Betoptic 0.25% suspension eye drops

Main information

  • Trade name:
  • Betoptic 0.25% suspension eye drops
  • Dosage:
  • 2.5mg/1ml
  • Pharmaceutical form:
  • Eye drops
  • Administration route:
  • Ocular
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Betoptic 0.25% suspension eye drops
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 11060000; GTIN: 5015664035003

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00101/0990
  • Last update:
  • 30-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

BETOPTIC

0.25% w/v eye drops, suspension

Betaxolol (as hydrochloride)

Package Leaflet - Information for the User

BETOPTIC 0.25 % 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 ).

1. What BETOPTIC 0.25 % is and

what it is used for

2. Before you use BETOPTIC 0.25 %

3. How to use BETOPTIC 0.25 %

4. Possible side effects

5. How to store BETOPTIC 0.25 %

6. Further information

Do not use BETOPTIC 0.25 % 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 ).

If you have a slow heart beat, heart failure

or disorders of heart rhythm ( irregular heart

beats ).

Ask your doctor for advice.

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

angle-closure glaucoma

dry eyes ( Sicca Syndrome )

Tell your doctor before you have an

operation that you are using BETOPTIC 0.25 %

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 0.25 %, but discuss it with

your doctor first.

Using other medicines

BETOPTIC 0.25 % 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 0.25 % 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 0.25 % if you are

pregnant unless your doctor considers it

necessary.

Do not use BETOPTIC 0.25 % 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

If your sight is affected in any way following

the use of BETOPTIC 0.25 %, 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 0.25 % ( benzalkonium

chloride ) that can discolour soft contact lenses.

BETOPTIC 0.25 % should only be used in the

eye ( s )

The usual dose

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

twice daily.

Remove the loose collar from the cap when

you open the bottle.

Not recommended for use in CHILDREN

Always use BETOPTIC 0.25 % exactly as your

doctor has told you. You should check with your

doctor or pharmacist if you are not sure.

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.

WHAT BETOPTIC

0.25 % IS AND WHAT IT IS USED FOR

IN THIS LEAFLET

BEFORE YOU USE BETOPTIC 0.25 %

HOW TO USE BETOPTIC 0.25 %

Continued over

How to use

Wash your hands before you start.

Shake the bottle well.

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

tip of the vial. 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 0.25 %, 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 0.25 % 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 0.25 %, ask your doctor or

pharmacist.

Brewery House,

The Maltings,

Silvester Street

Kingston-Upon-Hull

HU1 3HA

Tel: +44 (0) 1482 973000

The Maltings

Live Text:

Yes /

No /

Both

Alcon Puurs

Martin, Rosalyn

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Like all medicines, BETOPTIC* 0.25 % eye drops

suspension 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 0.25 % 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 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.

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.

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.

Keep out of the reach and sight of children.

Do not store above 25 °C.

Store the bottle in the original package in order

to protect from light.

Keep the bottle tightly closed.

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.

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.

What BETOPTIC 0.25 % contains

The active substance is betaxolol 2.5 mg / ml

( as the hydrochloride ).

The other ingredients are disodium edetate,

benzalkonium chloride, poly ( styrene

divinylbenzene ) sulphonic acid, carbomer,

boric acid, mannitol, N-lauroylsarcosine,

hydrochloric acid and / or sodium hydroxide

( to adjust pH ) and purified water.

What BETOPTIC 0.25 % looks like

and contents of the pack

BETOPTIC 0.25 % is a colourless, milky liquid

supplied in a pack containing 5 ml plastic

bottle with a screw cap.

Marketing authorisation holder :

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley,

Surrey, GU16 7SR,

United Kingdom.

Manufacturer :

SA Alcon-Couvreur NV,

Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in 02/2017.

POSSIBLE SIDE EFFECTS

HOW TO STORE BETOPTIC 0.25 %

FURTHER INFORMATION

© 2009, 2011, 2012, 2013, 2014 Novartis

a trademark of Novartis

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Production Site:

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28/02/2017

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TECH_INS_140x504_140x22_001

140x504_140x22 mm

649530 GB

649531 GB

Leaflet_Betoptic_LDMO_0.25% 5ML_GB

1587086

Cutting

Black

5095244_1

Martin, Rosalyn

Alcon Puurs

Both

No /

Yes /

Live Text:

The Maltings

Brewery House,

The Maltings,

Silvester Street

Kingston-Upon-Hull

HU1 3HA

Tel: +44 (0) 1482 973000

64953-1

02-2017

649531_GB_p1_LFT.indd 2

28/02/2017 08:44