BETAXOLOL 0.5% EYE DROPS

Active substance: BETAXOLOL HYDROCHLORIDE

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BETAXOLOL 0.5%
EYE DROPS
Betaxolol 5.0mg/ml(asbetaxololhydrochloride5.6mg/ml)
Please read this leaflet carefully before you start to take your medicine.
Keep this leaflet. You may need to read it again. If you have any further questions, please
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.
The medicine will be called Betaxolol in this leaflet.
In this leaflet:
1. What Betaxolol is and what is it used for
2. Before you use Betaxolol
3. How to use Betaxolol
4. Possible side effects
5. How to store Betaxolol
6. Further information

1. WHAT BETAXOLOL IS AND WHAT IS IT USED FOR
The active ingredient betaxolol belongs to a group ofmedicines called beta-blockers.
Betaxolol is used to treat raised pressure of eye (intraocular pressure) which occurs in
various conditions including glaucoma and ocular hypertension.
2. BEFORE YOU USE BETAXOLOL
Do not use if you:
• are allergic (hypersensitive) to betaxolol hydrochloride or beta-blockers or
to any other ingredient ofthis medicine (see section 6 for more details)
• have now or have had in 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)
• have a slow heart beat, heart failure or disorders ofheart rhythm (irregular heart beats).
Take special care with Betaxolol
Before you use Betaxolol please 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
• disturbances ofheart rate such as slow heart beat
• are suffering from muscle weakness, condition called myasthenia gravis
• diabetes as betaxolol may mask signs and symptoms oflow blood sugar
• overactivity of the thyroid gland as betaxolol may mask signs and symptoms
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)
Tell your doctor before you have an operation that you are using Betaxolol Eye Drops as
betaxolol may change effects of some medicines used during anaesthesia.
Taking 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 or medicines
to treat diabetes. Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription in
particular:
• a calcium antagonist (e.g. verapamil or diltiazem) often used to treat high blood
pressure, angina, or an abnormal heartbeat
• digoxin, often used to treat heart failure or an abnormal heartbeat
• medicines known as a catecholamine-depleting agents (e.g. rauwolfia alkaloids/
reserpine) used to treat high blood pressure
• a pressor amine (e.g. adrenaline) used to treat severe allergic reaction
• clonidine to treat high blood pressure
• quinidine, a medicine often used to treat abnormal heartbeat
• other beta-blockers (e.g. other preparations of Betaxolol both oral and/or ocular),
which belong to the same group of medicines
Pregnancy and breast-feeding
Do not use Betaxolol if you are pregnant unless your doctor considers it necessary.
Do not use Betaxolol if you are breast-feeding. Betaxolol may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
No effects on ability to drive and use machines have been reported. However do not drive or
operate machines if you experience any visual disturbance or dizziness after using the
product. Wait until this clears before driving or using machines.
Important information about some of the ingredients ofBetaxolol Eye Drops:
The eye drops contain benzalkonium chloride as preservative which may cause eye
irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the
eye drops and wait at least 15 minutes before reinserting. The preservative is known to
discolour soft contact lenses.
3. HOW TO USE BETAXOLOL
Always use Betaxolol exactly as your doctor has told you. You should check with your
doctor or pharmacist ifyou are not sure.
The usual dose is one drop into each affected eye(s) twice daily, approximately 12 hours
apart. If you are using in combination with another eye drop medicine, wait 5-15 minutes
before applying the second eye drop.
Use in children:
It is not recommended to use Betaxolol in children.
Instructions for use:
(please also refer to pictograms at the end of the leaflet)
• First wash your hands
• Avoid touching the eye (or any other surface) with the tip ofthe bottle
• If you wear soft contact lenses, they should be removed before using the eye
drops and wait at least 15 minutes before reinserting
• These drops are supplied as a sealed bottle with a spiked cap. When using the
bottle for the first time, screw the cap down tightly in order to pierce the tip of
the bottle
• Tilt your head back and look at the ceiling
• Pull the lower eyelid gently downwards
• Hold the bottle upside down above the eye and gently squeeze the bottle to release a
drop into your eye
• After using Betaxolol, press a finger into the comer of your eye, by the nose for 2
minutes. This helps to stop betaxolol getting into the rest of the body.
• Repeat for the other eye ifnecessary
• Replace and tighten the cap immediately afteruse.
Be careful not to touch the tip of the bottle on your eye or on any other surface.
Ocular solutions, if handled wrongly, can become contaminated by common bacteria and
cause eye infections. If you do develop any other eye condition whilst using this product,
see your doctor immediately.
Keep using your medicine until your doctor tells you to stop.
Ifyou use more Betaxolol than you should
If you accidentally use too much, contact your doctor or go to the nearest hospital
casualty department immediately.
Overdose:
There is no experience of an overdosage with Betaxolol which is unlikely when given as

eyedrops. The signs of overdosage include slow heart rate, drop of blood pressure,
breathing difficulties, andheart attack.
Ifyou forget to use Betaxolol
Apply the drops as soon as you remember. However, if it is almost time for your next dose,
do not double your dose and carry on with the normal schedule dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betaxolol can cause side effects, although not everybody gets them.
Ifyou experience a rare (these may affect between 1in1,000 and 1 in 10,000 patients) but
serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips,
tongue, or face or hives) to betaxolol, stop using the medication and contact your doctor
immediately.
You can usually carry on taking the drops, unless the effects are serious. If you're worried,
talk to a doctor or pharmacist. Do not stop using Betaxolol 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 intraveneous' and/or 'oral' as applicable betablocking agents. Incidence of side effects after topical ophthalmic administration is lower
than when medicines are, for example, taken by mouth or injected. Listed side effects
include reactions seen within the class of beta-blockers when used for treating eye
conditions:
The frequency of possible side effects listed below is defined using the following convention
Very common (affects more than 1 user in 10)
Common (affects 1to10 users in 100)
Uncommon (affects 1to10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)
Common: eye discomfort
Rare: Generalized 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, localized and
generalized rash, itchiness, severe sudden life-threatening allergic reaction. Low
blood glucose levels. Difficulty sleeping (insomnia), sleep disorders, depression, any
other psychiatric disturbances, confusion, nightmares, dizziness, unusual sensations
(like pins and needles), and headache. Signs and symptoms of eye irritation (e.g.
burning, stinging, itching, watering eyes, redness), inflammation of the eyelid,
inflammation in the eye, blurred vision, sensitivity to light, unequal pupils, changes
to the surface of the eye, pain, whitening of the membrane covering the inside of the
eyelid I white of the eye. Slow heart rate, heart failure. Low blood pressure,
Raynaud's phenomenon, cold hands and feet, worsening of leg pain when exercising.
Constriction of the airways in the lungs (predominantly in patients with pre-existing
disease), difficulty breathing, worsening of asthma. Nausea, diarrhoea, vomiting.
Hair loss, skin rash. Sexual dysfunction. Tiredness.
Frequency unknown: memory loss, fainting, stroke, reduced blood supply to the
brain, increases in signs and symptoms ofmyasthenia gravis (muscle disorder).
Detachment of the layer below the retina that contains blood vessels following
filtration surgery which may cause visual disturbances, decreased corneal sensitivity,
dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the
upper eyelid (making the eye stay half closed), double vision. Congestive heart
failure (heart disease with shortness of breath and swelling of the feet and legs due
to fluid build up), chest pain, palpitations, oedema (fluid build up), changes in the
rhythm or speed of the heartbeat, a type of heart rhythm disorder, heart attack.
Cough. Taste disturbances, indigestion, dry mouth, abdominal pain. Skin rash with
white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
Muscle pain not caused by exercise, muscle weakness. Decreased libido.
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.
5. HOW TO STORE BETAXOLOL
Keep all medicines out of the sight and reach of children.
Do not store at a temperature above 30°C.
Discard the bottle 28 days after opening, even if there is solution remaining.
Do not use Betaxolol after the expiry date which is stated on the bottle and on the carton the
bottle is packed in.
6. FURTHER INFORMATION
What Betaxolol contains
The active ingredient is betaxolol, where 5mg/ml betaxolol is equivalent to 5.6mg/ml of
betaxolol hydrochloride. This product also contains disodium edetate, sodium chloride,
benzalkonium chloride (as preservative) 0.01 % w/v and water for injection.
What Betaxolol look like and contents of the pack
One bottle ofBetaxolol contains 5 ml solution.
Your medicine is a clear colourless, sterile solution.
Marketing Authorisation Holder and Manufacturer
FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire,
P0157FE
PLnumber: 15872/0007
Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help.
This leaflet was last revised in: 07/2014

MODE OF USE

Tighten the cap

The spike in

Tilt head backwards.

Press a finger into

on the nozzle till

the cap will

Dispense drops with

the comer of eye,

the cap touches

pierce the tip

gentle pressure. Do not

by the nose

the shoulder.

of the bottle.

touch dropper tip to

for 2 minutes

the surface of the eye.

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Version 5

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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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