PALADOPT olopatadine (as hydrochloride) 1 mg/mL eye drop bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

olopatadine hydrochloride, Quantity: 1.11 mg/mL (Equivalent: olopatadine, Qty 1 mg/mL)

Disponible des:

Viatris Pty Ltd

Designació comuna internacional (DCI):

Olopatadine hydrochloride

formulario farmacéutico:

Eye Drops

Composición:

Excipient Ingredients: sodium hydroxide; water for injections; dibasic sodium phosphate; benzalkonium chloride; sodium chloride; hydrochloric acid

Vía de administración:

Ophthalmic

Unidades en paquete:

5 mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Treatment may be maintained for up to 14 weeks, if considered necessary.

Resumen del producto:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2015-10-23

Informació per a l'usuari

PALADOPT 0.1%
1
PALADOPT
0.1 % EYE DROPS
_Olopatadine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE
PALADOPT EYE DROPS.
This leaflet has been written to
answer some common
questions about PALADOPT.
It does not contain all of the
available information and does
not take the place of talking to
your doctor or pharmacist.
Before prescribing PALADOPT
for you or your child, your doctor
will have examined the eye and
decided that PALADOPT is the
right medicine.
Your doctor may have
prescribed PALADOPT for
another reason. Ask your doctor
if you have any questions about
why PALADOPT has been
prescribed for you or your child.
PALADOPT is not addictive.
The preservative in
PALADOPT Eye Drops
(benzalkonium chloride) may
be deposited in soft contact
lenses. You can put your soft
contact lenses into your eyes 15
minutes after you have used
PALADOPT Eye Drops.
DO NOT GIVE PALADOPT TO A
CHILD UNDER 3 YEARS. The
safety and effectiveness of
PALADOPT in children under
3 years have not been
established.
All medicines have risks and
IF YOU ARE NOT SURE WHETHER
benefits. In deciding to
prescribe PALADOPT for you
or your child, your doctor has
weighed the potential risks and
benefits of using this medicine.
The information in this leaflet
applies to PALADOPTL only.
This information does not apply
to similar products, even if they
contain the same ingredients.
IF YOU HAVE ANY CONCERNS
ABOUT USING PALADOPT,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need it
again.
WHAT PALADOPT EYE
DROPS IS USED FOR
PALADOPT belongs to the
group of medicines called
antihistamines and also to the
group of medicines called anti-
allergics.
PALADOPT 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 YOU USE
PALADOPT EYE
DROPS
_WHEN YOU MUST NOT USE IT_
DO NOT USE PALADOPT IF:
You are allergic to olopatadine
or to any other of the ingre

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
PALADOPT
_olopatadine eye drops _
1
NAME OF THE MEDICINE
Olopatadine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of eye drops contains 1.11 mg of olopatadine hydrochloride
(equivalent to 1 mg olopatadine) as
the active ingredient.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
The solution is clear and colourless..
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PALADOPT is 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
The recommended therapy is one to two drops of PALADOPT in the
affected eye(s) twice daily for up to 14
weeks.
PALADOPT is for individual patient use only.
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).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not for injection or oral ingestion
USE IN THE ELDERLY
No data available.
PAEDIATRIC USE
Safety and effectiveness have not been established in children below 3
years of age.
EFFECTS ON LABORATORY TESTS
No data available.
INSTRUCTION TO PATIENTS
PALADOPT 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 PALADOPT and should not reinsert
their lenses until at least 15 minutes after instillation of the eye
drops.
PALADOPT – PRODUCT INFORMATION
2
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 PALADOPT should be discarded after 28 days of opening.
4.5
INTERACTIONS
WITH
OTHER
M