SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Murine irritation & redness relief.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Naphazoline hydrochloride 0.012 % w/v Also contains Benzalkonium Chloride For a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Eye drops solution (eye drops)

Clear, colourless liquid

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Redness and minor irritations of the eye caused by, for example, dusty atmosphere, wind, swimming, smoke, air pollutants, and close work.

4.2 Posology and method of administration

Ocular

Adults and children 12 years and over

The recommended dosage is one or two drops into each eye two or three times daily.

Children under 12 years: Not recommended. There is no recorded experience of the product with this age group.

4.3. Contraindications

Glaucoma, corneal damage, acute iritis and other serious eye disease. Hypersensitivity to any ingredients.

Do not use at the same time as contact lenses. It is generally recommended that a short interval be allowed between the use of Murine and replacement of contact lenses, and that the duration of this ‘short interval’ should be about 15 minutes. This product should not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block.

4.4 Special warnings and precautions for use

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

Murine should not be used if there is raised pressure inside the eyeball (glaucoma), damage to the corneas, inflammation of the iris (acute iritis) or any other serious eye disease.

If there is any eye pain, vision changes, continued redness or irritation of the eye, or if the condition worsens or persists for more than 24 hours, use of the product should be discontinued and the doctor or pharmacist should be informed.

Discontinue use prior to use of anaesthetics which sensitise the myocardium to sympathomimetics (e.g. cyclopropane, halothane).

As with other sympathomimetics, use with caution in the presence of hypertension, diabetes, hyperthyroidism, cardiovascular abnormalities and arteriosclerosis.

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

4.5.    Interactions with other medicinal products and other forms of interaction

Currently there is no information regarding the use of Murine and the absorption of concomitant ocular products. However, patients should be advised to leave a short interval between the administration of Murine and other ocular products. It is generally recommended that this interval should be of about 15 minutes duration.

4.6.    Pregnancy and lactation

No special precautions.

4.7.    Effects on ability to drive and use machines

Do not drive or operate machinery if vision is blurred.

4.8    Undesirable effects

May cause slight dilation of pupil.

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 the national reporting system:

Yellow Card Scheme: Website: www.mhra.gov.uk/vellowcard

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. In addition, overdosage may cause increased redness of the eye. Treatment of side-effects is symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: S01GA01

Naphazoline is a sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor with a rapid and prolonged action in reducing swelling and congestion when applied to mucous membrane.

5.2. Pharmacokinetic Properties

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.

6.1.    List of Excipients

Benzalkonium chloride, boric acid (E284), borax (E285), purified water and disodium edetate.

6.2.    Incompatibilities

None known.

6.3    Shelf life

Unopened: 36 months 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 of liquid in a LDPE bottle fitted with a LDPE drop-forming plug and a polystyrene cap.

10 ml of liquid in a HDPE bottle fitted with a LDPE/DPE drop-forming plug and a polypropylene cap.

6.6    Special precautions for disposal

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

7    MARKETING AUTHORISATION HOLDER

Prestige Brands (UK) Limited 46 High Street

Yatton Somerset BS494HJ UK

8. MARKETING AUTHORISATION NUMBER

PL 18259/0003

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

15 October 2003

10 DATE OF REVISION OF THE TEXT

15/06/2016