Alphagan

Main information

  • Trade name:
  • Alphagan 0.2 % Eye drops, solution
  • Dosage:
  • 0.2 %
  • Pharmaceutical form:
  • Eye drops, solution
  • Units in package:
  • Bottle, dropper, 2.5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Piramal Enterprises Limited

Documents

Localization

  • Available in:
  • Alphagan 0.2 % Eye drops, solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ALPHAGAN® eye drops are effective for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7798
  • Authorization date:
  • 08-07-1996
  • Last update:
  • 27-09-2017

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

ALPHAGAN

Eye Drops-CMI Version 2.0 - PIv5.0

Page 1 of 4

A

LPHAGAN

EYE DROPS

[brimonidine tartrate]

Consumer Medicine

Information

What is in this leaflet

This leaflet answers some

common questions about

ALPHAGAN

eye 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

ALPHAGAN

eye drops against

the benefits they expect it will have

for you.

If you have any concerns about

using/taking this medicine, ask

your doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read

it again.

What ALPHAGAN

eye

drops are used for

ALPHAGAN

eye drops are used

to lower raised pressure in the eye

and to treat glaucoma. 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.

ALPHAGAN

eye drops are used,

either alone or in combination with

other eye drops/medicines, to

lower raised pressure within your

eye(s).

Mechanism of action:

ALPHAGAN

eye drops lower the

pressure in the eye by decreasing

the fluid produced and helping the

flow of fluid out of the eye

chamber.

Your doctor may have prescribed

ALPHAGAN

eye drops for

another reason. Ask your doctor if

you have any questions about why

ALPHAGAN

eye drops have

been prescribed for you.

Before you use

ALPHAGAN

®

eye drops

When you must not use it

Do not use ALPHAGAN eye drops

you have an allergy to

ALPHAGAN

eye drops or

any of the ingredients listed at

the end of this leaflet, some

symptoms of an allergic

reaction include skin rash,

itching, shortness of breath or

swelling of the face, lips or

tongue, which may cause

difficulty in swallowing or

breathing

you are taking monoamine

oxidase antidepressant

medication,

Check with your doctor if:

you are taking other

medication for depression, or

you have liver or kidney

disease, or

you have a severe,

uncontrolled heart condition,

you are breast-feeding. Your

baby may absorb this

medicine from breast milk and

therefore there is a possibility

of harm to the baby.

Do not use ALPHAGAN

drops if:

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.

Do not put the eye drops into your

eye(s) while you are wearing soft

contact lenses. The preservative

in ALPHAGAN

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

ALPHAGAN

eye drops.

If you are not sure whether you

should start using ALPHAGAN

eye drops, talk to your doctor.

Do not use ALPHAGAN

drops in a child or adolescent.

Safety and effectiveness in

paediatric patients have not been

established. It is particularly

important that the medicine is not

used in children under the age of 2

years.

Before you start to use it.

Tell your doctor if:

you have had an allergy to any

other medicines or any other

substances, such as foods,

preservatives or dyes.

you have or have had any

medical conditions, especially

the following:

severe heart disease

disease affecting your blood

vessels, including

Raynaud’s phenomenon or

fainting.

If you have not told your doctor

about any of the above, tell them

ALPHAGAN

Eye Drops-CMI Version 2.0 - PIv5.0

Page 2 of 4

before you use ALPHAGAN

drops.

Like most medicines,

ALPHAGAN

eye drops are not

recommended during pregnancy,

unless the benefits outweigh the

risk to the baby.

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.

Some medicines and

ALPHAGAN

eye drops may

interfere with each other. These

include:

medicines for high blood

pressure,

certain medicines to treat

depression, such as

monoamine oxidase inhibitors

and tricyclics,

medicines to relieve strong

pain or anesthetics,

any sedative-type medicines,

including alcohol and

antihistamines

any sympathomimetic

medicines.

Medicines used to treat asthma,

severe headaches or coughs and

colds may belong in the

sympathomimetic group.These

medicines may be affected by

ALPHAGAN

eye drops, or may

affect how well it works. You may

need different amounts of your

medicines, or you may need to

take different medicines.

Your doctor or pharmacist has

more information on medicines to

be careful with or avoid while using

ALPHAGAN

eye drops.

How to use ALPHAGAN

®

eye drops

How much to use

The usual dosage of eye drops is

one drop in the eye(s) every twelve

hours. If you are using more than

one eye drop product, wait 5 to 10

minutes before using the second

product so that the first eye drop is

not washed out by, or interacts

with the second.

Your doctor will tell you how many

drops you need to use each day.

Use ALPHAGAN eye drops only

when prescribed by your doctor.

Follow all directions given to you

by your doctor carefully. They may

differ from the information

contained in this leaflet.

Use ALPHAGAN

eye drops

every day, at about the same time

each day, unless your doctor tells

you otherwise. Using your eye

drops at 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 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

ALPHAGAN

eye drops, first tear

off the protective seal from the

bottle. 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. Shake the bottle gently.

3. Remove the cap.

4. Hold the bottle upside down in

one hand between your thumb

and forefinger or index finger.

5. Using your other hand, gently

pull down your lower eyelid to

form a pouch or pocket.

6. Tilt your head back and look

7. Put the tip of the bottle close to

your lower eyelid. Do not let

the tip touch your eye.

8. Release one drop into the

pouch or pocket formed

between your eye and eyelid by

gently squeezing the bottle.

9. Close your eye. Do not blink or

rub your eye.

10. 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.

11. Replace the cap, sealing it

tightly.

12. Wash your hands again with

soap and water to remove any

residue.

Wait 15 minutes before replacing

your contact lenses.

You may feel a slight burning

sensation in the eye shortly after

using the eye drops. If this

persists, or is very uncomfortable,

contact your doctor or pharmacist.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else to avoid

contaminating the eye drops.

Contaminated eye drops may give

you an eye infection.

How long to use it

ALPHAGAN

eye drops help

control your condition but does not

cure it. Therefore ALPHAGAN

eye drops must be used every

day. Continue using ALPHAGAN

eye drops for as long as your

doctor prescribes.

For some people ALPHAGAN

eye drops may have been

prescribed for a short time before

or after eye surgery.

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/taking

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.

ALPHAGAN

Eye Drops-CMI Version 2.0 - PIv5.0

Page 3 of 4

If you use too much

(overdose)

If you accidentally put several

drops in your eye(s), immediately

rinse your eye(s) with warm water.

If you think that you or anyone else

may have swallowed any or all of

the contents of a bottle of

ALPHAGAN

eye drops,

immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice,

or go to casualty at your nearest

hospital. In New Zealand call the

National Poisons Information

Centre (telephone 0800 POISON

or 0800 764 766)

Do this even if there are no signs

of discomfort or poisoning.

While you are using

ALPHAGAN

®

eye drops

Things you must do

Have your eye pressure checked

when your eye specialist says, to

make sure ALPHAGAN

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 ALPHAGAN

eye drops because of possible

contamination of the old one, or

may advise you to stop your

treatment with ALPHAGAN

drops.

If you become pregnant while

using ALPHAGAN

eye drops tell

your doctor immediately.

If you are about to be started on

any new medicine tell your doctor

and pharmacist that you are using

ALPHAGAN

eye drops.

Things you must not do

Do not give ALPHAGAN

drops to anyone else, even if they

have the same condition as you.

Do not stop using ALPHAGAN

eye drops without first talking to

your doctor. If you stop using your

eye drops, your eye pressures

may rise again and damage to

your eye may occur.

Things to be careful of

Be careful driving or operating

machinery until you know how

ALPHAGAN

eye drops affect

you.

ALPHAGAN

eye drops generally

do not cause any problems with

your ability to drive a car or

operate machinery. However,

ALPHAGAN

eye drops may

cause blurred vision/ dizziness/

drowsiness/ tiredness in some

people. Make sure you know how

you react to ALPHAGAN

drops or that your vision is clear

before driving a car or operating

machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using

ALPHAGAN

eye drops.

ALPHAGAN

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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them. Ask your

doctor or pharmacist to answer

any questions you may have.

Tell your doctor if you notice any of

the following and they worry you:

redness and swelling of the eye

redness and swelling of the

eyelids and surrounding area

discomfort

watering of the eye(s)

feeling of something in the

eye(s)

itching

conjunctivitis (discharge with

itching of the eye and crusty

eyelids)

dry eyes

blurred vision

irritation of the eye(s)

burning and stinging of the

eye(s)

excessive sensitivity to bright

light

eye ache/pain

whitening of the eye(s)

abnormal vision

headache

dizziness

fatigue/drowsiness

nasal dryness

oral dryness

abnormal taste

upper respiratory symptoms

systemic allergic reactions

gastro-intestinal symptoms

depression

weakness

These are usually mild side effects

that may occur occasionally.

Tell your doctor immediately if you

notice any of the following:

dizziness and light-

headedness, which may be due

to low blood pressure,

fast or irregular heart beat, also

called palpitations

These are serious side effects.

You may need urgent medical

attention. Serious side effects are

rare.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

After using ALPHAGAN

eye drops

Storage

Keep your eye drops in a cool

place where the temperature stays

below 25

C. Do not freeze the eye

drops.

Do not store it or any other

medicine in the bathroom or near

a sink. Do not leave it in the car or

on window sills. Do not carry the

eye drops in pockets of your

clothes. Heat and dampness can

destroy some medicines.

ALPHAGAN

Eye Drops-CMI Version 2.0 - PIv5.0

Page 4 of 4

Keep it where children cannot

reach it. A locked cupboard at

least one-and-a-half metres above

the ground is a good place to store

medicines.

Do not leave the top/lid off the

bottle for any length of time to

avoid contaminating the eye drops.

Disposal

Write the date on the bottle when

you open the eye drops and throw

out any remaining solution after

four weeks.

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 it looks like

The eye drops come in a 5 mL

sterile plastic bottle.

Ingredients

Active ingredient: brimonidine

tartrate.

Inactive ingredients:

benzalkonium chloride, polyvinyl

alcohol, sodium chloride, sodium

citrate, citric acid, and purified

water.

Manufacturer/Supplier

Allergan Australia Pty Ltd

810 Pacific Highway

Gordon, NSW 2072

Allergan New Zealand Ltd,

Auckland

ARTG number: AUST R 60297

For more information about

glaucoma, contact Glaucoma

Australia on 1800 500 880 or

Glaucoma New Zealand on 09 373

8779.

Date of preparation: January 2017

Marks owned by Allergan, Inc

26-11-2018

Mirvaso (Galderma International)

Mirvaso (Galderma International)

Mirvaso (Active substance: brimonidine) - Centralised - Renewal - Commission Decision (2018)7977 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2642/R/21

Europe -DG Health and Food Safety

1-8-2018

Champix (Pfizer Europe MA EEIG)

Champix (Pfizer Europe MA EEIG)

Champix (Active substance: varenicline tartrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5197 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/699/T/71

Europe -DG Health and Food Safety

4-6-2018

Champix (Pfizer Limited)

Champix (Pfizer Limited)

Champix (Active substance: varenicline tartrate) - Centralised - Yearly update - Commission Decision (2018)3620 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

28-5-2018

Procysbi (Chiesi Farmaceutici S.p.A.)

Procysbi (Chiesi Farmaceutici S.p.A.)

Procysbi (Active substance: mercaptamine (cysteamine bitartrate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3337 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2465/T/21

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EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3151 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/070/14/T/01

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18-5-2018

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/13/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety