Optrex Clear Eyes Eye Drops Solution Hamamelis Water 12.5% v/vNaphazoline Hydrochloride 0.01% w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NAPHAZOLINE HYDROCHLORIDE; Hamamelis water

Available from:

Optrex Limited

ATC code:

S01GA; S01GA51

INN (International Name):

NAPHAZOLINE HYDROCHLORIDE; Hamamelis water

Dosage:

12.5/0.01 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics used as decongestants; naphazoline, combinations

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

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111001011(970)
RB Nottingham
NA
0209384
Optrex
Core
Sore Eye
Drops
10ml
RB291739
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
PLEASE NOTE THAT ANY LOW RESOLUTION PAPER CANON COLOUR
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STUDIO USE ONLY
V2.0
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Multi Packaging Solutions (Tewkesbury, UK)
O-Lft-D0072048-130x194mm
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Paper White
Ireland
06/06/18
D
RYAN REILLY
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G=2; O=0; R=0;
- RR - 06/06/18 11:14:22
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1
LTH
PANTONE 286 C
COLOURS (LEAFLET)
RBH CONTACT:
Maria Mealiffe
• Read all of this leaflet carefully before you start using Optrex
Clear Eyes Eye Drops as it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• As your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet (see Section 4).
• You must talk to a doctor if

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2019
CRN008S55
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optrex Clear Eyes Eye Drops Solution Hamamelis Water 12.5%
v/vNaphazoline
Hydrochloride 0.01% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Hamamelis Water (Distilled Witch Hazel)
12.5 % v/v
Naphazoline Hydrochloride
0.01 % w/v
Excipients: Contains benzalkonium chloride solution 0.005% w/v and
ethanol 2.0%
v/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A colourless, clear or practically clear solution, practically free
from particles and with
the characteristic odour of witch hazel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For temporary symptomatic relief of redness of the eye due to minor
eye irritations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Forusebyadults and children over 12years.
Gentlysqueeze 1 or 2 drops into each eye, no more than 4 times daily.
If symptomsdonotresolvewithin24hours,thepatientshouldseea healthcare
professional. Thisproductisintended for intermittentor occasional
useand
shouldnotbe usedformorethan72hoursunless under medical supervision.
Children under 12years: Not to be used (see section 4.3)
METHOD OF ADMINISTRATION
For topical applicationtotheeye
Health Products Regulatory Authority
18 January 2019
CRN008S55
Page 2 of 7
4.3 CONTRAINDICATIONS
Hypersensitivity to hamamelis water, naphazoline or to any of the
excipients listed in
section 6.1.
Persons suffering from closed-angle glaucoma, serious eye disease, or
who have had
previous eye surgery.
Use in patients taking monoamine oxidase inhibitors or within 14 days
of stopping
such medication (see section 4.5).
Use in patients with contact lenses.
Not to be used in children younger than 12 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Personssufferingfromglaucoma,seriouseyediseasesorwhohave had previous
eye
surgery should not use this product.
Usewithcautiononaninflamedeye,as hyperaemiagreatly increas