MAALOX PLUS SUSPENSION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Magnesium Hydroxide; POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; ALUMINIUM HYDROXIDE

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

Magnesium Hydroxide; POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; ALUMINIUM HYDROXIDE

Units in package:

250 ml

Manufactured by:

Opella Healthcare Italy S.r.l.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
_ _
MAALOX
® PLUS SUSPENSION
_ _
Magnesium Hydroxide/Aluminium Hydroxide/Simethicone (200mg/225mg/25mg
per 5ml)
_ _
WHAT IS IN THIS LEAFLET
1. What Maalox
®
Plus is used for
2. How Maalox
®
Plus works
3. Before you use Maalox
®
Plus
4. How to use Maalox
®
Plus
5. While you are using it
6. Side effects
7. Storage and Disposal of Maalox
®
Plus
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT MAALOX
® PLUS IS USED FOR
To provide symptomatic relief of
hyperacidity plus alleviation of gas
symptoms associated with stomach or
intestinal ulcer, gastric inflammation,
heartburn, or gas pain after operation.
To provide symptomatic relief of
abdominal bloating.
HOW MAALOX
® PLUS WORKS
Maalox
®
Plus is a balanced mixture of
two antacids, aluminium hydroxide is a
slow antacid and magnesium hydroxide
is a quick acting one. Simethicone is a
gastric defoaming agent, used to
combine lots of small bubbles into
larger bubbles, which can be expelled
more easily.
BEFORE YOU USE MAALOX
® PLUS
-
_When you must not use it _
-
Hypersensitivity to active substance
or any of the ingredients; signs of an
allergic reaction are skin rash,
swelling of the lips, tongue, face and
throat, and breathing problems
-
Porphyria
-
Serious kidney problems
-
Children
-
Cachexia
-
_Before you start to use it_
Maalox
®
Plus Suspension is not
recommended for children.
Inform your doctor if you have kidney
disease.
_Pregnancy _
Maalox
®
Plus should only be used
when absolutely necessary. Consult
your doctor to make an evaluation of
the expected benefit for the mother in
relation to the risk for the fetus or baby.
_Lactation _
Maalox
®
Plus is considered compatible
with breast-feeding.
-
_Taking other medicines_
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including any that you buy
without a prescription from a
pharmacy, supermarket or health food
shop.
Some medicines may be affected by
magnesium hydro

Summary of Product characteristics

Maalox
®
Plus Suspension
Composition:
To provide symptomatic relief of hyperacidity plus alleviation of gas
symptoms, each teaspoonful (5ml) contains:
Pharmacological properties:
Pharmacodynamic properties
Pharmacotherapeutic group: Antacids with antiflatulents; ATC code:
A02AF02.
Mechanism of action
The antacid effect takes place in the stomach where, at the
appropriate dose, magnesium hydroxide and aluminum
hydroxide neutralize gastric acid production.
The constipating effect of aluminum hydroxide is counteracted by the
laxative effect of magnesium hydroxide.
Simeticone has an antiflatulent effect.
Pharmacokinetic properties
Absorption
When administered orally, aluminum hydroxide and magnesium hydroxide
react with the hydrochloric acid
produced in the stomach to form salts, which are only partly absorbed.
Excretion
Absorbed salts are excreted mainly in the urine.
Indications:
As an antacid for symptomatic relief of hyperacidity associated with
the diagnosis of peptic ulcer, gastritis, peptic
esophagitis, gastric hyperacidity, heartburn, or hiatal hernia. As an
antiflatulent to alleviate the symptoms of gas,
including postoperative gas pain.
Directions for Use:
2-4 teaspoonfuls, 4 times a day, taken 20 minutes to 1-hour after meal
and at bedtime, or as directed by a physician.
Maalox
®
Plus are not recommended for children.
Route of administration: Oral
Adverse Effects:
The frequency of the undesirable effects listed below is defined using
the following conventions:
Common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare
(≥1/10 000 to <1/1 000); very rare (<1/10 000);
not known (cannot be estimated from the available data).
Immune system disorders:
Frequency not known: angioedema, anaphylactic reactions,
hypersensitivity reactions, urticaria, pruritus.
Gastrointestinal disorders:
Uncommon: diarrhea or constipation.
_Frequency not known:_ abdominal pain.
Metabolism and nutrition disorders:
Very rare: hypermagnesemia, which has been observed with prolonged use
in patients with kidney impairment.
_Fre