1    NAME OF THE MEDICINAL PRODUCT

Murine Red & Sore Eyes 0.12mg/ml Eye Drops, Solution Cleareyes 0.12mg/ml Eye Drops, Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Naphazoline hydrochloride 0.12 mg/ml

Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Eye drops, solution Clear, colourless liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of occasional, minor redness and irritation of the eye.

Murine is indicated in adults and children aged 12 years and over.

4.2    Posology and method of administration

Posology

Adults and children 12 years and over: The recommended dosage is one or two drops into each eye two or three times daily. This product is for intermittent or occasional use only (see section 4.4).

Paediatric population

The safety and efficacy of Murine in children aged 0 to 12 years have not been established. No data are available.

Method of administration For ocular use

If other eye drops/eye ointments are additionally being used, an interval of approximately 15 minutes should be observed between the doses and any eye ointment should always be applied last.

4.3 Contraindications

Murine is contraindicated in subjects with: angle-closure glaucoma, a narrow chamber angle (at risk for acute glaucoma), previous attacks of acute glaucoma due to a narrow chamber angle, iritis or corneal damage. This product must not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

This product is for intermittent or occasional use only. Rebound effects have been reported after prolonged and/or excessive use of naphazoline containing eye drops.

Murine should not be used if there is an eye condition characterised by continued redness, pain or blurring of vision.

If there is any eye pain, vision changes, photophobia, continued redness or irritation of the eye, or if after 24 hours the condition worsens or shows no sign of improvement, discontinue use and consult a doctor.

Contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses; remove contact lenses prior to application and wait at least 15 minutes before re-insertion.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to naphazoline hydrochloride is negligible.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to naphazoline hydrochloride is negligible.

4.7 Effects on ability to drive and use machines

Murine has minor influence on the ability to drive and use machines as it may cause transient blurring of vision.

4.8 Undesirable effects

Very occasionally transient eye irritation (including stinging and itching), transient blurred vision, and mydriasis (pupil dilation) have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9    Overdose

Overdosage or accidental administration by mouth may cause depression of CNS, reduction of body temperature, bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension.

Overuse may produce increased redness of the eye. Should this occur, discontinue use. If the redness continues consult a doctor.

Treatment of side-effects is symptomatic.

5    PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics used as decongestants, ATC code: S01GA01

Mechanism of action: Naphazoline is a sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor that reduces swelling and congestion when applied to mucous membrane.

Murine has an onset of effect within 1 minute after instillation and the effect is maintained for at least 3 hours.

5.2    Pharmacokinetic properties

Absorption: Absorbed following instillation into conjunctival sacs.

5.3    Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium chloride solution Boric acid (E284)

Borax (E285)

Purified water Disodium edetate

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Unopened 10 mL: 3 years Unopened 5 mL: 2 years Opened: 1 month

6.4    Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5    Nature and contents of container

5 mL or 10 mL of liquid in a HD PE plastic bottle, drop-forming LDPE plastic plug and polypropylene plastic cap.

6.6    Special precautions for disposal

Do not use if the solution changes colour or becomes cloudy.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION    HOLDER

Prestige Brands (UK) Limited

57 Hight Street

Yatton

Somerset BS49 4EQ United Kingdom

8    MARKETING AUTHORISATION    NUMBER(S)

PL 18259/0009

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/05/2014

10 DATE OF REVISION OF THE TEXT

02/04/2015

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