Maalox Plus chewable tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aluminium hydroxide gel dried; Magnesium hydroxide; Simeticone

Available from:

Sanofi

ATC code:

A02AF01

INN (International Name):

Aluminium hydroxide gel dried; Magnesium hydroxide; Simeticone

Dosage:

200mg ; 200mg ; 25mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010100; GTIN: 5000283656838 5000283653189 5000283656258

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 (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)
�

Summary of Product characteristics

OBJECT 1
MAALOX PLUS TABLETS
Summary of Product Characteristics Updated 08-Jan-2018 | SANOFI
1. Name of the medicinal product
Maalox Plus Tablets
2. Qualitative and quantitative composition
Aluminium hydroxide gel (dried)
200mg
Magnesium hydroxide
200mg
Simeticone
25mg
3. Pharmaceutical form
Tablet
Bi-layered white and yellow tablets, 16mm in diameter, with 'Maalox'
embossed on one side.
4. Clinical particulars
4.1 Therapeutic indications
The symptomatic relief of:
1. Dyspepsia
2. Heartburn
3. Flatulence
4.2 Posology and method of administration
Route of administration: Oral
Adults (including elderly persons): 1-2 tablets well chewed, four
times a day, taken twenty minutes to one
hour after meals and at bedtime, or as required.
Children: Not recommended
4.3 Contraindications
Should not be used in patients who are severely debilitated or
suffering from kidney failure.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
Hypersensitivity to the active ingredients or to any of the
excipients.
4.4 Special warnings and precautions for use
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, 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, 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 increase. In