ALPHAGAN P

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRIMONIDINE TARTRATE

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

S01EA05

Pharmaceutical form:

OPHTHALMIC SOLUTION

Composition:

BRIMONIDINE TARTRATE 0.15 %W/V

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN INC., USA

Therapeutic group:

BRIMONIDINE

Therapeutic area:

BRIMONIDINE

Therapeutic indications:

Alphagan is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Authorization date:

2014-06-30

Patient Information leaflet

ALP APL APR 23 CL
Page 1 of 6
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
ALPHAGAN
® P
OPHTHALMIC SOLUTION
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
brimonidine tartrate 0.15% w/v
Inactive ingredients and allergens in this medicine: See section 6
’
Additional
information
‘.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others. It may harm them, even if it seems to you that their
illness/medical condition
is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Alphagan P is indicated for lowering intraocular pressure (IOP) in
patients with open
angle glaucoma or ocular hypertension.
THERAPEUTIC GROUP:
alpha-adrenergic receptor agonists.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
−
You are sensitive (allergic) to the active ingredient brimonidine
tartrate or any of
the other ingredients in this medicine (listed in section 6
’
Additional
information
’
).
−
In neonates and infants (under the age of 2 years).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TREATMENT WITH ALPHAGAN P, TELL YOUR DOCTOR IF:
ALP APL APR 23 CL
Page 2 of 6
•
You have, or had in the past kidney or liver problems.
•
You have, or had in the past heart problems.
•
You are suffering, or have suffered in the past, from depression,
decreased mental
capacities, decreased blood supply to the brain, or a blood pressure
disorder.
•
You are suffering, or have suffered in the past, from blood
circulation problems
which make the toes and fingers numb and pale. This is called
Raynaud’s
phenomenon.
CHILDREN AND ADOLESCENTS
Do not use Alphagan P in neonates and infants under the age of 2
years.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES

Summary of Product characteristics

ALP API APR 23 CL
Page
1
of
6
1
NAME OF THE MEDICINAL PRODUCT
ALPHAGAN
® P
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
brimonidine tartrate 0.15% w/v
For the full list of excipients, see section 12.
3
PHARMACEUTICAL
FORM
ophthalmic solution
4
INDICATIONS AND USAGE
ALPHAGAN® P
is indicated for lowering intraocular pressure (IOP) in patients with
open-angle
glaucoma or ocular hypertension.
5
DOSAGE AND ADMINISTRATION
The recommended dose is one drop of
ALPHAGAN
® P
in the affected eye(s) three times daily,
approximately 8 hours apart.
ALPHAGAN
® P
ophthalmic solution may be used concomitantly with
other topical ophthalmic drug products to lower intraocular pressure.
If more than one topical ophthalmic
product is to be used, the different products should be instilled at
least 5 minutes apart.
6
CONTRAINDICATIONS
6.1
NEONATES AND INFANTS (UNDER THE AGE OF 2 YEARS)
ALPHAGAN
® P
is contraindicated in neonates and infants (under the age of 2 years).
6.2
HYPERSENSITIVITY REACTIONS
ALPHAGAN
® P
is contraindicated in case of hypersensitivity to the active substance
or to any of the
excipients listed in section 12.
7
WARNINGS AND PRECAUTIONS
7.1
POTENTIATION OF VASCULAR INSUFFICIENCY
ALPHAGAN
® P
may potentiate syndromes associated with vascular insufficiency.
ALPHAGAN
® P
should be used with caution in patients with depression, cerebral or
coronary insufficiency, Raynaud
’
s
phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
7.2
SEVERE CARDIOVASCULAR DISEASE
Although brimonidine tartrate ophthalmic solution had minimal effect
on the blood pressure of patients in
clinical studies, caution should be exercised in treating patients
with severe cardiovascular disease.
7.3
CONTAMINATION OF TOPICAL OPHTHALMIC PRODUCTS AFTER USE
There have been reports of bacterial keratitis associated with the use
of multiple-dose containers of
topical ophthalmic products. These containers had been inadvertently
contaminated by patients who, in
most cases, had a concurrent corneal disease or a disruption of the
ocular ep