Patient leaflet - BETAGAN 0.5% W/V UNIT DOSE EYE DROPS SOLUTION
Artwork Template 0361201
| abbvie Package leaflet: Information BETAGAN ® 0.5% w/v Unit Dose Eye D Levobunolol hydrochloride Read all of this leaflet carefully this medicine.
| for the user rops, Solution before you start using d to read it again. ns, ask your doctor or pharmacist. ribed for you. Do not pass it on ven if their symptoms are the erious, or if you notice any side lease tell your doctor or pharmacist. | Tell your doctor before you have a BETAGAN as levobunolol may ch used during anaesthesia. Other medicines and BETAGA Tell your doctor or pharmacist if y used any other medicines. Tell your doctor before using B beta blockers to lower blood pre BETAGAN is also a beta blocker. Th whether there is likely to be a risk o your system. The following sympto
It is important to tell your doctor befor | n operation that you are using ange effects of some medicines 1 u are using or have recently ETAGAN if you are taking oral ssure. erefore your doctor needs to know f having too much beta blocker in ms could result from such a risk: le, upon standing) nsciousness e using BETAGAN, if you are taking: | To avoid contamination , do not l single-dose container touch your e Each container should only be us even if there is solution remaining. Wipe off any excess liquid from yo The proper application of your eye have any questions ask your docto If you use more BETAGAN than Putting too many drops in your eye unwanted side-effects. If you have eye(s), wash your eyes with clean the usual time. If, by accident, anyone drinks th doctor straight away . If you forget to use BETAGAN If you forget a dose apply it as soo | t the open-end of the ye or anything else. ed once , so do not re-use r cheek with a clean tissue. drops is very important. If you r or pharmacist. you should (s) is unlikely to lead to placed too many drops in your water. Put your next dose in at is medicine, contact your n as you remember, unless it | |
| In this leaflet: | ||||||
1. What BETAGAN is and wha 2. What you need to know bef 3. How to use BETAGAN
4. Possible side effects
5. How to store BETAGAN
-
6. Further information
1. What BETAGAN is and wha
BETAGAN is an eye drop. It is us the pressure that builds up in the
Your eyeball contains a watery liq drained out of the eye, and new li Glaucoma can occur when the liq enough. This leads to raised pres eventually damage your sight. BE production of liquid. This reduces
BETAGAN belongs to a group of
t it is used for ore you use BETAGAN
t it is used for
ed to treat glaucoma by lowering eye.
uid, which is constantly being quid is made to replace this. uid does not drain out quickly sure within the eyeball which can TAGAN works by reducing the the pressure inside the eye.
medicines called beta blockers.
- medicines to treat high blood
- medicines for heart conditions such as beta blockers, amiod
- another eyedrop to lower pressur
- medicines to dilate your pupil,
- other beta blockers by mouth
- medicines to treat diabetes
If the dose of any of your current tell your doctor.
Pregnancy and breast-feeding Tell your doctor before you start us or breast-feeding, think you may b have a baby.
BETAGAN should not be used du unless your doctor, having conside it for you.
Ask your doctor or pharmacist for
pressure (hypertension)
(for example irregular heartbeat) rone or digoxin
in the eye (glaucoma)
for example adrenaline
or as an eye drop
edicines is changed you should
ing BETAGAN if you are pregnant pregnant or are planning to
ring pregnancy or breast-feeding red all the risks, still recommends
advice before using any medicine.
out the forgotten dose. Then apply continue with your normal routine.
Do not use a double dose to make
If you stop using BETAGAN
Do not stop using BETAGAN or red until your doctor tells you to, since
BETAGAN should be used as advi any further questions on the use of pharmacist.
4. Possible side effects
Like all medicines, BETAGAN can not everyone gets them. The chanc described by the following categori
your next dose as usual and
up for a forgotten dose.
uce the amount you are using your symptoms may get worse.
sed by your doctor. If you have this product, ask your doctor or
cause side effects, although e of having a side effect is es:
Very common
Occurs in more th;
in 1 out of 10 patients
Common
Occurs in fewer th
an 1 out of 10 patients
2. What you need to know bef
Do not use BETAGAN if
- you are allergic to:
levobunolol
any other ingredients (see
- you have or have had asthma example severe chronic obstru where you have difficulty breat
- you have or have had heart p beat, heart failure or heart be
BETAGAN is not recommende
Take special care with BETAG
Talk to your doctor before using B have in the past suffered from:
ore you use BETAGAN
section 6 “Further information”)
or other lung diseases (for
ctive pulmonary disease (COPD)) hing, wheezing or a chronic cough
roblems such as slow heart at disorders (irregular heart beat).
d for use in children
N
ETAGAN if you suffer from, or
Driving and using machines
BETAGAN may cause tiredness, di Do not drive or use machinery until
3. How to use BETAGAN
Always use BETAGAN exactly as y should check with your doctor or p usual dose is 1 drop into the affec
Remove contact lenses prior to a 15 minutes after using the eye dro back in your eyes.
Your doctor will usually check you starting treatment. It may be nece BETAGAN to control your conditio
Instructions for use
- Wash your hands. Open one of th two strips of five single-dose (‘Uni the single-dose container you inte
zziness or blurred/abnormal vision. these symptoms have cleared.
our doctor has told you. You harmacist if you are not sure. The ted eye(s), 1 to 2 times a day.
pplication and wait at least ps before putting your lenses
r eye pressure 4 weeks after ssary to use another drug with
n.
e foil covered pouches containing t Dose’) containers. Make sure that nd to use is intact. The solution
—Uncommon—
Occurs in fewer th
an 1 out of 100 patients----------
Rare
Occurs in fewer th
an 1 out of 1,000 patients
Very rare
Occurs in fewer th
an 1 out of 10,000 patients
Unknown
The chance of hav
ing a side effect is unknown
You should contact your doctor immediately if you experience:
- rash, swallowing or breathing d lips, face, throat or tongue (the allergic reaction)
- breathing difficulties (including
- loss of consciousness (or feelin
- unusual or slow heart beat
- low blood pressure
The above side effects are serio life-threatening.
or go to a hospital
ifficulties, swelling of your e could be signs of a serious
asthma) g like this)
us and in rare cases can be
- coronary heart disease (symptom breathlessness or choking), hear
- disturbances of heart rate suc
- asthma, breathing problems or c
- poor blood circulation diseas Raynaud’s syndrome)
- diabetes as levobunolol may low blood sugar
- overactivity of the thyroid glan signs and symptoms of this c
- any allergies (especially if any
- problems with the surface of y
- eye surgery to lower the press
If you have a history of breathing doctor may monitor you more clo been reported following taking le
If you suffer from allergies, or hav aware that the usual dose of adre
s can include chest pain or tightness, t failure, low blood pressure h as slow heart beat
hronic obstructive pulmonary disease (such as Raynaud’s disease or
mask the signs and symptoms of
d as levobunolol may mask the ondition
of the allergies are severe)
our eyes
ure in your eye(s)
problems or heart disease your sely as in rare cases death has obunolol.
e a severe allergic reaction be naline may need to be increased.
should be used immediately after
Apply your eye drops in the fo
1. jO 2.%i^s
-
1. Tear one single-dose containe
-
2. Hold the single-dose containe uppermost) and twist off the to
-
3. Tilt your head back and look at the until there is a small pocket. Turn th and squeeze it to release a drop int
-
4. Whilst keeping the treated eye c corner (where the eye meets th
-
5. Repeat steps 3 and 4 for the ot
If a drop misses your eye, try agai
opening.
lowing way: '
r from the strip.
r upright (with the top p.
ceiling. Gently pull the lower lid down e single-dose container upside down o each eye that needs treatment.
:losed, press your finger against its ■ e nose) and hold for two minutes.
her eye, if it also needs treatment.
n.
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Package leaflet:
Information for the user
BETAGAN ® 0.5% w/v Unit Dose Eye Drops, Solution
Levobunolol hydrochloride
7'577MD209N
| The following side effects may b Very common side effects:
Common side effects:
Side effects with unknown frequ
| e seen with BETAGAN: s and outermost layer of the eye ency: tion in the eye, decreased the iris and inner eye or surface ng of vision, small breaks in the lammation, itching of the eye/ swelling/puffiness, eye discharge ss and eczema of eyelids, dy in the eye r fast heart beat, fainting es, throat irritation, nasal discomfort numbness or discoloration of the iness, decreased energy, headache, |
Other side effects reported with e In very rare cases, some patients layer at the front of the eye (the co patches on the cornea due to calc Reporting of side effects If you get any side effects, talk to includes any possible side effects | |
| sleeping problems
Like other medicines applied into into the blood. This may cause si beta-blocking agents taken by m effects after topical ophthalmic ad medicines are taken by mouth or below include additional reaction blockers when used for treating e
| ness and itching, rough patches of skin tion (such as swelling, redness of kin) the eyes, levobunolol is absorbed milar side effects as seen with outh or injected. Incidence of side ministration is lower than when injected. The side effects listed s seen within the class of beta-ye conditions: tions including swelling beneath areas such as the face and limbs, ay which may cause difficulty severe sudden life-threatening | also report side effects directly via United Kingdom Yellow Card Scheme Website: By reporting side effects you can the safety of this medicine. | |
5. How to store BETAGAN
Keep out of the reach and sight of
Do not use BETAGAN after the ex single-dose container label, the fo comes in and the carton after “EX last day of that month.
Store the BETAGAN single-dose them from light. Do not store abov
Make sure that the single-dose co
- Stroke, reduced blood su in signs and symptoms o disorder) and unusual se
- Low blood glucose levels
- Nightmares and memory
- Detachment of the layer blood vessels following fi visual disturbances, corn layer of the eyeball), drop the eye stay half closed),
- Heart attack, heart failure failure (heart disease with of the feet and legs due t your limbs.
- Cold hands and feet.
pply to the brain, increases f myasthenia gravis (muscle nsations like pins and needles.
.
loss.
elow the retina that contains ltration surgery which may cause eal erosion (damage to the front ping of the upper eyelid (making double vision.
, chest pain, congestive heart shortness of breath and swelling
o fluid build up), fluid build up in
container should only be used is solution remaining.
The carton can be reclosed after
Medicines should not be dispose waste. Ask your pharmacist how t required. These measures will hel
6. Further information
What BETAGAN contains
- The active substance is Levob
- The other ingredients are poly disodium edetate, sodium pho potassium phosphate monob pH) or hydrochloric acid (to ad
Each pack contains 30 or 60 of th strips of 5 single-dose containers pouches. Each container has 0.4
Not all pack sizes may be market
Marketing Authorisation Holde AbbVie Ltd.
Maidenhead
SL6 4UB
UK
Tel: 01628 561090
E-mail:
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
| in the lungs (predominantly in iseases like asthma), cough. stions, diarrhoea, dry mouth, y coloured appearance sening of psoriasis. y exercise. ased libido. ye drops containing phosphates: with severe damage to the clear rnea) have developed cloudy cium build-up during treatment. your doctor or pharmacist. This not listed in this leaflet. You can | Further information about glaucom International Glaucoma Associatio Tel: 01233 64 81 70 Fax: 01233 64 81 79 Email: (The IGA is an organisation which their relatives, and is not associate This leaflet was last revised in To listen to or req this leaflet in Brail audio please call, 0800 198 5000 (U Please be ready t fnllnwinn informal | a is available from: n (IGA) helps glaucoma patients and d with AbbVie.) ebruary 2022. uest a copy of le, large print or free of charge: K only). o give the ion: Levobunolol mber rovided by the titute of | |
| a: card help provide more information on f children. piry date which is stated on the il covered pouch the container P”. The expiry date refers to the containers in the pouch to protect e 25°C. ntainer is intact before use. Each | oowng n orma 0.5% reference nu PL 41042/0056. This is a service p Royal National Ins Blind People. | ||
| once. Do not re-use even if there opening. d of via wastewater or household o dispose of medicines no longer p to protect the environment. unolol hydrochloride 0.5% w/v (vinyl alcohol), sodium chloride, sphate dibasic, heptahydrate, asic, sodium hydroxide (to adjust just pH) and purified water | |||
contents of the pack
n solution in a plastic single-dose
ese single-dose containers. Two are presented in foil covered millilitres of eye drops inside.
ed.
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