Kidney disorders, such as citrates.
o Tuberculosis, such as lethambutol or lisoniazide.
o Infections such as fluoroquinolones, lincosamides, ketoconazole, cyclins, cephalosporins (cefpodoxime), dolutegravir, lelvitégravir, raltegravir and the antiviral treatment combination tenofovir alafenamide / emtricitabine / bictegravir, rilpivirine.
o Mental illnesses (psychoses) such as phenothiazine neuroleptics or sulpiride.
o High levels of potassium in the body, such as polystyrene sulfonate.
o Pain and/or fever, such as indomethacin or laspirin.
o Thyroid insufficiency, such as levothyroxine.
o Joint pain and abnormal body chemical reactions, such as penicillamine.
o Cancer, such as nilotinib or dasatinib monohydrate.
o Blood disorders such as leltrombopag olamine.
o High blood pressure in the lungs (pulmonary hypertension), such as riociguat.
o Uterine fibroids or emergency contraception, such as lulipristal.
- Drugs used for dental care, such as fluoride.
- Cholesterol-lowering drugs such as rosuvastatin.
As a precaution, oral medications should be taken at least 2 hours apart from antacids (4 hours for fluoroquinolones).
MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE, chewable tablet with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
This medicine should only be used during pregnancy on the advice of your doctor.
Breast-feeding may be continued while taking this medicine.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
MAALOX MAUX DESTOMAC SALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet contains sorbitol (E420), sucrose, benzyl alcohol and sodium.
This medicine contains sorbitol and sucrose. It is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
This medicine contains 125 mg sorbitol per tablet.
Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
This medicine contains 0.000072 mg benzyl alcohol per tablet.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. Large quantities of benzyl alcohol may accumulate in your body and cause side effects (known as "metabolic acidosis").
Ask your doctor or pharmacist for advice if you suffer from liver or kidney disease. Large quantities of benzyl alcohol may accumulate in your body and cause side effects (called "metabolic acidosis").
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet?
Dosage
- The usual dose is 1 to 2 tablets, to be sucked or chewed at the time of heartburn or acid reflux.
- Do not take more than 6 tablets per day (i.e. 6 to 12 tablets per day).
Duration of treatment
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Use is limited to 10 days.
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If symptoms worsen or persist after 10 days, do not increase the dose, but consult your doctor or pharmacist.
Method and route of administration
Oral administration.
This medicine is intended for adults and adolescents aged 15 and over.
If you have taken more MAALOX maux destomac aluminium hydroxide/magnesium hydroxide 400 mg/400 mg, chewable tablet than you should have :
Consult your doctor or pharmacist immediately.
Overdosage of oral magnesium does not generally lead to toxic reactions if the kidneys are functioning normally. Magnesium intoxication may, however, develop in cases of renal failure.
If you forget to take MAALOX maux destomac aluminium hydroxide/magnesium hydroxide 400 mg/400 mg, chewable tablet :
Not applicable.
If you stop taking MAALOX maux destomac hydroxyde daluminium/hydroxyde de magnésium 400 mg/400 mg, comprimé à croquer :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM/ HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet may cause undesirable effects, but these do not always occur in everyone.
Adverse reactions may occur at the frequencies defined below:
Very rare (affecting up to 1 in 10,000 people)
- hypermagnesemia. This has been observed after prolonged administration to patients with renal insufficiency.
Frequency undetermined (frequency cannot be estimated from available data)
- diarrhea or constipation,
- abdominal pain,
- decrease in the amount of phosphorus in the blood if you use this drug for a long time or in high doses,
- increase in the amount of aluminum in the blood,
- allergic reaction:
o pimples and/or redness of the skin,
o hives,
o sudden swelling of the face and neck which may cause difficulty in breathing (angioedema),
o sudden malaise with severe drop in blood pressure (anaphylactic shock).
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website : www.signalement-sante.gouv.fr.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE MAALOX MAUX DESTOMAC DALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE 400 mg/400 mg, chewable tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box after EXP. The expiration date refers to the last day of that month.
Shelf life after opening: 6 months.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What MAALOX MAUX DESTOMAC HYDROXYDE DALUMINIUM / HYDROXYDE DE MAGNESIUM 400 mg/400 mg, chewable tablet contains
- The active ingredients are :
Magnesium hydroxide.............................................................................................. 400 mg
Aluminum hydroxide................................................................................................... 400 mg
For one chewable tablet.
- Other ingredients include: mannitol, powdered sugar (3% starch), sorbitol (E420), saccharin sodium, mint powder*, magnesium stearate, saccharose.
*Composition de larôme limonene, menthone, isomenthone, menthyl acetate, neo-menthol, menthol.
Mint flavour powder contains benzyl alcohol. See section 2.
What MAALOX maux destomac aluminium hydroxide / magnesium hydroxide 400 mg/400 mg, chewable tablet is and what it contains
This medicine takes the form of a chewable tablet.
Boxes of 12, 20, 40 or 60 tablets in blister packs.
Boxes of 40 tablets in bottles.
Not all presentations may be marketed.
Marketing authorization holder
OPELLA HEALTHCARE FRANCE SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine, France
Marketing authorization holder
OPELLA HEALTHCARE FRANCE SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine, France
Manufacturer
LE NIGEN PHARMA
35, QUAI DU MOULIN DE CAGE
92230 GENNEVILLIERS
Or
EUROPHARTEC
(EUROPEENNE DE PHARMACOTECHNIE)
RUE HENRI MATISSE
63370 LEMPDES
Or
SANOFI WINTHROP INDUSTRIE
180 RUE JEAN JAURES
94702 MAISONS-ALFORT
Or
Sanofi S.r.l
S.S. 17 KM 22
67019 SCOPPITO (AQ)
ITALY
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH EDUCATION ADVICE
This medicine is intended to relieve stomach ache.
Heartburn and acid reflux can be caused by changes in diet (acidic or spicy foods, alcoholic beverages, etc.) or by certain medications (aspirin, anti-inflammatory drugs, etc.). Talk to your doctor or pharmacist.
To limit the onset of symptoms, observe the following rules of hygiene wherever possible:
- avoid heavy, high-fat meals,
- avoid certain foods such as chocolate, spices, peppers, citrus juices and soft drinks,
- vary your diet,
- normalize your weight and exercise,
- avoid strenuous exercise immediately after a meal,
- avoid smoking and limit alcohol consumption.
YOUR PHARMACIST AND DOCTOR KNOW ALL ABOUT MEDICINES.
DON'T HESITATE TO ASK THEM FOR DETAILS
NEVER LEAVE MEDICATION WITHIN THE REACH OF CHILDREN.