Alphagan P 1.5
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
24-05-2023
Summary of Product characteristics
(SPC)
24-05-2023
Active ingredient:
Brimonidine tartrate 1.5 mg/mL;
Available from:
AbbVie Limited
INN (International Name):
Brimonidine tartrate 1.5 mg/mL
Dosage:
1.5 mg/mL
Pharmaceutical form:
Eye drops, solution
Composition:
Active: Brimonidine tartrate 1.5 mg/mL Excipient: Boric acid Calcium chloride dihydrate Carmellose sodium Hydrochloric acid Magnesium chloride hexahydrate Potassium chloride Purified water Sodium borate pentahydrate Sodium chloride Sodium chlorite As Purite Sodium hydroxide
Units in package:
Bottle, dropper, LDPE bottle and polystyrene screw cap, 3 mL, 3 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Piramal Enterprises Limited
Therapeutic indications:
ALPHAGAN® P 1.5 eye drops are effective for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
Product summary:
Package - Contents - Shelf Life: Bottle, dropper, LDPE bottle and polystyrene screw cap, 3 mL - 3 mL - 18 months from date of manufacture stored at or below 25°C. Unopened 28 days opened stored at or below 25°C. Opened - Bottle, dropper, LDPE bottle and polystyrene screw cap, 5 mL - 5 mL - 18 months from date of manufacture stored at or below 25°C. Unopened 28 days opened stored at or below 25°C. Opened - Bottle, dropper, LDPE bottle and polystyrene screw cap, 10 mL - 10 mL - 24 months from date of manufacture stored at or below 25°C. Unopened 28 days opened stored at or below 25°C. Opened
Authorization date:
2004-12-16
Patient Information leaflet
ALPHAGAN P
®
1.5 eye drops CMI Version 3.0 – PI v5.0
Page 1 of 4
ALPHAGAN
P 1.5
EYE DROPS
[brimonidine tartrate 1.5 mg/mL]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ALPHAGAN
P 1.5 eye drops,
including how to use the eye
drops. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you using
ALPHAGAN
P 1.5 eye drops
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 THE
MEDICINE. You may need to read
it again.
WHAT ALPHAGAN
P 1.5
EYE DROPS ARE USED FOR
ALPHAGAN
P 1.5 eye drops are
used to lower raised pressure in
the eye and 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.
Eye 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 of
knowing that you have glaucoma
is to have your eye pressure, optic
nerve and visual field checked by
an eye specialist or optometrist.
If glaucoma is not treated it can
lead to serious problems, including
total blindness. In fact, untreated
glaucoma is one of the most
common causes of blindness.
ALPHAGAN
P 1.5 eye drops
lower the pressure in the eye by
decreasing the fluid produced and
helping t
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ALPHAGAN
®
P brimonidine tartrate Datasheet Version 7.0-CCDS v2.1
Page 1 of 10
1. PRODUCT NAME
ALPHAGAN
®
P 0.15% eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of ALPHAGAN® P 1.5 eye drops contains 1.5 mg brimonidine
tartrate,
equivalent to 0.99mg as brimonidine free base.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sterile ophthalmic solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALPHAGAN
®
P 1.5 eye drops are effective for lowering intraocular pressure in
patients with chronic open-angle glaucoma or ocular hypertension.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of ALPHAGAN
®
P 1.5 eye drops in the affected
eye(s) twice daily, approximately 12 hours apart.
If more than one topical ophthalmic medicine is to be used, other eye
drops should
not be used within five to ten minutes of using ALPHAGAN
®
P 1.5 eye drops.
In order to minimise systemic absorption of ALPHAGAN
®
P 1.5 eye drops, apply
pressure to the tear duct immediately following administration.
PAEDIATRIC USE
Safety and effectiveness of ALPHAGAN® P 1.5 eye drops in children has
not been
established, however during post-marketing surveillance, apnea,
bradycardia, coma,
hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory
depression, and
somnolence have been reported in neonates, infants, and children
receiving
brimonidine either for congenital glaucoma or by accidental oral
ingestion. Also see 4.3
Contraindications section.
USE IN PATIENTS WITH RENAL OR HEPATIC DISEASE
ALPHAGAN
®
P 1.5 eye drops have not been studied in patients with hepatic or
renal
impairment (see 4.4 Special warnings and precautions for use).
NEW ZEALAND DATA SHEET
ALPHAGAN
®
P brimonidine tartrate Datasheet Version 7.0-CCDS v2.1
Page 2 of 10
4.3 CONTRAINDICATIONS
ALPHAGAN
®
P 1.5 eye drops are contraindicated in patients with hypersensitivity
to
brimonidine tartrate or any of the excipients listed in section 6.1.
ALPHAGAN
®
P is
also contraindicate
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