Vidisic 0.2 % w/w eye gel

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Carbomer

Saadav alates:

Bausch + Lomb Ireland Limited

ATC kood:

S01XA; S01XA20

INN (Rahvusvaheline Nimetus):

Carbomer

Ravimvorm:

Eye gel

Terapeutiline ala:

Other ophthalmologicals; artificial tears and other indifferent preparations

Volitamisolek:

Marketed

Loa andmise kuupäev:

1993-08-11

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
Vidisic
® _0.2% w/w Eye Gel_
Carbomer
The name of your medicine is Vidisic 0.2 % w/w Eye Gel and it is
called Vidisic in this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However you still
need to use Vidisic carefully to get the best
results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
- 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.
_In this leaflet: _
1. What Vidisic is and what it is used for
2. What you need to know before you use Vidisic
3. How to use Vidisic
4. Possible side effects
5. How to store Vidisic
6. Contents of the pack and other information
1. WHAT VIDISIC IS AND WHAT IT IS USED FOR
Your gel contains the active ingredient carbomer, which acts as a
lubricant to treat symptoms of dry eye. It is a
soothing gel that is used as an artificial tear when the eyes are
lacking in tears.
Your eyes will normally produce just enough natural tears to allow
them to move easily and comfortably. If your
eyes do not produce enough tears they can become dry, red and painful.
Your gel keeps the surface of the eye lubricated when production of
tears is less than normal, and has a
refreshing, cooling action.
The carbomer in this gel holds moisture and releases this onto the
surface of the eye to help relieve the feeling of
dryness.
This gel can be used by children, adults and the elderly.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIDISIC
DO NOT USE VIDISIC:
• If you are allergic to Carbomer or any of the ingredients of this
medicine (liste

Toote omadused

Health Products Regulatory Authority
18 November 2022
CRN00CTS5
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vidisic 0.2 % w/w eye gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The product contains carbomer 0.2 % w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye gel.
Sterile, colourless, clear, aqueous eye gel, without visible
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For symptomtic relief of dry eyes associated with the sicca syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One drop into the conjunctive sac 3-5 times per day.
CHILDREN AND ADOLESCENTS AGED TO 18 YEARS:
The safety and efficacy of Vidisic 0.2 % w/w Eye Gel in children and
adolescents at the posology recommended in adults has
been established by clinical experience, but no clinical trial data
are available.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Should not be used for undiagnosed conjunctivitis.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Wearers of contact lenses should remove their lenses before Vidisic is
instilled and should wait for 15 minutes before they
insert them again.
Intolerance reactions to one of the ingredients may be seen in
isolated cases. Vidisic gel contains cetrimide as a preservative
which, particularly when used frequently or for a long period, may
cause ocular irritation (burning, redness, foreign body
sensation) and may damage the corneal epithelium. Preservative-free
medicinal products should therefore be preferred for
long-term treatment of chronic keratoconjuctivitis sicca.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Vidisic may prolong the contact-time of topically applied drugs in
ophthalmology.
Concomitant ocular medication should be administered 15 minutes prior
to the instillation of Vidisic.
Vidisic should always be the last medication to be administered.
Health Products Regulatory Authority
18 November 2022
CRN00CTS