Maalox Plus

Country: Malta

Language: English

Source: Medicines Authority

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:

ORAL SUSPENSION

Composition:

DIMETICONE 25 mg; ALUMINIUM HYDROXIDE 114 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 [phone] 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 (see section 6: Contents of the pack and
other information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• You are feeling very w

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Maalox Plus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of the suspension contains:
225mg of Aluminium Hydroxide (as aluminium hydroxide gel),
200 mg of magnesium hydroxide (as magnesium hydroxide paste) and
25 mg simethicone.
Excipients: Each 5ml also contains 224.85mg sorbitol (E420), 1.66mg
sodium, 3.667mg
ethanol, 3ppm sulphur dioxide (E220).
For the 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 dyspepsia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
_RECOMMENDED DOSAGE _
_ _
_Adults:_ One to two x 5 ml spoonfuls four times a day (after meals
and at bedtime) or as
required.
_ _
4.3
CONTRAINDICATIONS
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 SPECIAL PRECAUTIONS FOR USE
Page 2 of 6
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