Alcaine

Main information

  • Trade name:
  • Alcaine 0.5 % Eye drops, solution
  • Dosage:
  • 0.5 %
  • Pharmaceutical form:
  • Eye drops, solution
  • Units in package:
  • Bottle, plastic, LDPE drop-tainer, 15 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Siegfried Ltd

Documents

Localization

  • Available in:
  • Alcaine 0.5 % Eye drops, solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Alcaine eye drops are indicated for procedures in which a rapid and short-acting topical ophthalmic anaesthetic is indicated such as cataract surgery and suture removal from the cornea and in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, and other short corneal and conjunctival procedures.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 14831
  • Authorization date:
  • 25-01-2011
  • Last update:
  • 09-05-2018

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

Internal document code

Alc120418cNZ

ALCAINE

0.5% Eye Drops

Proxymetacaine hydrochloride

CONSUMER MEDICINE INFORMATION

What is in this leaflet

Please read this leaflet

carefully before you use

Alcaine Eye Drops.

This leaflet answers some

common questions about

Alcaine Eye Drops. It does not

contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet

was last updated on the date

listed on the final page. More

recent information on the

medicine may be available.

You should ensure that you

speak to your pharmacist or

doctor to obtain the most up to

date information on the

medicine.

You can also download the most

up to date leaflet from

www.medsafe.govt.nz.

The updates may contain

important information about the

medicine and its use of which

you should be aware.

All medicines have risks and

benefits. Your doctor has

weighed the expected benefits of

you using Alcaine against the

risks this medicine could have

for you.

The information in this leaflet

applies to Alcaine only. This

information does not apply to

similar products, even if they

contain the same ingredients.

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 Alcaine it is used

for

Alcaine contains the active

ingredient proxymetacaine

hydrochloride, which belongs to

a group of medicines called local

anaesthetics.

Alcaine is used, to temporarily

numb or block the feeling

(anaesthetise) of pain in your

eye(s) during short term medical

procedures. These procedures

include measuring the pressure

in your eye, cataract surgery,

removing stitches or a foreign

body from eye e.g. a bit of dirt.

The numbing effect of Alcaine

will wear off quickly, usually

about 15 minutes after the last

drop is put in your eye(s).

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you.

Your doctor may have

prescribed it for another reason.

Before you are given

Alcaine

When you must not be given

it

Alcaine should not be given to

you if you have an allergy to:

Any medicine containing

proxymetacaine

hydrochloride

Any other local

anaesthetics

Any of the ingredients in

Alcaine (these are listed

under

Product

Description

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

Do not use this medicine after

the expiry date printed on the

pack or if the seal around the

pack is broken or shows signs

of tampering.

If it is has expired or is

damaged, return it to your

pharmacist for disposal.

This medicine has been

developed for use in the eye

only. It is not to be swallowed

or injected.

If you are not sure whether

you should be given this

medicine talk to your doctor.

Before you are given it

Tell your doctor if you have

allergies to any other

medicines or any substances

such as foods, preservatives or

dyes.

Tell your doctor if you have or

have had any medical

conditions, especially the

following:

Epilepsy

Internal document code

Alc120418cNZ

Heart problems

Lung or breathing problems

Thyroid problems

Myasthenia gravis (a

disease of the muscles

causing drooping eyelids,

double vision, difficulty in

speaking and swallowing

and sometimes muscle

weakness in the arms or

legs).

Tell your doctor if you have

ever experienced a reaction to

any other local anaesthetics.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor will only use

Alcaine if necessary.

Ask your doctor for advice on

the risks and benefits involved.

Tell your doctor if you are

breast feeding.

Your doctor will only use

Alcaine if necessary.

Ask your doctor for advice on

the risks and benefits involved.

If you have not told your

doctor about any of the above,

tell them before you are given

Alcaine.

Long term use may lessen the

anaesthetic effect so that more of

the medicine is needed to

produce anaesthesia.

Long term use may also damage

the surface of the eye (cornea),

cause an eye infection or

permanent loss of sight.

It is very important that you

protect your eyes from irritating

chemicals, avoid touching or

rubbing your eye(s) until the

anaesthesia has worn off.

Taking or using other

medicines

Tell your doctor or pharmacist if

you are taking or using any other

medicines, including medicines

that you buy at a pharmacy or

health food shop without a

doctor’s prescription

.

Some medicines and Alcaine

may interfere with each other.

These include a group of

medicines called “cholinesterase

inhibitors”.

Your doctor will advise you and

decide whether or not to give

you Alcaine.

How Alcaine is given

How much is used

Your doctor will put the correct

number of drops of Alcaine into

your eye(s) before starting the

procedure on your eye.

Your doctor will not write a

prescription for Alcaine for your

own use. Alcaine has been

specifically developed to help a

doctor numb the feeling in your

eye(s) while attending to your

eye(s).

The usual dose is one to two

drops into your eye(s) before

starting the procedure on your

eye. The number of times you

will be given Alcaine during the

procedure will depend on the

type and length of procedure to

be performed. For example,

your doctor will put one to two

drops into your eye(s) just

before measuring the pressure in

your eye. However, if you are to

have minor surgery such as

removal of stitches your doctor

will put one to two drops in your

eye(s) every 5 to 10 minutes for

up to three doses.

It is very important that you do

not touch or rub your eye while

your eye is numb because you

may scratch the surface of your

eye and damage it. Your doctor

will put a patch over your eye

after finishing the procedure to

protect your eye and stop you

from touching it.

If you are wearing soft contact

lenses, you will be asked to

remove them prior to instillation

of the drops by your doctor.

You may put your soft contact

lenses back into your eyes after

the anaesthesia has worn off and

at least 15 minutes after you

have been given Alcaine

If you are given too much

(overdose)

The doctor giving you Alcaine

will be experienced in the use of

local anesthetics, so it is unlikely

that you will be given an

overdose.

If too many drops have been put

in accidentally in your eye(s)

immediately rinse your eye(s)

with warm water.

If you think that you or

someone else has swallowed

too much Alcaine, immediately

telephone the National

Poisons

Centre on 0800

POISON or 0800 764 766 or

your doctor for advice, or go

to Accident and Emergency at

the nearest hospital. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

After you are given

Alcaine

Things you must do

You must protect you

anaesthetised eye from dust

particles, which could cause

infection.

Things you must not do

Do not touch or rub your

eye(s) while they are numb.

You may scratch the surface of

the eye and damage it. Your

doctor will put a patch over your

eye after finishing the procedure

to protect your eye and stop you

from touching it.

Things to be careful of

Be careful driving or operating

machinery until you know how

Alcaine affects you and your

vision.

Internal document code

Alc120418cNZ

As with any eye medicines,

temporary blurred vision or

other visual disturbances may

affect the ability to drive or use

machinery in some people. If

blurred vision occurs, wait until

your vision is clear before

driving or operating machinery.

Side Effects

Tell your doctor as soon as

possible if you do not feel well

after Alcaine use.

All medicines can have side

effects. Sometimes they are

serious, however most of the

time they are not. You may

need to medical treatment if you

get some of the side effects.

Do not feel alarmed the list of

possible side effects. You may

not experience any of them.

Ask your doctor, nurse, or

pharmacist to answer any

questions you may have.

Tell your doctor, nurse or

pharmacist if you notice any of

the following and they worry

you:

Irritation, stinging and

burning feeling in the eye

Redness or watery eyes

Increased winking

Dilated pupils causing

blurred vision

Drying and splitting of the

skin on fingertips

A severe, immediate allergic

reaction involving the front

layer (the cornea) of the eye.

Occasionally some people notice

untoward effects in the rest of

their body as a result of Alcaine

use.

Tell your doctor immediately

or go to Accident and

Emergency at your nearest

hospital at the first sign of an

allergic reaction such skin

rash or hives.

You may need urgent medical

attention or hospitalisation.

Tell your doctor if you notice

any unwanted effects even if

they do not appear in the list

above.

Other side effects not listed

above may also occur in some

patients.

After using Alcaine

Storage

Alcaine will be stored by your

doctor or pharmacist under

the recommended conditions.

It should be stored between 2°

to 8° C (Refrigerate, do not

freeze). Protect from light.

Alcaine should be used in a

single patient only.

Product Description

What it looks like

Alcaine Eye Drops are a sterile,

clear liquid that comes in a 15

mL dropper bottle.

Ingredients

Alcaine Eye Drops contain

proxymetacaine hydrochloride

0.5% (5 mg in 1 mL) as the

active ingredient.

Alcaine Eye Drops also contain:

glycerol

benzalkonium chloride (as a

preservative)

purified water

hydrochloric acid and/or

sodium hydroxide (to adjust

pH).

Supplier

Alcaine is supplied in New

Zealand by:

Pharmaco (NZ) Ltd

4 Fisher Crescent

Mount Wellington

Auckland 1060

New Zealand.

PO Box 4079

Auckland 1140

New Zealand.

Free Phone: 0800 804 079.

Date of Preparation

This leaflet was prepared in

April 2018.

Alcaine

is a trademark of

Alcon.

Alcon

Laboratories

(Australia) Pty Ltd 2018.

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12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety