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ALPHAGAN EYE DROPS

Active substance(s): BRIMONIDINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ALPHAGAN® EYE DROPS
BRIMONIDINE TARTRATE 0.2% EYE DROPS
(brimonidine tartrate)

Your medicine is avaliable using one of the above names but will
be referred to as Alphagan throughout the leaflet.

Read all of this leaflet carefully before you
start using this medicine.






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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Alphagan is and what it is used for
Before you use Alphagan
How to use Alphagan
Possible side effects
How to store Alphagan
Further information

1. What Alphagan is and what it is used for
Alphagan is used to reduce pressure within the eye.
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. The
active ingredient in Alphagan is brimonidine tartrate, which works
by reducing pressure within the eyeball.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Tell your doctor if you are taking any of the following medicines:

pain killers, sedatives, opiates, barbiturates or are regularly
consuming alcohol.

anaesthetics.

to treat a heart condition or to lower blood pressure.

that can affect the metabolism like chlorpromazine,
methylphenidate and reserpine.

which work on the same receptor as Alphagan, for example
isoprenaline and prazosin.

monoamine oxidase (MAO) inhibitors and other
antidepressants.

medicines for any condition, even if unrelated to your eye
condition.

or if the dose of any of your current medicines is changed.
These could affect your treatment with Alphagan.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any
medicine. Tell your doctor if you are pregnant or planning to
become pregnant.
Alphagan should not be used while breast-feeding.

Driving and using machines




Alphagan may cause blurred or abnormal vision. This effect
may seem worse at night or in reduced lighting.
Alphagan may also cause drowsiness or tiredness in some
patients.
If you experience any of these symptoms, do not drive or
use machinery until the symptoms are cleared.

Important information about some of the
ingredients of Alphagan

2. Before you use Alphagan

A preservative in Alphagan (benzalkonium chloride) may cause eye
irritation and is also known to discolour soft contact lenses.
Therefore, avoid contact with soft lenses. If you wear soft contact
lenses take them out before using these eye drops and then wait
15 minutes after using Alphagan before inserting your lenses.

Do not use Alphagan

3. How to use Alphagan



Always use Alphagan exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.






If you are allergic (hypersensitive) to brimonidine tartrate or
any of the other ingredients of Alphagan.
If you are taking monoamine oxidase (MAO) inhibitors or
certain 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).

Take special care with Alphagan

Before you take this medicine, tell your doctor:

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 kidney or liver problems.

If being given to a child between the age of 2 and 12 years
because Alphagan is not recommended for use in this age
group.

Instructions for use

Alphagan comes as eye drops. Always wash your hands before
applying eye drops. Your prescription label tells you how many
drops to use at each dose. If you use Alphagan with another eye
drop, wait 5-15 minutes before applying the second eye drop.
Apply your eye drops in the following way:

Adults

The usual dose is one drop twice daily in the affected eye(s),
approximately 12 hours apart.

Children under 12 years

Alphagan must not be used for infants below 2 years of age.
Alphagan is not recommended for use in children (from 2 years
until 12 years).

Page 1 of 2

1.
2.
3.
4.

Tilt your head back and look at the ceiling.
Gently pull the lower eyelid down until there is a small pocket.
Squeeze the upturned dropper bottle to release a drop into
your eye.
Whilst keeping the affected eye closed, press your finger
against the corner of the closed eye (the side where the eye
meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else.
Replace and tighten the cap straight after use.

If you use more Alphagan than you should
Adults

In adults who were instilling more drops than prescribed, the side
effects reported were those already known to occur with Alphagan.

Adults who accidentally swallowed Alphagan experienced decrease
in blood pressure, which in some patients was followed by the
increase in blood pressure.

Children

Serious side effects were reported in children who accidentally
swallowed Alphagan. Signs included sleepiness, floppiness, low
body temperature, paleness and breathing difficulties. Should this
happen, contact your doctor immediately.

Adults and Children

If Alphagan has been accidentally swallowed or if you have used
more Alphagan than you should, please contact your doctor
immediately.

If you forget to use Alphagan

If you forget to take a dose, apply it as soon as you remember. If,
however, it is almost time for your next dose, you should omit the
missed dose altogether and then follow your normal routine.

If you stop using Alphagan

To be effective Alphagan must be used every day. Do not stop
using Alphagan until your doctor tells you to. If you have any
further questions on the use of this product, ask your doctor or
pharmacist.

Uncommon:





Depression
Palpitations or changes in heart rate
Dry nose
General allergic reactions.

4. Possible side effects

Rare:

Like all medicines, Alphagan can cause side effects, although not
everybody gets them. The chance of having a side effect is
described by the following categories:

Very rare:

Very common
Common
Uncommon
Rare
Very rare

Occurs
Occurs
Occurs
Occurs
Occurs

in
in
in
in
in

more than 1 out of 10 patients
fewer than 1 out of 10 patients
fewer than 1 out of 100 patients
fewer than 1 out of 1,000 patients
fewer than 1 out of 10,000 patients

The following eye side effects may be seen with Alphagan.








Alphagan is a clear eyedrop solution.

Each bottle contains 5ml of the medicine.

Manufacturer

Manufactured by: Allergan, Hormigueros, Puerto Rico.
And
Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.

Shortness of breath

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Sleeplessness
Fainting
High blood pressure
Low blood pressure

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

Side effects where the occurrence is unknown:


What Alphagan looks like and contents of the pack

Skin reactions including redness, face swelling, itching, rash
and widening of blood vessels

PL No: 08929/0035

POM

Leaflet revision and issue date (Ref): 15.01.15

Reporting of side effects

Alphagan® is a registered trademark of Allergan Inc.

Very common:

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.




By reporting side effects you can help provide more information on
the safety of this medicine.

For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder:
Allergan Ltd., The Parkway, Marlow, Bucks, SL7 1YL
United Kingdom
Tel: +44 (0)1628 494026
e-mail: uk_medinfo@allergan.com

Affecting the eye


Irritation of the eye (eye redness, burning, stinging, a feeling
of something in the eye, itching, follicles or white spots on
the see-through layer which covers the surface of the eye)
Blurred vision
An allergic reaction in the eye

Common:









Local irritation (inflammation and swelling of the eyelid,
swelling of the see-through layer which covers the surface of
the eye, sticky eyes, pain and tearing)
Sensitivity to light
Erosion on the surface of the eye and staining
Eye dryness
Whitening of the see-through layer which covers the surface
of the eye
Abnormal vision
Inflammation of the see-through layer which covers the
surface of the eye

Very rare:



Inflammation within the eye
Reduction in pupil size

5. How to store Alphagan










Side effects where the occurrence is unknown:


Itching of eyelids

Affecting the body
Very common:




Headache
Dry mouth
Tiredness/drowsiness

6. Further information
What Alphagan contains


Common:







Dizziness
Cold-like symptoms
Symptoms involving the stomach and digestion
Abnormal taste
General weakness

Keep out of the sight and reach of children.
Store the bottle at or below room temperature (25°C).
Do not use the bottle if the tamper-proof seal on the bottle is
broken before first use. The product should not be used after
the expiry date (This is printed on both the bottle label and
on the carton the bottle is packed in). The expiry date refers
to the last day of that month.
Throw the bottle away 28 days after opening, even if
there is solution remaining.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any
other signs of deterioration, take it to your pharmacist who
will advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



The active ingredient is brimonidine tartrate 0.2% w/v
(2.0mg/ml) equivalent to brimonidine base 0.13% w/v
(1.3mg/ml).
One ml solution contains 2mg of brimonidine tartrate
equivalent to 1.3mg brimonidine base.
It also contains benzalkonium chloride as a preservative,
polyvinyl alcohol 1.4% (14mg/ml), sodium chloride,
sodium citrate dihydrate, citric acid monohydrate,
purified water, hydrochloric acid or sodium hydroxide to
adjust pH.
Page 2 of 2

Further information about glaucoma is available from:
International Glaucoma Association (IGA)
Tel: 01233 64 81 70
Fax: 01233 64 81 79
Email: info@iga.org.uk
(The IGA is an organisation which helps glaucoma patients and
their relatives, and is not associated with Allergan.)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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