BETAGAN® 0.5% w/v Unit Dose Eye Drops, Solution
1. What BETAGAN is and what it is used for
2. What you need to know before you use BETAGAN
3. How to use BETAGAN
4. Possible side effects
5. How to store BETAGAN
6. Further information
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.
BETAGAN is not recommended for use in children
Talk to your doctor before using BETAGAN if you suffer from, or have in the past suffered from:
If you have a history of breathing problems or heart disease your doctor may monitor you more closely as in rare cases death has been reported following taking levobunolol.
If you suffer from allergies, or have a severe allergic reaction be aware that the usual dose of adrenaline may need to be increased.
If you need to have a general anaesthetic, tell your doctor or dentist that you are using BETAGAN.
Tell your doctor or pharmacist if you are using or have recently used any other medicines.
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:
It is important to tell your doctor before using BETAGAN, if you are taking;
If the dose of any of your current medicines is changed you should tell your doctor.
Tell your doctor before you start using BETAGAN if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
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.
BETAGAN may cause tiredness, dizziness or blurred/abnormal vision. Do not drive or use machinery until these symptoms have cleared.
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.
Remove contact lenses prior to application and wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
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 two minutes.
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.
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 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.
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.
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
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:
Common side effects:
Side effects with unknown frequency:
Like other medicines applied into the eyes, levobunolol is absorbed into the blood. This may cause similar side effects as seen with ‘intravenous’ and/ or ‘oral’ beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are taken by mouth or injected. The side effects listed below include additional reactions seen within the class of beta-blockers when used for treating eye conditions:
Other side effects reported with eye drops containing phosphates:
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
By reporting side effects you can help provide more information on the safety of this medicine.
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.
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. Two strips of 5 single-dose containers are, presented in foil covered pouches. Each container has 0.4 millilitres of eye drops inside.
Not all pack sizes may be marketed.
If you would like further information or require this leaflet in a large print format, please contact Medical Information at Allergan Ltd., UK on Tel: +44 1628 494026 or E-mail: firstname.lastname@example.org
Further information about glaucoma is available from:
(The IGA is an organisation which helps glaucoma patients and their relatives, and is not associated with Allergan.)