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ALPHAGAN 0.2% EYE DROPS

Active substance(s): BRIMONIDINE TARTRATE

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Alphagan® 0.2% w/v Eye Drops, Solution
(Brimonidine tartrate)

Patient Information Leaflet
Your medicine is known by the above name but will be referred to as
Alphagan throughout this 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) What Alphagan is and what it is used for
2) Before you use Alphagan
3) How to use Alphagan
4) Possible side effects
5) How to store Alphagan
6) 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.

2) Before you use Alphagan
Do not use Alphagan
• 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.
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
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.

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.
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).
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:
1.

2.

3.

4.

1. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Squeeze the upturned dropper bottle to release a drop into your eye.
4. 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.

4) Possible side effects
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 common

Occurs in more than 1 out of 10 patients

Common

Occurs in fewer than 1 out of 10 patients

Uncommon

Occurs in fewer than 1 out of 100 patients

Rare

Occurs in fewer than 1 out of 1,000 patients

Very rare

Occurs in fewer than 1 out of 10,000 patients

The following eye side effects may be seen with Alphagan.
Affecting the eye
Very common:
• 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
Side effects where the occurrence is unknown:
• Itching of eyelids
Affecting the body
Very common:
• Headache
• Dry mouth
• Tiredness/drowsiness
Common:
• Dizziness
• Cold-like symptoms
• Symptoms involving the stomach and digestion
• Abnormal taste
• General weakness
Uncommon:
• Depression
• Palpitations or changes in heart rate,
• Dry nose
• General allergic reactions.

Rare:
• Shortness of breath
Very rare:
• Sleeplessness
• Fainting
• High blood pressure
• Low blood pressure
Side effects where the occurrence is unknown:
• Skin reactions including redness, face swelling, itching, rash and
widening of blood vessels
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Alphagan
• Do not use after the expiry date printed on the carton or bottle label.
°
• Alphagan 0.2% Eye Drops should not be stored above 25 C.
• Do not use the bottle if the tamper-proof seal on the bottle is broken
before first use.
• Throw the bottle away 28 days after opening, even if there is
solution remaining.
• Keep out of the sight and reach of children.
• If your doctor tells you to stop using the solution, please take it back to the
pharmacist for safe disposal. Only keep the solution if your doctor tells
you to.
• If the solution becomes discolored or shows signs of any other
deterioration, you should seek the advice of your pharmacist who will
advise you what to do.
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.

6) Further information
What Alphagan contains:
• The active ingredient in Alphagan 0.2% Eye Drops is Brimonidine tartrate
0.2% w/v (2.0mg/ml) equivalent to brimonidine base 0.13% w/v
(1.3mg/ml).
• Alphagan 0.2% Eye Drops also contains benzalkonium chloride as a
preservative, Liquifilm (polyvinyl alcohol), sodium chloride, sodium citrate
dihydrate, citric acid monohydrate, purified water and sodium hydroxide or
hydrochloric acid to adjust pH.
What Alphagan looks like and content of the pack
Alphagan 0.2% Eye Drops is a clear colorless to light yellow sterile
ophthalmic solution and each bottle contains 5ml of the medicine.
Each 5ml white plastic dropper bottle has a purple screw on compliance cap
and tamper evident seal.
PL 10383/0759

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Allergan Pharmaceuticals (Ireland) Ltd.;
Castlebar Road Westport, Co Mayo Ireland. Procured from within the EU
and repackaged by the Product Licence holder: Primecrown Ltd., 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 29.04.2015
Alphagan is a registered trademark of Allergan Inc., USA.

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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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