Maalox oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium hydroxide; Aluminium hydroxide gel dried

Available from:

Sanofi

ATC code:

A02AD01

INN (International Name):

Magnesium hydroxide; Aluminium hydroxide gel dried

Dosage:

39mg/1ml ; 44mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010100; GTIN: 5012877344137

Patient Information leaflet

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.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you.
- 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet (see section 4).
- You must talk to a doctor if you do not feel better
or if you feel worse
WHAT IS IN THIS LEAFLET:
1. What Maalox Suspension is and what it is used for
2. What you need to know before you take Maalox
Suspension
3. How to take Maalox Suspension
4. Possible side effects
5. How to store Maalox Suspension
6. Contents of the pack and other information
Maalox
Suspension
contains
two
different
medicines. They are called aluminium hydroxide
and magnesium hydroxide. They belong to a
group of medicines called antacids.
Maalox Suspension is used for:
• Heartburn or when your stomach has too much
acid (indigestion)
• Inflammation of the stomach (gastritis), and
• When prescribed by a doctor it may also be
used for lowering the amount of acid in your
stomach or gut (intestine) when you have an
ulcer
Maalox
Suspension
works
by
lowering
the
amount of acid in your stomach.
DO NOT TAKE MAALOX SUSPENSION IF:
• You are allergic to aluminium hydroxide or
magnesium hydroxide or any of the other
ingredients in Maalox Suspension (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)
• You have kidney problems. Long term exposure
to high doses of Maalox Suspension can lead to
dementia.
• You have severe stomach pain
• Your bowel is partially or fully blocked
Do not take this medicine if any of the above apply
to you. If you a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Maalox 175mg/200mg Oral Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral solution contains:
Aluminium hydroxide 175mg
Magnesium hydroxide 200mg
Excipients with known effect:
This medicinal product contains 0.0068 mmol (0.157 mg) of sodium and
50 mg of
sorbitol per 5 ml dose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension
White oral suspension, homogenous after shaking
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn
and gastric
hyperacidity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
_Adults (including the elderly): _
10 – 20 ml taken 20 minutes to one hour after meals and at bedtime
or as required.
Maalox can be taken with water or milk if required.
Paediatric population:
Not recommended for children under 14 years.
METHOD OF ADMINISTRATION
For oral administration.
Shake before use.
4.3
CONTRAINDICATIONS
Maalox should not be used in patients who are severely debilitated or
suffering from
renal insufficiency, or if there is severe abdominal pain and/or the
possibility of bowel
obstruction.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
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.