Maalox

Package Leaflet: Information for the Patient

Maalox (35 mg + 40 mg)/ml, Oral Suspension

Aluminum Hydroxide + Magnesium Hydroxide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, including those not listed in the Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.
• If After 7 Days there is no Improvement or You Feel Worse, Consult a Doctor.

Table of Contents of the Package 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 Package and Other Information

1. What is Maalox and What is it Used for

Maalox is a Combination Medication with Local Antacid Action, which Neutralizes Excess Hydrochloric Acid in Gastric Juice, and has a Protective and Astringent Effect on 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 (GERD),
• Heartburn and Indigestion due to Hyperacidity, and as an Adjuvant 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 Medication (listed in Section 6),
• If You have Severe Kidney Failure (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 Failure or those Undergoing Hemodialysis,
• In Children Under 6 Years of Age, the Medication Should be Administered After Consulting a Doctor,
• In Elderly Patients,
• When Taking the Medication for More than 2 Weeks or in Patients with a 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 Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking, or Have Recently Taken, as well as any Medications You Plan to Take, as Maalox may Interact with the Action of Certain Medications or Certain Medications may Interact with the Action of Maalox.

In Particular:

• Medications Used to Treat Heart Conditions, such as Digoxin, Quinidine, Metoprolol, Atenolol, and Propranolol
• Medications Used to Treat Anemia, such as Iron Salts
• Medications Used to Treat Gastric Ulcers and Reduce Gastric Acid, such as Ranitidine or Cimetidine (H2 Receptor Antagonists)
• Medications Used to Treat Malaria, such as Chloroquine
• Medications Used to Treat Certain Bone Disorders, such as Bisphosphonates
• Medications Used to Treat Allergic Reactions, Inflammatory Reactions, or Abnormal Immune Reactions, such as Glucocorticosteroids
• Medications Used to Treat Kidney Disorders, such as Citrates
• Medications Used to Treat Tuberculosis, such as Ethambutol, Isoniazid
• Medications 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 Fumaric Acid Tenofovir Alafenamide/Emtricitabine/Bictegravir (as Sodium Salt), Rilpivirine.
• Medications Used to Treat Mental Illnesses (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 in Dentistry, such as Sodium Fluoride
• Medications Used to Treat Hypothyroidism, such as Levothyroxine
• Medications Used to Treat Joint Pain and Abnormal Chemical Reactions in the Body, such as Penicillamine
• Medications Used to Lower Cholesterol Levels, such as Rosuvastatin
• Medications Used to Treat Cancer, such as Nilotinib, Dasatinib (as Monohydrate)
• Medications Used to Treat Blood Disorders, such as Eltrombopag with Olamine
• Medications Used to Treat High Blood Pressure in the Lungs (Pulmonary Hypertension), such as Riociguat.

As a Precaution, it is Recommended to Plan the Intake of any Oral Medication and Antacid at an Interval of at Least 2 Hours (in the Case of Fluoroquinolones - More than 4 Hours).

Concomitant Use of Maalox with:

• Quinidine (Used to Treat Heart Rhythm Disorders and to Prevent them) may Increase Quinidine Levels in the Blood and Lead to its Overdose
• Polystyrene Sulfonate (Used to Treat Hyperkalemia - Excessive Potassium Levels in the Blood) Reduces the Antacid Effect of Maalox. Maalox Reduces the Effectiveness of Polystyrene Sulfonate. Concomitant Use of these Medications Increases the Risk of Metabolic Alkalosis in Patients with Kidney Failure and Intestinal Obstruction.

Magnesium Hydroxide and Other Medications

Magnesium Hydroxide may Interact with the Action of Certain Medications or Certain Medications may Interact with the Action 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 Failure.

Maalox with Food and Drink

Take the Medication After a Meal.

Pregnancy, Breastfeeding, and Fertility

This Medication may be Used During Pregnancy Only on the Advice of a Doctor.

Maalox can be Continued During Breastfeeding.

If You are Pregnant or Breastfeeding, Think You may be Pregnant, or are Planning to Have a Child, Consult a Doctor Before Taking this Medication.

Driving and Operating Machines

No Negative Effect of the Medication on the Ability to Drive and Operate Machines has been Observed.

Maalox Contains Sorbitol

The Medication Contains 102.888 mg of Sorbitol in 10 ml of Suspension.

Sorbitol is a Source of Fructose. If You have been Diagnosed with Intolerance to some Sugars or have been Diagnosed with Hereditary Fructose Intolerance, a Rare Genetic Disorder in which the Body does not Break Down Fructose, Consult a Doctor Before Taking the Medication or Giving it to a Child.

Maalox Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Dose, which means the Medication is Considered "Sodium-Free".

3. How to Take Maalox

Usual Dose:

1 Tablespoon (10 ml) Approximately 90 Minutes After a Meal or During Pain.

Maximum Dose: 140 ml/Day.

Shake Before Use.

Overdose of Maalox

In Case of Suspected Overdose, Consult a 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 Dose.

If You have any Further Questions on the Use of this Medication, Consult a Doctor.

4. Possible Side Effects

Like all Medications, 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, Light-Colored Stool.

• Hypermagnesemia (Increased 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 Available Data):

• Hypersensitivity Reactions, such as Itching, Hives, Angioedema, and Anaphylactic Reactions
• Hyperaluminemia (Increased Aluminum Content 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 Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +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 the Medication.

5. How to Store Maalox

Store at a Temperature Below 25°C, Use Within 6 Months of First Opening.

Keep the Medication Out of Sight and Reach of Children.

Do not Use this Medication After the Expiration Date Stated on the Packaging.

Medications should not be Disposed of via Wastewater or Household Waste.

Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Maalox Contains

• The Active Substances of the Medication are: Aluminum Hydroxide, Magnesium Hydroxide

Active Substances:

Bottle

60 ml

Bottle

355 ml

Aluminum Hydroxide

2.1 g

Bottle

250 ml

8.75 g

12.425 g

Magnesium Hydroxide

14.2 g

• The Other Excipients are: Hydrochloric Acid, Anhydrous Citric Acid, Peppermint Oil, Mannitol, Bromhexine Hydrochloride, Sodium Saccharin, Sorbitol 70%, Hydrogen Peroxide 30%, Purified Water. 100 ml of Suspension Contains 3.5 g of Aluminum Hydroxide and 4.0 g of Magnesium Hydroxide.

What Maalox Looks Like and What the Package Contains

A PET Bottle with a PP Cap and a Foam Polyethylene Seal, Containing 60 ml, 250 ml, or 355 ml of Suspension, in a Cardboard Box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Opella Healthcare Poland Sp. z o.o.

ul. Marcina Kasprzaka 6

01-211 Warsaw

Manufacturer

Opella Healthcare Italy S.r.l.

Viale Europa 11

21040 Origgio (VA)

Italy

A.Nattermann & Cie. GmbH

Nattermannallee 1

50829 Cologne

Germany