Maalox oral suspension in sachet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MAGNESIUM HYDROXIDE__; ALUMINIUM HYDROXIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

MAGNESIUM HYDROXIDE__; ALUMINIUM HYDROXIDE

Unit dalam pakej:

4.3ml x 20 Sachets; 4.3ml x 6 Sachets

Dikeluarkan oleh:

Sanofi S.r.I.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MAALOX
®
ORAL SUSPENSION IN SACHET
Magnesium Hydroxide / Aluminium Hydroxide (400mg / 460mg)
WHAT IS IN THIS LEAFLET
1.
What Maalox
®
is used for
2.
How Maalox
®
works
3.
Before you use Maalox
®
4.
How to use Maalox
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Maalox
®
8.
Product Description
9.
Manufacturer and
Product Registration
Holder
10.
Date of revision
WHAT MAALOX
® IS USED FOR
The name of your medicine is
Maalox
®
Oral Suspension in
sachets (called Maalox
®
throughout this leaflet).
Maalox
®
is used for:
• Stomach ulcer
• Inflammation or irritation of the
stomach
• Inflammation of esophagus
(esophagus is the tube that sends
food
from your throat down to your
stomach)
•
Gastric hyperacidity
(excess production of
stomach acid)
•
Heartburn
• Hiatal hernia (the stomach pushes
through the opening in the
diaphragm
where the esophagus and stomach
meet)
HOW MAALOX
®
WORKS
Maalox
®
contains two different
medicines. They are called
aluminium hydroxide and
magnesium hydroxide. They
belong to a group of medicines
called antacids. Maalox
®
works
by lowering the amount of acid in
your stomach.
BEFORE YOU USE MAALOX
®
_-When you must not use it _
Do not take Maalox
®
if:
•
You are allergic
(hypersensitive) to any
ingredients of Maalox
®
•
Signs of an allergic reaction
include: a rash, swallowing or
breathing problems, swelling of
your lips, face, throat or tongue
•
You have porphyria (a rare
hereditary blood metabolism
disorder)
•
You have severe kidney
problems, as the medicinal
products contains magnesium
•
Your body is severely
emaciated (cachexia)
Do not take this medicine if any of
the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Maalox
®
.
_-Before you start to use it _
Take special care with Maalox
®
and contact your doctor if
•
You have intestinal problems or
constipation, if you have non-
serious kidney problems or if you
are elderly, as this medici

Ciri produk

15 mm
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aluminium oxide .................................... 230.00 mg
As hydrated Aluminium oxide ................ 460.00 mg
Magnesium hydroxide ............................ 400.00 mg
for one sachet
PRODUCT DESCRIPTION
MAALOX
®
oral suspension is a white to faintly yellow, homogeneous suspension.
It is packed into sachets of 4.3 ml
equivalent to 6 g of suspension.
PHARMACEUTICAL FORM
Oral suspension in sachets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
As an antacid for symptomatic relief of hyperacidity associated with
the diagnosis of peptic ulcer, gastritis, peptic eso-
phagitis, gastric hyperacidity, heartburn, or hiatal hernia.
POSOLOGY AND METHOD OF ADMINISTRATION
FOR USE IN ADULTS ONLY (aged 15 years and over)
•
1 to 2 sachets per intake when heartburn or acid regurgitation occurs.
•
MAALOX
®
oral suspension may be taken 20 minutes to one hour after meals and at
bedtime or as required.
•
Maximum number of doses per day: 6.
•
No more than 12 sachets should be taken per day.
•
Knead the sachet carefully before opening.
Drink the suspension as is; do not dilute.
CONTRAINDICATIONS
•
Hypersensitivity to any of the ingredients of the product,
•
Severe renal insufficiency, as the medicinal product contains
magnesium.
•
Patients with porphyria.
•
Generally contraindicated in children.
•
Cachexia
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aluminium hydroxide may cause constipation and magnesium salts
overdose may cause hypomotility of the intestine;
large doses of this medicinal product may trigger or aggravate
intestinal obstruction and ileus in patients with higher
risk, such as those with renal impairment, primary constipation,
impaired intestinal motility, infants (0 to 24 months)
and 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