NOTICE
ANSM - Updated on : 17/10/2025
Product name
XOLAAM, chewable or suckable tablet
Aluminum hydroxide, magnesium hydroxide
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor 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.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 10 days.
What does this leaflet contain?
1. What is Xolaam chewable or suckable tablet and what is it used for?
2. What do I need to know before taking Xolaam, chewable or suckable tablet?
3. How do I take Xolaam, chewable or suckable tablet?
4. What are the possible side effects?
5. How do I keep Xolaam, chewable or suckable tablet?
6. Package contents and other information.
1. WHAT IS XOLAAM, chewable or suckable tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antacids - ATC code: A: digestive system and metabolism
XOLAAM. This drug belongs to the family of antacids. They act by neutralizing stomach acidity.
It 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 XOLAAM, chewable or suckable tablet?
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Never take Xolaam, chewable or suckable tablet:
- if you are allergic to aluminum hydroxide, magnesium hydroxide or any of the other ingredients listed in section 6.
- if you have severe kidney disease (severe renal failure).
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Ask your doctor or pharmacist before taking Xolaam, chewable or suckable tablet.
Before taking Xolaam, consult your doctor:
- If your symptoms 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 failure) or are on dialysis, you should consult a doctor, as Xolaam contains aluminium and magnesium. Accumulation of aluminum and magnesium can lead to serious neurological disease (encephalopathy).
This drug may cause or aggravate constipation in patients at risk, such as those with kidney failure or the elderly.
Prolonged use of this drug should be avoided in patients with impaired renal function.
Medical advice is recommended in the event of prolonged use or if you are at risk of phosphorus deficiency (e.g. low phosphorus diet).
Other medicinal products and Xolaam, chewable or suckable tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Some medicines can be influenced by magnesium hydroxide or affect its effectiveness. Tell your doctor or pharmacist if you are already taking salicylates, and in particular medicines used to treat :
- The heart, such as metoprolol, latenolol and propranolol.
- Anaemia, such as iron salts.
- Ulcers and gastric acidity, such as ranitidine or cimetidine (H2-receptor antagonists).
- Malaria, such as chloroquine.
- Bone diseases, such as bisphosphonates.
- Certain allergic, inflammatory or abnormal immune reactions, such as glucocorticoids or fexofenadine.
- Kidney disorders, such as citrates.
- Tuberculosis, such as lethambutol or lisoniazide.
- Infections, such as fluoroquinolones, lincosamides, ketoconazole, cyclins, cephalosporins (cefpodoxime), dolutegravir, lelvitégravir, raltegravir and rilpivirine.
- Mental illnesses (psychoses), such as phenothiazine neuroleptics or sulpiride.
- High levels of potassium in the body, such as catioresins.
- Pain and/or fever, such as indomethacin or laspirin.
- Thyroid insufficiency, such as levothyroxine.
- Joint pain and abnormal body chemical reactions, such as penicillamine.
- Cancer, such as nilotinib or dasatinib monohydrate.
- Blood disorders, such as leltrombopag olamine.
- High blood pressure in the lungs (pulmonary hypertension), such as riociguat.
- Uterine fibroids or emergency contraception, such as lulipristal.
- Drugs used for dental care, such as fluoride.
- Cholesterol-lowering drugs such as rosuvastatin.
As a precautionary measure, oral medications should be taken at least 2 hours apart from antacids (4 hours apart for fluoroquinolones).Xolaam interacts with other oral medications. Do not take Xolaam at the same time as another drug, and allow at least 2 hours between doses.
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This medicine contains antacids (aluminum hydroxide and magnesium hydroxide). Other drugs contain them. Do not combine them, as the maximum recommended doses may be exceeded (see " How to take xolaam, chewable or suckable tablet ").
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Xolaam, chewable or suckable tablet with food and drink.
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advicebefore taking this medicine.
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medication.
Breast-feeding
This medicine may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
Xolaam, chewable or suckable tablet contains sorbitol and sucrose.
This medicine contains sucrose. If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
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 medication.
3. HOW DO I TAKE XOLAAM, chewable or suckable tablet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
- The recommended 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 Xolaam, chewable or suckable 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 Xolaam, chewable or suckable tablet
Not applicable.
If you stop taking Xolaam, chewable or suckable tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects may occur:
Very rare adverse reactions:
Hypermagnesemia. This has been observed after prolonged administration to patients with renal failure.
Undesirable effects of undetermined frequency (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 Urticaria,
o Sudden swelling of the face and neck which may cause difficulty in breathing (angioedema),
- 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 Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE XOLAAM, chewable or suckable tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the carton after {EXP}, which refers to the last day of that month.
Keep the blister packs in their original packaging.
Do not dispose of any medicine with your 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 Xolaam chewable or suckable tablet contains
- The active ingredients are :
Aluminum hydroxide............................................................................................. 400.00 mg
Magnesium hydroxide.......................................................................................... 400.00 mg
For one tablet.
- The other components are :
Mannitol, sorbitol, sodium saccharin, starch powdered sucrose, mint flavoring, magnesium stearate, sucrose for direct compression.
What Xolaam chewable or suckable tablet is and what it contains
Chewable or suckable tablet, box of 40.
Marketing authorization holder
SUN PHARMA FRANCE
31 RUE DES POISSONNIERS
92200 NEUILLY SUR SEINE
Marketing authorization holder
SUN PHARMA FRANCE
31 RUE DES POISSONNIERS
92200 NEUILLY SUR SEINE
Manufacturer
AVENTIS PHARMA S.p.A.
PIAZZALE TURR, 5
MILAN
ITALY
or
EUROPHARTEC
EUROPEENNE DE PHARMACOTECHNIE,
1 RUE HENRI MATISSE
63370 LEMPDES
or
DELPHARM EVREUX
5, AVENUE DU GUESCLIN
27000 EVREUX
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 later by the holder].
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.