VIDISIC

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

CARBOMER

Saadav alates:

Bausch & Lomb UK Limited

ATC kood:

S01XA20

INN (Rahvusvaheline Nimetus):

CARBOMER

Annus:

0.2 %w/w

Ravimvorm:

Eyegel

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

artificial tears and other indifferent preparations

Volitamisolek:

Marketed

Loa andmise kuupäev:

1993-08-11

Infovoldik

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 (listed in Section 6).
• If you think you have

Toote omadused

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 symptomatic 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___