Geltears 0.2 % w/w carbomer eye gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbomer

Available from:

Bausch Health Ireland Limited

ATC code:

S01XA; S01XA20

INN (International Name):

Carbomer

Dosage:

0.2 percent weight/weight

Pharmaceutical form:

Eye gel

Therapeutic area:

Other ophthalmologicals; artificial tears and other indifferent preparations

Authorization status:

Marketed

Authorization date:

1997-02-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_GELTEAR® _
0.2% w/w Carbomer eye gel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told 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.
WHAT IS IN THIS LEAFLET
1. What GelTears is and what it is used for
2. What you need to know before you use GelTears
3. How to use GelTears
4. Possible side effects
5. How to store GelTears
6. Contents of the pack and other information
1. WHAT GELTEARS IS AND WHAT IT IS USED FOR?
GelTears is a clear colourless liquid gel and contains a lubricant
that is used as a substitute for natural 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 and irritated. It can also be used in
patients who suffer from sore eyes because their
tear film is unstable. GelTears will help keep your eyes comfortable.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GELTEARS
DO NOT USE GelTears if you are allergic to any of the ingredients of
this medicine (listed in section 6).
OTHER MEDICINES AND GELTEARS
If GelTears is used at the same time with other eye drops/eye
ointments, there should be an application time interval of
approximately 15 minutes between use of such other medications and
GelTears should always be the last medication to be
applied.
Tell your doctor or pharmacist if you are taking, have recently or
might take any other medicines.
WARNINGS AND PRECAUTIONS
Your vision may become blurred if too much gel is added at one time,
or if you use your medicine more often than is
requir

Summary of Product characteristics

Health Products Regulatory Authority
02 May 2019
CRN008VKT
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geltears 0.2% w/w Carbomer Eye Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.2% w/w carbomer .
Excipients contains 0.01% w/w Benzalkonium chloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye gel.
Homogeneous, colourless, gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Substitution of tear fluid in the management of dry eye conditions,
including keratoconjunctivitis sicca and unstable tear film.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children and adolescents aged to 18
years:
One drop to be instilled into the conjunctival fold of each affected
eye 3 - 4 times daily or as required, depending on the
degree of discomfort.
The safety and efficacy of GelTears in children and adolescents at the
posology recommended for adults has been established
by clinical experience, but no clinical trial data are available
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blurred vision can occur if too much gel is instilled at one time, or
if the gel is used too frequently. This effect can last for up to
an hour. Recovery can be aided by blinking vigorously for a few
seconds. If this fails, the lower eyelid should be manipulated
until the gel returns to the lower fornix and normal vision is
restored.
Contact lenses should be removed during treatment with GelTears.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No significant interactions have been reported.
4.6 FERTILITY, PREGNANCY AND LACTATION
Safety for use in pregnancy and lactation has not been established,
therefore, GelTears should not be used in these
circumstances.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
As with other ophthalmic preparations, transient blurring of vision
may occur on instillation. If affected,