MAALOX SACHETS 460/400 Milligram Oral Suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-10-2016
Summary of Product characteristics
(SPC)
05-10-2016
Active ingredient:
ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
A02AB10
INN (International Name):
ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE
Dosage:
460/400 Milligram
Pharmaceutical form:
Oral Suspension
Administration route:
Oral use
Units in package:
20 sachets each containing 4.3ml of oral suspension
Prescription type:
Product not subject to medical prescription
Manufactured by:
A. Nattermann & Cie GmbH
Therapeutic area:
COMBINATIONS
Therapeutic indications:
For the relief of the symptoms of dyspepsia
Authorization status:
Authorised
Authorization date:
2015-07-10
Patient Information leaflet
Reference: 11923 1.3.1.3 - Leaflet Text - PIL - 460mg,
400mg - 2016-04-12 - 0000 - CCDSv3-5 - 540/110/6 1.5
MAALOX SACHETS 460MG/400MG ORAL SUSPENSION
_aluminium hydroxide_
_magnesium hydroxide _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
-
If any side effects gets serious, or if you notice any side effect
not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Maalox is and what it is used for
2. Before you take Maalox
3. How to take Maalox
4. Possible side effects
5. How to store Maalox
6. Further information
1.
WHAT MAALOX IS AND WHAT IT IS USED FOR
Maalox Sachets contains two different medicines. They are
called Aluminium
hydroxide and Magnesium hydroxide. They belong to a group of
medicines called
antacids. Maalox Sachets are used for:
• Heartburn or when your stomach has too much acid (indigestion)
• Lowering the amount of acid in your stomach or gut (intestine)
when you have an
ulcer.
Maalox works by lowering the amount of acid in your stomach.
2.
BEFORE YOU USE MAALOX
DO NOT TAKE MAALOX IF:
You are allergic (hypersensitive) to Aluminium hydroxide or
Magnesium
hydroxide or any of the other ingredients in Maalox Sachets (see
Section 6:
Further 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 weak and have no energy (debilitated).
You have kidney problems.
You have low levels of phosphate (called ‘hypophosphataemia’.
This is
shown up in blood tests.
You have severe stomach pain.
Your bowel is partial
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maalox Sachets 460mg/400mg Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 460mg Aluminium hydroxide (aluminium oxide hydrated) and 400mg Magnesium hydroxide.
Excipients: Each 4.3ml sachet also contains 140mg of sorbitol (E420) and 3144.32 mg of Sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White to faintly yellow homogeneous suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms of dyspepsia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
_Adults: _One to Two sachets taken 20 minutes to one hour after meals and at night as required or as directed by the
physician
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 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, 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
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