MAALOX PLUS SUSPENSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE; SIMETHICONE

Available from:

PHARMA SHALOM

Pharmaceutical form:

SUSPENSION

Composition:

ALUMINIUM HYDROXIDE 175 MG / 5 ML; MAGNESIUM HYDROXIDE 200 MG / 5 ML; SIMETHICONE 25 MG / 5 ML

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE

Therapeutic indications:

Antacid, antiflatulent, relief of sensation of heatburn.

Authorization date:

2022-10-31

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 PLUS SUSPENSION
Active ingredients and their quantity per dosage unit:
EACH TEASPOON (5 ML) OF SUSPENSION CONTAINS:
Aluminium hydroxide 175 mg
Magnesium hydroxide 200 mg
Simethicone 25 mg
Inactive ingredients: see “Important information about some of the
ingredients in this medicine”
section and section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
Keep this leaflet; you may need to read it again.
Use according to the instructions in the Dosage section in this
leaflet. Consult the pharmacist
if you need further information.
Refer to the doctor if symptoms worsen or are not improving.
The medicine is not intended for children under 6 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Maalox Plus contains three different medicines: two that belong to the
group called antacids
and one which is an anti-foaming agent.
Maalox Plus is used as an antacid, anti-flatulence agent and to
relieve the sensation of
heartburn in the digestive system.
THERAPEUTIC GROUP:
antacid and anti-flatulence agent in the digestive system.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF YOU:
•
are sensitive (allergic) to aluminium hydroxide, magnesium hydroxide,
simethicone 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.
•
feel severe exhaustion.
•
are suffering from kidney problems/kidney failure.
•
are suffering from severe abdominal pain or partial or full bowel
obstruction.
•
are suffering from a low blood phosphate level (hypophosphatemia).
This condition can
be identified in your blood tests.
Do not take the medicine if o

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Maalox Plus Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5ml of the suspension contains: 175 mg of Aluminum Hydroxide (as
aluminium hydroxide
gel), 25 mg of simethicone and 200mg of Magnesium Hydroxide
Also contains 320 mg of sorbitol liquid 70% per 5 ml
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
Antacid, antiflatulent, relief of sensation of heartburn
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults
5-10ml, four times a day, taken 20 minutes to 1 hour after meals and
at bedtime or as
required.
Children
Child 6–12 years 5 mL 3–4 times daily
Child 12–18 years 5–10 mL 4 times daily,
taken 20 minutes to 1 hour after meals and at bedtime when required
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 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 a