BETAGAN 0.5% w/v Unit Dose Eye Drops, Solution
Levobunolol hydrochloride
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
What BETAGAN is and what it is used for
BETAGAN is an eye drop. It is used to treat glaucoma by lowering the pressure that builds up in the eye.
Your eyeball contains a watery liquid, which is constantly being drained out of the eye, and new liquid is made to replace this. Glaucoma can occur when the liquid does not drain out quickly enough. This leads to raised pressure within the eyeball which can eventually damage your sight. BETAGAN works by reducing the production of liquid. This reduces the pressure inside the eye.
BETAGAN belongs to a group of medicines called beta blockers.
Before you use BETAGAN
Do not use BETAGAN
- If you are allergic (hypersensitive) to:
levobunolol
other ingredients listed in section 6 - If you have or have had asthma or other lung diseases where you have difficulty breathing, wheezing or a chronic cough
- If you have or have had heart problems such as heart weakness or heart beat disorders.
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:
- asthma
- breathing problems
- heart problems (including cardiac failure and slow heart beat)
- poor circulation
- diabetes or low blood sugar (hypoglycaemia)
- any allergies (since beta blockers can make these worse)
- skin problems
- alopecia (hair loss)
If you have a history of breathing problems or heart disease 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 to lower blood pressure.
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. The following symptoms could result from such a risk:
- low blood pressure (for example, upon standing)
- slow heart beat
- dizziness/temporary loss of consciousness
- low pressure in the eye ball
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 it for you.
Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
BETAGAN may cause tiredness, dizziness or blurred/abnormal vision (especially at night or in reduced lighting). Do not drive or use machinery until these symptoms have cleared.
How to use BETAGAN
Always use BETAGAN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is 1 drop into the affected eye(s), 1 to 2 times a day.
Instructions for use
- Wash your hands. Open one of the foil covered pouches containing five single-dose ('Unit Dose') containers which are arranged in a strip. Make sure that the single-dose container you intend to use is intact. The solution should be used immediately after opening.
Apply your eye drops in the following way:
- 1. Tear one single-dose container from the strip.
- 2. Hold the single-dose container upright (with the top uppermost) and twist off the top.
- 3. Tilt your head back and look at the ceiling. Gently pull the lower lid down until there is a small pocket. Turn the single-dose container upside down and squeeze it to release a drop into each eye that needs treatment.
- 4. Whilst keeping the treated eye closed, press your finger against its corner (where the eye meets the nose) and hold for one minute.
- 5. Repeat steps 3 and 4 for the other eye, if it also needs treatment.
If a drop misses your eye, try again.
To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
Each container should only be used once, so do not re-use even if there is solution remaining.
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.
BETAGAN should be used as advised by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, BETAGAN can cause side effects, although not everyone 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
Unknown: The chance of having a side effect is unknown
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 (including asthma)
- loss of consciousness (or feeling like this)
- unusual or slow heart beat
- low blood pressure
The above side effects are serious and in rare cases can be life-threatening.
The following side effects may be seen with BETAGAN:
Very common side effects:
- eye irritation
- irritation/redness of the outermost layer of the eye
Common side effects:
- inflammation of the eyelids and outermost layer of the eye
Side effects with unknown frequency:
- asthma
- breathing difficulties
- temporary loss of consciousness
- slow heart beat
- unusual or irregular heart beat
- low blood pressure
- allergic reaction
- swelling of the face
- decreased blinking
- inflammation of the iris and inner eye
- trouble with your vision
- itching of the eye/eye lids
- eye and/or eyelid swelling/puffiness
- eye discharge or tearing
- redness of the eye
- double vision
- drooping of the eye lid
- depression
- lack of coordination
- confusion
- dizziness
- sleepiness, decreased energy, weakness
- headache
- browache
- throat irritation
- nasal discomfort
- nausea
- belching
- blood tests may show increase in liver enzymes
- skin rashes, flaking, and itching
- rough patches of skin
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store BETAGAN
Keep out of the reach and sight of children.
Do not use BETAGAN after the expiry date which is stated on the single-dose container label, the foil covered pouch the container comes in and the carton after “EXP”. The expiry date refers to the last day of that month.
Store the BETAGAN single-dose containers in the pouch to protect them from light. Do not store above 25°C.
Make sure that the single-dose container is intact before use. Each container should only be used once. Do not re-use even if there is solution remaining.
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.
Further information
What BETAGAN contains
- The active substance is Levobunolol hydrochloride 0.5% w/v
- The other ingredients are poly(vinyl alcohol), sodium chloride, disodium edetate, sodium phosphate dibasic, heptahydrate, potassium phosphate monobasic, sodium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH) and purified water
What BETAGAN looks like and contents of the pack
BETAGAN is a colourless to brown solution in a plastic single-dose ('Unit Dose') container.
Each pack contains 30 or 60 of these single-dose containers, arranged in strips of 5, and presented in foil covered pouches. Each container has 0.4 millilitres of eye drops inside.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Further information about glaucoma is available from:
info@iga.org.uk
(The IGA is an organisation which helps glaucoma patients and their relatives, and is not associated with Allergan.)
This leaflet was last approved in September 2009.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Levobunolol 0.5% reference number PL 00426/0072.
This is a service provided by the Royal National Institute of Blind People.
© 2008 Allergan, Inc., Irvine CA 92612
Marks owned by Allergan, Inc.
Betagan 0 5% UD UK PIL 2009-09-23.doc
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