BETAGAN® UNIT DOSE

(Levobunolol hydrochloride 0.5%)

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before you start to use your medicine.

IF YOU HAVE DIFFICULTY IN READING THIS PATIENT INFORMATION LEAFLET AND WOULD LIKE A LARGE PRINT VERSION, PLEASE CONTACT THE MEDICAL INFORMATION MANAGER AT ALLERGAN (UK) ON               01494 444722       .

If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

• The active ingredient in Betagan Unit Dose is: Levobunolol hydrochloride 0.5% w/v
• It also contains: Liquifilm® (polyvinyl alcohol), disodium edetate, sodium phosphate dibasic, potassium phosphate monobasic, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH) and purified water.
• Betagan Unit Dose is a sterile eye drop and each vial contains 0.4 ml of the medicine. Each pouch contains five vials. This pack contains 30 vials.
• Betagan Unit Dose works by reducing the pressure in the eyeball.

Betagan Unit Dose is used to treat eye conditions, including glaucoma, where there is increased pressure in the eye.

Before you use this medicine

Tell your doctor:

• (a) If you suffer from, or have in the past suffered from, asthma, bronchitis, emphysema, any other lung disease or heart disease. In these cases, Betagan Unit Dose should not be used.
• (b) If you are pregnant or breast-feeding.
• (c) If you are using any other medication, whether it has been purchased from a chemist or pharmacist, or prescribed for you by a doctor.
• (d) If you are allergic to any of the ingredients; Betagan Unit Dose should not be used in this case.
• (e) If you are using any medication to treat high blood pressure. It is possible that the combination of your medication with Betagan may further lower your blood pressure and pulse rate. If you are using oral beta-blockers this may have the effect of further lowering the pressure of your eye.

A small amount of Betagan applied to the eye may be absorbed by the body.

Dosage

The recommended adult dose is one drop of Betagan Unit Dose once or twice daily in the affected eye(s). Follow the instructions on your prescription label carefully, and ask your doctor or pharmacist to explain anything that you do not understand. This medicine controls, but does not cure, conditions such as glaucoma.
To be effective it must be used every day. It may be necessary to use another drug with Betagan Unit Dose to control your condition.
Use in children is not currently recommended.

How to use the product

Betagan Unit Dose comes as eyedrops. Your prescription label tells you how many drops to use at each dose.
Apply your eye drops in the following way:

• 1. Twist off the tab to open the vial.
• 2. Tilt your head back and look at the ceiling.
• 3. Gently pull the lower eyelid down until there is a small pocket.
• 4. Squeeze the upturned vial to release a drop into your eye.
• 5. Release the lower lid, and close your eye for 30 seconds.

Avoid touching the vial tip against your eye or anything else.
Discard vial after use.
The proper application of your eye drops is very important.
If you have any questions ask your doctor or pharmacist.

Overdosage

If you accidentally place too many drops in your eye(s), wash the eye(s) with water. Apply your next dose at the normal time. The application of too many drops is, however, unlikely to lead to unwanted side-effects.
If the medicine is drunk by accident, contact your doctor.

Missed doses

If you forget to use 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, Betagan Unit Dose can cause unwanted effects in some users. You may experience mild stinging and/or burning when the drops are applied.
If you experience any of the following you should see your doctor:

• Redness or itching of the eyes and swelling of the eyelids
• Difficulty in breathing
• Wheezing or shortness of breath
• Slow or irregular heartbeat
• Faintness or dizziness
• Headache
• Excessive tiredness
• Jerky and irregular movements
• Skin rash
• Itching
• Changes in liver function
• Stroke
• Cardiac arrest
• Heart failure
• Nausea
• Depression

You should also see your doctor if you experience any other unusual or unexpected effects.
Contact your doctor if your eyesight worsens or if you have eye pain.

Storage

Keep the medicine in a safe place out of the reach of children.
Store the medicine at or below 25°C (room temperature) and keep the vials in the pouch, protected from light.

Warnings

The product should not be used after the expiry date. (The expiry date is printed on both the vial and the pouch and on the top of the carton that the pouches are packed in.)
This medicine is for your use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

Further information

You may obtain further information from your doctor or pharmacist, who have more detailed information about 'Betagan Unit Dose' and your eye condition.