OPTREX EYE LOTION 13 %v/v Eye Lotion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
HAMAMELIS WATER, ETHANOL
Available from:
Optrex Limited
INN (International Name):
HAMAMELIS WATER, ETHANOL
Dosage:
13 %v/v
Pharmaceutical form:
Eye Lotion
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization date:
1983-04-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optrex 13% v/v Eye Lotion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hamamelis Water (Distilled Witch Hazel) 13.0 % v/v.
Also contains Ethanol 2% v/v and Benzalkonium chloride 0.01% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Lotion
A clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical preparation for relief of mild degrees of irritation, inflammation and congestion such as may occur with
allergic conjunctivitis, blepharitis, exposure to external irritants.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration to the eye.
ADULTS AND CHILDREN OVER 3 YEARS OF AGE AND THE ELDERLY
Always clean the Eye Bath by boiling in water before use. Fill 1/3
rd
full. Do not dilute the lotion. Bend the head
slightly forward apply the Eye Bath and rock the head from side to side for at least ½ minute keeping the eyelid open so
that the lotion bathes the eye’s surface thoroughly. Repeat with fresh lotion to the other eye. Never re-apply used lotion.
To cleanse without the Eye Bath – pour lotion only clean cotton wool and gently wipe the eyelid.
Apply twice daily or as required.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Not to be used whilst wearing or 15 minutes before inserting hydrophilic (soft) contact lenses.
Use in the presence of ulceration in the eye or obvious infection.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For serious eye problems or if symptoms persist consult your doctor.
For external use only.
Not suitable for use with hydrophilic (soft) contact lenses.
Contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses. Remove
contact lenses prior to
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