ASILONE ANTACID Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
ALUMINIUM HYDROXIDE DIMETHICONE 350
Available from:
SSL International PLC
INN (International Name):
ALUMINIUM HYDROXIDE DIMETHICONE 350
Pharmaceutical form:
Tablets
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization date:
2007-10-11
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asilone Antacid Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Activated dimeticone 270 mg
Dried aluminium hydroxide 500 mg
_For excipients, see 6.1._
3 PHARMACEUTICAL FORM
Chewable tablet.
A round, white, flat tablet with bevelled edge, with “Asilone Antacid” embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiflatulent and antacid; for the relief of dyspeptic symptoms of functional or organicorigin, including flatulence and
associated abdominal distension, heartburn, hiatus hernia, and oesophagitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults including the Elderly
One or two tablets to be chewed or sucked before meals and at bedtime or when required. For heartburn, they should
be sucked only.
Children
Asilone Antacid Tablets are not recommended for children under 12 years of age.
4.3 CONTRAINDICATIONS
Antacid preparations should not be administered in severe debilitation or renal impairment. Do not use during the first
trimester of pregnancy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Asilone Antacid Tablets are not recommended in flatulent abdominal distention possibly related to intestinal
obstruction.
Asilone Antacid tablets contain 1.1g of Sucrose per tablet and are therefore not recommended for diabetic patients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2010_
_CRN 2079002_
_page number: 1_
Label states:
If symptoms persist consult your doctor.
Not suitable for children under 12 years of age.
Keep all medicines out of the reach of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Antacids may interfere with the ab
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