APO-OLOPATADINE olopatadine (as hydrochloride) 1 mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olopatadine hydrochloride

Available from:

Apotex Pty Ltd

INN (International Name):

Olopatadine hydrochloride

Authorization status:

Registered

Patient Information leaflet

APO-OLOPATADINE EYE
DROPS
_Contains the active ingredient olopatadine (as olopatadine
hydrochloride)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about olopatadine. It does
not contain all 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
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Olopatadine eye drops. It contains
the active ingredient olopatadine
hydrochloride.
It is used to treat allergic
conjunctivitis, which is inflammation
of the eye due to pollens that cause
an allergic response to give watery,
itchy and/or red eyes.
Before prescribing olopatadine for
you or your child, your doctor will
have examined the eye and decided
that olopatadine is the right medicine.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Olopatadine belongs to the group of
medicines called antihistamines and
also to the group of medicines called
anti-allergics.
There is no evidence that this
medicine is addictive.

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-OLOPATADINE (OLOPATADINE HYDROCHLORIDE)
EYE DROPS
1
NAME OF THE MEDICINE
Olopatadine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olopatadine eye drops are a sterile, isotonic, preserved solution for
topical application to the
eye. The solution is buffered to a pH of approximately 7 so that it is
within the physiological
range of the ocular surface fluid.
It is available as a 1 mg/mL (0.1%) strength, present as 1.11 mg/mL
olopatadine hydrochloride.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Olopatadine eye drops are indicated for the treatment of the signs and
symptoms of seasonal
allergic conjunctivitis. Treatment may be maintained for up to 14
weeks, if considered
necessary.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Olopatadine eye drops are intended for ophthalmic administration.
DOSAGE
The recommended therapy is one to two drops in the affected eye(s),
twice daily, for up to
14 weeks.
4.3
CONTRAINDICATIONS
Olopatadine
eye
drops
are
contraindicated
in
patients
hypersensitive
to
olopatadine
hydrochloride or any other component of the preparation (see SECTION
6.1 LIST OF EXCIPIENTS).
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
NOT FOR INJECTION OR ORAL INGESTION.
INSTRUCTION TO PATIENTS
Olopatadine contains the preservative benzalkonium chloride, which may
cause eye irritation
and be deposited in or discolour soft (hydrophilic) contact lenses.
Avoid contact with soft
contact lenses. Patients who wear soft contact lenses should remove
their lenses prior to
instilling olopatadine eye drops and should not reinsert their lenses
until at least 15 minutes
after instillation of the eye drops.
To prevent contaminating the dropper tip and solution, care should be
taken not to touch the
eyelids or surrounding areas with the dropper tip of the bottle. The
bottle should be tightly
closed when not in use.
Each bottle of olopatadine eye dr