Maalox

Package leaflet: Information for the patient

Maalox (35 mg + 40 mg)/ml, oral suspension
Aluminium hydroxide + Magnesium hydroxide
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or
as directed by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If symptoms do not improve after 7 days or worsen, contact your doctor.

Contents of the leaflet

1. What Maalox is and what it is 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 Maalox is and what it is used for

Maalox is a combination medicine with local action that neutralizes excess hydrochloric acid in gastric juice, has an astringent effect and protects the mucous membranes of the stomach and duodenum.
It does not cause excessive neutralization of gastric contents or secondary stimulation of acid secretion.
Maalox is indicated for symptomatic treatment of disorders of the upper gastrointestinal tract associated with hyperacidity:

• gastric dyspepsia,
• gastroesophageal reflux in hiatal hernia,
• indigestion, heartburn due to hyperacidity, and as adjunctive treatment in:
• duodenal ulcer disease,
• gastric ulcer disease.

2. Important information before taking Maalox
When not to use Maalox

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

Warnings and precautions
Before starting Maalox, discuss it with your doctor or pharmacist.
Exercise special caution when using Maalox:

• in patients with renal impairment or undergoing hemodialysis,
• in children under 6 years of age – use only after consultation with a doctor,
• in elderly patients,
• when using the medicine for longer than 2 weeks or in patients at risk of hypophosphatemia (low serum inorganic phosphate levels), medical consultation is recommended.

Children
In young children, use of magnesium hydroxide may lead to hypermagnesemia, especially if renal dysfunction or dehydration is present.

Maalox and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, because Maalox may affect the action of certain medicines or certain medicines may affect the action of Maalox.
In particular:

• Medicines used in heart treatment, such as digoxin, quinidine, metoprolol, atenolol and propranolol
• Medicines used in the treatment of anaemia, such as iron salts
• Medicines used in the treatment of gastric ulcers and reducing gastric acidity, such as ranitidine or cimetidine (H2 receptor antagonists)
• Medicines used in the treatment of malaria, such as chloroquine
• Medicines used in the treatment of certain bone disorders, such as bisphosphonates
• Medicines used in the treatment of certain allergic reactions, inflammatory conditions or abnormal immune responses, such as glucocorticosteroids
• Medicines used in the treatment of kidney disorders, such as citrates
• Medicines used in the treatment of tuberculosis, such as ethambutol, isoniazid
• Medicines used in the treatment of infections, such as fluoroquinolones, lincosamides, ketoconazole, tetracyclines, cephalosporins (cefpodoxime and cefdynir), dolutegravir, elvitegravir, raltegravir (potassium salt), and combined antiviral therapy including tenofovir alafenamide fumarate/emtricitabine/bictegravir (sodium salt), rilpivirine
• Medicines used in the treatment of mental disorders (psychoses), such as phenothiazines, neuroleptics
• Medicines used in the treatment of elevated potassium levels in the body, such as polystyrene sulfonate
• Medicines used in pain treatment, such as diflunisal, indomethacin
• Medicines used in dentistry, such as sodium fluoride
• Medicines used in the treatment of hypothyroidism, such as levothyroxine
• Medicines used in the treatment of joint pain and abnormal chemical reactions in the body, such as penicillamine
• Medicines used to lower cholesterol levels, such as rosuvastatin
• Medicines used in the treatment of cancer, such as nilotinib, dasatinib (monohydrate form)
• Medicines used in the treatment of blood disorders, such as eltrombopag olamine
• Medicines used in the treatment of high blood pressure in the lungs (pulmonary hypertension), such as riociguat

As a precaution, oral administration of any other medicine and antacid should be separated by at least 2 hours (in the case of fluoroquinolones – more than 4 hours).
Concomitant use of Maalox with:

• quinidine (used in the treatment of cardiac arrhythmias and their prevention) may increase quinidine plasma concentration and lead to overdose
• polystyrene sulfonate (used in the treatment of hyperkalemia – high potassium levels in blood) reduces the acid-neutralizing effect of Maalox. Maalox reduces the effectiveness of polystyrene sulfonate. Concurrent 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 certain medicines or certain medicines may affect the efficacy of magnesium hydroxide. Inform your doctor or pharmacist if you are taking:

• salicylates.

Aluminium hydroxide and citrates may increase serum aluminium levels, especially in patients with renal impairment.

Maalox with food and drink
Take the medicine after meals.

Pregnancy, breastfeeding and fertility
This medicine may be used during pregnancy only on the advice of a doctor.
Maalox may be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Driving and operating machinery
No negative effect of the medicine on the ability to drive or operate machinery has been observed.

Maalox contains sorbitol
The medicine contains 102.888 mg of sorbitol in 10 ml of suspension.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or hereditary fructose intolerance – a rare genetic disorder in which the patient's body cannot break down fructose – the patient should consult a doctor before taking the medicine or giving it to a child.

Maalox contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Maalox

Usual dose:
1 tablespoon (10 ml) approximately 90 minutes after a meal or during pain.
Maximum dose: 140 ml/day.
Shake before use.
Taking more Maalox than recommended
If an overdose is suspected, seek medical advice.
Missing a dose of Maalox
If a dose is missed, take it as soon as possible, except when 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 about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Uncommon (less frequent than in 1 out of 100 people): diarrhoea or constipation.
Very rare (less frequent than in 1 out of 10,000 people): nausea, vomiting, or pale-coloured stools may occur.

• Hypermagnesaemia (increased magnesium concentration in blood serum): including hypermagnesaemia observed after long-term use of magnesium hydroxide in patients with impaired renal function.

Frequency unknown (frequency cannot be estimated from the available data):

• Hypersensitivity reactions such as itching, urticaria, angioedema, and anaphylactic reactions
• Hyperaluminaemia (increased aluminium content in body tissues)
• Hypophosphataemia (decreased concentration of inorganic phosphates in blood serum)
• Abdominal pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Maalox

Store below 25 °C and use within 6 months after first opening.
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 must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Maalox contains

• The active substances in this medicine are: Aluminium hydroxide, Magnesium hydroxide

Active substances: bottle bottle bottle
60 ml 250 ml 355 ml
Aluminium hydroxide 2.1 g 8.75 g 12.425 g
Magnesium hydroxide 2.4 g 10 g 14.2 g

• Other ingredients are: diluted hydrochloric acid, anhydrous citric acid, peppermint oil, mannitol, domiphen bromide, sodium saccharin, sorbitol 70%, hydrogen peroxide 30%, purified water. 100 ml of suspension contains 3.5 g aluminium hydroxide and 4.0 g magnesium hydroxide.

What Maalox looks like and contents of the pack
PET bottle closed with a PP screw cap with a polyethylene foam seal,
containing 60 ml, 250 ml or 355 ml of suspension, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Poland

Manufacturers
Opella Healthcare Italy S.r.l.
Viale Europa 11
21 040 Origgio (VA)
Italy

A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne
Germany

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Poland
tel.: +48 22 280 00 00