ZADITEN ketotifen 250microgram/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketotifen fumarate, Quantity: 0.345 mg/mL (Equivalent: ketotifen fumarate, Qty 0.25 mg/mL; Equivalent: ketotifen, Qty 0.25 mg/mL)

Available from:

Care Pharmaceuticals Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: water for injections; glycerol; sodium hydroxide; benzalkonium chloride

Administration route:

Ophthalmic

Units in package:

1 x 5mL, 1 x 2.5mL

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

The symptomatic short term treatment of seasonal allergic conjuctivitis in adults and children 3 years or older.

Product summary:

Visual Identification: Clear, colourless to faintly yellow solution.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-07-19

Patient Information leaflet

ZADITEN
® EYE DROPS
1.0%
_Ketotifen_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Zaditen Eye Drops.
This leaflet answers some common
questions about Zaditen Eye Drops.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
You can also download the most up
to date leaflet from
www.novartis.com.au.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
Zaditen Eye Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Zaditen only. This information
does not apply to similar products,
even if they contain the same
ingredients.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZADITEN IS USED
FOR
Zaditen contains the active
ingredient, ketotifen, which is an
anti-inflammatory medicine. It works
by blocking the allergic response and
reducing inflammation.
This medicine is used for short term
treatment of the symptoms of
seasonal allergic conjunctivitis
(itchy, watery or swollen eyes and/or
eyelids).
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN GIVEN TO
YOU.
Your pharmacist or doctor may have
given it for another reason.
This medicine is not addictive.
It is available from your pharmacy.
_USE IN CHILDREN_
Zaditen is not recommended for use
in children under 3 years.
The safety and effectiveness of
Zaditen in this age group has not
been established.
BEFORE YOU USE
ZADITEN
DO NOT USE ZADITEN EY

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZADITEN (KETOTIFEN) EYE
DROPS SOLUTION
1
NAME OF THE MEDICINE
ketotifen as ketotifen fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zaditen is a sterile ophthalmic solution containing ketotifen for
topical administration to the eye.
Each 1.0 mL contains 345 µg ketotifen fumarate corresponding to 250
µg ketotifen.
Excipients with known effect: Benzalkonium chloride (multidose bottle
only).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye Drops - clear, colourless to faintly yellow, sterile ophthalmic
solution for administration to the
eye.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Symptomatic short term treatment of seasonal allergic conjunctivitis
in adults and children 3 years
or older.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults, elderly and children (age 3 and older): One drop of Zaditen
into the conjunctival sac twice
daily.
INSTRUCTIONS FOR USE AND HANDLING
MULTIDOSE BOTTLE:
The contents and dispenser remain sterile until the original closure
is broken. To avoid
contamination, do not touch any surface with the dropper tip. The tip
of the container should also
not come into contact with the eye as this may cause injury to the
eye. The multidose formulation
of Zaditen eye drops contains benzalkonium chloride as a preservative,
which may be deposited in
soft contact lenses and may possibly discolor soft contact lenses (see
Section 4.4 Special Warnings
and Precautions for Use).
After opening, Zaditen should not be used for more than 4 weeks and
any remaining contents should
be discarded.
After cap is removed, if tamper evident snap collar is loose, remove
before using the product.
2
SINGLE DOSE UNITS:
The contents remain sterile until the original closure is broken. To
avoid contamination do not touch
any surface with the tip of the container. The tip of the container
should also not come into contact
with the eye as this may cause injury to the eye. After opening,
single dose units must be used
immediately. Con