Alphagan P 1.5

Main information

  • Trade name:
  • Alphagan P 1.5 1.5 mg/mL Eye drops, solution
  • Dosage:
  • 1.5 mg/mL
  • Pharmaceutical form:
  • Eye drops, solution
  • Units in package:
  • Bottle, dropper, LDPE bottle and polystyrene screw cap, 3 mL, 3 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Piramal Enterprises Limited

Documents

Localization

  • Available in:
  • Alphagan P 1.5 1.5 mg/mL Eye drops, solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ALPHAGAN® P 1.5 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:
  • 11926
  • Authorization date:
  • 16-12-2004
  • Last update:
  • 27-09-2017

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

ALPHAGAN P

1.5 eye drops CMI Version 2.0 – PI v3.0

Page 1 of 4

ALPHAGAN

P 1.5

EYE DROPS

[brimonidine tartrate 1.5 mg/mL]

Consumer Medicine

Information

What is in this leaflet

This leaflet answers some

common questions about

ALPHAGAN

P 1.5 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 benefits and

risks. Your doctor has weighed

the risks of you using

ALPHAGAN

P 1.5 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 ALPHAGAN

P 1.5

eye drops are used for

ALPHAGAN

P 1.5 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.

Eye 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

P 1.5 eye drops

lower the pressure in the eye by

decreasing the fluid produced and

helping the flow of fluid out of the

eye chamber.

Although ALPHAGAN

P 1.5 eye

drops help control your glaucoma,

it does not cure it.

ALPHAGAN

P 1.5 eye drops are

used, either alone or together with

other eye drops/medicines, to

lower raised pressure within your

eye(s).

ALPHAGAN

P 1.5 eye drops are

only available with a doctor’s

prescription from pharmacies.

Your doctor may have prescribed

ALPHAGAN

P 1.5 eye drops for

you instead of ALPHAGAN

drops. The main difference

between ALPHAGAN

P 1.5 and

ALPHAGAN

is the preservative;

ALPHAGAN

P 1.5 contains

‘Purite’ (hence the ‘P’) whereas

ALPHAGAN

contains

benzalkonium chloride (see

Product Description).

ALPHAGAN

P 1.5 belongs to a

family of medicines called alpha-

adrenergic agonists.

Your doctor may have prescribed

ALPHAGAN

P 1.5 eye drops for

another reason. Ask your doctor if

you have any questions about why

ALPHAGAN

P 1.5 eye drops

have been prescribed for you.

Before you use

ALPHAGAN

P 1.5 eye

drops

When you must not use it

Do not use ALPHAGAN

P 1.5

eye drops if:

you have an allergy to

ALPHAGAN

P 1.5 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,

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.

If you are not sure whether you

should start using ALPHAGAN

1.5 eye drops, talk to your doctor.

Do not use ALPHAGAN

P 1.5

eye 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:

1. you have had an allergy to any

other medicines or any other

substances, such as foods,

preservatives or dyes.

2. you are pregnant or intend to

become pregnant. Your doctor

will discuss the possible risks

and benefits of using

ALPHAGAN

P 1.5 during

pregnancy.

ALPHAGAN P

1.5 eye drops CMI Version 2.0 – PI v3.0

Page 2 of 4

3. you are breast-feeding or

intend to breast-feed. Your

doctor will discuss the possible

risks and benefits of using

ALPHAGAN

P 1.5 when

breast-feeding.

4. you have or have had any

medical conditions, especially

the following:

liver or kidney disease

severe, uncontrolled heart

disease or poor blood flow

to the heart

poor blood flow to the brain

depression

Raynaud’s syndrome. This

is a condition marked by

numbness, tingling and

colour change (white, blue,

then red) in the fingers

when they are exposed to

cold.

dizziness on standing up,

especially when getting up

from a sitting or lying

position

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

P 1.5

eye drops may interfere with each

other. These include:

medicines for high blood

pressure

medicines used to treat some

heart problems

digoxin, a medicine used to

treat heart failure

certain medicines to treat

depression, such as tricyclics,

medicines to relieve strong

pain or anaesthetics,

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

P 1.5 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

P 1.5 eye

drops.

How to use ALPHAGAN

P

1.5 eye drops

How much to use

Your doctor will tell you how many

drops you need to use each day.

Use ALPHAGAN

P 1.5 eye drops

only when prescribed by your

doctor.

The usual dosage of eye drops is

one drop in the eye(s) every

twelve hours.

Follow all directions given to you

by your doctor carefully. The

directions may differ from the

information contained in this

leaflet.

Use ALPHAGAN

P 1.5 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.

After using ALPHAGAN

P 1.5,

wait at least 5 - 10 minutes before

putting any other eye drops in your

eye.

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.

To open a new bottle of

ALPHAGAN

P 1.5 eye drops,

first tear off the protective seal

from the bottle. The contents are

sterile if 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. 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.

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.

ALPHAGAN

P 1.5 eye drops are

for use in eyes only.

How long to use it

ALPHAGAN

P 1.5 eye drops

help control your condition but do

not cure it. Therefore

ALPHAGAN

P 1.5 eye drops

must be used every day.

Continue using ALPHAGAN

1.5 eye drops for as long as your

doctor prescribes.

ALPHAGAN P

1.5 eye drops CMI Version 2.0 – PI v3.0

Page 3 of 4

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 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

P 1.5 eye drops,

immediately telephone your doctor

or Poisons Information Centre

(New Zealand Freephone 0800

764 766) for advice, or go to

Accident and Emergency at your

nearest hospital.

Do this even if there are no signs

of discomfort or poisoning.

While you are using

ALPHAGAN

P 1.5 eye

drops

Things you must do

Have your eye pressure checked

when your eye specialist says, to

make sure ALPHAGAN

P 1.5

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 ALPHAGAN

P 1.5

eye drops because of possible

contamination of the old one, or

may advise you to stop your

treatment with ALPHAGAN

P 1.5

eye drops.

If you become pregnant while

using ALPHAGAN

P 1.5 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

P 1.5 eye drops.

Things you must not do

Do not give ALPHAGAN

P 1.5

eye drops to anyone else, even if

they have the same condition as

you.

Do not stop using ALPHAGAN

1.5 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

P 1.5 eye drops

affect you. ALPHAGAN

P 1.5

eye drops generally do not cause

any problems with your ability to

drive a car or operate machinery.

However, ALPHAGAN

P 1.5 eye

drops may cause blurred vision/

dizziness/ drowsiness/ tiredness in

some people. Make sure you

know how you react to

ALPHAGAN

P 1.5 eye 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

P 1.5 eye drops.

ALPHAGAN

P 1.5 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:

allergic reactions including red

and swollen eye(s), watery

eye(s), discomfort or feeling of

something in the eye(s), itchy

or irritated eye(s)

redness of the eye(s) or

eyelid(s)

swollen eyelid(s) and/or

surrounding area

burning and stinging of the

eye(s)

eye discharge

swelling of the eyelid(s)

eye pain

eye dryness

excessive sensitivity to bright

light

sore eye(s) and blurred vision

visual disturbances

problems seeing clearly

unusual tiredness or weakness

headache

oral dryness

runny or blocked nose,

sneezing, facial pressure or

pain

itchy eyelid(s)

discharge, crusty eyelashes

drowsiness

sore throat

changes in sensation of taste

or smell

These are usually mild side effects

that may occur occasionally.

Tell your doctor immediately if you

notice any of the following:

blurred vision, halos around

light

a loss of feeling to the surface

of the eye

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.

ALPHAGAN P

1.5 eye drops CMI Version 2.0 – PI v3.0

Page 4 of 4

After using ALPHAGAN

P

1.5 eye drops

Storage

Keep your eye drops in a cool

place where the temperature stays

below 25

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.

Keep it where children cannot

reach it. A locked cupboard at

least one-and-a-half metres (5

feet) above the ground is a good

place to store medicines.

Do not leave the 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.

Preservative: Sodium chlorite (as

Purite

).

Inactive ingredients: Carmellose

sodium, boric acid, borax, sodium

chloride, potassium chloride,

calcium chloride, magnesium

chloride and purified water.

Manufacturer/Supplier

Allergan Australia Pty Ltd

810 Pacific Highway, Gordon

NSW 2072

ABN 85 000 612 831

Toll free: 1800 252 224 (Australia)

ARTG Number: AUST R 158888

Allergan New Zealand Ltd,

Cnr Manu Tapu Drive & Joseph

Hammond Pl, Auckland

International Airport, Mangere,

Auckland

New Zealand Freephone:

0800 659 912

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

Europe -DG Health and Food Safety

18-5-2018

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

Europe -DG Health and Food Safety

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