Refresh Ophthalmic 1.4%w/v + 0.6%w/v Eye Drops Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Povidone; Polyvinyl Alcohol

Boleh didapati daripada:

AbbVie Limited

Kod ATC:

S01XA20

INN (Nama Antarabangsa):

Povidone; Polyvinyl Alcohol

Borang farmaseutikal:

Eye drops, solution

Kawasan terapeutik:

artificial tears and other indifferent preparations

Status kebenaran:

Not marketed

Tarikh kebenaran:

1989-03-07

Risalah maklumat

CARTON TEXT
Refresh Opthalmic 1.4% w/v + 0.6% w/v Eye drops, solution
Polyvinyl alcohol, 1.4% w/v + Povidone 0.6% w/v
30 single dose vials x 0.4 ml
30 single dose vials. Each vial contains 0.4 ml of the eye drop,
solution. For irritated or dry eyes.
Eye lubricant. For ocular use.
Active substances:
LIQUIFILM (Polyvinyl alcohol) 1.4% w/v and povidone 0.6% w/v. Other
ingredients: sodium
chloride, purified water, sodium hydroxide or hydrochloric acid (to
adjust pH).
USAGE:
Refreshes and lubricates your eyes and treats symptoms associated with
dry eyes. These
symptoms are typically tired eyes, soreness, burning or itching.
WARNINGS:
Do not use if you are allergic to polyvinyl alcohol, povidone or to
any of the other ingredients.
If you wear contact lenses you must remove them before using the eye
drops and wait at least 15
minutes before putting them back in. Do not use if solution changes
colour or becomes cloudy. If
you are using other eye drops, leave at least 15 minutes before
putting in the Refresh Ophthalmic
drops. May cause short term blurring of vision. Do not drive or use
machinery unless your vision
is clear. The frequency of the following undesirable effects is not
known (cannot be estimated
from the available data): Eye disorders: eye irritation, eye pain, red
eye, eye redness, watery eye,
vision blurred, itchy eye, foreign body sensation, eye discharge,
hypersensitivity.
Use immediately after opening. Do not store opened vials. If symptoms
persist or you experience
eye pain, a change in vision, eye irritation or any new or unexpected
side effects, stop use and
see your doctor.
DOSAGE AND APPLICATION:
Ensure vial is intact. Twist off tab, apply 1 or 2 drops in eye(s) as
needed or directed, discard
vial. Individual vials are portable and convenient to use. To avoid
contamination or possible eye
injury, do not touch tip to any surface, including the eye. Do not use
Refresh after the expiry date
which is stated on the carton and vial after EXP. The expiry date
refers to the last day of the
month.
KEEP OUT OF

Ciri produk

Health Products Regulatory Authority
01 April 2022
CRN00CNH1
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Refresh Ophthalmic 1.4%w/v + 0.6%w/v Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyvinyl alcohol
1.4
% w/v
Povidone
0.6
% w/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a lubricant and artificial tear in dry eye and other ocular
irritation syndromes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage schedule: Ensure container is intact. Twist off tab and apply
one or two drops in each eye as needed, or as directed. No
special dosage for the elderly or for children.
Route of administration: Ocular instillation.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the other
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation, pain, redness and changes in vision occur or worsen,
treatment should be discontinued and a new assessment
considered.
To avoid contamination or possible eye injury, the dropper tip should
not be allowed to touch the eye or any other surface.
Contact lenses should be removed before each application and may be
reinserted after 15 minutes.
Concomitant ocular medication should be administered 15 minutes prior
to the instillation of Refresh Ophthalmic.
As Refresh Ophthalmic may delay penetration of other drugs, it should
be used last if it is the more viscous product.
Do not use if solution changes colour or becomes cloudy.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No known drug interactions.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
01 April 2022
CRN00CNH1
Page 2 of 3
Safety of the use of Refresh Ophthalmic during pregnancy and lactation
has not been established. However, Polyvinyl alcohol
and Povidone do not appear to be absorbed from the gastrointestinal
tract and are not metabolised following injectio