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 BETAGAN is and what it is used for
• 2. Before you use BETAGAN
• 3. How to use BETAGAN
• 4. Possible side effects
• 5. How to store BETAGAN
• 6. Further information

Do not use BETAGAN

• If you are allergic (hypersensitive) to:
  levobunolol
  benzalkonium chloride
  other ingredients listed in section 6
• If you have or have had asthma or other lung diseases (e.g. emphysema) where you have difficulty breathing, wheezing or a chronic cough
• If you have heart problems such as heart weakness, heart beat disorders or cardiac failure
• If you have chest pain when resting (Prinzmetal’s angina)
• If you have a tumour of the adrenal glands (these are near your kidneys) which results in high blood pressure which has not been treated
• If a blood test suggests that you have too much acidity in the blood
• If you suffer from low blood pressure

BETAGAN is not recommended for use in children

Take special care with BETAGAN

Talk to your doctor before using BETAGAN if you suffer from, or have in the past suffered from:

• breathing problems
• heart problems
• diabetes
• thyroid problems
• poor circulation
• any allergies (since beta blockers can make these worse)

If you have a history of breathing problems or heart disease or diabetes your doctor may monitor you more closely.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Tell your doctor before using BETAGAN if you are taking oral beta blockers.

BETAGAN is also a beta blocker. Therefore your doctor needs to know whether there is likely to be a risk of having too much beta blocker in your system.

Pregnancy and breast-feeding

Tell your doctor before you start using BETAGAN if you are pregnant or planning to become pregnant or if you are breast-feeding.

BETAGAN should not be used during pregnancy or breast-feeding unless your doctor, having considered all the risks, still recommends BETAGAN for you.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

BETAGAN may cause dizziness, tiredness or temporary blurred vision. Do not drive or use tools or machinery until these symptoms have cleared.

Important information about some of the ingredients of BETAGAN

Contact lenses

• Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
• A preservative in BETAGAN (called benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.

Instructions for use

• You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. Apply your eye drops in the following way:

• 1. Wash your hands. Tilt your head back and look at the ceiling.
• 2. Gently pull the lower eyelid down until there is a small pocket.
• 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
• 4. Whilst keeping the eye closed, press your finger against its corner (where the eye meets the nose) and hold for 30 seconds.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the dropper touch your eye or anything else.

Replace and tighten the cap straight after use.

Wipe off any excess liquid from your cheek with a clean tissue.

The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist.

If you use more BETAGAN than you should

Putting too many drops in your eye(s) is unlikely to lead to unwanted side-effects. If you have placed too many drops in your eye(s), wash your eyes with clean water. Put your next dose in at the usual time.

If, by accident, anyone drinks this medicine, contact your doctor straight away.

If you forget to use BETAGAN

If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then apply your next dose as usual and continue with your normal routine.

Do not use a double dose to make up for a forgotten dose.

If you stop using BETAGAN

Do not stop using BETAGAN or reduce the amount you are using until your doctor tells you to, since your symptoms may get worse.

You should contact your doctor or go to a hospital immediately if you experience:

• rash, swallowing or breathing difficulties, swelling of your lips, face, throat or tongue (these could be signs of a serious allergic reaction)
• breathing difficulties
• unusual heart beat
• slow heart beat
• chest pain
• low blood pressure

The above side effects are serious and in rare cases can be life-threatening.

You should see your doctor if any of the following effects prove troublesome or if they are long-lasting:

• poor vision
• eye burning or eye stinging
• itchiness and/or redness of the eye
• eye and/or eyelid swelling/puffiness
• inflamed eyelid, iris and inner and outer eye
• dry eye
  
  
• allergic reaction or hypersensitivity
• skin rashes and itching
  
  
• headache
• dizziness (for a short while)
• difficulty with balance (for a short while)
• tingling or numbness of the hands or feet
  
  
• feeling very tired
• sleep disturbances
• hallucinations
• confusion
• depression
• feeling sick or vomiting or diarrhoea
• erection problems

What BETAGAN contains

• The active substance is Levobunolol hydrochloride 0.5% w/v
• The other ingredients are benzalkonium chloride, disodium edetate, polyvinyl alcohol, sodium chloride, sodium phosphate dibasic heptahydrate, potassium phosphate monobasic, sodium metabisulphite, sodium hydroxide or hydrochloric acid (to adjust pH) and purified water

What BETAGAN looks like and contents of the pack

BETAGAN is a colourless to light yellow solution in a white plastic bottle.

Each pack contains 1 or 3 plastic bottles, each with a screw cap.

If you have been given a bottle containing 5 millilitres of solution then this bottle will be approximately half full. Alternatively, if you have been given a bottle containing 10 millilitres of solution then this bottle will be approximately two-thirds full.

Not all pack sizes may be marketed.

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