MAALOX PLUS CHEWABLE TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALUMINIUM OXIDE HYDRATED; DIMETHICONE; MAGNESIUM HYDROXIDE

Available from:

PHARMA SHALOM

ATC code:

A02AB10

Pharmaceutical form:

CHEWABLE TABLETS

Composition:

MAGNESIUM HYDROXIDE 200 MG; DIMETHICONE 25 MG; ALUMINIUM OXIDE HYDRATED 200 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE

Therapeutic area:

COMBINATIONS

Therapeutic indications:

Antacid, antiflatulent, relief of sensation of heartburn.

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
CHEWABLE TABLETS
Active ingredients and their quantity per dosage unit:
EACH TABLET CONTAINS:
Aluminium Oxide hydrated 200 mg
Magnesium hydroxide 200 mg
Dimethicone 25 mg
Inactive ingredients: see 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.
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, an 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 (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. This condition can be
identified in your
blood tests.
Do not take the medicine if one of the conditions listed above applies
to you. If you are
uncertain, talk to your doctor or pharmacist before using the
medicine.
SPECIAL WARNINGS

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Maalox Plus Chewable Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of Magnesium Hydroxide, 200mg of Hydrated
Aluminium Oxide
and 25mg of Dimethicone.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Bi-layered, white/pale yellow circular, bevel-edged, lemon flavoured
chewable tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antacid, antiflatulent, relief of sensation of heartburn
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Recommended Dosage:
Adults (including elderly persons): 1-2 tablets well chewed, four
times a day, taken twenty
minutes to one hour after meals and at bedtime, or as required.
Children: Not recommended.
4.3
CONTRAINDICATIONS
Should not be used in patients who are Hypersensitivity to the active
ingredients or to any of
the 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.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
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 depletio