drug-medicine : alphagan

PATIENT INFORMATION LEAFLET

ALPHAGAN® 0.2% (2 mg/ml) eye drops, solution
(Brimonidine [(R,R)-tartrate] 0.2%)

Please read this leaflet carefully before you start to take your medicine. If you have any questions, or are not sure about anything, please ask your doctor or pharmacist.

What is ALPHAGAN®?

ALPHAGAN®'s active ingredient is Brimonidine [(R,R)-tartrate] 0.2% w/v (2.0mg/ml) equivalent to brimonidine base 0.13% w/v (1.3mg/ml).
It 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.
It is an eyedrop and each bottle contains 5 ml of the medicine.
The active ingredient in ALPHAGAN®, Brimonidine tartrate, works by reducing pressure within the eyeball.

What is ALPHAGAN® used for?

It is used to reduce pressure within the eye and can be used either alone or with another eyedrop which lowers pressure for the treatment of increased pressure in the eye in glaucoma or ocular hypertension.

When ALPHAGAN® should not be used

It must not be used by patients who are allergic to any of the ingredients. It should also not be used in patients receiving monoamine oxidase (MAO) inhibitors or patients on certain antidepressants. You must inform your doctor if you are taking any antidepressant drug. Furthermore, ALPHAGAN® should not be used by women who are lactating (i.e. producing milk) and neither should ALPHAGAN® be given to infants/babies.

Appropriate Precautions for Use

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 you are pregnant. ALPHAGAN® should not be used while breast-feeding.
If you drive a car or operate machinery as it may cause drowsiness / tiredness or blurred / abnormal vision in some patients. These effects may seem worse at night or in reduced lighting.
If you wear soft (hydrophilic) contact lenses.
If you are taking pain killers, sedatives or are regularly consuming alcohol.
If you are taking medicines to treat a problem with your metabolism or if you are taking drugs for a heart condition or to lower blood pressure.
If you are taking any other medication.

Whilst taking this medicine, tell your doctor:

If you are given any other medicines for any condition, even if unrelated to your eye condition.
If the dose of any of your current medicines is changed.

These could effect your treatment with ALPHAGAN®.

How to take your medication

Alphagan® is not recommended for use in children.
The recommended ALPHAGAN® dosage is to apply one drop twice daily, approximately 12 hours apart. If you use it with another eye drop, wait 5-15 minutes before applying the second eye drop.

Follow the instructions on your prescription label carefully, and ask your doctor or pharmacist to explain anything that you do not understand.
To be effective it must be taken every day.
If you wear soft contact lenses take them out before using these eye drops and then wait 15 minutes after instilling ALPHAGAN® before inserting your lenses, as the preservative in these eyedrops is known to discolour soft contact lenses. It may also cause eye irritation.

How to use the product

ALPHAGAN® comes as eyedrops. Always wash your hands before applying eye drops. Your prescription label tells you how many drops to use at each dose. Apply your eye drops in the following way:

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.

Overdosage

Adults
There is no experience in adults of an overdosage with ALPHAGAN® which is unlikely when given as eyedrops. If it has been swallowed then you should contact your doctor.

Babies
A few incidences of overdose have been reported in babies. Signs include sleepiness, floppiness, low body temperature and breathing difficulties.
If any of these occur, contact your doctor immediately.

Missed doses

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.

Side effects

As with all medicines, ALPHAGAN® can cause unwanted effects in some users. You may experience the following effects on your eye(s):
Very common: (These may affect more than 1 person in every 10 people)
An allergic reaction in the eye, follicles or white spots on the conjunctiva, blurred vision, eye redness, burning, stinging, a feeling of something in the eye or itching.
Common: (These may affect up to 9 people in every 100 people)
Changes to the surface of the eye, inflammation of the eyelid, inflammation of the conjunctiva, abnormal vision, sticky eyes, swelling of the eyelid or conjunctiva, sensitivity to light, irritation, eyelid redness, aching or pain, dryness, tears or, whitening of the conjunctiva.
Very rare: (Affecting less than 1 person in 10 thousand people)
Eye inflammation or a reduction in pupil size.
Some of these effects may be due to an allergy to the active ingredient or any of the other ingredients.

You may also experience the following effects in other parts of the body:
Very common: (These may affect more than 1 person in every 10 people)
Headache, tiredness/drowsiness and dry mouth.
Common: (These may affect up to 9 people in every 100 people)
Dizziness, gastrointestinal symptoms, cold-like symptoms, general weakness or abnormal taste.
Uncommon: (These may affect up to 9 people in every 1000 people):
General allergic reactions, depression, palpitations or changes in heart rate or dry nose.
Rare: (These may affect up to 9 people in 10 thousand people)
Shortness of breath.
Very rare: (Affecting less than 1 person in 10 thousand people)
Fainting, high or low blood pressure or sleeplessness.

If you experience these or any other side-effects with ALPHAGAN®, you should contact your doctor, and any severe and/or worsening effects should be reported as quickly as possible as the treatment may have to be stopped.

Storage

Keep the bottle in a safe place out of the reach and sight of children.
Do not store the bottle at a temperature above 25°C.

Warnings

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).
Throw the bottle away 28 days after opening, even if there is solution remaining.
This medicine is for your use only. It can only be prescribed by a doctor. Never give it to anyone else as it may harm them even if their symptoms are the same as yours.

Important:

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who have access to additional information.