Brimonidine 0.2% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Brimonidine tartrate

Available from:

FDC International Ltd

ATC code:

S01EA05

INN (International Name):

Brimonidine tartrate

Dosage:

2mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5050135001194

Patient Information leaflet

BRIMONIDINE TARTRATE
0.2% w/v Eye drops
Brimonidine tartrate
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor, pharmacist or
nurse.
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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.
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If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
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Your medicine, Brimonidine Tartrate 0.2% w/v Eye Drops will be
referred to as Brimonidine in this leaflet.
What is in this leaflet:
1. What Brimonidine is and what it is used for
2. What you need to know before you use Brimonidine
3. How to use Brimonidine
4. Possible side effects
5. How to store Brimonidine
6. Contents of the pack and other information
1. WHAT BRIMONIDINE IS AND WHAT IT IS USED FOR
Brimonidine Eye Drops are a sterile, preserved, aqueous solution used
as eye drops. The active ingredient
brimonidine tartrate works by reducing pressure within the eyeball. It
is used to reduce pressure in the eye in the
conditions of glaucoma or ocular hypertension. The medicine may be
used alone or in conjunction with another
eye drop that reduces pressure in the eye.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRIMONIDINE
Do not use Brimonidine
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if you are allergic (hypersensitive) to Brimonidine or any of the
other ingredients of this medicine (listed in
section 6).
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if you are taking a monoamine oxidase (MAO) inhibitors medicine or a
tricyclic antidepressants medicine
(you should check with your doctor if you are taking any medicines for
depression)
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if you are breast feeding
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in new born babies or children under 2 years
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Brimonidine
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if you suffer from depression
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if you suffer from heart disease or heart problems
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if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Brimonidine Tartrate 0.2% w/v Eye Drops.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Brimonidine tartrate 0.2% w/v (2.0 mg/ml).
Excipients include Benzalkonium chloride 0.005% w/v.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, greenish-yellow solution.
4.1
THERAPEUTIC INDICATIONS
For reduction of elevated intraocular pressure (IOP) in patients with
open
angle glaucoma or ocular hypertension.
-
As monotherapy in patients in whom topical beta-blocker therapy is
contra-
indicated.
-
As adjunctive therapy to other intraocular pressure lowering
medications
when the target intraocular pressure is not achieved with a single
agent. (See
section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
No clinical studies have been performed in adolescents (12 to 17
years).
Brominidine eye drops shoud not be used in children aged below 12
years and are
contraindicated in neonates and infants (less than 2 years of age)
(see sections 4.3, 4.4
& 4.9). It is known that severe adverse reactions can occur in
neonates. The safety and
efficacy of brimonidine has not been established in children.
_Adults including the elderly: _
One drop into the affected eye(s) twice daily, approximately 12 hours
apart.
No dosage adjustment is required in elderly patients.
To reduce possible systemic absorption, it is recommended that the
lachrymal sac be
compressed at the medial canthus (punctul occlusion) for one minute
immediately
after the instillation of each drop.
If more than one topical ophthalmic drug is to be administered, they
should be
instilled 5 to 15 minutes apart.
_Patients with renal and hepatic impairment: _
Brimonidine eye drops have not been studied in patients with renal or
hepatic
impairment (see section 4.4).
Method of administration
_Precautions to be taken before handling or administering the
medicinal product _
_ _
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s)