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:

Hamamelis water; NAPHAZOLINE HYDROCHLORIDE

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

S01GA; S01GA51

INN (International Name):

Hamamelis water; NAPHAZOLINE HYDROCHLORIDE

Dosage:

12.5 %w/v + 0.01 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Sympathomimetics used as decongestants; naphazoline, combinations

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEAR EYES EYE DROPS SOLUTION
HAMAMELIS WATER 12.5% V/V
NAPHAZOLINE HYDROCHLORIDE 0.01% W/V
Removes redness fast and sooths sore eyes

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.

Ask 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 you do not feel better or if you feel
worse after 24 hours.
WHAT IS IN THIS LEAFLET
1. What Optrex Clear Eyes Eye Drops are and what are they used for
2. What you need to know before you use Optrex Clear Eyes Eye Drops
3. How to use Optrex Clear Eyes Eye Drops
4. Possible side effects
5. How to store Optrex Clear Eyes Eye Drops
6. Contents of the pack and other information
1. WHAT OPTREX CLEAR EYES EYE DROPS ARE AND WHAT THEY ARE USED FOR
Optrex Clear Eyes Eye Drops are an eye drop solution. They are used to
•
Relieve redness
•
Soothe irritation
Caused by the day to day effects of modern living such as dusty, smoky
atmospheres, eye strain and chlorine in swimming
pools.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTREX CLEAR EYES EYE DROPS
DO NOT USE THIS PRODUCT IF YOU
•
are allergic or sensitive to hamamelis water, naphazoline or any of
the ingredients listed in section 6
•
suffer from closed-angle glaucoma, other eye disease or have had eye
surgery
•
are under 12 years old
•
are taking monoamine oxidase inhibitors (MAOIs), or within 14 days of
stopping such medicine
WARNINGS AND PRECAUTIONS

for external use only

if there is no improvement after 24 hours, your symptoms get worse or
you get new symptoms (such as eye pain,
changes in vision), stop using this product and seek advice from your
doctor or pharmacist

if you are being treated for high blood pressure, arteriosclerosis,
cardiovasc

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2020
CRN009ZYS
Page 1 of 5
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
Excipient(s) with known effect:
benzalkonium chloride 0.0025 mg/drop
ethanol 2.0 % v/v.
For the 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:
For use by adults and children over 12 years.
Gently squeeze 1 or 2 drops into each eye, no more than 4 times daily.
If symptoms do not resolve within 24 hours,the patient should see a
healthcare professional. This product is intended for
intermittent or occasional use and should not be used for more than 72
hours unless under medical supervision.
Children under 12 years: Not to be used (see section 4.3)
METHOD OF ADMINISTRATION
For topical application to th eeye
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.
Health Products Regulatory Authority
23 December 2020
CRN009ZYS
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Persons suffering from glaucoma, serious eye diseases or who have had
previous eye surgery should not use this product.
Use with ca