MAALOX PLUS 4% + 3.5% + 0.5% ORAL SUSPENSION MINT FLAVOUR 250 ML PET BOTTLE

Name
MAALOX PLUS 4% + 3.5% + 0.5% lemon-flavored oral suspension
Magnesium hydroxide + Aluminum hydroxide + Simethicone


What is it and what is it for?
This medicine contains the following active ingredients: magnesium hydroxide and aluminium hydroxide which act as antacids in the stomach, and simethicone which absorbs intestinal gas.

MAALOX PLUS is a medicine used for the treatment of:
• symptoms of excess stomach acid (hyperacidity) such as burning and pain even in case of inflammation of the esophagus (esophagitis) and hyperacidity when it is accompanied by digestive disorders (dyspepsia);
• symptoms of excess air in the stomach and intestines when associated with hyperacidity.

Talk to your doctor if you do not feel better or if you feel worse.


What you need to know before taking the medicine
Do not use MAALOX PLUS
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction are skin rashes, swelling of the lips, tongue, face and throat, breathing problems;
- if you suffer from porphyria (a rare hereditary disorder of blood metabolism);
- if you have serious kidney problems;
- if your body is severely wasted (cachexia);
- in children and adolescents under 18 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX PLUS:
- if you have intestinal problems or constipation, if you have minor kidney problems or are elderly because this medicine may make intestinal problems worse;
- if you are on a low-phosphorus diet, have low blood phosphate levels (hypophosphatemia), or are on long-term treatment. This medicine reduces blood phosphate levels and may cause bone problems (see "Possible side effects").

If you are taking this medicine at a high dose or if you are prone to diarrhoea, be careful as this medicine may cause diarrhoea (see section 4 “Possible side effects”).

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
In young children, the use of magnesium hydroxide may cause hypermagnesemia, particularly if they have kidney damage or dehydration.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking MAALOX PLUS and contact your doctor or nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rashes, itching, hives and dizziness, these may be symptoms of serious allergic reactions (angioedema and anaphylactic reaction).

The following side effects may occur with the use of this medicine:
Uncommon (may affect up to 1 in 100 people):
- constipation (constipation) or diarrhoea (see section 2 “Warnings and precautions”).
Very rare (may affect up to 1 in 10,000 people):
- hypermagnesemia, including observations after prolonged administration to patients with renal impairment.
Frequency not known (frequency cannot be estimated from the available data)
- excessive reaction of the body to foreign substances (hypersensitivity reaction), more or less itchy skin rash characterized by the appearance of bumps on the skin (hives), itching;
- alterations in the levels of aluminium and phosphate in the blood which may cause bone problems (see section 2 “Warnings and precautions”);
- abdominal pain.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.