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

• 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.

1. What ALPHAGAN is and what it is used for
2. What you need to know before you use ALPHAGAN
3. How to use ALPHAGAN
4. Possible side effects
5. How to store ALPHAGAN
6. Contents of the pack and other information

• 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).

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 kidney or liver problems.

ALPHAGAN is not recommended for use in children between the ages of 2 and 12 years.

ALPHAGAN should not usually be used in adolescents aged 12 to 17 as clinical studies have not been performed in this age group.

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use ALPHAGAN if you are pregnant unless your doctor considers it necessary.

ALPHAGAN should not be used while breast-feeding.

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.

ALPHAGAN contains 0.25 mg benzalkonium chloride in each 5 ml of solution which is equivalent to 0.05 mg/ml.

Benzalkonium chloride is a preservative which may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart. Do not change the dose or stop taking ALPHAGAN without speaking to your doctor.

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).

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. 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.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Replace and tighten the cap straight after use.

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 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.

To be effective ALPHAGAN must be used every day. Do not stop using ALPHAGAN until your doctor tells you to.

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:

• United Kingdom

• Ireland

• Malta

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

• The active substance is brimonidine tartrate. One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other ingredients are benzalkonium chloride as a preservative, poly(vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide or hydrochloric acid for pH-adjustment.

ALPHAGAN is a clear, greenish-yellow to light greenish-yellow eye drop solution in a plastic bottle. Each bottle contains either 2.5 ml, 5 ml or 10 ml of the medicine.

ALPHAGAN is available in packs of 1, 3 or 6 bottles. Not all pack sizes may be marketed.

UK

Malta

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Alphagan 0,2% Augentropfen

Germany Alphagan 0,2 % m/V (2 mg/ml) Augentropfen

Belgium, Finland, Greece, Iceland, Luxembourg, Norway, Portugal Alphagan

Denmark, Ireland, Italy, Netherlands, Sweden, United Kingdom Alphagan 0.2%

France ALPHAGAN 0,2% (2mg/ml), collyre en solution

Spain Alphagan 2 mg/ml colirio en solución