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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIMETICONE, ALUMINIUM OXIDE, HYDRATED, MAGNESIUM HYDROXIDE

Available from:

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

ATC code:

A02AF02

INN (International Name):

DIMETICONE, ALUMINIUM OXIDE, HYDRATED, MAGNESIUM HYDROXIDE

Pharmaceutical form:

CHEWABLE TABLET

Composition:

DIMETICONE 25 milligram(s) ; ALUMINIUM OXIDE, HYDRATED 200 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

_PACK. ITEM:_
ARKHÉ S.N.C.
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1 - Prima realizzazione
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03-10-2019
IST MAALOX PLUS 200MG
IE I01
ISTRUZIONI
IE: IRELAND
89034102
89032408
62C0005
1110111100
167 X 304,8MM
SINGOLA
3
-
-
740322
9 PT SU 10 PT
2 - Modifica testo reg.
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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
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
help

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 salts may cause central nervous depress