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 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 with the product in this age group.
4.3 Contraindications
Glaucoma, corneal damage, acute iritis and other serious eye disease.
Hypersensitivity to any ingredient.
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 symptathomimetics, 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 Interaction 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.
4.9 Overdose
Overdose 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 membranes.
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. Pharmaceutical Particulars
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: 24 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
10 ml of liquid in a plastic bottle, drop-forming plug and cap.
6.6 Special Precautions For Disposal And Other Handling
Do not use if the solution changes colour or becomes cloudy.
7. Marketing Authorisation Holder
Prestige Brands (UK) Limited
3 Scotlands Drive
Farnham Common
Slough
Berkshire SL2 3ES
United Kingdom
8. Marketing Authorisation Number(S)
PL18259/0003
9. Date Of First Authorisation/Renewal Of The Authorisation
15 October 2003
10. Date Of Revision Of The Text
5th May 2010
11 DOSIMETRY (IF APPLICABLE)
Not applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not applicable
Recent History:
5th May 2010 – 0034 - Type IB Az Group – Sections 2, 3, 4.2, 5.1
31st March 2010 – 0033 - Type IB A.2.b – Section 1
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