Alutril Forte 500 mg/250 mg chewable tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MAGNESIUM TRISILICATE, ALUMINIUM HYDROXIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

A02AD01

INN (International Name):

MAGNESIUM TRISILICATE 500 mg ALUMINIUM HYDROXIDE 250 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

MAGNESIUM TRISILICATE 500 mg ALUMINIUM HYDROXIDE 250 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Product summary:

Licence number in the source country: Cyprus - 19914

Authorization status:

Authorised

Authorization date:

2016-06-28

Patient Information leaflet

Package leaflet: Information for the patient
Alutril Forte 500 mg/250 mg chewable tablets
Magnesium Trisilicate / Hydrated Aluminium Oxide
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask you pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. 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, after taking the
medicine.
What is in this leaflet
1.
What Alutril Forte is and what it is used for
2.
What you need to know before you take Alutril Forte
3.
How to take Alutril Forte
4.
Possible side effects
5.
How to store Alutril Forte
6.
Contents of the pack and other information
1.
What Alutril Forte is and what it is used for
Magnesium trisilicate and hydrated aluminium oxide, the active
ingredients of Alutril Forte,
act on the gastrointestinal tract in order to neutralize hydrochloric
acid.
Alutril Forte is indicated for the relief of gastric hyperacidity,
indigestion and heartburn when
occurring alone or in association with peptic ulcer.
2.
What you need to know before you take Alutril Forte
Do not take Alutril Forte
-
if you are allergic to magnesium trisilicate or to hydrated aluminium
oxide or to any of
the other ingredients of this medicine (listed in section 6).
-
if you suffer from renal dysfunction.
-
if you are undergoing chronic haemodialysis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alutril Forte.
Prolonged use of antacids
containing aluminium in patients undergoing chronic haemodialysis
carries the risk of
encephalopathy.
Other medicines and Alutril Forte
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. A numbe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICAL PRODUCT
Alutril Forte 500 mg/250 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 500 mg magnesium trisilicate and 250 mg
hydrated aluminium
oxide.
Excipient(s) with known effect
This product contains 100 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White, round, flat, scored, flavoured chewable tablets.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Alutril Forte is indicated for the relief of gastric hyperacidity,
indigestion and heartburn when
occurring alone or in association with peptic ulcer.
4.2
Posology and method of administration
Posology
Adults
Two or four tablets to be chewed or sucked after meals or whenever
symptoms occur.
Elderly
As for adults.
Children (6-12 years)
Half the adult dose or as directed by the physician.
The maximum daily dosage is 24 tablets which should not be taken for
more than 2 weeks.
Method of administration
_____________________________________________________________________________________________________
cy-spc-alutril-forte-ch-tabs-v02-r00-a0 Page 1 of 4
Oral.
4.3
Contraindications
Alutril Forte is contra-indicated in patients with hypersensitivity to
the active substances or to
any of the excipients listed in section 6.1.
4.4
Special warnings and precautions for use
Prolonged use of antacids containing aluminium in patients undergoing
chronic haemodialysis
carries the risk of encephalopathy.
Alutril Forte should not be given for prolonged or intensive therapy
to patients with severe
renal dysfunction, since hypermagnesaemia may develop.
This product contains sucrose. If you have been told by your doctor
that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per dose
(maximum daily dose),
that is to say essentially ‘sodium-free’.
4.5
Interaction with