Maalox

Package Leaflet: Information for the Patient

Maalox (460 mg + 400 mg)/ 4.3 ml, Oral Suspension

Aluminum hydroxide + Magnesium hydroxide

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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 1. What is Maalox and what is it used for
• 2. Important information before using Maalox
• 3. How to use Maalox
• 4. Possible side effects
• 5. How to store Maalox
• 6. Package contents and other information

1. What is Maalox and what is it used for

Maalox is a combination medicine with a local anti-acid effect, neutralizing excess hydrochloric acid in gastric juice, and protecting the gastric and duodenal mucosa. It does not cause excessive neutralization of gastric 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
• heartburn and dyspepsia due to hyperacidity, and as an adjunct in the treatment of:
• duodenal ulcer
• gastric ulcer.

2. Important information before using Maalox

When not to use Maalox

• if the patient is allergic to aluminum hydroxide, magnesium hydroxide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe renal impairment (see Warnings and precautions).

Warnings and precautions

Before taking Maalox, the patient should discuss it with a doctor or pharmacist. Particular caution should be exercised when using Maalox:

• if the patient has renal impairment or is undergoing hemodialysis,
• in children under 6 years of age, the medicine should be administered after consulting a doctor,
• in elderly patients,
• when using the medicine for more than 2 weeks or in patients at risk of hypophosphatemia (low phosphate levels in the blood), a doctor's consultation is recommended.

Children
Using magnesium hydroxide in young children may lead to hypermagnesemia, especially if they have renal impairment or dehydration.

Maalox and other medicines

The patient should inform the doctor or pharmacist about all medicines being taken or planned to be taken, 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 gastric 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 disorders (psychosis), such as phenothiazines, neuroleptics
• medicines used to treat high potassium levels in the blood, 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, the patient should plan to take any oral medicine and antacid at an interval of at least 2 hours (for fluoroquinolones, more than 4 hours).
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 anti-acid effect of Maalox. Maalox reduces the effectiveness of polystyrene sulfonate. Concomitant use of these medicines increases the risk of metabolic alkalosis in patients with renal 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. The patient should inform the doctor or pharmacist if they are taking:

• salicylates.

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

Maalox with food and drink

The medicine should be taken after a meal.

Pregnancy, breastfeeding, and fertility

This medicine may be used during pregnancy only on the advice of a doctor. The patient can continue to take Maalox while breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.

Driving and using machines

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

Maalox contains sucrose and sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
The medicine contains 140 mg of sorbitol in each sachet.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine or giving it to their child.

3. How to use Maalox

The usual dose is 1-2 sachets when pain occurs, not exceeding 6 doses (12 sachets) per day.
Shake before use.

Use in children

Before using Maalox in children under 6 years of age, a doctor should be consulted.

Overdose of Maalox

In case of suspected overdose, the patient should consult a doctor.

Missed dose of Maalox

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult a 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.
Very rare (less than 1 in 10,000 people): nausea, vomiting, pale stools.

• hypermagnesemia (elevated magnesium levels in the blood): including hypermagnesemia observed after long-term use of magnesium hydroxide in patients with renal impairment.

Frequency not known (frequency 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 the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Maalox

There are no special precautions for storage.
The medicine should be kept out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging.
The medicine should not be used if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Maalox contains

• The active substances are: Aluminum hydroxide 460 mg, Magnesium hydroxide 400 mg
• The other excipients are: Sucrose solution 64%, liquid non-crystallizing sorbitol, xanthan gum, guar gum, natural lemon tree flavor, sodium chloride, hydrogen peroxide 30%.

What Maalox looks like and what the package contains

Sachets containing 4.3 ml of suspension, packaged in 20 sachets per box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Manufacturer
Opella Healthcare Italy S.r.l.
Viale Europa 11
21 040 Origgio (VA)
Italy
A.Nattermann &Cie.GmbH
Nattermannallee 1

• 50829 - Cologne, Germany

For more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 280 00 00
Date of last revision of the package leaflet:August 2022