Isopto Carpine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pilocarpine hydrochloride 20 mg/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Pilocarpine hydrochloride 20 mg/mL

Dosage:

2 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Pilocarpine hydrochloride 20 mg/mL Excipient: Benzalkonium chloride Boric acid Hypromellose Purified water Sodium citrate dihydrate

Units in package:

Bottle, dropper, LDPE with PP cap; 1 x 15 mL, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Anidro do Brazil Extracoes S.A.

Therapeutic indications:

Pilocarpine hydrochloride is a miotic (parasympathomimetic) used to control intraocular pressure. It may be used in combination with other miotics, beta blockers, carbonic anhydrase inhibitors, sympathomimetics, or hyperosmotic agents.

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, LDPE with PP cap - 15 mL - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

ISOPTO CARPINE
®
EYE DROPS
1
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 symp

Summary of Product characteristics

Internal document code
1
iso200921iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ISOPTO
®
CARPINE pilocarpine hydrochloride eye drops 1%
ISOPTO
®
CARPINE pilocarpine hydrochloride eye drops 2%
ISOPTO
®
CARPINE pilocarpine hydrochloride eye drops 4%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Isopto Carpine contains the active ingredient pilocarpine
hydrochloride 1%, 2%
or 4%.
Excipient with known effect
Benzalkonium chloride is included as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sterile eye drop solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pilocarpine hydrochloride is a miotic (parasympathomimetic) used to
control intraocular
pressure. It may be used in combination with other miotics, beta
blockers, carbonic anhydrase
inhibitors, sympathomimetics, or hyperosmotic agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instill two drops topically in the eye(s) up to three or four times
daily. Under selected
conditions, more frequent instillations may be indicated. Individuals
with heavily pigmented
irides may require larger doses.
Method of administration
Isopto Carpine is for ocular use.
Discard eye drops four weeks after opening.
4.3
CONTRAINDICATIONS
Miotics are contraindicated in conditions where papillary constriction
is undesirable such as
in acute iritis or anterior uveitis and in pupillary block glaucoma.
Hypersensitivity to any of the components listed under section 6.1
List of excipients
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For topical use only. NOT FOR INJECTION.
Information for Patients
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
Internal document code
2
iso200921iNZ
compromised trabecular outflow.
Caution is advised in the presence of corne