GELTEARS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-09-2017
Summary of Product characteristics
(SPC)
25-08-2017
Active ingredient:
CARBOMER
Available from:
Bausch & Lomb UK Limited
ATC code:
S01XA20
INN (International Name):
CARBOMER
Dosage:
0.2 %w/w
Pharmaceutical form:
Eyegel
Prescription type:
Product not subject to medical prescription
Therapeutic area:
artificial tears and other indifferent preparations
Authorization status:
Marketed
Authorization date:
1997-02-07
Patient Information leaflet
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
GELTEARS
Carbomer 0,2% w/w
eye gel
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UK/IRELAND (UK/IE)
Nr wykrojnika
Spec No
12036
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
49202PB574/5-IE/UK
Nr korekty
Proof No
1
Data
Date
09-03-2017
Kod farmaceutyczny
Pharmacode
1134
Kod wersji
Valeant version code
P1UKIE02
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 9 PT
Wymiar ulotki
PIL size
120 X 360 MM
Krój czcionki
Font used
Frutiger Neue LT W1G
Condensed
FRUTIGER NEUE LT W1G
BOLD CONDENSED
Gramatura papieru
Paper weight
UP TO MANUFACTURER
Komentarze Comments (Reason for the change)
- CMC CHANGE - REPLACING PURIFIED WATER WITH WFI
- PMR_ICN-17-0295-A
- FACTORY (PACKING SITE): DR MANN
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
Read the complete document
Summary of Product characteristics
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
INTERACTION
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.
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Read the complete document
