Maalox 200mg/175mg per 5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Magnesium hydroxide; Aluminium hydroxide

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

A02AD; A02AD01

INN (International Name):

Magnesium hydroxide; Aluminium hydroxide

Dosage:

200mg/175 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Combinations and complexes of aluminium, calcium and magnesium compounds; ordinary salt combinations

Authorization status:

Marketed

Authorization date:

1982-04-19

Patient Information leaflet

MAALOX® 200MG/175MG PER 5MLORAL SUSPENSION
_magnesium hydroxide _
_aluminium hydroxide _
_ _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
This medicine is available without prescription. However, you still
need to use Maalox Oral
Suspension
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet.
• You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
IN THIS LEAFLET:
1. WHAT MAALOX ORAL SUSPENSION IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX ORAL SUSPENSION
3. HOW TO TAKE MAALOX ORAL SUSPENSION
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MAALOX ORAL SUSPENSION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MAALOX ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Maalox Oral Suspension contains two different medicines.
They are called magnesium hydroxide and aluminium hydroxide. They
belong to a group of
medicines
called antacids. Maalox Oral Suspension is used for:
• The relief of indigestion (dyspepsia)
Maalox Oral Suspension works by lowering the amount of acid in your
stomach.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX ORAL SUSPENSION
DO NOT TAKE MAALOX ORAL SUSPENSION IF:
• You are allergic (hypersensitive) to aluminium hydroxide or
magnesium hydroxide or any of the
other
ingredients in Maalox Oral Suspension (see Section 6: Contents of the
pack and other information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue
• You are feeling very weak and have no energy (debilitated)
• You have kidney problems
• You have low levels of phosphate (called “hypophosphataemia”).
This is shown up in blood tests
Do

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2021
CRN009V1S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maalox 200mg/175mg per 5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the suspension contains:
200 mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste),
175 mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel).
Excipients: Each 5ml also contains 71.45mg sorbitol (E420) and 1.59mg
sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White, viscous, aqueous oral suspension with a peppermint odour and
taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms of dyspepsia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
Adults: One to Two x 5 ml spoonfuls taken 20 minutes to one hour after
meals and at night as required or as directed by the
physician.
Children: Not recommended
4.3 CONTRAINDICATIONS
Use in severely debilitated patients or in those suffering from kidney
failure.
Use in patients who are hypersensitive to the active ingredients or to
any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aluminium hydroxide may cause constipation and magnesium salts
overdose may cause hypomotility of the bowel; large doses
of this product may trigger or aggravate intestinal obstruction and
ileus in patients at higher risk such as those with renal
impairment, infants less than 2 years, or the elderly..
Aluminium hydroxide is not well absorbed from the gastrointestinal
tract, and systemic effects are therefore rare in patients
with normal renal function. However, excessive doses or long-term use,
or even normal doses in patients with low-phosphorus
diets or in infants less than 2 years, may lead to phosphate depletion
(due to aluminium-phosphate binding) accompanied by
increased bone resorption and hypercalciuria with the risk of
osteomalacia. Medical advice is recommended in case of
long-term use or in patients at ri