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BETOPTIC 0.5% W/V EYE DROPS

Active substance(s): BETAXOLOL HYDROCHLORIDE

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64950-0

Package Leaflet - Information for the User

BETOPTIC

* 0.5% w/v eye drops, solution
Betaxolol (as 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 your 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 get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

IN THIS LEAFLET
1. What BETOPTIC 0.5 % is and what
it is used for

4. Possible side effects
5. How to store BETOPTIC 0.5%

2. Before you use BETOPTIC 0.5 %

6. Further information

3. How to use BETOPTIC 0.5 %

1

WHAT BETOPTIC* 0.5 % IS AND WHAT IT IS USED FOR

BETOPTIC 0.5 % belongs to a group of
medicines known as beta blockers.

2

It is used to treat glaucoma or ocular
hypertension ( high pressure in the eye ) by
reducing the fluid pressure in your eye(( s ).

BEFORE YOU USE BETOPTIC 0.5 %

Do not use BETOPTIC 0.5 %
eye drops, solution...

Using other medicines
BETOPTIC 0.5 % can affect or be affected by
other medicines you are using, including other
eye drops for the treatment of glaucoma. Tell your
doctor if you are using or intend to use medicines
to lower blood pressure, heart medicine,
medicines to treat diabetes or medicines to
treat emotional, behavioural or mental disorders
such as anxiety or depression.

• If you are allergic to betaxolol, beta-blockers
or any of the other ingredients listed in section
6. Ask your doctor for advice.
• If you have now or have had in the past,
respiratory problems such as severe
asthma, severe chronic obstructive
bronchitis (severe lung condition which may
cause wheeziness, difficulty in breathing and /or
long-standing cough).
• If you have a slow heart beat, heart failure
or disorders of heart rhythm (irregular
heartbeats).

BETOPTIC 0.5 % may reduce the
effectiveness of adrenaline, which can be
used to treat serious allergic reactions
(anaphylaxis). Tell your doctor if you have a
history of anaphylaxis or allergic reactions.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.

Take special care...
Before you use this medicine, tell your doctor if
you have now or have had in the past
• coronary heart disease (symptoms can
include chest pain or tightness, breathlessness
or choking), heart failure, low blood
pressure (hypotension)
• disturbances of heart rate such as slow
heart beat (bradycardia)
• breathing problems, asthma or chronic
obstructive pulmonary disease (lung
disease which may cause wheeziness, difficulty
in breathing and /or long-standing cough).
• poor blood circulation disease (such as
Raynaud’s disease or Raynaud’s syndrome).
• diabetes, as betaxolol may mask the signs
and symptoms of low blood sugar
• overactivity of the thyroid gland as
betaxolol may mask the signs and symptoms
• a muscle weakening disease such as
myasthenia gravis. Your symptoms may get
worse
• angle-closure glaucoma
• dry eyes (Sicca Syndrome)

If you are using more than one type of eye
drop, wait 5 minutes between using each one.
Eye ointments should be administered last.

Pregnancy and breast-feeding
Do not use BETOPTIC 0.5 % if you are
pregnant unless your doctor considers it
necessary.
Do not use BETOPTIC 0.5% if you are breastfeeding. Betaxolol may get into your breast-milk.
Ask your doctor for advice before taking any
medicine during breast-feeding.

Driving and using machines
If your sight is affected in any way following the
use of BETOPTIC 0.5 %, you should not drive
or use any machines.

Important information if you wear
Contact Lenses
Do not use the drops while wearing contact
lenses. Wait at least 15 minutes after use before
putting your lenses back in. There is a
preservative in BETOPTIC 0.5 % (benzalkonium
chloride) that can discolour soft contact lenses.

Tell your doctor before you have an
operation that you are using BETOPTIC 0.5% as
betaxolol may change the effects of some
medicines used during anaesthesia.
If any of these apply
y you may still be able to
use BETOPTIC 0.5%, but discuss it with your
doctor first.

3

HOW TO USE BETOPTIC 0.5 %

BETOPTIC 0.5 % should only be used in the
eye(( s ).

Remove the loose collar from the cap when
you open the bottle.

The usual dose

Always use BETOPTIC 0.5 % 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 in the affected eye(( s )
twice daily.

1

2

3

How to use
• Wash your hands before you start.
• Twist off the bottle cap.
• Hold the bottle pointing down, between your
thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a finger, until
there is a ‘pocket’ between the eyelid and your
eye. The drop will go in here (picture 1).
• Bring the bottle tip close to the eye. Do this in
front of a mirror if it helps.
• Do not touch your eye or eyelid,
surrounding areas or other surfaces with the
dropper. It could infect the drops.

• Gently press on the base of the bottle to
release one drop at a time (picture 2).
• Do not squeeze the bottle, only a gentle
press on the bottom is needed.
• If you use drops in both eyes, repeat the steps
for your other eye. Put the bottle cap firmly
back on immediately after use.
• After using BETOPTIC 0.5 %, press a finger
into the corner of your eye by the nose
(picture 3) for 2 minutes. This helps to stop
betaxolol getting into the rest of the body.

• If a drop misses your eye, try again.
• If you miss a dose, just take it as soon as
possible. However, if it is almost time for your
next dose, skip the missed dose and go back
to your regular dosing schedule. Do not use a
double dose to make up for a missed dose.

• If you use more BETOPTIC 0.5 % than you
should it can be washed out of your eye with
warm water.
If you have any further questions on the use
of BETOPTIC 0.5 %, ask your doctor or
pharmacist.

Continued over

4

POSSIBLE SIDE EFFECTS

Like all medicines, BETOPTIC* 0.5% eye drops
solution can cause side effects, although not
everybody gets them.
You can usually carry on taking the drops, unless
the effects are serious. If you are worried, talk to a
doctor or pharmacist. Do not stop using
BETOPTIC 0.5% without speaking to your doctor.
Like other medicines applied into eyes, betaxolol
is absorbed into the blood. This may cause
similar side effects as seen with beta-blockers
given by injection or taken by mouth. Incidence of
side effects after beta-blockers are used in the
treatment of eye conditions is lower than when
medicines are, for example, taken by mouth or
injected. Listed side effects include reactions
seen following treatment with Betaxolol eye drops
and within the class of other beta-blockers used
for treating eye conditions.
Side effects experienced by patients during
clinical trials with BETAXOLOL eye drops are
Very common (may affect more than
1 in 10 users) :
• Eye discomfort (includes a feeling of something
in the eye)
Common (affects 1 to 10 users in 100) :
• Blurred vision, watery eyes
• Headache
Uncommon (affects 1 to 10 users in 1000) :
• Inflammation of the eye surface, conjunctivitis
or symptoms of conjunctivitis, visual
impairment, sensitivity to light, painful, dry or
tired eyes, excessive blinking, irritated, red or
swollen eyes, a feeling of something in the eye,
eye itchiness, eye discharge, weeping eyelids,
bloodshot eyes.
• Slow heart beat or unusually rapid heart beat
• Asthma, difficulty breathing, blocked nose
• Nausea
Rare (affects 1 to 10 users in 10,000) :
• Cataract formation, decreased sensitivity of
the eye, inflammation of eyelid
• Anxiety, difficulty sleeping (insomnia),
depression
• Fainting
• Low blood pressure
• Cough, runny nose
• Taste disturbances
• Inflamed , itchy skin or rash, hair loss
• Libido decreased
The following side effects have also been
reported by people using BETAXOLOL eye drops.
The frequency cannot be estimated from the
available data :
• Hypersensitivity reaction
• Dizziness
• Changes in the rhythm or speed of the
heartbeat
• Loss or lack of strength

5

An increased in Anti Nuclear Antibodies has also
been seen in patients taking ophthalmic beta
blockers.

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 the Yellow Card
Scheme at : www.mhra.gov.uk /yellowcard
By reporting side effects, you can help provide
more information on the safety of this medicine.

HOW TO STORE BETOPTIC 0.5%






Keep out of the reach and sight of children.
Do not store above 25°C.
Keep the bottle tightly closed.
Keep in the outer carton in order to protect
from light.
• Do not use the drops after the expiry date
(marked ‘Exp’) on the bottle and the carton.
The expiry date refers to the last day of that
month.

6

Additional side effects have been seen with other
ophthalmic beta-blockers and could potentially
occur with BETOPTIC eye drops. The frequency
is unknown:
• Generalised allergic reactions including
swelling beneath the skin (that can occur in
areas such as the face and limbs, and can
obstruct the airway which may cause difficulty
swallowing or breathing), hives (or itchy rash),
localised and generalised rash, itchiness,
severe sudden life-threatening allergic reaction.
• Low blood glucose levels.
• Nightmares, memory loss, hallucinations,
delusions and confusion.
• Stroke, reduced blood supply to the brain,
increases in signs and symptoms of
myasthenia gravis (muscle disorder), unusual
sensations (like pins and needles).
• Detachment of the layer below the retina that
contains blood vessels following filtration
surgery which may cause visual disturbances,
corneal erosion (damage to the front layer of
the eyeball), drooping of the upper eyelid
(making the eye stay half closed), double
vision.
• Chest pain, palpitations, oedema (fluid build
up), congestive heart failure (heart disease with
shortness of breath and swelling of the feet and
legs due to fluid build up), a type of heart
rhythm disorder, heart attack, heart failure.
• Raynaud’s phenomenon, cold hands and feet
with a blue colour, leg pains (especially if you
have a history of poor circulation).
• Constriction of the airways in the lungs
(predominantly in patients with pre-existing
disease).
• Indigestion, diarrhoea, dry mouth, abdominal
pain, vomiting.
• Skin rash with white silvery coloured
appearance (psoriasiform rash) or worsening of
psoriasis.
• Muscle pain not caused by exercise.
• Sexual dysfunction, impotence.
• Tiredness.

• Stop using the bottle 4 weeks after first
opening, to prevent infections.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer
required. These measures will help to protect
the environment.
• Do not pass this medicine on to others. It
may harm them even if their symptoms are the
same as yours.

FURTHER INFORMATION

What BETOPTIC 0.5 % contains
• The active substance is betaxolol 5 mg /ml
(as the hydrochloride).
• The other ingredients are sodium chloride,
disodium edetate, benzalkonium chloride,
hydrochloric acid and /or sodium hydroxide
(to adjust pH) and purified water.

Marketing authorisation holder :
Alcon Laboratories (UK) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR
United Kingdom

What BETOPTIC 0.5 % looks like
and contents of the pack
BETOPTIC 0.5 % is a clear, colourless liquid
supplied in a pack containing a 5 ml plastic bottle
with a screw cap.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in August 2014.

®

* a trademark of Novartis
© 2010, 2011, 2012, 2013, 2014 Novartis

08-2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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