Maalox 400mg/400mg Chewable Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-05-2021
Summary of Product characteristics
(SPC)
16-03-2021
Active ingredient:
Magnesium hydroxide; Aluminium oxide, hydrated
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
A02AD; A02AD01
INN (International Name):
Magnesium hydroxide; Aluminium oxide, hydrated
Dosage:
400mg/400 milligram(s)
Pharmaceutical form:
Chewable tablet
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
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAALOX®
400MG/400MG CHEWABLE TABLETS
ALUMINIUM OXIDE, HYDRATED 400MG MAGNESIUM HYDROXIDE 400MG
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE 01 403 5600 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 Chewable Tablets
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
You must contact a doctor if your symptoms worsen or do not improve
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist
IN THIS LEAFLET:
1.
WHAT MAALOX CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX CHEWABLE TABLETS
3.
HOW TO TAKE MAALOX CHEWABLE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAALOX CHEWABLE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MAALOX CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
Maalox Chewable Tablets contain two different Medicines called
aluminium oxide, hydrated and magnesium
hydroxide. They belong to a group of medicines called antacids.
Maalox Chewable Tablets are used for:
.
The relief of indigestion (dyspepsia)
Maalox Chewable Tablets work by lowering the amount of acid in your
stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX CHEWABLE TABLETS
DO NOT TAKE MAALOX CHEWABLE TABLETS IF:
.
You are allergic (hypersensitive) to aluminium oxide, hydrated,
magnesium hydroxide or any of the
other ingredients in Maalox Chewable Tablets (see Section 6: Further
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 not take th
Read the complete document
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 400mg/400mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
400 mg of Aluminium oxide, hydrated
400 mg of Magnesium Hydroxide.
Excipients: Each tablet contains 192mg confectioners sugar (containing
no less than 97% sucrose), 125mg sorbitol (E420) and
59.2 mg sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet
Flat, circular, bevel-edged white chewable tablet of diameter 1.4 cm
with 'Mx' engraved on both sides and having an odour of
peppermint.
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: 1-2 tablets chewed 4 times daily, taken 20 minutes to 1 hour
after meals and at bedtime, or as directed by the
physician. A maximum of 8 tablets in a 24 hour period should not be
exceeded, nor should the maximum dose continue for
more than 2 weeks except under the direction of 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.
Health Products Regulatory Authority
15 March 2021
CRN009V1S
Page 2 of 5
However, excessive doses or long-term use, or even normal doses in
patients with low-p
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