Maalox Plus Chewable Tablets 200mg/200mg/25mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIMETICONE, ALUMINIUM OXIDE, HYDRATED, MAGNESIUM HYDROXIDE

Available from:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

ATC code:

A02AF02

INN (International Name):

DIMETICONE 25 mg ALUMINIUM OXIDE, HYDRATED 200 mg MAGNESIUM HYDROXIDE 200 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

DIMETICONE 25 mg ALUMINIUM OXIDE, HYDRATED 200 mg MAGNESIUM HYDROXIDE 200 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2005-11-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAALOX® PLUS 200MG/200MG/25MG CHEWABLE TABLETS
hydrated aluminium oxide 200mg magnesium hydroxide 200mg dimeticone
(as simeticone) 25mg
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 Plus 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 PLUS CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS CHEWABLE TABLETS
3.
HOW TO TAKE MAALOX PLUS CHEWABLE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAALOX PLUS CHEWABLE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MAALOX PLUS CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
Maalox Plus Chewable Tablets contain three different medicines:
•
The first two medicines are called hydrated aluminium oxide, and
magnesium hydroxide. They
belong to a group of medicines called antacids.
•
The other medicine is called dimeticone (as simeticone). It belongs to
a group of medicines called
antifoaming agents.
Maalox Plus Chewable Tablets are used for:
•
The relief of indigestion (dyspepsia)
•
Heartburn
•
Wind (flatulence)
Maalox Plus Chewable Tablets work by lowering the amount of acid in
your stomach. The anti- foaming
agent in Maalox Plus Chewable Tablets helps to remove gas from your
stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS CHEWABLE TABLETS
DO NOT TAKE MAALOX PLUS CHEWABLE TABLETS IF:
•
You are allergic (hypersensitive) to hydrated aluminium oxide,
magnesium hydroxide, dimeticone
(as simeticone) or any of the other ingredients in Maalox Plus
Chewable Tab

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Maalox Plus Chewable Tablets 200mg/200mg/25mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
200 mg of Magnesium Hydroxide (as magnesium hydroxide paste)
200mg of Hydrated Aluminium Oxide
25mg of Dimeticone (as simeticone)
Excipients with known effect:
Sorbitol (E420) 45 mg
Glucose 500.5 mg
Sucrose 75 mg
Ethanol 0.00004 mg
Sulphur dioxide (E220) 13 ppm
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable Tablet.
Bi-layered, white/yellow tablets engraved with “Maalox” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of heartburn, indigestion, flatulence and dyspepsia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
Adults: One to two tablets four times a day (after meals and at
bedtime) or as required.
Children: Not recommended
4.3
CONTRA-INDICATIONS
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 risk of phosphate depletion.
Magnesium salt