OXYLIN LIQUIFILM 0.025% W/V EYE DROPS, SOLUTION 0.025 %w/v Eye Drops Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

OXYMETAZOLINE HYDROCHLORIDE

Tilgjengelig fra:

Allergan Pharmaceuticals Ireland

INN (International Name):

OXYMETAZOLINE HYDROCHLORIDE

Dosering :

0.025 %w/v

Legemiddelform:

Eye Drops Solution

Resept typen:

Product subject to prescription which may not be renewed (A)

Autorisasjon status:

Withdrawn

Autorisasjon dato:

0000-00-00

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxylin Liquifilm 0.025% w/v Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre contains 0.25mg Oxymetazoline Hydrochloride
Excipients: Benzalkonium Chloride 0.04mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxylin is indicated in adults for symptomatic relief of redness due to non-infectious irritation of the conjunctiva.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
1-2 drops into the eye(s) every 8 hours.
_Paediatric population_
The safety and efficacy of Oxylin in children aged <18 years have not been established. No data are available.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed
at the medial canthus (punctal occlusion) for one minute immediately following the instillation of each drop.
To avoid contamination, do not let the tip of the dropper touch your eye or anything else.
4.3 CONTRAINDICATIONS
• Hypersensitivity to the active substance or to any of the excipients.
• Patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment, since hypertensive
crisis may occur.
• Patients with uncontrolled hypertension, cardiac irregularities, hyperglycaemia (diabetes mellitus) and
hyperthyroidism.
• Patients in whom pupillary dilation should be avoided (angle-closure glaucoma or those with critically narrow
angles).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/07/2011_
_CRN 2085725_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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