Maalox Plus
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
30-06-2018
Summary of Product characteristics
(SPC)
30-06-2018
Active ingredient:
DIMETICONE; ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE
Available from:
Sanofi Malta Limited
ATC code:
A02AF02
INN (International Name):
DIMETICONE; ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE
Pharmaceutical form:
CHEWABLE TABLET
Composition:
DIMETICONE 25 mg; ALUMINIUM HYDROXIDE 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
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE 0845 372 7101 FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to use Maalox Plus 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Maalox Plus Tablets are and what they are
used for
2. What you need to know before you take Maalox
Plus Tablets
3. How to take Maalox Plus Tablets
4. Possible side effects
5. How to store Maalox Plus Tablets
6. Contents of the pack and other information
1. WHAT MAALOX PLUS TABLETS ARE AND WHAT THEY ARE USED FOR
Maalox Plus Tablets contain three different medicines:
-
The first two medicines are called dried aluminium
hydroxide gel and magnesium hydroxide. They
belong to a group of medicines called antacids.
-
The other medicine is called simeticone. It belongs
to a group of medicines called anti-foaming agents.
Maalox Plus Tablets is used for:
-
The relief of indigestion (dyspepsia)
-
Heartburn
-
Wind (flatulence)
Maalox Plus Tablets work by lowering the amount
of acid in your stomach. The anti-foaming agent in
Maalox Plus Tablets helps to remove gas from your
stomach.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS TABLETS DO NOT TAKE MAALOX PLUS TABLETS IF:
•
You are allergic (hypersensitive) to dried aluminium
hydroxide gel, magnesium hydroxide, simeticone
or any of the other ingredients in Maalox Plus
Tablets (listed in section 6)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• You are feeling very weak and have no energy
(debilitated)
Read the complete document
Summary of Product characteristics
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Maalox Plus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
magnesium hydroxide
200 mg
aluminium hydroxide (dried)
200 mg
simethicone
25 mg
3.
PHARMACEUTICAL FORM
Bi-layered, white/pale yellow circular, bevel-edged, lemon flavoured
chewable
tablets, with
the monogram “Rorer” embossed on one face and “Maalox” on the
other.
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
CONTRAINDICATIONS
Use in severely debilitated patients or in those suffering from kidney
failure.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose
malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Page 2 of 5
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-
phosphorous 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.
In patients with renal impairment, plasma levels of both aluminium and
magnesium
increa
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