MAALOX SUSPENSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE

Available from:

PHARMA SHALOM

ATC code:

A02AD01

Pharmaceutical form:

SUSPENSION

Composition:

ALUMINIUM HYDROXIDE 175 MG / 5 ML; MAGNESIUM HYDROXIDE 200 MG / 5 ML

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

SANOFI S.P.A., ITALY

Therapeutic area:

ORDINARY SALT COMBINATIONS

Therapeutic indications:

Antacid.

Authorization date:

2020-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s prescription
Name of the preparation and its form:
MAALOX SUSPENSION
Active ingredients and their quantity per dosage unit:
Each teaspoon (5 ml) contains:
Aluminium hydroxide 175 mg
Magnesium hydroxide 200 mg
Inactive ingredients – see section 6 and “Important information
about some of the ingredients
in this medicine” section.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have additional questions,
refer to the doctor or pharmacist.
Keep this leaflet; you may need to read it again.
Take this preparation according to the instructions in the Dosage
section in this leaflet or
according to the doctor’s instructions. Consult the pharmacist if
you need further information.
Refer to the doctor if symptoms worsen or are not improving.
If one of the side effects worsens or if you suffer from a side effect
not mentioned in this leaflet,
refer to the doctor or pharmacist.
The medicine is not intended for children under 14 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Maalox Suspension contains two different medicines that belong to the
group called antacids.
The preparation is intended to reduce the amount of gastric acid and
to relieve the sensation
of heartburn.
Therapeutic group: antacids.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE IF:
•
you are allergic to aluminium hydroxide or magnesium hydroxide or to
any of the other
ingredients of the medicine (see section 6). Signs of an allergic
reaction include: rash,
swallowing or breathing problems, swelling of the lips, face, throat
or tongue.
•
you feel severe exhaustion.
•
you are suffering from kidney problems. Prolonged exposure to high
doses of Maalox
Suspension may lead to dementia.
•
you are suffering from severe abdominal pain.
•
you are suffering from partial or full bowel obstruction.
Do not take t

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Maalox Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the suspension contains:
200 mg of Magnesium Hydroxide and
175 mg of Aluminium Hydroxide.
Excipients with known effect:
This medicinal product contains 1.4 mg of sodium saccharin 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, viscous, aqueous oral suspension with a peppermint odour and
taste.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antacid
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Recommended Dosage
_ _
_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.
_CHILDREN: _
Not recommended for children under 14 years.
METHOD OF ADMINISTRATION
For oral administration: Shake before use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
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.
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
deplet