Isopto Carpine 4% Eye Drops

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pilocarpine hydrochloride, Quantity: 40 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: boric acid; sodium citrate dihydrate; purified water; benzalkonium chloride; hypromellose

Administration route:

Ophthalmic

Units in package:

15mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In the treatment of glaucoma.

Product summary:

Visual Identification: Clear solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

ISOPTO CARPINE
® EYE
DROPS
_1%, 2% AND 4%_
_Pilocarpine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU USE ANY ISOPTO
CARPINE EYE DROPS.
This leaflet answers some common
questions about ISOPTO CARPINE.
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 IN AUSTRALIA FROM
WWW.NOVARTIS.COM.AU AND FROM
WWW.MEDSAFE.GOVT.NZ IN NEW
ZEALAND.
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
ISOPTO CARPINE against the risks
this medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ISOPTO
CARPINE IS USED FOR
ISOPTO CARPINE is used to treat
glaucoma. Glaucoma is a condition
in which the pressure of fluid in the
eye may be high. However, some
people with glaucoma may have
normal eye pressure.
Glaucoma is usually caused by a
build up of the fluid which flows
through the eye. This build up occurs
because the fluid drains out of your
eye more slowly than it is being
pumped in. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
to rise. This raised pressure may
damage the back of the eye resulting
in gradual loss of sight. Damage can
progress so slowly that the person is
not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage to
the back of the eye.
There are usually no symptoms of
glaucoma. The only way o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ISOPTO CARPINE
(PILOCARPINE HYDROCHLORIDE) EYE DROPS, 1%, 2%, 4%
1
NAME OF THE MEDICINE
Pilocarpine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pilocarpine hydrochloride 1%, 2%, and 4%, hypromellose 0.5%,
benzalkonium chloride 0.01%, boric
acid, sodium citrate and purified water.
3
PHARMACEUTICAL FORM
Isopto carpine 1% / 15mL clear eye drops solution
Isopto carpine 2% / 15mL clear eye drops solution
Isopto carpine 4% / 15mL clear eye drops solution
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
In the treatment of glaucoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Topically, 1-2 drops in the eye(s) 3-4 times daily.
4.3
C
ONTRAINDICATIONS
Miotics are contraindicated in conditions where pupillary constriction
is undesirable such as in acute
iritis or anterior uveitis.
Hypersensitivity to the active substance or to any of the excipients.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Sensitivity is infrequently observed. If reaction occurs, discontinue
use.
Retinal detachment has been reported when miotics are used in
susceptible individuals, such as
young patients with myopia or patients with history of retinal
detachment.
Miotics should be avoided in acute inflammatory diseases of the
anterior chamber.
A paradoxical rise in intraocular pressure may be observed in patients
with severely compromised
trabecular outflow.
2
Caution is advised in the presence of corneal or conjunctival damage
to avoid excessive penetration
which can produce systemic toxicity.
ISOPTO CARPINE should be used with caution in patients with acute
cardiac failure, bronchial
asthma, peptic ulcer, hyperthyroidism, gastro-intestinal spasms,
Parkinson’s Disease, urinary tract
obstruction, recent myocardial infarction, hypertension and
hypotension due to the risk of
exacerbating these conditions.
ISOPTO CARPINE contains benzalkonium chloride which may cause eye
irritation and is known to
discolour soft contact lenses. Avoid contact with soft contact lenses.
Patients must b