Maalox Plus oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium hydroxide; Aluminium hydroxide gel dried; Simeticone

Available from:

Sanofi Consumer Healthcare

INN (International Name):

Magnesium hydroxide; Aluminium hydroxide gel dried; Simeticone

Dosage:

39mg/1ml ; 44mg/1ml ; 5mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010100; GTIN: 5012877343635 5000283655855 5000283657682

Patient Information leaflet

4831221A
V05 - 01-12-2017
_4831220A_
Istruzione - Fronte
Maalox Plus - 250 ml
UK
Origgio
Origgio
Stesa 157 x 315 mm.
1302
1
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10 pt
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For Sanofi use only
Impianti di proprietà
Sanofi S.p.A.
Vietata la manomissione - Rendere dopo la stampa
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Technical Data
_PACKAGING TEAM_
Sanofi
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 careful-
ly to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more informa-
tion 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 is and what it is used for
2. What you need to know before you take Maa-
lox Plus
3. How to take Maalox Plus
4. Possible side effects
5. How to store Maalox Plus
6. Contents of the pack and other information
Maalox Plus contains 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 is used for:
• The relief of indigestion (dyspepsia)
• Heartburn
• Wind (flatulence)
Maalox Plus works by lowering the amount of
acid in your stomach. The anti-foaming agent
in Maalox Plus help

Summary of Product characteristics

OBJECT 1
MAALOX PLUS SUSPENSION
Summary of Product Characteristics Updated 08-Jan-2018 | SANOFI
1. Name of the medicinal product
Maalox Plus
2. Qualitative and quantitative composition
The active components of Maalox Plus are:
Dried Aluminium Hydroxide Gel
230mg/5ml
Magnesium Hydroxide
200mg/5ml
Simeticone
25mg/5ml
Also contains 320mg of sorbitol (E420), per 5ml.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Oral suspension
White suspension, homogenous after shaking, with the odour and taste
of lemon.
4. Clinical particulars
4.1 Therapeutic indications
The symptomatic relief of:
1. Dyspepsia.
2. Heartburn.
3. Flatulence.
4.2 Posology and method of administration
For oral administration:
Adults
5-10ml taken 20 minutes to 1 hour after meals and at bedtime or as
required.
Children
As an appropriate proportion of the adult dose.
Children under 5 years
Maximum of 5ml t.d.s.
Elderly
The normal adult dose is appropriate.
4.3 Contraindications
Should not be used in patients who are hypersensitive to any of the
active substances or excipients, are
severely debilitated or suffering from kidney failure, or
hypophosphataemia.
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-phosphorous 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