Skip to Content

BETAXOLOL HYDROCHLORIDE 0.25% W/V EYE DROPS SUSPENSION

Active substance(s): BETAXOLOL

View full screen / Print PDF » Download PDF ⇩
Transcript
S307 LEAFLET Betoptic 20150619

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

BETOPTIC 0.25% w/v EYE DROPS SUSPENSION
(betaxolol hydrochloride)
Your medicine is marketed using the above name but will be
referred to as Betoptic Eye Drops throughout the following patient
information leaflet.
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 Eye Drops are and what they are used for
2. Before you use Betoptic Eye Drops
3. How to use Betoptic Eye Drops
4. Possible side effects

Using other medicines
Betoptic Eye Drops 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.
Betoptic Eye Drops 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.
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 Eye Drops if you are pregnant unless your
doctor considers it necessary.
Do not use Betoptic Eye Drops if you are breast-feeding.
Betaxolol may get into your breast-milk.
Ask your doctor for advice before taking any medicine during
breast-feeding.
Driving and using machines

5. How to store Betoptic Eye Drops

If your sight is affected in any way following the use of Betoptic Eye
Drops, you should not drive or use any machines.

6. Further information

Important information if you wear Contact Lenses

1. WHAT BETOPTIC EYE DROPS ARE AND WHAT THEY ARE
USED FOR

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 Eye Drops (benzalkonium chloride) that can
discolour soft contact lenses.

Betoptic Eye Drops belongs to a group of medicines known as
beta blockers.
It is used to treat chronic open-angle glaucoma or ocular
hypertension (high pressure in the eye) by reducing the fluid
pressure in your eye (s).

3. HOW TO USE BETOPTIC EYE DROPS
Betoptic Eye Drops should only be used in the eye(s)
The usual dose
The usual dose is 1 drop in the affected eye(s) twice daily.

2. BEFORE YOU USE BETOPTIC EYE DROPS

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

Do not use Betoptic Eye Drops, suspension...

Not recommended for use in CHILDREN



If you are allergic to betaxolol, beta-blockers or any of the other
ingredients listed in section 6.



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).

Always use Betoptic Eye Drops exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
How to use


Wash your hands before you start.



Shake the bottle well.



Twist off the bottle cap.

Ask your doctor for advice.



Hold the bottle pointing down,
between your thumb and fingers.

Take special care...



Tilt your head back.



coronary heart disease (symptoms can include chest pain or
tightness, breathlessness or choking), heart failure, low blood
pressure (hypotension)

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).





disturbances of heart rate such as slow heart beat
(bradycardia)

Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.





breathing problems, asthma or chronic obstructive
pulmonary disease (lung disease which may cause
wheeziness, difficulty in breathing and/or long-standing cough).

Do not touch your eye or eyelid,
surrounding areas or other surfaces
with the tip of the vial. It could infect
the drops.



poor blood circulation disease (such as Raynaud’s disease
or Raynaud’s syndrome)





Gently press on the base of the
bottle to release one drop at a time
(picture 2).

diabetes, as betaxolol may mask the signs and symptoms of
low blood sugar





Do not squeeze the bottle, only a gentle press on the bottom
is needed.

overactivity of the thyroid gland as betaxolol may mask the
signs and symptoms





If you use drops in both eyes, repeat the steps for your other
eye. Put the bottle cap firmly back on immediately after use.

angle-closure glaucoma





dry eyes (Sicca Syndrome)

After using Betoptic Eye Drops, 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 have a slow heart beat, heart failure or disorders of
heart rhythm (irregular heart beats).

Before you use this medicine, tell your doctor if you have now or
have had in the past


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



If you use more Betoptic Eye Drops than you should it can
be washed out of your eye with warm water.

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).

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 Eye Drops without speaking to your doctor.



Constriction of the airways in the lungs (predominantly in
patients with pre-existing disease).



Indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.

Like other medicines applied into eyes, betaxolol is absorbed into
the blood. This may cause similar side effects as seen with betablockers 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.



Skin rash with white silvery coloured appearance (psoriasiform
rash) or worsening of psoriasis.



Muscle pain not caused by exercise.



Sexual dysfunction, impotence.



Tiredness.

If you have any further questions on the use of Betoptic Eye
Drops, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betoptic Eye Drops suspension can cause side
effects, although not everybody gets them.

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

An increase 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.
5. HOW TO STORE BETOPTIC EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Uncommon (affects 1 to 10 users in 1000):



Do not store above 25°C.





Store the bottle in the outer carton in order to protect from light.



Stop using the bottle 28 Days after first opening, to prevent
infections.



Do not use after the expiry date printed on the carton label or
bottle.



If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

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 the 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

Additional side effects have been seen with other ophthalmic beta
blockers and could potentially occur with Betoptic Eye Drops. The
frequency is unknown.


6. FURTHER INFORMATION
What Betoptic Eye Drops contain


The suspension contains the active ingredient betaxolol
hydrochloride equivalent to 0.25%w/v betaxolol base.



Betoptic Eye Drops also contain the following: carbomer, boric
acid, mannitol, N-lauroylsarcosine, benzalkonium chloride, poly
(styrene divinylbenzene) sulfonic acid, disodium edetate and
purified water. It may also contain small amounts of
hydrochloric acid and/or sodium hydroxide to adjust the acidity
or alkalinity of the product to ensure comfort of the product in
the eye.
What Betoptic Eye Drops look like and contents of the pack
Betoptic Eye Drops are packaged in a carton containing a 5ml
plastic bottle fitted with a dropper plug, white plastic screw cap and
tamper evident ring. The bottle contains a cloudy white suspension.
Betoptic Eye Drops are available in bottles containing 5ml of
solution.

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.

Product Licence holder



Low blood glucose levels.



This product is manufactured by either of the below manufacturers-

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

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
ALCON CUSI S.A., Camil Fabra 58, 08320 El Masnou,
Barcelona, Spain.

POM

PL: 19488/0307

Leaflet revision date: 19 June 2015
Betoptic is a registered trade mark of Alcon Inc, Switzerland.
S307 LEAFLET Betoptic 20150619

S307 LEAFLET Betaxolol 20150619

PACKAGE LEAFLET: INFORMATION FOR THE USER

BETAXOLOL HYDROCHLORIDE 0.25% w/v EYE DROPS
SUSPENSION
Your medicine is marketed using the above name but will be
referred to as Betaxolol Eye Drops throughout the following patient
information leaflet.
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 Betaxolol Eye Drops are and what they are used for
2. Before you use Betaxolol Eye Drops

Using other medicines
Betaxolol Eye Drops 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.
Betaxolol Eye Drops 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.
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 Betaxolol Eye Drops if you are pregnant unless your
doctor considers it necessary.
Do not use Betaxolol Eye Drops if you are breast-feeding.
Betaxolol may get into your breast-milk.

3. How to use Betaxolol Eye Drops

Ask your doctor for advice before taking any medicine during
breast-feeding.

4. Possible side effects

Driving and using machines

5. How to store Betaxolol Eye Drops

If your sight is affected in any way following the use of Betaxolol
Eye Drops, you should not drive or use any machines.

6. Further information

Important information if you wear Contact Lenses
1. WHAT BETAXOLOL EYE DROPS ARE AND WHAT THEY ARE
USED FOR
Betaxolol Eye Drops belongs to a group of medicines known as
beta blockers.

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 Betaxolol Eye Drops (benzalkonium chloride) that
can discolour soft contact lenses.

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

3. HOW TO USE BETAXOLOL EYE DROPS

2. BEFORE YOU USE BETAXOLOL EYE DROPS

The usual dose is 1 drop in the affected eye(s) twice daily.

Do not use Betaxolol Eye Drops, suspension...


If you are allergic to betaxolol, beta-blockers or any of the other
ingredients listed in section 6.



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).

Betaxolol Eye Drops should only be used in the eye(s)
The usual dose
Remove the loose collar from the cap when you open the bottle.
Not recommended for use in CHILDREN
Always use Betaxolol Eye Drops exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.
How to use


Wash your hands before you start.



Shake the bottle well.



Twist off the bottle cap.

Ask your doctor for advice.



Hold the bottle pointing down,
between your thumb and fingers.

Take special care...



Tilt your head back.

Before you use this medicine, tell your doctor if you have now or
have had in the past



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).



If you have a slow heart beat, heart failure or disorders of
heart rhythm (irregular heart beats).



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)

Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.





breathing problems, asthma or chronic obstructive
pulmonary disease (lung disease which may cause
wheeziness, difficulty in breathing and/or long-standing cough).

Do not touch your eye or eyelid,
surrounding areas or other surfaces with
the tip of the vial. It could infect the drops.





poor blood circulation disease (such as Raynaud’s disease
or Raynaud’s syndrome)

Gently press on the base of the
bottle to release one drop at a time
(picture 2).



diabetes, as betaxolol may mask the signs and symptoms of
low blood sugar



Do not squeeze the bottle, only a gentle
press on the bottom is needed.



overactivity of the thyroid gland as betaxolol may mask the
signs and symptoms



If you use drops in both eyes, repeat the steps for your other
eye. Put the bottle cap firmly back on immediately after use.



angle-closure glaucoma





dry eyes (Sicca Syndrome)

After using Betaxolol Eye Drops, 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.

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



If you use more Betaxolol Eye Drops than you should it can
be washed out of your eye with warm water.

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).

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 Betaxolol Eye Drops without speaking to your doctor.



Constriction of the airways in the lungs (predominantly in
patients with pre-existing disease).



Indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.

Like other medicines applied into eyes, betaxolol is absorbed into
the blood. This may cause similar side effects as seen with betablockers 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.



Skin rash with white silvery coloured appearance (psoriasiform
rash) or worsening of psoriasis.



Muscle pain not caused by exercise.



Sexual dysfunction, impotence.



Tiredness.

If you have any further questions on the use of Betaxolol Eye
Drops, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betaxolol Eye Drops suspension can cause side
effects, although not everybody gets them.

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

An increase 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.
5. HOW TO STORE BETAXOLOL EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Uncommon (affects 1 to 10 users in 1000):



Do not store above 25°C.





Store the bottle in the outer carton in order to protect from light.



Stop using the bottle 28 Days after first opening, to prevent
infections.



Do not use after the expiry date printed on the carton label or
bottle.



If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

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 the 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

Additional side effects have been seen with other ophthalmic beta
blockers and could potentially occur with Betaxolol Eye Drops. The
frequency is unknown.


6. FURTHER INFORMATION
What Betaxolol Eye Drops contain


The suspension contains the active ingredient betaxolol
hydrochloride equivalent to 0.25%w/v betaxolol base.



Betaxolol Eye Drops also contain the following: carbomer, boric
acid, mannitol, N-lauroylsarcosine, benzalkonium chloride, poly
(styrene divinylbenzene) sulfonic acid, disodium edetate and
purified water. It may also contain small amounts of
hydrochloric acid and/or sodium hydroxide to adjust the acidity
or alkalinity of the product to ensure comfort of the product in
the eye.
What Betaxolol Eye Drops look like and contents of the pack
Betaxolol Eye Drops are packaged in a carton containing a 5ml
plastic bottle fitted with a dropper plug, white plastic screw cap and
tamper evident ring. The bottle contains a cloudy white suspension.
Betaxolol Eye Drops are available in bottles containing 5ml of
solution.
Product Licence holder

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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



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

Manufacturer
This product is manufactured by either of the below manufacturersALCON CUSI S.A., Camil Fabra 58, 08320 El Masnou,
Barcelona, Spain.

POM

PL: 19488/0307

Leaflet revision date: 19 June 2015

S307 LEAFLET Betaxolol 20150619

Expand view ⇕

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.

Hide