ASILONE Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

MAGNESIUM OXIDUM LEVE ALUMINIUM HYDROXIDE DIMETHICONE 350

Available from:

Seton Products Ltd

Pharmaceutical form:

Oral Suspension

Authorization date:

2002-10-11

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asilone Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light magnesium oxide 70 mg/5 ml
Dried aluminium hydroxide 420 mg/5ml
Activated dimeticone 135 mg/5ml
_For excipients, see 6.1._
3 PHARMACEUTICAL FORM
Oral suspension.
A white mobile suspension with the taste and odour of peppermint and aniseed.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiflatulent and antacid; for the relief of dyspeptic symptoms of functional or organic origin, 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 5ml spoonfuls after meals and at bedtime or when required, up to a maximum of four times daily.
Children
The suspension formulation is 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 is not recommended in flatulent abdominal distention possibly related to intestinal obstruction.
If symptoms persist consult your doctor.
Not suitable for children under 12 years of age.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2010_
_CRN 2079002_
_page number: 1_
Keep all medicines out of reach of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Antacids may interfere with the absorption of tetracyclines, rifampicin, warfarin and digoxin if given concomitantly.
Antacids should preferably not be taken at the same time as other dr
                                
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