Maalox Plus 200mg/175mg/25mg Oral Suspension

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

SIMETHICONE, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE

Disponibil de la:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

Codul ATC:

A02AF02

INN (nume internaţional):

MAGNESIUM HYDROXIDE 200 mg SIMETHICONE 25 mg ALUMINIUM HYDROXIDE 175 mg

Forma farmaceutică:

ORAL SUSPENSION

Compoziție:

MAGNESIUM HYDROXIDE 200 mg SIMETHICONE 25 mg ALUMINIUM HYDROXIDE 175 mg

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

DRUGS FOR ACID RELATED DISORDERS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2005-11-04

Prospect

MAALOX® PLUS 200MG/175MG/25MG PER 5ML
ORAL SUSPENSION
_magnesium hydroxide _
_aluminium hydroxide _
_simethicone _
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 Oral
Suspension 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
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
•
You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
IN THIS LEAFLET:
1.
What Maalox Plus Oral Suspension is and what it is used for
2.
What you need to know before you take Maalox Plus Oral Suspension
3.
How to take Maalox Plus Oral Suspension
4.
Possible side effects
5.
How to store Maalox Plus Oral Suspension
6.
Contents of the pack and other information
1.
WHAT MAALOX PLUS ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Maalox Plus Oral Suspension contains three different medicines:
•
The first two medicines are called magnesium hydroxide and aluminium
hydroxide. They belong to
a group of medicines called antacids.
•
The other medicines is called simeticone. It belongs to a group of
medicines called anti-foaming
agents.
Maalox Plus Oral Suspension is used for:
•
The relief of indigestion (dyspepsia)
•
Heartburn
•
Wind (flatulence)
Maalox Plus Oral Suspension works by lowering the amount of acid in
your stomach. The anti-
foaming agents in Maalox Plus Oral Suspension helps to remove gas from
your stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS ORAL SUSPENSION
DO NOT TAKE MAALOX PLUS ORAL SUSPENSION IF:
•
You are allergic (hypersensitive) to magnesium hydroxide, aluminium
hydroxide, simeticone or any
of the other ingredients in Maalox Plus Oral Suspension (see Section
6: Contents of the pack and
other information). Signs of an allergic reaction in

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Maalox Plus 200mg/175mg/25mg Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of the suspension contains:
200mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste).
175mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel)
25mg of Simeticone
Excipients: Each 5ml also contains 224.85mg sorbitol (E420), 1.66mg
sodium, 3.667mg ethanol, 3ppm
sulphur dioxide (E220).
For a 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 dysepsia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
_Adults:_
One to Two x 5ml spoonfuls 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
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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.
Ma