XALAMOL

Main information

  • Trade name:
  • XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217150
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217150

XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

19/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle

Product Type

Single Medicine Product

Effective date

1/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to

beta-blockers, prostaglandins or other intraocular pressure lowering medications. XALAMOL 50/5 should not be used to initiate therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Discard 4 weeks after

opening

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

2.5 mL in 5 mL bottle

(S4) Prescription Only Medicine

Components

1. XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle

Dosage Form

Eye Drops, solution

Route of Administration

Ophthalmic

Visual Identification

Clear, colourless solution

Active Ingredients

Latanoprost

50 microgram/mL

Timolol maleate

6.83 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:52:20 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

XALAMOL

Xalamol

®

Latanoprost/Timolol maleate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Xalamol. 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 Xalamol

against the benefits it is expected to

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 Xalamol is used

for

Xalamol is 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

pressure is associated with damage to

the back of the eye.

There are usually no symptoms of

glaucoma. 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.

Xalamol is made up of 2 active

ingredients, latanoprost and timolol

maleate. Latanoprost works by

allowing more fluid to flow out from

within your eye(s). Timolol maleate

lowers the pressure in the eye by

reducing the production of fluid.

Latanoprost belongs to a family of

medicines called prostaglandin

agonists. Timolol maleate belongs to

a family of medicines called beta-

blockers.

Although Xalamol helps control your

glaucoma it does not cure it. So you

must keep using it until your doctor

tells you to stop.

Ask your doctor if you have any

questions about why Xalamol has

been prescribed for you.

Your doctor may have prescribed it

for another reason.

Xalamol is not recommended for use

in children. The safety and

effectiveness of Xalamol in children

have not been established.

you have an allergy to Xalamol

or any of the ingredients listed

at the end of this leaflet

Symptoms of an allergic reaction

may include:

asthma, wheezing or shortness of

breath

swelling of the face, lips or

tongue which may cause

difficulty in swallowing or

breathing

hives, itching or skin rash

fainting.

you have asthma, or a history of

asthma, chronic obstructive

lung disease (emphysema) or

other breathing problems

you have certain heart

conditions, such as a very slow

heart rate, an irregular

heartbeat, or heart failure

the bottle/packaging shows

signs of tampering

the expiry date on the pack 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 Xalamol, talk to

your doctor.

Before you start to use it

pumped in. Since new fluid continues

Tell your doctor if:

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

Before you use

Xalamol

When you must not use it

Do not use Xalamol 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

There is no adequate experience

with Xalamol in pregnant

XALAMOL

women, therefore, it should not

be used during pregnancy.

3. you are breast-feeding or

intend to breast-feed

One of the active ingredients in

Xalamol has been detected in

breast milk. Because of the

potential harm to the infant,

nursing women should either stop

using Xalamol or stop breast-

feeding while using it.

4. you have or have had any

medical conditions, especially

the following:

heart disease

lung disease

circulation problems

any other types of glaucoma or

eye conditions

diabetes

myasthenia gravis

hyperthyroidism.

Tell your doctor if you plan to have

surgery.

If you have not told your doctor

about any of the above, tell him or

her before you use Xalamol.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

some medicines used to treat

Parkinson's disease, such as

selegiline

adrenaline, a hormone used in the

treatment of asthma, slow or

irregular heartbeat, acute allergic

disorders and glaucoma

some medicines that may have

been prescribed to help you pass

urine or restore normal bowel

movements

narcotics such as morphine used

to treat moderate to severe pain

eye drops which contain an

ingredient called thiomersal. If

using such eye drops as well as

Xalamol, you should wait at least

5 minutes between using these

eye drops and Xalamol

medicines used to treat diabetes

or high blood sugar

some other eye drops that contain

a beta-blocker or a prostaglandin.

The use of two or more beta-

blocker eye drops and/or two or

more prostaglandin eye drops at

the same time is not

recommended.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while using

Xalamol.

Use Xalamol 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.

How to use it

If you are wearing soft contact

lenses, remove them before putting

the drops in your eye.

The preservative in Xalamol

(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 Xalamol.

If using other eye drops in addition

to Xalamol, wait at least 5 minutes

before putting any other drops in

your eye(s).

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else.

Touching the dropper tip against

something may contaminate the eye

drops and give you an eye infection.

You may find it easier to put drops in

your eye while you are sitting or

lying down.

1. Wash your hands well with soap

and water.

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Xalamol may

interfere with each other. These

include:

certain medicines used to treat

high blood pressure or heart

conditions such as beta-blockers,

calcium channel blockers or

digoxin

certain medicines used to treat

irregular heartbeats such as

amiodarone and quinidine

some medicines used to treat

depression, such as phenelzine,

fluoxetine or paroxetine

How to use Xalamol

Use Xalamol 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.

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 much to use

The usual dose of Xalamol is one

drop into the affected eye, or eyes,

once daily.

2. Twist off the protective overcap

from the bottle.

3. Unscrew the inner cap.

4. Use your finger to gently pull

down the lower eyelid of your

affected eye.

5. Tilt your head back and look up.

6. Place the tip of the bottle close to

but not touching your eye.

Squeeze the bottle gently so that

only one drop goes into your eye,

then release the lower eyelid.

Close your eye. Do not blink or

rub your eye.

7. While your eye is closed, place

your index finger against the

inside corner of your eye and

press against your nose for about

XALAMOL

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.

8. Screw the inner cap back on the

bottle.

9. Wash your hands again with soap

and water to remove any residue.

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.

How long to use it

Continue using Xalamol every day

for as long as your doctor

prescribes.

Xalamol helps control your

condition but does not cure it.

If you forget to use it

If you miss a dose, skip the dose

you missed and use your next dose

when you are meant to.

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 Xalamol,

immediately telephone your doctor

or the Australian Poisons

Information Centre (telephone 131

126) or go to Accident and

Emergency at your nearest

hospital. Do this even if

there are no signs of discomfort or

poisoning.

If Xalamol is accidentally

swallowed, or if you use too many

drops, you may feel light-headed or

dizzy, you may faint, have a very

slow pulse rate, or have wheezing or

difficulty breathing. Other effects

include headache, nausea, abdominal

pain, fatigue, hot flushes and

sweating.

While you are using

Xalamol

Things you must do

To make sure Xalamol is working

properly, have your eye pressure

checked regularly. Have your eyes

checked regularly for any other

changes, including a change in eye

colour.

A slow change in eye colour, which

may be permanent, has been reported

to occur in some patients who use

Xalamol. Your doctor will decide

whether you should continue using

Xalamol.

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 Xalamol because of

possible contamination of the old

one, or may advise you to stop your

treatment with Xalamol.

If you become pregnant while

using Xalamol tell your doctor

immediately.

If you are about to be started on

any new medicine tell your doctor

and pharmacist that you are using

Xalamol.

Tell all doctors and pharmacists

who are treating you that you are

using Xalamol.

Things you must not do

Do not give Xalamol to anyone

else, even if they have the same

condition as you.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop using Xalamol 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

Xalamol affects you.

Xalamol generally does not cause any

problems with your ability to drive a

car or operate machinery. However, it

may cause blurred vision in some

people. Make sure you know how you

react to Xalamol or that your vision is

clear before driving a car or operating

machinery.

Side effects

Check with your doctor as soon as

possible if you have any problems

while using Xalamol, even if you

do not think the problems are

connected with the medicine or are

not listed in this leaflet.

Like other medicines, Xalamol can

cause some side effects. If they

occur, most are likely to be minor

and temporary. However, some may

be serious and need medical

attention.

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:

a slow change in eye colour over

a period of time. The iris may

become browner in colour and

appear darker. This change may

be permanent and more

noticeable if you are only being

treated in one eye

blurred vision, double vision or

other visual problems

XALAMOL

allergic reactions including

redness, swelling and/or itching

of the eye

burning, grittiness or stinging of

the eyes

eye pain

redness or watering of the eye/s

irritation or feeling of having

something in the eye, dry eyes

discharge, itching of the eye/s,

crusty eyelashes

drooping of eyelid/s

darkening, thickening,

lengthening or an increase in the

number of eye lashes and fine

hair on the eyelids

misdirected eye lashes sometimes

causing eye irritation

darkening of the skin of the

eyelids

crusting, redness, thickening,

itching or burning of the eyelids

sensitivity to light

headache

tiredness, weakness

sleepiness

ringing or buzzing in the ears

difficulty sleeping, nightmares

change in mood such as

depression, anxiety or

nervousness

confusion, disorientation or

memory loss

hallucinations

feeling sick (nausea) or vomiting,

upset or painful stomach

diarrhoea

anorexia

dry mouth

change to your sense of taste

cold hands or feet

numbness, tingling and colour

change (white, blue then red) in

fingers when exposed to the cold

(Raynaud's Phenomenon)

numbness or tingling in the

fingers or toes

cough

nasal congestion

hair loss or thinning

less desire for sex

impotence or sexual dysfunction

muscle/joint pain

skin rash.

Tell your doctor immediately if

you notice any of the following:

fast or irregular heartbeat, also

called palpitations

dizziness and light-headedness,

which may be due to low blood

pressure

skin rash, itching

swelling of hands, feet, ankles or

legs.

These may be serious side effects.

You may need urgent medical

attention. Serious side effects are

rare.

If any of the following happen, stop

using Xalamol and tell your doctor

immediately or go to Accident and

Emergency at your nearest

hospital:

wheezing, difficulty in breathing

(asthma or worsening of asthma)

shortness of breath

very slow pulse, chest pain

fainting

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

white deposits or plaque in the

cornea causing the transparent

front part of your eye to look

white or cloudy.

These are very serious side effects.

You may need urgent medical

attention. These side effects are rare.

Tell your doctor if you notice any

other effects.

Other side effects not listed above

may also occur in some patients.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After using Xalamol

Storage

Keep your eye drops in a safe place

away from the sight and reach of

children.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Before opening Xalamol, keep the

bottle in its box in a refrigerator

(2°C - 8°C) protected from light.

After opening Xalamol, keep the

bottle in its box in a cool place

where the temperature stays below

25°C, but do not refrigerate. Keep

the box properly closed and

protected from light.

Do not store Xalamol 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.

Put the top back on the bottle right

away after use 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.

Open a new bottle every 4 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.

If your doctor tells you to stop

using the eye drops or they have

passed their expiry date, ask your

XALAMOL

pharmacist what to do with any

remaining solution.

Product description

What it looks like

Xalamol eye drops come in a plastic

bottle with a dropper and screw cap

inside a protective overcap. Remove

this overcap before use.

When you first receive your Xalamol

bottle, it will appear half full. This

corresponds to 2.5 mL of eye drop

solution, giving a minimum of 80

drops. This volume is enough to last

4 weeks if used in both eyes.

Ingredients

The active ingredients in Xalamol

eye drops are latanoprost and timolol

maleate. Each 1 mL of Xalamol

contains 50 micrograms of

latanoprost and 5 mg of timolol

(equivalent to 6.83 mg timolol

maleate). Each drop contains about

1.5 micrograms of latanoprost and

150 micrograms of timolol.

Xalamol eye drops also contain:

sodium chloride

sodium phosphate monobasic

monohydrate

sodium phosphate dibasic

anhydrous

Water for Injections

benzalkonium chloride (as a

preservative).

Identification

Xalamol can be identified by the

Australian Register Number AUST R

217150, which is found on the box.

Supplier

Xalamol is supplied in Australia by:

Aspen Pharma Pty Ltd

34-36 Chandos Street

St.Leonards, 2065, NSW

Australia

For more information about

glaucoma, contact Glaucoma

Australia Inc. (telephone 1800 500

880).

This leaflet was written in September

2014.

Registered Trademark.

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