Maalox Plus 200mg/175mg/25mg Oral Suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SIMETHICONE, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

A02AF02

INN (International Name):

SIMETHICONE, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE

Pharmaceutical form:

ORAL SUSPENSION

Composition:

SIMETHICONE 25 milligram(s) ; ALUMINIUM HYDROXIDE 175 milligram(s) ; MAGNESIUM HYDROXIDE 200 milligram(s)

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/175MG/25MG PER 5ML
ORAL SUSPENSION
_magnesium hydroxide_
_aluminium hydroxide_
_simeticone_
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 Plus 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 Plus Oral Suspension is and what it is used for
2. What you need to know before you take Maalox Plus Oral Suspension
3. How to take Maalox Plus Oral Suspension
4. Possible side effects
5. How to store Maalox Plus Oral Suspension
6. Contents of the pack and other information
1. WHAT MAALOX PLUS ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Maalox Plus Oral Suspension contains three different medicines:
• The first two medicines are called magnesium hydroxide and
aluminium hydroxide. They belong to a
group of medicines called antacids.
• The other medicines is called simeticone. It belongs to a group of
mdicines called anti-foaming agents.
Maalox Plus Oral Suspension is used for:
• The relief of indigestion (dyspepsia)
• Heartburn
• Wind (flatulence)
Maalox Plus Oral Suspension works by lowering the amount of acid in
your stomach. The anti-foaming
agents in Maalox Plus Oral Suspension helps to remove gas from your
stomach.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS ORAL SUSPENSION
DO NOT TAKE MAALOX PLUS ORAL SUSPENSION IF:
• You are allergic (hypersensitive) to magnesium hydroxide,
aluminium hydroxide, simeticone or any of
the other ingredients in Maalox Plus Oral Sus

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Maalox Plus 200mg/175mg/25mg Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of the suspension contains:
200mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste).
175mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel)
25mg of Simeticone
Excipients: Each 5ml also contains
224.85mg sorbitol (E420), 1.66mg sodium, 3.667mg
ethanol, 3ppm sulphur dioxide (E220).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
A white lemon flavoured oral suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of heartburn, indigestion, flatulence and dysepsia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
_Adults: _
One to Two x 5ml spoonfuls 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 salts may cause central nervous depression in t