Alphagan 0.2% w/v (2 mg/ml) eye drops, solution

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Brimonidine tartrate

متاح من:

Lexon (UK) Ltd

ATC رمز:

S01EA05

INN (الاسم الدولي):

Brimonidine tartrate

جرعة:

0.2 percent weight/volume

الشكل الصيدلاني:

Eye drops, solution

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

brimonidine

الوضع إذن:

Authorised

تاريخ الترخيص:

2017-03-31

نشرة المعلومات

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor
or pharmacist.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET:
What ALPHAGAN is and what it is used
for
What you need to know before you use
ALPHAGAN
How to use ALPHAGAN
Possible side effects
How to store ALPHAGAN
Contents of the pack and other information WHAT ALPHAGAN IS AND WHAT IT IS USED FOR
ALPHAGAN is used to reduce pressure within the
eye.
The active ingredient in ALPHAGAN is brimonidine
tartrate which belongs to a group of medicines
called alpha-2 adrenergic receptor agonists and
works by reducing pressure within the eyeball.
It can be used either alone, when beta-blocker eye
drops are contraindicated, or with another eye drop,
when a single medicine is not enough to lower the
increased pressure in the eye, in the treatment of
open angle glaucoma or ocular hypertension. WHAT YOU NEED TO KNOW BEFORE YOU USE ALPHAGAN
DO NOT USE ALPHAGAN
•
If you are allergic (hypersensitive) to brimonidine
tartrate or any of the other ingredients of this
medicine (listed in section 6).
•
If you are taking monoamine oxidase (MAO)
inhibitors or certain other antidepressants. You
must inform your doctor if you are taking any
antidepressant drug.
•
If you are breast-feeding.
•
In infants/babies (from birth until 2 years). WARNINGS AND PRECAUTIONS
Talk to your doctor before using ALPHAGAN
•
If you suffer or have suffered from depression,
reduced mental capacity, reduced blood supply to
the brain, heart problems, a disturbed blood
supply of the limbs or a blood pressure disorder.
•
If you have or have had in the past kidn

خصائص المنتج

Health Products Regulatory Authority
08 January 2021
CRN00C05R
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alphagan 0.2% w/v (2 mg/ml) eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 2.0 mg brimonidine tartrate, equivalent to
1.3 mg of brimonidine.
Excipient with known effect
Benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from Spain_
Clear, greenish-yellow to light greenish-yellow solution.
4 CLINICAL PARTICULARS
As per PA0148/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0148/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Poly (vinyl alcohol)
Sodium chloride
Sodium citrate
Citric acid monohydrate
Purified water
Sodium hydroxide or hydrochloric acid for pH adjustment
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
After first opening use within 28 days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Health Products Regulatory Authority
08 January 2021
CRN00C05R
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic bottle containing 5ml of eye drop solution.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/015/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
March 2017
10 DATE OF REVISION OF THE TEXT
January 2021