Betagan

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Levobunolol hydrochloride 0.5% w/v;  ;  ;  
Available from:
Allergan New Zealand Ltd
INN (International Name):
Levobunolol hydrochloride 0.5% w/v
Dosage:
0.5 %
Pharmaceutical form:
Eye drops, solution
Composition:
Active: Levobunolol hydrochloride 0.5% w/v       Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Disodium edetate Hydrochloric acid Monobasic potassium phosphate Polyvinyl alcohol Purified water Sodium chloride Sodium hydroxide Sodium metabisulfite
Units in package:
Bottle, dropper, 1x5mL, 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Piramal Enterprises Limited
Product summary:
Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light
Authorization number:
TT50-3870a
Authorization date:
1985-12-05

BETAGAN

®

EYE DROPS 0.5%

(levobunolol hydrochloride 5 mg per mL)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about BETAGAN

drops, including how to use the eye

drops. It does not contain all the

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using BETAGAN

eye drops against the benefits they

expect it will have for you.

If you have any concerns about

using this medicine, ask your doctor

or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What BETAGAN

®

eye drops are

used for

BETAGAN

eye drops are a beta

blocking agent used to lower

increased pressure in the eye.

Your doctor has prescribed

BETAGAN

eye drops to control

increased pressure in the eye or to

treat an acute increase in pressure

that can occur after eye operations.

Sometimes your doctor may give

you another medicine or eye drop

as well as BETAGAN

eye drops to

help you.

Glaucoma is a condition in which

the pressure of fluid in the eye may

be high. However, some people

with glaucoma may have normal

eye pressure. Glaucoma is usually

caused by a build up of the fluid

which flows through the eye. This

build up occurs because the fluid

drains out of your eye more slowly

than it is being pumped in. Since

new fluid continues to enter the eye,

joining the fluid already there, the

pressure continues to rise. This

raised pressure may damage the

back of the eye resulting in gradual

loss of sight. Damage can

progress so slowly that the person

is not aware of this gradual loss of

sight. Sometimes even normal eye

pressure is associated with damage

to the back of the eye.

There are usually no symptoms of

glaucoma. The only way of

knowing that you have glaucoma is

to have your eye pressure, optic

nerve and visual field checked by

an eye specialist or optometrist. If

glaucoma is not treated it can lead

to serious problems, including total

blindness. In fact, untreated

glaucoma is one of the most

common causes of blindness.

BETAGAN

eye drops lower

the pressure in the eye by

decreasing the production of fluid in

the eye chamber.

BETAGAN

eye drops

can be used alone or together

with other eyedrops/medicines

to lower raised pressure within

your eyes.

Although BETAGAN

eye drops

help control your condition,

they will not cure it.

BETAGAN

eye drops are only

available with a doctor’s

prescription from pharmacies.

Your doctor may have

prescribed BETAGAN

drops for another reason.

Ask your doctor if you have

any questions about why

BETAGAN

eye drops have

been prescribed for you.

For more information about

glaucoma, contact Glaucoma NZ

(telephone 64 9373 8779).

Before you use BETAGAN

®

eye

drops

When you must not use it

Do not use BETAGAN

eye drops

you are allergic or very sensitive

(hypersensitive) to any of its

ingredients listed at the end of

this leaflet especially sodium

metabisulfite

you suffer from asthma or have

a history of asthma disease

you have heart or lung disease

the seal around the cap is

broken

the bottle/packaging shows

signs of tampering

the product does not look quite

right

the expiry date on the bottle or

carton has passed.

If you use this medicine after the

expiry date has passed, it may not

work effectively.

Do not put the eye drops into your

eye(s) while you are wearing soft

contact lenses. The preservative in

BETAGAN

eye drops

(benzalkonium chloride) may be

deposited in soft contact lenses.

You can put your soft contact

lenses back into your eyes 15

minutes after you have used

BETAGAN

eye drops.

If you are not sure whether you

should start using BETAGAN

drops, talk to your doctor.

It is not known if BETAGAN

drops are safe and useful for

children and adolescents under 18

years.

These drops are for topical use

only.

Before you start to use it

Tell your doctor if:

you have difficulty in breathing

you suffer from diabetes or have

low blood sugar

you have an overactive thyroid

gland

you are allergic to other

beta-blockers

you are scheduled to have

surgery using a general

anaesthetic

you are pregnant or intend to

become pregnant

you are breast-feeding or

intend to breast-feed.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket

or health food shop.

BETAGAN

eye drops can increase

the effect of beta-blockers which

are taken orally.

When BETAGAN

eye drops are

taken with adrenaline, enlargement

of the pupils may occur.

Beta-blockers and catecholamine

depleting drugs taken together may

cause dizziness or fainting.

How to use BETAGAN

®

eye

drops

How much to use

Your doctor will tell you how many

drops you need to use each day.

Use BETAGAN

eye drops only as

prescribed by your doctor.

The usual dose of BETAGAN

drops is one drop in the affected

eye(s) twice a day.

Follow all directions given to you by

your doctor carefully. The

directions may differ from the

information contained in this leaflet.

Use BETAGAN

eye drops every

day, at about the same time each

day, unless your doctor tells you

otherwise. Using your eye drops

ate the same time each day will

have the best effect on your eye

pressure. It will also help you

remember when to use the eye

drops.

If you are using more than one eye

drop product, wait 5 minutes before

using the second product.

If you are being changed from one

eye drop to another, follow your

doctor’s instructions carefully as to

when to stop the old drops and

when to start the new drops.

How to use it

You may find it easier to put drops

in your eye while you are sitting or

lying down.

If you are wearing soft contact

lenses, remove them before

putting the drops in your eye.

To open a new bottle of

BETAGAN

eye drops first tear off

the protective seal from the bottle.

The contents are sterile if the seal

is intact.

The seal will break and you can pull

it off and then throw it away.

1. Wash your hands well with soap

and water.

2. Remove the lid/cap.

3. Hold the bottle upside down in

one hand between your thumb

and forefinger or index finger.

4. Using your other hand, gently

pull down your lower eyelid to

form a pouch or pocket.

5. Tilt your head back and look up.

6. Put the tip of the bottle close to

your lower eyelid. Do not let it

touch your eye.

7. Release one drop into the pouch

or pocket formed between your

eye and eyelid by gently

squeezing the bottle.

8. Close your eye. Do not blink or

rub your eye.

9. While your eye is closed, place

your index finger against the

inside corner of your eye and

press against your nose for

about two minutes. This will

help to stop the medicine from

draining through the tear duct to

the nose and throat, from where

it can be absorbed into other

parts of your body. Ask your

doctor for more specific

instructions on this technique.

10. Replace the lid/cap, sealing it

tightly.

11. Wash your hands again with

soap and water to remove any

residue.

Wait 15 minutes before replacing

your contact lenses.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else to avoid

contaminating the eye drops.

How long to use it

BETAGAN

eye drops help control

your condition, but do not cure it.

Therefore, BETAGAN

eye drops

must be used every day. Continue

using BETAGAN

eye drops for as

long as your doctor prescribes.

If you forget to use it

If it is almost time for your next

dose, skip the dose you missed and

use your next dose when you are

meant to. Otherwise, use the drops

as soon as you remember, and

then go back to using them as you

would normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

Do not use double the amount to

make up for the dose that you

missed.

If you use too much

(overdose)

If you accidentally put several drops

in your eyes, flush the eye(s) with

water or saline solution.

If you think that you or anyone else

may have swallowed any or all of

the contents of a bottle of

BETAGAN

eye drops, immediately

telephone your doctor or the

National Poisons Centre on 0800

POISON or 0800 764 766 for

advice, or go to casualty at your

nearest hospital.

Do this even if there are no signs of

discomfort or poisoning.

While you are using BETAGAN

®

eye drops

Things you must do

Have your eye pressure checked

when your eye specialist says, to

make sure BETAGAN

eye drops

are working.

If you develop an eye infection,

receive an eye injury, or have eye

surgery tell your doctor.

Your doctor may tell you to use a

new container of BETAGAN

drops because of possible

contamination of the old one.

If you become pregnant while using

BETAGAN

eye drops tell your

doctor immediately.

If you wear soft contact lenses,

remove them before using

BETAGAN

eye drops. Leave your

lenses out for at least 15 minutes

after putting in the eye drops.

Tell your doctor if your condition

gets worse or does not get better

while using BETAGAN

eye drops.

If you are about to start any new

medicine tell your doctor and

pharmacist that you are using

BETAGAN

eye drops.

Things you must not do

Do not give BETAGAN

eye drops

to anyone else, even if they have

the same condition as you.

Do not stop using BETAGAN

drops without first talking to your

doctor. If you stop using your eye

drops, your eye pressure may rise

again and damage to your eye may

occur.

Things to be careful of

BETAGAN

eye drops are not

expected to cause any problems

with your ability to drive a car or

operate machinery. However, they

may cause blurred vision/

dizziness/tiredness in some people.

As a general precaution be careful

driving or operating machinery until

you know how BETAGAN

drops affect you.

Side effects

Tell your optical practitioner, doctor

or pharmacist as soon as possible if

you do not feel well while you are

using BETAGAN

eye drops.

BETAGAN

eye drops help most

people with high eye pressure and

glaucoma, but it may have

unwanted side effects in a few

people.

All medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of the side effects.

Check with your doctor as soon as

possible if you have any problems

while taking BETAGAN

eye drops,

even if you do not think the

problems are connected with the

medicine or are not listed in this

leaflet.

Ask your optical practitioner, doctor

or pharmacist any questions you

may have.

Tell your doctor if you notice any of

the following and they worry you:

Stinging, burning or foreign body

feeling when it is instilled in the

Inflammation of the eyelid

Rarely the following effects have

been seen:

Headaches, tiredness, dizziness,

itching, inflammation of the iris,

clumsiness and lack of co-

ordination, abnormal tiredness,

difficulty sleeping, hair losss, hives,

decreased heart rate and blood

pressure and decreased sensitivity

of the front layer of the eyeball.

After using BETAGAN

®

eye drops

Storage

Keep your eye drops in a cool, dark

place where the temperature stays

below 25

Keep the bottle where children

cannot reach it.

Do not leave the top/lid off the

bottle for any length of time to avoid

contaminating the eye drops.

Disposal

Throw out any remaining solution

after 4 weeks from the date of

opening.

Eye drops contain a preservative

which helps prevent germs growing

in the solution for the first four

weeks after opening the bottle.

After this time there is a greater risk

that the drops may become

contaminated and cause an eye

infection. A new bottle should be

opened.

If your doctor tells you to stop using

the eye drops or they have passed

their expiry date, ask your

pharmacist what to do with any

remaining solution.

Product description

What BETAGAN

®

eye drops look

like:

The eye drops are supplied in a

5mL sterile plastic bottle.

Ingredients

Active ingredient:

Levobunolol hydrochloride 5.0

mg/mL

Preservative:

Benzalkonium chloride

Inactive ingredients:

Polyvinyl alcohol

Disodium edetate

Sodium metabisulphite

Sodium phosphate

Potassium phosphate

Sodium chloride

Purified water

Manufacturer/Supplier

ALLERGAN NEW ZEALAND

LIMITED

Cnr Manu Tapu Drive & Joseph

Hammond Place,

Auckland International Airport,

New Zealand

Freephone: 0800 659 912 (NZ)

Date of preparation:

April 2017

® Marks owned by Allergan, Inc.

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

DATA SHEET

1.

PRODUCT NAME

BETAGAN

5mg/mL eye drops

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

levobunolol hydrochloride 5mg/mL

For full list of excipients, see section 6.1 List of Excipients.

3.

PHARMACEUTICAL FORM

Clear, colourless to slightly yellow, sterile ophthalmic solution.

4.

CLINICAL PARTICULARS

4.1 Therapeutic Indications

Control of intraocular pressure in patients with open angle glaucoma.

Control of ocular hypertension.

Treatment of acute increased intraocular pressure following laser capsulotomy and

extra-capsular cataract extraction.

4.2 Dosage and Method of Administration

The recommended dose is one drop of BETAGAN

0.5% eye drops in the affected

eye(s) twice a day. Studies have also shown that IOP is controlled in many patients

with one drop of BETAGAN

0.5% eye drops in the affected eye(s) once a day.

Careful monitoring of patients is advised, particularly in the first few days after starting

treatment or if the dose of BETAGAN

eye drops is increased.

Dosages above one drop of BETAGAN

0.5% eye drops twice daily are not generally

more effective. If the patient's IOP is not at a satisfactory level on this regimen,

concomitant therapy with dipivefrine and/or adrenaline, and/or pilocarpine and other

miotics,

and/or

systemically

administered carbonic

anhydrase

inhibitors,

such

acetozolamide, can be instituted.

In order to minimise systemic absorption of BETAGAN

eye drops, apply pressure to

the tear duct immediately following administration of the drug.

Paediatric Population

Safety and effectiveness in children have not been established.

4.3 Contraindications

BETAGAN

eye drops are contraindicated in those individuals with bronchial asthma

or with a history of bronchial asthma or severe chronic obstructive pulmonary disease

(see 4.4 Special Warnings and Precautions for use); sinus bradycardia; sick sinus

syndrome (including sino-atrial nodal block); second or third degree atrioventricular

block not controlled with a pacemaker; overt cardiac failure (see 4.4 Special Warnings

and Precautions for use); cardiogenic shock; or hypersensitivity to any component of

this product (see 5.3 Preclinical Safety Data).

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

4.4 Special Warnings and Precautions for use

BETAGAN

drops

should

used

with

caution

patients

with

known

hypersensitivity to other ß-adrenergic blocking agents. Use with caution in patients

with known diminished pulmonary function.

In patients with angle-closure glaucoma, the immediate objective of treatment is to re-

open the angle. This requires, in most cases, constricting the pupil with a miotic.

BETAGAN

eye drops have little or no effect on the pupil. When BETAGAN

drops are used to reduce elevated IOP in angle-closure glaucoma, it should be

followed by a miotic and not used alone.

As with other topically applied ophthalmic drugs, BETAGAN

eye drops may be

absorbed

systemically.

same

adverse

reactions

found

with

systemic

administration of ß-adrenergic blocking agents may occur with topical administration.

For example, severe respiratory reactions and cardiac reactions, including death due

to bronchospasm in patients with asthma, and rarely death in association with cardiac

failure, have been reported with topical application of ß-adrenergic blocking agents

(see 4.3 Contraindications).

The preservative in BETAGAN

, benzalkonium chloride, may be absorbed by soft

contact lenses. BETAGAN

eye drops should not be used while wearing soft

contact lenses. Patients should be instructed to remove lenses before instilling

BETAGAN

eye drops and wait at least 15 minutes after instilling BETAGAN

drops before re-inserting their lenses.

Cardiac Failure: Sympathetic stimulation may be essential for support of the

circulation in individuals with diminished myocardial contractility, and its inhibition

by ß-adrenergic receptor blockade may precipitate more severe failure.

BETAGAN

should be used with caution in patients with cardiovascular disease

(e.g.

coronary

heart

disease,

Prinzmetal’s

angina

cardiac

failure)

hypotension.

Due to its negative effects on conduction time, beta-blockers should only be given

with caution to patients with first degree heart block.

Vascular

Disorders:

Patients

with

severe

peripheral

circulatory

disturbance/disorders

(e.g.

Raynaud’s

phenomenon)

should

treated

with

caution.

Obstructive Pulmonary Disease: Patients with mild/moderate chronic obstructive

pulmonary

disease

should,

general,

receive

beta

blockers,

including

levobunolol; however, if levobunolol is deemed necessary in such patients, it

should be administered with caution.

In Patients without a History of Cardiac Failure: Continued depression of the

myocardium with ß-blocking agents over a period of time can, in some cases, lead

to cardiac failure. At the first sign of symptoms of cardiac failure, BETAGAN

drops should be discontinued.

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Non-allergic Bronchospasm: In patients with non-allergic bronchospasm or with

a history of non-allergic bronchospasm, (e.g. chronic bronchitis, emphysema),

BETAGAN

eye drops should be administered with caution since they may block

bronchodilation

produced

endogenous

exogenous

catecholamine

stimulation of ß

-receptors.

Major

Surgery:

necessity

desirability

withdrawal

ß-adrenergic

blocking agents prior to major surgery is controversial. ß-adrenergic blockade

impairs the ability of the heart to respond to ß-adrenergically mediated reflex

stimuli. Levobunolol may impair compensatory tachycardia and may augment the

risk of hypotension when used with general anaesthesia in surgical procedures.

Some patients

receiving ß-adrenergic blocking agents

have been subject

protracted severe hypotension during anaesthesia. For these reasons, in patients

undergoing elective surgery, gradual withdrawal of ß-adrenergic blocking agents

may be appropriate. The anaesthetist must be informed if the patient is using

levobunolol.

If necessary during surgery, the effects of ß-adrenergic blocking agents may be

reversed

sufficient

doses

such

agonists

isoprenaline,

dopamine,

dobutamine or noradrenaline acid tartrate (see 4.9 Overdose).

Diabetes Mellitus: ß-adrenergic blocking agents should be administered with caution

to patients subject to spontaneous hypoglycaemia or to diabetic patients (especially

those with labile diabetes) who are receiving insulin or oral hypoglycaemic agents. ß-

adrenergic

blocking

agents

mask

signs

symptoms

acute

hypoglycaemia.

Hyperthyroidism/Thyrotoxicosis: ß-adrenergic blocking agents may mask certain

clinical signs (e.g. tachycardia) of hyperthyroidism. Patients suspected of developing

thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of ß-adrenergic

blocking agents which might precipitate a thyroid storm.

Metabisulfite Sensitivity: Contains sodium metabisulfite, a sulfite which may cause

allergic-type reactions including anaphylactic symptoms and life-threatening or less

severe asthmatic episodes in certain susceptible people. The overall prevalence of

sulfite sensitivity in the general population is unknown and probably low. Sulfite

sensitivity is seen more frequently in asthmatic rather than in non-asthmatic people.

Muscle

Weakness:

ß-adrenergic

blockade

been

reported

potentiate

muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia,

ptosis and generalised weakness).

Risk of anaphylactic reaction: While taking ß blockers, patients with a history of

atopy or a history of severe anaphylactic reactions to a variety of allergens may be

more reactive to repeated challenge, either accidental, diagnostic or therapeutic.

Such patients may be unresponsive to the usual doses of adrenaline used to treat

allergic reactions.

Corneal

diseases:

Ophthalmic

beta-blockers

induce

dryness

eyes.

Patients with corneal diseases should be treated with caution.

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Choroidal detachment: Choroidal detachment after filtration procedures has

been reported with the administration of aqueous suppressant therapy (e.g.,

timolol).

Other

beta-blocking

agents:

Caution

should

exercised

when

used

concomitantly with systemic beta-andrenergic blocking agents because of the

potential for additive effects on systemic beta-blockage. The response of these

patients should be closely observed. The use of two topical beta-adrenergic

blocking agents is not recommended.

4.5 Interaction with other medicines and other forms of interactions

BETAGAN

eye drops should be used with caution in patients who are receiving a ß-

adrenergic receptor blocking agent orally, because of the potential for additive effects

on systemic ß-blockade and on intraocular pressure.

Although BETAGAN

eye drops used alone have little or no effect on pupil size,

mydriasis resulting from concomitant use of BETAGAN

eye drops and mydriatic

agents such as adrenaline may occur.

Close observation of the patient is recommended when a ß-blocker is administered to

patients

receiving

catecholamine-depleting

drugs

such

reserpine,

because

possible

additive

effects

production

hypotension

and/or

marked

bradycardia, which may produce vertigo, syncope or postural hypotension.

There

potential

additive

effects

resulting

hypotension,

and/or

marked

bradycardia when eye drops with levobunolol are administered concomitantly with oral

calcium

channel

blockers,

beta-blocking

agents,

anti-arrhythmics

(including

amiodarone) digitalis glycosides or parasympathomimetics.

Patients receiving ß-adrenergic blocking agents along with either oral or intravenous

calcium

antagonists should

be monitored

possible

atrioventricular

conduction

disturbances, left ventricular failure and hypotension. In patients with impaired cardiac

function, simultaneous use should be avoided altogether.

The concomitant use of ß-adrenergic blocking agents with digitalis may have additive

effects

prolonging

atrioventricular

conduction

time.

Phenothiazine-related

compounds and ß-adrenergic blocking agents may have additive hypotensive effects

due to the inhibition of each other’s metabolism.

Beta blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta

blockers can mask the signs and symptoms of hypoglycaemia.

Concomitant

beta

blocker

with

anaesthetic

drugs

attenuate

compensatory tachycardia and increase the risk of hypotension. The anaesthetist must

therefore be informed if the patient is taking levobunolol.

4.6 Fertility, Pregnancy and Lactation

Pregnancy

Pregnancy Category C.

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Beta adrenergic blocking agents may cause pharmacological effects of beta-

blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia)

in the fetus and newborn infant. During the latter stages of pregnancy and birth,

these drugs should be given only after weighing the needs of the mother against

the risk to the fetus. If BETAGAN

is administered until delivery, the neonate

should be carefully monitored during the first days of life.

There are no adequate and well-controlled studies in pregnant women. BETAGAN

eye drops should not be used during pregnancy unless clearly necessary.

Breast-feeding

It is not known whether the drug is excreted in human milk. Systemic ß-blockers

and topical timolol maleate are known to be excreted in human milk. Caution

should be exercised when BETAGAN

eye drops are administered to a nursing

woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime study of mice there were statistically significant (p<0.05) increases in the

incidence of benign leiomyomas in female mice at 200 mg/kg/day (14,000 times the

maximum recommended human dose for glaucoma), but not at 12 or 50 mg/kg/day

(850 and 3,500 times the human dose). In a two-year oral study of levobunolol HCl in

rats

there

statistically

significant

(p<0.05)

increase

incidence

hepatomas in male rats administered 12,800 times the recommended human dose for

glaucoma. Similar differences were not observed in rats administered oral doses

equivalent to 350 times to 2,000 times the recommended human dose for glaucoma.

Levobunolol did not show evidence of mutagenic activity in a battery of microbiological

and mammalian in vitro and in vivo assays. Reproduction and fertility studies in rats

showed no adverse effects on male or female fertility at doses up to 1,800 times the

recommended human dose for glaucoma.

4.7 Effects on Ability to Drive and Use Machines

As BETAGAN

eye drops may cause transient blurring, fatigue and/or drowsiness

on instillation, caution is required with the use of hazardous machinery or driving,

which are not recommended unless symptoms have cleared.

4.8 Undesirable Effects

The following adverse effects have been reported rarely with the use of BETAGAN

eye drops: iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria and

pruritus.

Decreased corneal sensitivity has been noted in a small number of patients. Although

levobunolol has minimal membrane-stabilising activity, there remains the possibility of

decreased corneal sensitivity after prolonged use.

Clinical Studies Experience

Frequency categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon

(≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known

(cannot be estimated from available data).

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Eye Disorders

Very Common: Eye irritation, Eye pain

Common: Blepharitis, Conjunctivitis

Postmarketing Experience: Levobunolol hydrochloride

The following adverse reactions have been identified during postmarketing use of

levobunolol eye drops in clinical practice. Because postmarketing reporting of these

reactions is voluntary and from a population of uncertain size, it is not always possible

to reliably estimate the frequency of these reactions.

Eye Disorders

Conjunctival/Ocular hyperemia, Conjunctivitis allergic, Corneal reflex decreased, Eye

discharge, Eye/Eyelid edema, Eye/Eyelids pruritus, Foreign body sensation in the eye,

Iridocyclitis, Keratitis, Lacrimation increased, Punctate keratitis, Vision blurred

General Disorders and Administration Site Conditions

Face edema, Fatigue/Asthenia

Nervous System Disorders

Confusion, Dizziness, Headache, Insomnia, Lethargy, Somnolence

Psychiatric Disorders

Depression

Cardiac Disorders

Atrioventricular block, Bradycardia, Palpitations, Syncope

Vascular Disorders

Hypotension, Raynaud’s phenomenon

Respiratory, Thoracic, and Mediastinal Disorders

Asthma, Dyspnea, Nasal discomfort, Throat irritation

Gastrointestinal Disorders

Nausea

Skin and Subcutaneous Tissue Disorders

Alopecia, Dermatitis contact (including allergic contact dermatitis), Erythema of eyelid,

Eyelid eczema, Lichenoid keratosis, Pruritis, Rash, Skin exfoliation, Urticaria

Adverse Drug Reactions – Other Ophthalmic Beta-blockers

The following additional adverse reactions have been reported with ophthalmic use of

and ß

(non-selective) adrenergic blocking agents:

Eye Disorders

Choroidal detachment following filtration surgery (see

4.4 Special Warnings and

Precautions for use), Corneal erosion, Diplopia, Dry eye, Ptosis, Visual disturbances

including refractive changes (due to withdrawal of miotic therapy in some cases)

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Immune System Disorders

Anaphylaxis, Systemic allergic reactions including angioedema

Metabolism and Nutrition Disorders

Hypoglycaemia, Masked symptoms of hypoglycaemia in insulin-dependent diabetics

(see 4.4 Special Warnings and Precautions for use)

Psychiatric Disorders

Insomnia, Memory loss, Nervousness, Nightmares

Nervous System Disorders

Cerebral ischemia, Cerebrovascular accident, Increases in signs and symptoms of

myasthenia gravis, Paresthesia.

Cardiac Disorders

Arrhythmia,

Heart block,

Cerebral

vascular

accident.

Cerebral

ischemia,

Cardiac

arrest, Cardiac failure, Chest pain, Congestive heart failure, Edema.

Vascular Disorders

Cold hands and feet

Respiratory, Thoracic, and Mediastinal Disorders

Bronchospasm (predominantly in patients with pre-existing bronchospastic disease),

Cough, Respiratory failure (predominantly in patients with pre-existing bronchospastic

disease), Shortness of breath

Gastrointestinal Disorders

Abdominal pain upper, Diarrhea, Dysgeusia, Dry mouth, Dyspepsia, Vomiting.

Skin and Subcutaneous Tissue Disorders

Psoriasiform rash or exacerbation of psoriasis, Hypersensitivity including localised and

generalised rash.

Musculoskeletal and Connective Tissue Disorders

Arthropathy, Myalgia

Reproductive System and Breast Disorders

Decreased libido, Sexual dysfunction

General Disorders and Administration Site Conditions

Thirst

Other reactions associated with the oral use of non-selective adrenergic blocking

agents should be considered potential effects with ophthalmic use of these agents.

4.9 Overdose

data

available

regarding

overdose

humans.

Should

accidental

ocular

overdose occur, flush eye(s) with water or normal saline. If accidentally ingested,

efforts to decrease further absorption may be appropriate (gastric lavage).

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

The most common signs and symptoms to be expected with overdose of a systemic ß-

adrenergic blocking agent are symptomatic bradycardia, hypotension, bronchospasm

and acute cardiac failure. Should these symptoms occur, discontinue BETAGAN

drops and initiate appropriate supportive therapy. The following supportive measures

should be considered:

Symptomatic bradycardia: Use atropine sulfate intravenously in a dosage of

0.25 mg to 2 mg to induce vagal blockade. If bradycardia persists, intravenous

isoprenaline hydrochloride should be administered cautiously.

In refractory

cases the use of transvenous cardiac pacemaker should be considered.

Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine,

dobutamine or noradrenaline acid tartrate.

In refractory cases the use of

glucagon hydrochloride may be useful.

Bronchospasm:

isoprenaline

hydrochloride.

Additional

therapy

with

aminophylline may be considered.

Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen

should be instituted immediately. In refractory cases the use of intravenous

aminophylline is suggested. This may be followed, if necessary, by glucagon

hydrochloride which may be useful.

Heart block (second or third degree): Use isoprenaline hydrochloride or a

transvenous pacemaker.

For advice on the management of overdose please contact the National Poisons

Centre on 0800 POISON (0800 764766).

5.

PHARMACEUTICAL PROPERTIES

5.1. Pharmacodynamic Properties

Levobunolol hydrochloride (HCl) is a non-cardioselective ß-adrenoceptor blocking

agent, equipotent at both ß1 and ß2 receptors. Levobunolol HCl is greater than 60

times more potent than its dextro isomer in its ß-blocking activity, yet equipotent in its

potential for direct myocardial depression. Accordingly, the levo isomer, levobunolol

HCl, is used. Levobunolol HCl does not have significant local anaesthetic (membrane

stabilising) or intrinsic sympathomimetic activity.

The primary mechanism of the ocular hypotensive action of levobunolol hydrochloride

(HCl) in reducing IOP appears to be a decrease in aqueous humor production.

BETAGAN

drops

reduce

with

little

effect

pupil

size

accommodation in contrast to the miosis which cholinergic agents are known to

produce. The blurred vision and night blindness often associated with miotics would

not be expected and have not been reported with the use of BETAGAN

eye drops.

This is particularly important in cataract patients with central lens opacities who would

experience decreased visual acuity with pupillary constriction.

ß-adrenergic receptor blockade reduces cardiac output in both healthy subjects and

patients with heart disease. In patients with severe impairment of myocardial function,

ß-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic

nervous system necessary to maintain adequate cardiac function.

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

ß-adrenergic receptor blockade in the bronchi and bronchioles results in increased

airway resistance from unopposed parasympathetic activity. Such an effect in patients

with asthma or other bronchospastic conditions is potentially dangerous.

BETAGAN

eye drops (levobunolol HCl) have been shown to be an active agent in

lowering elevated as well as normal intraocular pressure (IOP), whether or not

accompanied by glaucoma. Elevated IOP presents a major risk factor in glaucomatous

field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage

and visual field loss.

The onset of action with one drop of BETAGAN

eye drops can be detected within one

hour after treatment, with maximum effect seen between 2 and 6 hours. A significant

decrease in IOP can be maintained for up to 24 hours following a single dose.

5.2. Pharmacokinetic Properties

5.3. Preclinical Safety Data

In several controlled clinical studies of four years duration, IOP was well-controlled in

the majority of subjects treated with 0.5% levobunolol HCl b.i.d, with annual retention

rates of over 80%. The mean IOP decrease from baseline was between 5.8 mmHg

and 7.8 mmHg. A total of 72 subjects remained on this agent over the entire four years

treatment. No significant effects on pupil size, tear production or corneal sensitivity

was observed in any of these studies. BETAGAN

eye drops at the concentrations

tested, when applied topically, decreased heart rate and blood pressure in some

patients. Efficacy was at least comparable to that of timolol over the entire study

period.

In clinical trials the use of BETAGAN

eye drops has been associated with transient

ocular burning and stinging in about 1 in 3 patients, and blepharoconjunctivitis in about

1 in 20 patients. Decreases in heart rate and blood pressure have been reported (see

4.3 Contraindications and 4.4 Special Warnings and Precautions for use).

6.

PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

PRESERVATIVE: benzalkonium chloride

INACTIVES: polyvinyl alcohol (LIQUIFILM

), sodium metabisulfite, disodium

edetate, sodium phosphate dibasic, potassium phosphate, sodium chloride,

purified water and hydrochloric acid or sodium hydroxide to adjust pH.

6.2. Incompatibilities

In the absence of compatibility studies, this medicine must not be mixed with other

medicines.

6.3. Shelf Life:

24 months

6.4. Special Precautions for Storage:

Store below 25

BETAGAN

5% levobunolol hydrochloride Datasheet Version 3.0

Protect from light and excessive heat.

Discard unused contents 4 weeks after opening.

To avoid contamination of the solution, keep container tightly closed. Do not touch

dropper tip to any surface. Contents are sterile if seal is intact.

6.5. Nature and Contents of Container

5 mL dropper bottles

6.6. Special Precautions for Disposal

No special requirements for disposal

7.

MEDICINE SCHEDULE

Prescription Medicine

8.

SPONSOR

Allergan New Zealand Ltd

Corner of Manu Tapu Drive and

Joseph Hammond Place

Auckland International Airport

Mangere AUCKLAND

Toll free telephone: 0800 659 912

9.

DATE OF FIRST APPROVAL

15 December 1985

10.

DATE OF REVISION OF TEXT

29 March 2017

Registered Trademark of Allergan Inc.

2017 Allergan, Inc.

SUMMARY TABLE OF CHANGES

Sections changed

Summary of new information

All headings amended to align to Medsafe’s updated DS requirements and sections within the Data Sheet

have been moved under the appropriate headings in line with Medsafe’s updated DS requirements.

Amended in line with Medsafe’s updated DS requirements

Amended in line with Medsafe’s updated DS requirements

Addition of safety information in line with the Company Core Data Sheet

Addition of safety information in line with the Company Core Data Sheet

Additional information included in line with Medsafe’s updated DS requirements

Additional information included in line with Medsafe’s updated DS requirements

Additional information included in line with Medsafe’s updated DS requirements

Date of first approval of BETAGAN

0.5 mg/mL has been included in line with

Medsafe’s updated DS requirements

Amendment of the date of revision of text

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