APO-OLMESARTAN

Main information

  • Trade name:
  • APO-OLMESARTAN olmesartan medoxomil 20 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-OLMESARTAN olmesartan medoxomil 20 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221052
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221052

APO-OLMESARTAN olmesartan medoxomil 20 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

5/02/2015

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. APO-OLMESARTAN olmesartan medoxomil 20 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

24/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

APO-OLMESARTAN is indicated for the treatment of hypertension.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-OLMESARTAN olmesartan medoxomil 20 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

20 mg tablet: Yellow film-coated, round, biconvex tablets debossed with

323 one one side, and L on the other side. Blister pack of 30.

Active Ingredients

Olmesartan medoxomil

20 mg

© 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 01:41:47 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

Version 02

APO-OLMESARTAN

Olmesartan medoxomil

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about APO-

OLMESARTAN.

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 taking

APO-OLMESARTAN against

the benefits he/she expects it

will have for you.

If you have any concerns

about taking this

medicine, ask your doctor

or pharmacist.

Keep this leaflet with your

APO-OLMESARTAN

tablets.

You may need to read it again.

What APO-

OLMESARTAN is used

for

APO-OLMESARTAN is

used to treat high blood

pressure which is sometimes

called hypertension.

Everyone has blood pressure.

This pressure helps push blood

all around your body. Your

blood pressure changes at

different times of the day,

depending on how busy or

worried you are. You have

hypertension (high blood

pressure) when your blood

pressure stays higher than is

needed, even when you are

calm and relaxed.

There are usually no symptoms

of hypertension. The only way

of knowing that you have

hypertension is to have your

blood pressure checked on a

regular basis. If high blood

pressure is not treated it can

lead to serious health

problems, including stroke,

heart disease and kidney

failure.

How APO-

OLMESARTAN works

APO-OLMESARTAN belongs

to a group of medicines known

as angiotensin-II receptor

antagonists. Angiotensin-II is a

substance produced in the body

which causes blood vessels to

tighten. APO-OLMESARTAN

blocks the action of

angiotensin-II and therefore

relaxes your blood vessels.

This helps lower your blood

pressure.

Your doctor may have

prescribed APO-

OLMESARTAN for another

reason. Ask your doctor if you

have any questions about why

APO-OLMESARTAN has

been prescribed for you.

APO-OLMESARTAN is not

addictive.

This medicine is available only

with a doctor's prescription.

Before you take APO-

OLMESARTAN

When you must not take it

Do not take APO-

OLMESARTAN if:

you have serious

problems with your

kidneys

you have serious

problems with your liver

you have diabetes and are

taking a medicine called

aliskiren to reduce blood

pressure

you have an allergy to

olmesartan or any of the

ingredients listed at the

end of this leaflet

Symptoms of an allergic

reaction to olmesartan may

include skin rash, itchiness,

shortness of breath, swelling

of the face, lips or tongue,

muscle pain or tenderness or

joint pain.

Do not take olmesartan if

you are pregnant or

breastfeeding.

Olmesartan may enter your

womb or it may pass into the

breast milk and there is the

possibility that your baby may

be affected.

If pregnancy is discovered

APO-OLMESARTAN should

be discontinued as soon as

possible.

Version 02

Do not take APO-

OLMESARTAN after the

expiry date printed on the

pack or if the packaging is

torn or shows signs of

tampering.

If you are not sure

whether you should start

taking APO-

OLMESARTAN, talk to

your doctor.

Before you start to take it

Tell your doctor if you

have allergies to:

any other medicines

any other substances, such

as foods, preservatives or

dyes.

Tell your doctor if you have

or have had any medical

conditions, especially the

following:

kidney problems

liver problems

heart problems

excessive vomiting or

diarrhoea recently

high levels of potassium in

your blood

problems with your adrenal

glands (small glands above

the kidneys).

You must also tell your

doctor if you:

are following a very low

salt diet

you are or intend to

become pregnant or plan to

breastfeed.

If you have not told your

doctor about any of the

above, tell him/ her before

you start taking APO-

OLMESARTAN.

Taking other medicines

Tell your doctor or

pharmacist 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

olmesartan may interfere with

each other. These include:

other medicines used to

treat high blood pressure

other diuretics, also known

as fluid or water tablets

non-steroidal anti-

inflammatory drugs

(NSAIDs) or COX-2

inhibitors, medicines used

to relieve pain, swelling

and other symptoms of

inflammation, including

arthritis

potassium supplements or

potassium-containing salt

substitutes

lithium, a medicine used to

treat mood swings and

some types of depression.

any medicines that contain

aliskiren

These medicines may be

affected by olmesartan, or may

affect how well it works. You

may need different amounts of

your medicine, or you may

need to take different

medicines. Your doctor will

advise you.

In general, olmesartan has

been shown not to interfere

with other medicines.

However, it is important to

tell your doctor and

pharmacist about any

medicines you are taking or

plan to take.

Use in children

The safety and effectiveness

of APO-OLMESARTAN in

children aged less than 1 year

has not been established.

How to take APO-

OLMESARTAN

Follow all directions given

to you by your doctor or

pharmacist carefully.

They may differ from the

information contained in this

leaflet.

Your doctor or pharmacist

will tell you which APO-

OLMESARTAN tablet you

will need to take each day.

This depends on your

condition and whether or not

you are taking any other

medicines.

If you do not understand

the instructions on the box,

ask your doctor or

pharmacist for help.

How much to take

Tablets:

For most adult patients, the

usual starting dose of APO-

OLMESARTAN is 20 mg

once a day. The dose may need

to be increased to APO-

OLMESARTAN 40 mg once a

day if necessary.

For children 6-18 years

(weighing 35 kg or more):

One APO-OLMESARTAN

20mg tablet once daily.

For children 6-18 years

(weighing less than 35 kg):

Version 02

10mg tablet once daily.

APO-OLMESARTAN tablets

cannot be divided to

accommodate 10 mg dosing.

Olmesartan 10 mg tablets are

available from alternative

brands when the 10 mg

strength is required.

For children 1-5 years

(weighing 5 kg or more):

The dose will vary depending

on your child's weight.

How to take it

Tablets:

Swallow APO-

OLMESARTAN whole with

a full glass of water.

Do not chew the

tablets.

When to take it

Take APO-

OLMESARTAN at about

the same time each day,

with or without food.

Taking APO-

OLMESARTAN at the same

time each day will have the

best effect. It will also help

you remember when to take

APO-OLMESARTAN. It

does not matter whether you

take it with or without food.

How long to take it

APO-OLMESARTAN helps

control your condition, but

does not cure it. Therefore

you must take APO-

OLMESARTAN every day.

Continue taking your

medicine for as long as your

doctor tells you.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take your next

dose when you are meant to.

Otherwise, take it as soon as

you remember and then go

back to taking your medicine

as you would normally.

Do not take a double dose to

make up for the dose that

you missed.

This may increase the chance

of you getting an unwanted

side effect.

If you are not sure what to

do, ask your doctor or

pharmacist.

If you have trouble

remembering to take your

medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the Australian

Poisons Information Centre

(telephone 13 11 26) or go to

Accident and Emergency at

the nearest hospital, if you

think that you or anyone else

may have taken too much

APO-OLMESARTAN. Do

this even if there are no signs

of discomfort or poisoning.

Keep telephone numbers for

these places handy.

If you take too much APO-

OLMESARTAN, you may

feel light-headed, dizzy or

you may faint. You may also

have a fast heartbeat.

While you are using

APO-OLMESARTAN

Things you must do

If you are about to be started

on any new medicine, tell

your doctor, dentist or

pharmacist that you are

taking APO-

OLMESARTAN.

Make sure you drink enough

water during exercise and

hot weather when you are

taking APO-

OLMESARTAN, especially

if you sweat a lot.

If you do not drink enough

water while taking APO-

OLMESARTAN, you may feel

faint, light-headed or sick. This

is because your blood pressure

is dropping suddenly. If you

continue to feel unwell, tell

your doctor.

If you have excess vomiting

and/or diarrhoea while

taking APO-

OLMESARTAN, tell your

doctor.

You may lose too much

water and salt and your

blood pressure may drop too

much.

If you feel light-headed or

dizzy after taking your first

dose of APO-

OLMESARTAN, or when

your dose is increased, tell

your doctor immediately.

If you plan to have

surgery that needs a

general anaesthetic, tell

your doctor or dentist

that you are taking APO-

OLMESARTAN.

Your blood pressure may

drop suddenly.

If you become pregnant

while taking APO-

OLMESARTAN, tell

your doctor

immediately.

If you are about to have any

Version 02

blood tests, tell your doctor

that you are taking APO-

OLMESARTAN.

APO-OLMESARTAN may

interfere with the results of

some tests.

Have your blood pressure

checked when your doctor

says, to make sure APO-

OLMESARTAN is working.

Go to your doctor regularly

for a check-up.

Your doctor may occasionally

do a blood test to check your

potassium levels and see how

your kidneys are working.

Things you must not do

Do not give APO-

OLMESARTAN to anyone

else, even if they have the

same condition as you.

Do not take APO-

OLMESARTAN to treat

any other complaints unless

your doctor or pharmacist

tells you to.

Do not stop taking APO-

OLMESARTAN, or lower

the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed,

dizzy or faint when getting

out of bed or standing up,

get up slowly.

Standing up slowly, especially

when you get up from bed or

chairs, will help your body get

used to the change in position

and blood pressure. If this

problem continues or gets

worse, talk to your doctor.

Be careful driving or

operating machinery

until you know how

APO-OLMESARTAN

affects you.

As with other medicines in

this class, APO-

OLMESARTAN may cause

dizziness, light-headedness or

tiredness in some people.

Make sure you know how

you react to APO-

OLMESARTAN before you

drive a car, operate

machinery, or do anything

else that could be dangerous

if you are dizzy or light-

headed. If this occurs do not

drive. If you drink alcohol,

dizziness or light-headedness

may be worse.

Things that would be

helpful for your blood

pressure

Some self help measures

suggested below may help

your condition. Talk to your

doctor or pharmacist about

these measures and for more

information.

Alcohol - your doctor may

advise you to limit your

alcohol intake.

Weight - your doctor may

suggest losing some weight

to help lower your blood

pressure and help lessen

the amount of work your

heart has to do. Some

people may need a

dietician's help to lose

weight.

Diet - eat a healthy diet

which includes plenty of

fresh vegetables, fruit,

bread, cereals and fish.

Also eat less fat and sugar

(especially saturated fat)

which includes sausages,

fatty meats, full cream

dairy products, biscuits,

cakes, pastries, chocolates,

chips and coconut.

Monounsaturated and

polyunsaturated fats from

olive oil, canola oil,

avocado and nuts are

beneficial in small

quantities.

Salt - your doctor may

advise you to watch the

amount of salt in your diet.

To reduce your salt intake

you should avoid using salt

in cooking or at the table

and avoid cooked or

processed foods containing

high sodium (salt) levels.

Exercise - regular exercise,

maintained over the long

term, helps to reduce blood

pressure and helps get the

heart fitter. Regular

exercise also improves

your blood cholesterol

levels, helps reduce your

weight and stress levels,

and improves your sleep,

mood and ability to

concentrate. However, it is

important not to overdo it.

Walking is good exercise,

but try to find a route that

is reasonably flat. Before

starting any exercise, ask

your doctor about the best

kind of programme for

you.

Smoking - your doctor may

advise you to stop smoking

or at least cut down. There

are enormous benefits to be

gained from giving up

smoking. There are many

professionals, organisations

and strategies to help you

quit. Ask your doctor or

pharmacist for further

information and advice.

Side effects

Tell your doctor or

Version 02

pharmacist as soon as

possible if you do not feel

well while you are taking

APO-OLMESARTAN.

APO-OLMESARTAN helps

most people with high blood

pressure, 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.

If you are over 65 years of

age you may have an

increased chance of getting

side effects.

Ask your doctor or

pharmacist to answer any

questions you may have.

Following is a list of possible

side effects. Do not be

alarmed by this list. You may

not experience any of them.

Tell your doctor or

pharmacist if you notice any

of the following and they

worry you:

feeling light-headed, dizzy

or faint

cough

headache

feeling sick (nausea) or

vomiting

stomach pain

diarrhoea

an uncomfortable feeling in

the stomach

unusual tiredness or

weakness, fatigue

'flu-like' symptoms

runny or blocked nose, or

sneezing

bronchitis

sore throat and discomfort

when swallowing

(pharyngitis)

swelling of the hands, feet

or ankles

back pain

urinary tract infection.

These are common side effects.

They are generally mild.

Tell your doctor as soon as

possible if you notice any of

the following:

skin rash or itchiness

aching, tender or weak

muscles not caused by

exercise

painful joints

fast heart beat

shortness of breath or

tightness in the chest

swelling of the hands, feet

or ankles

symptoms that may

indicate high potassium

levels in the blood, such as

nausea, diarrhoea, muscle

weakness, change in heart

rhythm.

These may be serious side

effects. You may need

medical attention. Serious

side effects are rare.

If any of the following

happen, stop taking APO-

OLMESARTAN and either

tell your doctor immediately

or go to Accident and

Emergency at your nearest

hospital:

swelling of the face, lips,

mouth, tongue or throat

which may cause difficulty

in swallowing or breathing

chest pain. These are very

serious side effects. You

may need urgent medical

attention or hospitalisation.

These side effects are very

rare.

Other side effects not

listed above may occur in

some patients. Tell your

doctor or pharmacist if

you notice anything that

is making you feel unwell.

After using APO-

OLMESARTAN

Storage

Tablets:

Keep your tablets in the box

until it is time to take them.

If you take the tablets out of

the box they will not keep

well.

Keep your tablets in a cool

dry place where the

temperature stays below

25°C.

Do not store APO-

OLMESARTAN or any

other medicine in the

bathroom or near a sink.

Do not leave it on a

windowsill or in the car on

hot days.

Heat and dampness can destroy

some medicines.

Keep it where children

cannot reach it.

A locked cupboard at least

one-anda-half metres above the

ground is a good place to store

medicines.

Disposal

If your doctor or pharmacist

tells you to stop taking APO-

OLMESARTAN or the

tablets have passed their

expiry date, ask your

pharmacist what to do with

any that are left over.

Version 02

Product description

What it looks like

APO-OLMESARTAN

tablets come in two

strengths and each has a

different appearance:

APO-OLMESARTAN 20

mg - yellow film coated,

round, biconvex tablets

debossed with ‘323’ on one

side and ‘L’ on other side

APO-OLMESARTAN 40

mg - yellow film coated,

oval shape, biconvex

tablets debossed with

‘L324’ on one side and

plain on other side

A box of APO-

OLMESARTAN contains 30

tablets.

Ingredients

Active ingredients:

APO-OLMESARTAN 20

mg tablet - 20 mg

olmesartan medoxomil per

tablet

APO-OLMESARTAN 40

mg tablet - 40 mg

olmesartan medoxomil per

tablet.

Other ingredients:

lactose monohydrate

microcrystalline cellulose

low-substituted

hydroxypropylcellulose

hydroxypropylcellulose

magnesium stearate

Opadry Yellow 03F82788

APO-OLMESARTAN tablets

do not contain sucrose,

tartrazine or any other azo

dyes.

APO-OLMESARTAN

Supplier

APO-OLMESARTAN is

supplied in Australia by:

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

Australia

Australian Registration

Numbers

APO-OLMESARTAN 20

mg tablets AUST R

221052

APO-OLMESARTAN 40

mg tablets AUST R

221063

This leaflet was prepared in

March 2017.

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