Maalox

Patient Information Leaflet

MAALOX 3.65% + 3.25% oral suspension

Magnesium hydroxide + Aluminium hydroxide
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX is and what it is used for
2. What you need to know before taking MAALOX
3. How to take MAALOX
4. Possible side effects
5. How to store MAALOX
6. Contents of the pack and other information

1. What MAALOX is and what it is used for

This medicine contains two active substances: magnesium hydroxide and aluminium hydroxide.
These belong to a group of medicines called "antacids". MAALOX works by reducing the amount of
acid in your stomach.
This medicine is used to treat the following symptoms:

• occasional heartburn;
• occasional stomach acidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX

Do not use MAALOX

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely debilitated (cachexia);
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX:

• if you have intestinal problems or constipation, if you have mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if treatment is long-term. This medicine reduces phosphate levels in the blood and may cause bone problems.
  Children and adolescents
  This medicine must not be used in children and adolescents under 18 years of age. In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if renal impairment or dehydration is present.

Other medicines and MAALOX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, as some medicines may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol;
• medications used to treat anaemia such as iron salts;
• medications used to treat ulcers and stomach acidity such as ranitidine or cimetidine (H--antagonists);
• medications used to treat malaria such as chloroquine;
• medications used to treat certain bone diseases such as bisphosphonates;
• medications used to treat certain allergic, inflammatory or abnormal immune reactions such as glucocorticoids;
• medications used to treat kidney diseases such as citrates;
• medications used to treat tuberculosis such as ethambutol, isoniazid;
• medications used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medications used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics;
• medications used to treat high potassium levels in the body such as polystyrene sulfonate;
• medications used to treat pain such as diflunisal, indomethacin;
• medications used for dental care such as sodium fluoride;
• medications used to treat underactive thyroid such as levothyroxine;
• medications used to treat joint pain and abnormal body chemistry reactions such as penicillamine;
• medications used to lower cholesterol such as rosuvastatin;
• medications used to treat cancers such as nilotinib, dasatinib monohydrate;
• medications used to treat blood disorders such as eltrombopag olamine;
• medications used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat.

Additionally, inform your doctor or pharmacist if you are taking:

• medicines containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medicines containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medicine), due to the risk of increased quinidine levels;
• salicylates.

As a precaution, wait at least 2 hours between taking MAALOX and any other oral medicine (4 hours in the case of fluoroquinolone antibiotics).

Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under their supervision.
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

MAALOX contains:

• parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
• approximately 98 mg of sorbitol in 10 ml (2 teaspoons). Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take MAALOX

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose for adults and adolescents over 18 years of age is: 2–4 teaspoonfuls of oral suspension, taken 4 times daily, 20–60 minutes after meals and before bedtime.
Instructions for use: Shake the bottle well before use. You may take this medicine alone or mixed with water or milk.

If you take more MAALOX than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you take excessive doses of this medicine, you may experience:

• diarrhoea (see section 2 “Warnings and precautions”), abdominal pain and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems, or are elderly.

If you forget to take MAALOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking MAALOX and contact your doctor or go immediately to the nearest hospital if you experience:
difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rash,
itching, hives, or dizziness, as these may be symptoms of severe 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 or diarrhoea.

Very rare (may affect up to 1 in 10,000 people):

• hypermagnesaemia, including cases observed after prolonged administration in 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, even severe), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;
• changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 “Warnings and precautions”);
• abdominal pain.

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

5. How to store MAALOX

Keep this medicine out of the sight and reach of children.
Do not store at temperatures below 4°C.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MAALOX contains

• The active substances are: magnesium hydroxide and aluminium hydroxide. 100 ml of suspension contain 3.65 g of magnesium hydroxide and 3.25 g of aluminium hydroxide.
• The other components are: methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, citric acid monohydrate, sorbitol liquid non-crystallizable, mannitol, peppermint essence, sodium saccharin, purified water.

Description of the appearance of MAALOX and package contents
MAALOX 3.65% + 3.25% oral suspension is supplied in a 200 ml bottle containing oral suspension.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturer
Opella Healthcare Italy S.r.l.
Viale Europa, 11 - 21040 Origgio (VA) - Italy

Patient information leaflet: information for the patient

MAALOX 4% + 3.5% oral suspension, peppermint flavor

Magnesium hydroxide + Aluminium hydroxide
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX is and what it is used for
2. What you need to know before taking MAALOX
3. How to take MAALOX
4. Possible side effects
5. How to store MAALOX
6. Package contents and other information

1. What MAALOX is and what it is used for

This medicine contains two active substances: magnesium hydroxide and aluminium hydroxide. These belong to a group of medicines called "antacids". MAALOX works by reducing the amount of acid in your stomach.

This medicine is used to treat the following symptoms:

• occasional heartburn;
• occasional excessive stomach acidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX

Do not use MAALOX

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, and breathing difficulties;
• if you suffer from porphyria (a rare inherited disorder of blood metabolism);
• if you have severe kidney problems;
• if you are severely weakened (cachexia);
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX:

• if you have intestinal problems or constipation, if you have mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems (see "Possible side effects");
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if treatment is long-term. This medicine reduces phosphate levels in the blood and may cause bone problems (see "Possible side effects").
  Children and adolescents
  This medicine must not be used in children and adolescents under 18 years of age. In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if renal impairment or dehydration is present.

Other medicines and MAALOX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, as some drugs may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol;
• medications used to treat anaemia such as iron salts;
• medications used to treat ulcer and stomach acidity such as ranitidine or cimetidine (H\2 antagonists);
• medications used to treat malaria such as chloroquine;
• medications used to treat certain bone diseases such as bisphosphonates;
• medications used to treat certain allergic, inflammatory or abnormal immunological reactions such as glucocorticoids;
• medications used to treat kidney diseases such as citrates;
• medications used to treat tuberculosis such as ethambutol, isoniazid;
• medications used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medications used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics;
• medications used to treat high potassium levels in the body such as polystyrene sulfonate;
• medications used to treat pain such as diflunisal, indomethacin;
• medications used for dental care such as sodium fluoride;
• medications used to treat underactive thyroid such as levothyroxine;
• medications used to treat joint pain and abnormal chemical reactions in the body such as penicillamine;
• medications used to lower cholesterol such as rosuvastatin;
• medications used to treat cancers such as nilotinib, dasatinib monohydrate;
• medications used to treat blood disorders such as eltrombopag olamine;
• medications used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat.

Additionally, inform your doctor or pharmacist if you are taking:

• medications containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medications containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medication), due to the risk of increased quinidine levels;
• salicylates.

As a precaution, wait at least 2 hours between taking MAALOX and any other oral medication (4 hours in the case of fluoroquinolone antibiotics).

Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under medical supervision.
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

MAALOX contains:

• approximately 100 mg of sorbitol in 10 ml (2 teaspoons). Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take MAALOX

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is: 2–4 teaspoonfuls of oral suspension, 4 times daily, taken 20–60 minutes after meals and before bedtime. Do not exceed the recommended doses.
Instructions for use: Shake the bottle well before use. You may take this medicine alone or mixed with water or milk.
Use the medicine within 6 months after first opening.
If you take more MAALOX than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take high doses of this medicine, you may experience:

• diarrhoea, abdominal pain, and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems, or are elderly.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take MAALOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MAALOX and contact your doctor or go immediately to the nearest hospital if you
experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or
tongue, skin rash, itching, hives, or dizziness, as these may be symptoms of severe 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 or diarrhoea.
  Very rare (may affect up to 1 in 10,000 people):

• Hypermagnesaemia, including cases reported after prolonged administration in patients with renal impairment.
  Frequency not known (cannot be estimated from the available data):

• Excessive reaction of the body to foreign substances (hypersensitivity reaction, even severe), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;

• Changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 “Warnings and precautions”);

• Abdominal pain.

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

5. How to store MAALOX

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Use the medicine within 6 months after first opening.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAALOX contains

• The active substances are: magnesio idrossido and alluminio idrossido. 100 ml of suspension contain 4 g of magnesio idrossido and 3.5 g of alluminio idrossido.
• Other components are: hydrochloric acid (10%), citric acid (monohydrate), peppermint essence, mannitol (E421), domiphen bromide, sodium saccharin, 70% non-crystallizable liquid sorbitol (E420), hydrogen peroxide 30% solution, and purified water.

Description of the appearance of MAALOX and contents of the pack
MAALOX 4% + 3.5% oral suspension is presented in a 250 ml bottle.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturers
Opella Healthcare Italy S.r.l.
Viale Europa, 11 – 21040 Origgio (VA) - Italy
A. Nattermann & Cie. GmbH
Nattermannallee 1 – 50829 Cologne - Germany

Patient Information Leaflet

MAALOX 400 mg + 400 mg chewable tablets

Magnesium hydroxide + Aluminium oxide, hydrated
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX is and what it is used for
2. What you need to know before taking MAALOX
3. How to take MAALOX
4. Possible side effects
5. How to store MAALOX
6. Package contents and other information

1. What MAALOX is and what it is used for

This medicine contains two active substances: magnesium hydroxide and aluminium oxide, hydrated. These belong to a group of medicines called "antacids". MAALOX works by reducing the amount of acid in your stomach.
This medicine is used to treat the following symptoms:

• occasional heartburn;
• occasional stomach acidity.

Consult your doctor if you do not feel better or if your condition worsens.

2. What you should know before taking MAALOX

Do not use MAALOX

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely debilitated (cachexia);
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX:

• if you have intestinal problems or constipation, if you have mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if treatment is long-term. This medicine reduces phosphate levels in the blood and may cause bone problems.
  Children and adolescents
  This medicine must not be used in children and adolescents under 18 years of age. In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if renal impairment or dehydration is present.

Other medicines and MAALOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, as some drugs may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol;
• medications used to treat anemia such as iron salts;
• medications used to treat ulcers and stomach acidity such as ranitidine or cimetidine (H--antagonists);
• medications used to treat malaria such as chloroquine;
• medications used to treat certain bone diseases such as bisphosphonates;
• medications used to treat certain allergic, inflammatory or abnormal immunological reactions such as glucocorticoids;
• medications used to treat kidney diseases such as citrates;
• medications used to treat tuberculosis such as ethambutol, isoniazid;
• medications used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medications used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics;
• medications used to treat high potassium levels in the body such as polystyrene sulfonate;
• medications used to treat pain such as diflunisal, indomethacin;
• medications used for dental care such as sodium fluoride;
• medications used to treat underactive thyroid (hypothyroidism) such as levothyroxine;
• medications used to treat joint pain and abnormal body chemistry reactions such as penicillamine;
• medications used to lower cholesterol such as rosuvastatin;
• medications used to treat cancers such as nilotinib, dasatinib monohydrate;
• medications used to treat blood disorders such as eltrombopag olamine;
• medications used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat.

In addition, inform your doctor or pharmacist if you are taking:

• medications containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medications containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medication), due to the risk of increased quinidine levels;
• salicylates.

As a precaution, wait at least 2 hours between taking MAALOX and any other oral medication (4 hours in case of fluoroquinolone antibiotics).

Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under medical supervision.
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

MAALOX contains:

• approximately 125 mg of sorbitol per tablet (sorbitol is a source of fructose) and sucrose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.
• 0.000072 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take MAALOX

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose for adults and adolescents over 18 years of age is: 1-2 tablets 4 times a day, to be taken 20-60 minutes after meals and before going to bed.
Instructions for use: Chew or suck the tablets thoroughly. After taking this medicine, you may drink water or milk.

If you take more MAALOX than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take excessive doses of this medicine, you may experience:

• diarrhoea (see section 2 “Warnings and precautions”), abdominal pain, and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems, or are elderly.

If you forget to take MAALOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking MAALOX and contact your doctor or go to the nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rash, itching, hives, or dizziness, as these may be symptoms of severe 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 or diarrhoea (see section 2 “Warnings and precautions”).
  Very rare (may affect up to 1 in 10,000 people):
• Hypermagnesaemia, including observations after prolonged administration in patients with renal impairment.
  Frequency not known (frequency cannot be estimated from the available data):
• Excessive immune response to foreign substances (hypersensitivity reaction, even severe), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;
• Changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 “Warnings and precautions”);
• Abdominal pain.

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

5. How to store MAALOX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MAALOX contains

• The active substances are: magnesium hydroxide and aluminium oxide, hydrated. Each tablet contains 400 mg of magnesium hydroxide and 400 mg of aluminium oxide, hydrated.
• The other components are: powdered sucrose with starch, sorbitol, mannitol, magnesium stearate, powdered peppermint flavour, sodium saccharin, sucrose.

Description of the appearance of MAALOX and contents of the pack
MAALOX 400 mg + 400 mg chewable tablets are supplied in a carton containing 40, 50 or 60 chewable tablets.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturer
Sanofi S.r.l.
S.S.17 Km 22
IT-67019 Scoppito (AQ) - Italy

Patient information leaflet

MAALOX 400 mg + 400 mg chewable sugar-free tablets

Magnesium hydroxide + Aluminium oxide, hydrated
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX is and what it is used for
2. What you need to know before taking MAALOX
3. How to take MAALOX
4. Possible side effects
5. How to store MAALOX
6. Contents of the pack and other information

1. What MAALOX is and what it is used for

This medicine contains two active substances: magnesium hydroxide and aluminium oxide, hydrated. These belong to a group of medicines called "antacids". MAALOX works by reducing the amount of acid in your stomach.

This medicine is used to treat the following symptoms:

• occasional heartburn;
• occasional excessive stomach acidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX

Do not use MAALOX

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you have porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely weakened (cachexia);
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX:

• if you have intestinal problems or constipation, if you have mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if you require long-term treatment. This medicine reduces phosphate levels in the blood and may cause bone problems.
  Children and adolescents
  This medicine must not be used in children and adolescents under 18 years of age. In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if they have kidney damage or dehydration.

Other medicines and MAALOX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, as some medicines may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medicines such as digoxin, quinidine, metoprolol, atenolol and propranolol;
• medicines used to treat anaemia such as iron salts;
• medicines used to treat ulcer and stomach acidity such as ranitidine or cimetidine (H*2* antagonists);
• medicines used to treat malaria such as chloroquine;
• medicines used to treat certain bone diseases such as bisphosphonates;
• medicines used to treat certain allergic, inflammatory or abnormal immune reactions such as glucocorticoids;
• medicines used to treat kidney diseases such as citrates;
• medicines used to treat tuberculosis such as ethambutol, isoniazid;
• medicines used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, potassium raltegravir, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medicines used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics;
• medicines used to treat high potassium levels in the body such as polystyrene sulfonate;
• medicines used to treat pain such as diflunisal, indometacin;
• medicines used for dental care such as sodium fluoride;
• medicines used to treat underactive thyroid such as levothyroxine;
• medicines used to treat joint pain and abnormal body chemistry reactions such as penicillamine;
• medicines used to lower cholesterol such as rosuvastatin;
• medicines used to treat cancers such as nilotinib, dasatinib monohydrate;
• medicines used to treat blood disorders such as eltrombopag olamine;
• medicines used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat.

In addition, inform your doctor or pharmacist if you are taking:

• medicines containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medicines containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medicine), due to the risk of increased quinidine levels;
• salicylates.

As a precaution, wait at least 2 hours between taking MAALOX and any other oral medicine (4 hours in case of fluoroquinolone antibiotics).

Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under their supervision.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine does not affect the ability to drive or use machinery.

MAALOX chewable tablets, red fruit flavour contain:

• approximately 110 mg of sorbitol per tablet (sorbitol is a source of fructose) and maltitol. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolise fructose, speak to your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

MAALOX chewable tablets, lemon flavour contain:

• approximately 110 mg of sorbitol per tablet (sorbitol is a source of fructose) and maltitol. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolise fructose, speak to your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
• 0.000068 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take MAALOX

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose in adults and adolescents over 18 years of age is: 1-2 tablets 4 times a day, to be taken 20-60 minutes after meals and before going to bed.
Instructions for use: Chew or suck the tablets thoroughly. After taking this medicine, you may drink water or milk.

If you take more MAALOX than you should
If you accidentally ingest or take an excessive dose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take high doses of this medicine, you may experience:

• diarrhoea (see section 2 "Warnings and precautions"), abdominal pain and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems or are elderly.

If you forget to take MAALOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking MAALOX and contact your doctor or go to the nearest hospital immediately if you
experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or
tongue, skin rash, itching, hives, or dizziness, as 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 (stipsis) or diarrhoea (see section 2 “Warnings and precautions”).
  Very rare (may affect up to 1 in 10,000 people):
• hypermagnesaemia. This has been observed after prolonged administration in 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, even severe), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;
• changes in blood levels of aluminium and phosphate which may cause bone problems (see section 2 “Warnings and precautions”);
• abdominal pain.

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

5. How to store MAALOX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAALOX contains
MAALOX 400 mg + 400 mg sugar-free chewable tablets, lemon flavour:

• The active substances are: magnesium hydroxide and aluminium oxide, hydrate. Each tablet contains 400 mg of magnesium hydroxide and 400 mg of aluminium oxide, hydrate.
• The other components are: liquid non-crystallisable sorbitol, maltitol, glycerol 85 per cent, sodium saccharin, lemon flavour, talc, magnesium stearate.

MAALOX 400 mg + 400 mg sugar-free chewable tablets, red fruit flavour:

• The active substances are: magnesium hydroxide and aluminium oxide, hydrate. Each tablet contains 400 mg of magnesium hydroxide and 400 mg of aluminium oxide, hydrate.
• The other components are: liquid non-crystallisable sorbitol, maltitol, glycerol 85 per cent, sodium saccharin, red fruit flavour, talc, magnesium stearate.

Description of MAALOX and contents of the pack
MAALOX 400 mg + 400 mg sugar-free chewable tablets, red fruit flavour, are available in a box containing 30 chewable tablets.
MAALOX 400 mg + 400 mg sugar-free chewable tablets, lemon flavour, are available in boxes containing 20, 30 or 40 chewable tablets.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturer
Sanofi S.r.l.
S.S. 17 Km 22 - 67019 Scoppito (AQ) - Italy

Patient Information Leaflet

MAALOX 460 mg + 400 mg oral suspension

Aluminium oxide, hydrated + Magnesium hydroxide
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX is and what it is used for
2. What you need to know before taking MAALOX
3. How to take MAALOX
4. Possible side effects
5. How to store MAALOX
6. Contents of the pack and other information

1. What MAALOX is and what it is used for

This medicine contains two active substances: magnesium hydroxide and aluminium oxide, hydrated. These
belong to a group of medicines called "antacids". MAALOX works by reducing the amount of
acid in your stomach.
This medicine is used to treat the following symptoms:

• occasional heartburn;
• occasional excessive stomach acidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking MAALOX

Do not use MAALOX

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited disorder of blood metabolism);
• if you have severe kidney problems;
• if your body is severely weakened (cachexia);
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX:

• if you have intestinal problems or constipation, if you have mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if you are undergoing long-term treatment. This medicine reduces phosphate levels in the blood and may cause bone problems. If you are taking this medicine at a high dosage or if you are prone to diarrhea, be careful, as this medicine may cause diarrhea (see section 4 “Possible side effects”).

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if renal impairment or dehydration is present.

Other medicines and MAALOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following listed medicines, as some medicines may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol
• medicines used to treat anemia such as iron salts
• medicines used to treat ulcers and stomach acidity such as ranitidine or cimetidine (H--antagonists)
• medicines used to treat malaria such as chloroquine
• medicines used to treat certain bone diseases such as bisphosphonates
• medicines used to treat certain allergic, inflammatory or abnormal immunological reactions such as glucocorticoids
• medicines used to treat kidney diseases such as citrates
• medicines used to treat tuberculosis such as ethambutol, isoniazid
• medicines used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medicines used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics
• medicines used to treat high potassium levels in the body such as polystyrene sulfonate
• medicines used to treat pain such as diflunisal, indomethacin
• medicines used for dental care such as sodium fluoride
• medicines used to treat underactive thyroid such as levothyroxine
• medicines used to treat joint pain and abnormal chemical reactions in the body such as penicillamine
• medicines used to lower cholesterol such as rosuvastatin
• medicines used to treat cancers such as nilotinib, dasatinib monohydrate
• medicines used to treat blood disorders such as eltrombopag olamine
• medicines used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat

Moreover, inform your doctor or pharmacist if you are taking:

• medicines containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medicines containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medicine), due to the risk of increased quinidine levels;
• salicylates.

As a precaution, wait at least 2 hours between taking MAALOX and any other oral medicine (4 hours in case of fluoroquinolone antibiotics).

Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under medical supervision.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

MAALOX contains:

• approximately 3 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus (in case of taking more than one sachet per day). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• 140 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take MAALOX

Take this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions.
If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose in adults and adolescents over 18 years of age is: 1-2 sachets of oral suspension
4 times daily, taken 20-60 minutes after meals and before bedtime.
Instructions for use: Shake well before use by gently massaging the sachet.

If you take more MAALOX than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take excessive doses of this medicine, you may experience:

• diarrhoea (see section 2 “Warnings and precautions”), abdominal pain, and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems, or are elderly.

If you forget to take MAALOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking MAALOX and contact your doctor or go immediately to the nearest hospital if you
experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or
tongue, skin rash, itching, hives, or dizziness, as these may be symptoms of severe 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 or diarrhoea (see section 2 "Warnings and precautions").
  Very rare (may affect up to 1 in 10,000 people):

• Hypermagnesaemia, including cases observed after prolonged administration in patients with renal impairment.
  Frequency not known (frequency cannot be estimated from the available data):

• Excessive reaction of the body to foreign substances (hypersensitivity reactions, even severe ones), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;

• Changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 "Warnings and precautions");

• Abdominal pain.

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

5. How to store MAALOX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAALOX contains
MAALOX 460 mg + 400 mg oral suspension, lemon-lime flavour

• The active substances are: aluminium oxide, hydrate and magnesium hydroxide. Each 4.3 ml sachet of suspension contains 460 mg of aluminium oxide, hydrate and 400 mg of magnesium hydroxide.
• Other components are: sucrose solution 64%, sorbitol liquid non-crystallisable, xanthan gum, guar, natural lemon-lime flavour, sodium chloride.

MAALOX 460 mg + 400 mg oral suspension, blackcurrant flavour

• The active substances are: aluminium oxide, hydrate and magnesium hydroxide. Each 4.3 ml sachet of suspension contains 460 mg of aluminium oxide, hydrate and 400 mg of magnesium hydroxide.
• Other components are: sucrose solution 64%, sorbitol liquid non-crystallisable, xanthan gum, guar, blackcurrant flavour, sodium chloride.

Description of the appearance of MAALOX and package contents
MAALOX 460 mg + 400 mg oral suspension, lemon-lime flavour is supplied in sachets containing 4.3 ml of oral suspension each and is available in packs of 20 sachets.
MAALOX 460 mg + 400 mg oral suspension, blackcurrant flavour is supplied in sachets containing 4.3 ml of oral suspension each and is available in packs of 20 or 30 sachets.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/B - 20158 Milan - Italy

Manufacturers
Opella Healthcare Italy S.r.l. - Viale Europa, 11 - 21040 Origgio (VA) – Italy
A. Nattermann & Cie. GmbH - Nattermannallee 1 – D-50829 – Cologne (Germany)

Package leaflet: information for the patient

MAALOX PLUS 4% + 3.5% + 0.5% oral suspension lemon flavour

Magnesium hydroxide + Aluminium hydroxide + Simethicone
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX PLUS is and what it is used for
2. What you need to know before taking MAALOX PLUS
3. How to take MAALOX PLUS
4. Possible side effects
5. How to store MAALOX PLUS
6. Package contents and other information

1. What MAALOX PLUS is and what it is used for

This medicinal product contains the following active substances: magnesium hydroxide and aluminium hydroxide, which act as antacids in the stomach, and simeticone, which absorbs intestinal gases.
MAALOX PLUS is a medicine used to treat:

• symptoms due to excess stomach acidity (hyperacidity), such as burning and pain, including cases of inflammation of the oesophagus (oesophagitis), and hyperacidity associated with digestive disorders (dyspepsia);
• symptoms due to excess air in the stomach and intestine when associated with hyperacidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX PLUS

Do not use MAALOX PLUS

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rash, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely debilitated (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 mild kidney problems or are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if treatment is long-term. This medicine reduces phosphate levels in the blood and may cause bone problems (see section 4 “Possible side effects”).

If you are taking this medicine at a high dosage or are prone to diarrhea, be careful
because this medicine may cause diarrhea (see section 4 “Possible side effects”).
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if renal impairment or dehydration is present.
Other medicines and MAALOX PLUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, as some medicines may be affected by magnesium hydroxide or may affect its action.
In particular:

• heart medicines such as digoxin, quinidine, metoprolol, atenolol and propranolol;
• medicines used to treat anaemia such as iron salts;
• medicines used to treat ulcers and stomach acidity such as ranitidine or cimetidine (H~2~ antagonists);
• medicines used to treat malaria such as chloroquine;
• medicines used to treat certain bone diseases such as bisphosphonates;
• medicines used to treat certain allergic, inflammatory or abnormal immune reactions such as glucocorticoids;
• medicines used to treat kidney diseases such as citrates;
• medicines used to treat tuberculosis such as ethambutol, isoniazid;
• medicines used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medicines used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics;
• medicines used to treat high potassium levels in the body such as polystyrene sulfonate;
• medicines used to treat pain such as diflunisal, indomethacin;
• medicines used for dental care such as sodium fluoride;
• medicines used to treat underactive thyroid such as levothyroxine;
• medicines used to treat joint pain and abnormal body chemistry reactions such as penicillamine;
• medicines used to lower cholesterol such as rosuvastatin;
• medicines used to treat cancers such as nilotinib, dasatinib monohydrate;
• medicines used to treat blood disorders such as eltrombopag olamine;
• medicines used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat.

Additionally, inform your doctor or pharmacist if you are taking:

• medicines containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medicines containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medicine), due to the risk of increased quinidine levels;
• salicylates.

Inform your doctor or pharmacist if you are taking aspirin or medicines containing acetylsalicylic acid, or antibiotics containing tetracyclines or tetracycline salts.
As a precaution, leave at least 2 hours between taking MAALOX PLUS and any other oral medicine (4 hours in the case of fluoroquinolone antibiotics).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should only be taken if your doctor considers it necessary and under medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MAALOX PLUS contains:

• sorbitol (E420): this medicine contains 448 mg of sorbitol in 10 ml (2 teaspoons). Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine;
• alcohol: this medicine contains 8.2 mg of alcohol (ethanol) in 10 ml (2 teaspoons). 10 ml of this medicine is equivalent to 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects;
• sucrose and invert sugar: if your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine;
• sulfur dioxide (E220): rarely may cause severe hypersensitivity reactions and bronchospasm;
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take MAALOX PLUS

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose for adults and adolescents over 18 years of age is: 2-4 teaspoonfuls of oral suspension 4 times daily, taken 20-60 minutes after meals and before bedtime.
Instructions for use: Shake the bottle well before use. You may take this medicine alone or mixed with water or milk.
If you take more MAALOX PLUS than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take excessive doses of this medicine, you may experience:

• diarrhoea (see section 2 “Warnings and precautions”), abdominal pain and vomiting;
• worsening of intestinal problems if you suffer from constipation or are elderly.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take MAALOX PLUS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking MAALOX PLUS and contact your doctor or go to the nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rash, itching, hives, or 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 (stipsis) or diarrhoea (see section 2 “Warnings and precautions”).
  Very rare (may affect up to 1 in 10,000 people):
• hypermagnesaemia, including cases observed after prolonged administration in patients with renal impairment.
  Frequency not known (frequency cannot be estimated from the available data):
• excessive immune response to foreign substances (hypersensitivity reaction), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;
• changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 “Warnings and precautions”);
• abdominal pain.

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

5. How to store MAALOX PLUS

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Use the medicine within 6 months after first opening.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAALOX PLUS contains

• The active substances are: magnesium hydroxide, aluminium hydroxide and simeticone. 100 ml of suspension contain 4 g of magnesium hydroxide, 3.5 g of aluminium hydroxide and 0.50 g of simeticone.
• The other components are: domiphen bromide, citric acid monohydrate, sodium saccharin, sorbitol (E420) 70% liquid non-crystallising, methylcellulose, hydroxypropylcellulose, microcrystalline cellulose and sodium carmellose, hydrogen peroxide 30% solution, lemon flavour (containing ethanol), Swiss cream flavour (containing ethanol, invert sugar, sucrose, sulphur dioxide (E220)) and purified water.

Description of the appearance of MAALOX PLUS and package contents
MAALOX PLUS 4% + 3.5% + 0.5% oral suspension is presented in a 250 ml PET bottle.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturers
Opella Healthcare Italy S.r.l.
Viale Europa, 11 – 21040 Origgio (VA) - Italy
A.Nattermann & Cie. GmbH
Nattermannallee 1 – 50829 Cologne - Germany

Patient Information Leaflet

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension

Magnesium hydroxide + Aluminium hydroxide + Dimethicone
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX PLUS is and what it is used for
2. What you need to know before taking MAALOX PLUS
3. How to take MAALOX PLUS
4. Possible side effects
5. How to store MAALOX PLUS
6. Contents of the pack and other information

1. What MAALOX PLUS is and what it is used for

This medicinal product contains the following active substances: magnesium hydroxide and aluminium hydroxide, which act as antacids in the stomach, and dimethicone, which absorbs intestinal gases.
Maalox Plus is a medicine used to treat:

• symptoms caused by excess stomach acid (hyperacidity), such as heartburn and pain, including cases of inflammation of the oesophagus (oesophagitis), and hyperacidity when accompanied by digestive disturbances (dyspepsia);
• symptoms caused by excess air in the stomach and intestine when associated with hyperacidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX PLUS

Do not use MAALOX PLUS

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rashes, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely weakened (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 non-severe kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if you require long-term treatment. This medicine reduces phosphate levels in the blood and may cause bone problems.

If you are taking this medicine at a high dosage or are prone to diarrhea, be careful
because this medicine may cause diarrhea (see section 4 “Possible side effects”).
Children and adolescents
This medicine must 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
renal impairment or dehydration is present.
Other medicines and MAALOX PLUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
of the following medicines, as some medicines may be affected by magnesium
hydroxide or may influence its effectiveness.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol
• medications used to treat anemia such as iron salts
• medications used to treat ulcers and stomach acidity such as ranitidine or cimetidine (H antagonists)
• medications used to treat malaria such as chloroquine
• medications used to treat certain bone diseases such as bisphosphonates
• medications used to treat certain allergic, inflammatory or abnormal immunological reactions such as glucocorticoids
• medications used to treat kidney diseases such as citrates
• medications used to treat tuberculosis such as ethambutol, isoniazid
• medications used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine;
• medications used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics
• medications used to treat high potassium levels in the body such as polystyrene sulfonate
• medications used to treat pain such as diflunisal, indomethacin
• medications used for dental care such as sodium fluoride
• medications used to treat underactive thyroid such as levothyroxine
• medications used to treat joint pain and abnormal chemical reactions in the body such as penicillamine
• medications used to lower cholesterol such as rosuvastatin
• medications used to treat cancers such as nilotinib, dasatinib monohydrate
• medications used to treat blood disorders such as eltrombopag olamine
• medications used to treat high pressure in the lungs (pulmonary hypertension) such as riociguat

In addition, inform your doctor or pharmacist if you are taking:

• medications containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medications containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medication), due to the risk of increased quinidine levels;
• salicylates.

Inform your doctor or pharmacist if you are taking aspirin or medications containing acetylsalicylic acid or
antibiotics containing tetracyclines or tetracycline salts.
As a precaution, wait at least 2 hours between taking MAALOX PLUS and any oral medication (4 hours in the case of fluoroquinolone antibiotics).
Pregnancy and breastfeeding
This medicine should only be taken if your doctor considers it necessary and under medical supervision.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MAALOX PLUS contains:

• parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
• 448 mg of sorbitol (E420) in 10 ml (2 teaspoons). Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• alcohol: this medicine contains 9.5 mg of alcohol (ethanol) in 10 ml (2 teaspoons). 10 ml of this medicine is equivalent to 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects;
• sucrose and invert sugar: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
• sulfur dioxide (E220): rarely may cause severe hypersensitivity reactions and bronchospasm;
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take MAALOX PLUS

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses unless otherwise advised by your doctor.
The recommended dose for adults and adolescents over 18 years of age is: 2-4 teaspoonfuls of oral suspension, 4 times daily, taken 20-60 minutes after meals and before bedtime.
Instructions for use: Shake the bottle well before use. You may take this medicine alone or mixed with water or milk.

If you take more MAALOX PLUS than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take excessive doses of this medicine, you may experience:

• diarrhoea (see section 2 “Warnings and precautions”), abdominal pain and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems or are elderly.

If you forget to take MAALOX PLUS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop taking MAALOX PLUS and contact your doctor or go to the nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rash, itching, hives, or dizziness, as 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 (stipsis) or diarrhoea (see section 2 "Warnings and precautions").
  Very rare (may affect up to 1 in 10,000 people):

• hypermagnesaemia, including cases observed after prolonged administration in patients with renal impairment.
  Frequency not known (frequency cannot be estimated from the available data):

• excessive body reaction to foreign substances (hypersensitivity reaction, even severe), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;

• changes in blood levels of aluminium and phosphate which may cause bone problems (see section 2 "Warnings and precautions");

• abdominal pain.

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

5. How to store MAALOX PLUS

Keep this medicine out of the sight and reach of children.
Do not store at temperatures below 4°C.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAALOX PLUS contains

• The active substances are: magnesium hydroxide, aluminium hydroxide and dimethicone. 100 ml of suspension contain 3.65 g of magnesium hydroxide, 3.25 g of aluminium hydroxide and 0.50 g of dimethicone.
• The other components are: methylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose, hydroxypropylcellulose, citric acid, sodium saccharin, sorbitol (E420) liquid non-crystallising, lemon flavour (containing ethanol), Swiss cream flavour (containing ethanol, invert sugar, sucrose, sulphur dioxide (E220)), purified water.

Description of the appearance of MAALOX PLUS and contents of the pack
MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension is supplied in a 200 ml bottle of oral suspension.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milan - Italy
Manufacturer
Opella Healthcare Italy S.r.l.
Viale Europa, 11 - 21040 Origgio (VA) - Italy

Patient Information Leaflet

MAALOX PLUS 200 mg + 200 mg + 25 mg Chewable Tablets

Magnesium hydroxide + Hydrated aluminium oxide + Dimethicone
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you notice no improvement or if your symptoms worsen.

Contents of this leaflet:

1. What MAALOX PLUS is and what it is used for
2. What you need to know before taking MAALOX PLUS
3. How to take MAALOX PLUS
4. Possible side effects
5. How to store MAALOX PLUS
6. Contents of the pack and other information

1. What MAALOX PLUS is and what it is used for

This medicine contains the following active substances: magnesium hydroxide and aluminium hydroxide, which reduce the amount of acid in the stomach, and dimethicone, which absorbs intestinal gases.
Maalox Plus is a medicine used for the treatment of:

• symptoms due to excess stomach acid (hyperacidity), such as burning and pain, including cases of inflammation of the oesophagus (oesophagitis), and hyperacidity associated with digestive disturbances (dyspepsia);
• symptoms due to excess air in the stomach and intestine when associated with hyperacidity.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MAALOX PLUS

Do not use MAALOX PLUS

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction include skin rash, swelling of the lips, tongue, face and throat, breathing difficulties;
• if you suffer from porphyria (a rare inherited blood metabolism disorder);
• if you have severe kidney problems;
• if you are severely debilitated (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 mild kidney problems, or if you are elderly, as this medicine may worsen intestinal problems;
• if you are on a low-phosphorus diet, if you have low phosphate levels in the blood (hypophosphatemia), or if you require long-term treatment. This medicine reduces phosphate levels in the blood and may cause bone problems.

If you are taking this medicine at a high dosage or are prone to diarrhea, be careful
because this medicine may cause diarrhea (see section 4 “Possible side effects”).
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if
renal impairment or dehydration is present.
Other medicines and MAALOX PLUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
of the following listed medicines, as some medicines may be affected by magnesium
hydroxide or may affect its action.
In particular:

• heart medications such as digoxin, quinidine, metoprolol, atenolol and propranolol
• medications used to treat anemia such as iron salts
• medications used to treat ulcer and stomach acidity such as ranitidine or cimetidine (H--antagonists)
• medications used to treat malaria such as chloroquine
• medications used to treat certain bone diseases such as bisphosphonates
• medications used to treat certain allergic, inflammatory or abnormal immune reactions such as glucocorticoids
• medications used to treat kidney diseases such as citrates
• medications used to treat tuberculosis such as ethambutol, isoniazid
• medications used to treat infections such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir potassium, and antiviral combination treatments containing tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine);
• medications used to treat mental disorders (psychosis) such as phenothiazines, neuroleptics
• medications used to treat high potassium levels in the body such as polystyrene sulfonate
• medications used to treat pain such as diflunisal, indomethacin
• medications used for dental care such as sodium fluoride
• medications used to treat underactive thyroid such as levothyroxine
• medications used to treat joint pain and abnormal chemical reactions in the body such as penicillamine
• medications used to lower cholesterol such as rosuvastatin
• medications used to treat cancers such as nilotinib, dasatinib monohydrate
• medications used to treat blood disorders such as eltrombopag olamine
• medications used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat

In addition, inform your doctor or pharmacist if you are taking:

• medicines containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
• medicines containing aluminium hydroxide and citrates, due to the risk of increased aluminium levels in the blood;
• quinidine (a heart medicine), due to the risk of increased quinidine levels;
• salicylates.

Inform your doctor or pharmacist if you are taking aspirin or medicines containing acetylsalicylic acid or
antibiotics containing tetracyclines or tetracycline salts.
As a precaution, wait at least 2 hours between taking MAALOX PLUS and any oral medicine (4 hours in the case of fluoroquinolone antibiotics).
Pregnancy and breastfeeding
This medicine should only be taken if considered necessary by your doctor and under medical supervision.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MAALOX PLUS contains sorbitol, sucrose, glucose and sodium:

• 45 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, consult your doctor before taking this medicine.
• sucrose and about 500 mg of glucose, which should be considered in patients with diabetes mellitus, especially if more than 10 tablets are taken per day. If your doctor has diagnosed you with intolerance to certain sugars, contact him or her before taking this medicine.
• less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take MAALOX PLUS

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses unless otherwise advised by your doctor.
The recommended dose for adults and adolescents over 18 years of age is: 2–4 tablets four times daily, to be taken 20–60 minutes after meals and before bedtime.
Instructions for use: Chew or suck the tablets thoroughly. After taking this medicine, you may drink water or milk.

If you take more MAALOX PLUS than you should
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take high doses of this medicine, you may experience:

• diarrhea (see section 2 “Warnings and precautions”), abdominal pain, and vomiting;
• worsening of intestinal problems if you suffer from constipation, have mild kidney problems, or are elderly.

If you forget to take MAALOX PLUS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking MAALOX PLUS and contact your doctor or go immediately to the nearest hospital if you
experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rashes, itching, urticaria, or dizziness, as these may be symptoms of serious allergic reactions (angioedema and anaphylactic reaction).

The following side effects may occur with this medicine:
Uncommon (may affect up to 1 in 100 people):

• Constipation (stipsis) or diarrhoea (see section 2 “Warnings and precautions”). Very rare (may affect up to 1 in 10,000 people):
• Hypermagnesaemia, including cases observed after prolonged administration in patients with renal impairment. Frequency not known (cannot be estimated from the available data):
• Excessive immune response to foreign substances (hypersensitivity reaction, including severe cases), skin rash with or without itching, characterised by the appearance of swellings on the skin (urticaria), pruritus;
• Changes in blood levels of aluminium and phosphate, which may cause bone problems (see section 2 “Warnings and precautions”);
• Abdominal pain.

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

5. How to store MAALOX PLUS

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MAALOX PLUS contains

• The active substances are: magnesium hydroxide, aluminium oxide, hydrate and dimethicone. Each tablet contains 200 mg of magnesium hydroxide, 200 mg of aluminium oxide, hydrate and 25 mg of dimethicone.
• The other components are: maize starch, citric acid, pregelatinized starch, glucose, mannitol, sucrose, sorbitol (E420), non-crystallizable liquid sorbitol, talc, magnesium stearate, sodium saccharin, lemon flavor, Swiss cream flavor, E 172.

Description of the appearance of MAALOX PLUS and pack sizes
MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets is supplied in a box containing 12,
30, 50 or 60 chewable tablets.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B - 20158 Milano - Italy
Manufacturer
Sanofi S.r.l.
S.S.17 Km 22
IT-67019 Scoppito (AQ)