Maalox

Package Leaflet: Information for the Patient

Maalox (400 mg + 400 mg), Tablets

Aluminum Hydroxide + Magnesium Hydroxide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

• 1. What is Maalox and what is it used for
• 2. Important information 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 is Maalox and what is it used for

Maalox is a combination medicine with local anti-acid action, which neutralizes excess stomach acid, protects and soothes the stomach and duodenum mucosa. It does not cause excessive neutralization of stomach contents and secondary stimulation of acid secretion.

Maalox is indicated for the symptomatic treatment of upper gastrointestinal disorders associated with hyperacidity:

• gastritis,
• gastroesophageal reflux disease (GERD),
• heartburn and acid regurgitation due to hyperacidity, and as an adjunct in the treatment of:
• duodenal ulcer disease,
• gastric ulcer disease.

2. Important information before taking Maalox

When not to take Maalox

• if you are allergic to aluminum hydroxide, magnesium hydroxide, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney impairment (see Warnings and precautions).

Warnings and precautions

Before taking Maalox, discuss it with your doctor or pharmacist.

Be cautious when taking Maalox:

• in patients with kidney impairment or those undergoing hemodialysis,
• in children under 6 years of age, consult a doctor before administration,
• in elderly patients,
• when taking the medicine for more than 2 weeks or in patients at risk of hypophosphatemia (low phosphate levels in the blood), consult a doctor.

Children

The use of magnesium hydroxide in young children may lead to hypermagnesemia, especially if they have kidney function disorders or dehydration.

Maalox and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, as Maalox may affect the action of some medicines or some medicines may affect the action of Maalox.

In particular:

• medicines used to treat heart conditions, such as digoxin, quinidine, metoprolol, atenolol, and propranolol
• medicines used to treat anemia, such as iron salts
• medicines used to treat stomach ulcers and reduce stomach acid, such as ranitidine or cimetidine (H2 receptor antagonists)
• medicines used to treat malaria, such as chloroquine
• medicines used to treat certain bone disorders, such as bisphosphonates
• medicines used to treat allergic reactions, inflammatory reactions, or abnormal immune reactions, such as glucocorticoids
• medicines used to treat kidney disorders, such as citrates
• medicines used to treat tuberculosis, such as ethambutol, isoniazid
• medicines used to treat infections, such as fluoroquinolones, lincosamides, ketoconazole, cyclines, cephalosporins (cefpodoxime and cefdinir), dolutegravir, elvitegravir, raltegravir (as potassium salt), and combination antiviral therapy including tenofovir alafenamide/emtricitabine/bictegravir (as sodium salt), rilpivirine.
• medicines used to treat mental illnesses (psychoses), 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 in dentistry, such as sodium fluoride
• medicines used to treat hypothyroidism, such as levothyroxine
• medicines used to treat joint pain and abnormal chemical reactions in the body, such as penicillamine
• medicines used to lower cholesterol levels, such as rosuvastatin
• medicines used to treat cancer, such as nilotinib, dasatinib (as monohydrate)
• medicines used to treat blood disorders, such as eltrombopag with olamine
• medicines used to treat high blood pressure in the lungs (pulmonary hypertension), such as riociguat.

As a precaution, plan to take any oral medicine and antacid at least 2 hours apart (for fluoroquinolones, more than 4 hours apart).

Concomitant use of Maalox with:

• quinidine (used to treat heart rhythm disorders and prevent them) may increase quinidine levels in the blood and lead to its overdose
• polystyrene sulfonate (used to treat hyperkalemia - high potassium levels in the blood) reduces the antacid effect of Maalox. Maalox reduces the effectiveness of polystyrene sulfonate. Concomitant use of these medicines increases the risk of metabolic alkalosis in patients with kidney impairment and intestinal obstruction.

Magnesium Hydroxide and other medicines

Magnesium hydroxide may affect the action of some medicines or some medicines may affect the effectiveness of magnesium hydroxide. Tell your doctor or pharmacist if you are taking:

• salicylates.

Aluminum hydroxide and citrates may increase aluminum levels in the blood, especially in patients with kidney impairment.

Maalox with food and drink

Take the medicine after a meal.

Pregnancy, breastfeeding, and fertility

This medicine may be used during pregnancy only on the advice of a doctor.

You can continue taking Maalox while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

No negative effect on the ability to drive and use machines has been observed.

Maalox contains sucrose

Maalox contains 245.44 mg of sucrose in each tablet.

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Maalox contains sorbitol

Maalox contains 125 mg of sorbitol in each tablet. Sorbitol is a source of fructose.

If you have been diagnosed with an intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, in which your body does not break down fructose, consult your doctor before taking the medicine or giving it to your child.

Maalox contains benzyl alcohol

Maalox contains 0.000072 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.

Administration of benzyl alcohol to newborns (up to 4 weeks of age) is associated with a risk of serious side effects, including breathing difficulties (so-called "gasping syndrome").

Do not give Maalox to newborns (up to 4 weeks of age) without a doctor's advice.

Do not give Maalox to young children (under 3 years of age) for more than a week without a doctor's or pharmacist's advice.

Women who are pregnant or breastfeeding should consult their doctor before taking the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Patient with liver or kidney disease should consult their doctor before taking the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Maalox contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Maalox

1-2 tablets should be sucked or chewed after a meal or during pain.

If you feel that the effect of Maalox is too strong or too weak, consult your doctor.

Overdose of Maalox

If you suspect an overdose of Maalox, consult your doctor.

Missed dose of Maalox

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose.

Do not take a double dose to make up for a missed tablet.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Maalox can cause side effects, although not everybody gets them.

Uncommon (less than 1 in 100 people): diarrhea or constipation.

Rare (less than 1 in 10,000 people): nausea, vomiting, pale stools.

• hypermagnesemia (elevated magnesium levels in the blood): including hypermagnesemia observed after prolonged use of magnesium hydroxide in patients with kidney function disorders.

Frequency not known (cannot be estimated from the available data):

• hypersensitivity reactions, such as itching, hives, angioedema, and anaphylactic reactions
• hyperaluminemia (elevated aluminum levels in the body)
• hypophosphatemia (low phosphate levels in the blood)
• abdominal pain.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Maalox

Store in a temperature below 25°C.

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Maalox contains

• -The active substances are: Aluminum Hydroxide 400 mg, Magnesium Hydroxide 400 mg
• The other excipients are: mannitol, sorbitol, sodium saccharin, peppermint flavor*, magnesium stearate, sucrose, sucrose containing 3% starch. *peppermint flavor contains benzyl alcohol.

What Maalox looks like and contents of the pack

1 pack contains 20 or 40 tablets in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Opella Healthcare Poland Sp. z o.o.

ul. Marcina Kasprzaka 6

01-211 Warsaw

Manufacturer

Sanofi S.r.l.

S.S. 17 km 22

67019 Scoppito (AQ)

Italy