Patanol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Olopatadine hydrochloride 0.111% w/v (equivalent to 0.1% w/v olopatadine)

Dosage:

0.1% w/v

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine   Excipient: Benzalkonium chloride Dibasic sodium phosphate Hydrochloric acid Sodium chloride Sodium hydroxide

Units in package:

Bottle, dropper, 1mL LDPE Sample pack, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Kyowa Hakko Bio Co., Ltd

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, 5mL LDPE - 5 mL - 24 months from date of manufacture stored at or below 25°C. for finished product manufactured at Alcon Cusi SA only 36 months from date of manufacture stored at or below 25°C. for finished product manufactured at other sites 28 days opened stored at or below 25°C

Authorization date:

2001-03-09

Patient Information leaflet

Internal document code
pat090623cNZ is based on PI pat090623iNZ
1
PATANOL
®
_Olopatadine hydrochloride 0.1% _
Eye Drops
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE PATANOL
EYE DROPS.
This leaflet answers some
common questions about Patanol
eye drops. 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 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.medsafe.govt.nz.
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 risks of you using
Patanol against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PATANOL IS
USED FOR
Patanol eye drops belong to the
group of medicines called
antihistamines.
Patanol eye drops are used to
treat seasonal, allergic
conjunctivitis, which is an
inflammation of the eye due to
pollens that cause an allergic
response to give watery, itchy
and/or red eyes.
Before prescribing Patanol eye
drops for you, your doctor will
have examined your eye(s) and
decided that Patanol eye drops is
the right medicine for you.
Your doctor may have
prescribed Patanol eye drops for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
PATANOL EYE DROPS HAVE BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor’s prescription.
Patanol eye drops are not
addictive.
_USE IN CHILDREN _
Pantanol eye drops are not
recommended for use in children
under 3 years of age.
The safety and effectiveness of
Patanol
eye
dro

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PATANOL EYE DROPS, SOLUTION 0.1% W/V
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Patanol Eye Drops contains 1.11 mg olopatadine
hydrochloride which is
equivalent to 1.0 mg olopatadine (0.1%).
Excipient with known effect
Benzalkonium chloride 0.1 mg per 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is clear and colourless to pale yellow. The solution is
buffered to a pH of
approximately 7.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Patanol Eye Drops are indicated for the treatment of the signs and
symptoms of allergic
conjunctivitis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
The recommended therapy is one to two drops of Patanol Eye Drops in
the affected
eye(s) twice daily.
4.3.
CONTRAINDICATIONS
Patanol
Eye
Drops
are
contraindicated
in
patients
hypersensitive
to
olopatadine
hydrochloride or any other component of the preparation listed under
Section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
NOT FOR INJECTION OR ORAL INGESTION.
Paediatric use
Safety and effectiveness have not been established in children below 3
years of age.
Instructions to patients
Patanol 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 Patanol 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 Patanol Eye Drops should be discarded within 28 days of
opening
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Interactions with other medications have not been investigate