Olmertan

Main information

  • Trade name:
  • Olmertan olmesartan medoxomil 40 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Olmertan olmesartan medoxomil 40 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221050
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221050

Olmertan olmesartan medoxomil 40 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

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. Olmertan olmesartan medoxomil 40 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

26/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olmertan 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. Olmertan olmesartan medoxomil 40 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

40 mg tablet: Yellow film-coated, oval shaped, biconvex tablets debossed

with L324 on one side, and plain on the other side. Blister pack of 30.

Active Ingredients

Olmesartan medoxomil

40 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 01:43:07 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

OLMERTAN

Olmesartan medoxomil

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about OLMERTAN.

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

OLMERTAN 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

OLMERTAN tablets.

You may need to read it again.

What OLMERTAN is used

for

OLMERTAN 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 OLMERTAN works

OLMERTAN 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.

OLMERTAN blocks the action of

angiotensin-II and therefore relaxes

your blood vessels. This helps

lower your blood pressure.

Your doctor may have prescribed

OLMERTAN for another reason.

Ask your doctor if you have any

questions about why OLMERTAN

has been prescribed for you.

OLMERTAN is not addictive.

This medicine is available only

with a doctor's prescription.

Before you take

OLMERTAN

When you must not take it

Do not take OLMERTAN 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

OLMERTAN should be

discontinued as soon as possible.

Do not take OLMERTAN 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

OLMERTAN, 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 OLMERTAN

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

OLMERTAN in children aged

less than 1 year has not been

established.

How to take OLMERTAN

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 OLMERTAN 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

For most adult patients, the usual

starting dose of OLMERTAN is 20

mg once a day. The dose may need

to be increased to OLMERTAN 40

mg once a day if necessary.

For children 6-18 years (weighing

35 kg or more):

One OLMERTAN 20mg tablet

once daily.

For children 6-18 years

(weighing less than 35 kg):

One OLMERTAN 10mg tablet

once daily.

For children 1-5 years (weighing 5

kg or more):

The dose will vary depending on

your child's weight.

How to take it

Swallow OLMERTAN whole

with a full glass of water.

Do not chew the tablets.

When to take it

Take OLMERTAN at about

the same time each day, with

or without food.

Taking OLMERTAN at the same

time each day will have the best

effect. It will also help you

remember when to take

OLMERTAN. It does not matter

whether you take it with or

without food.

How long to take it

OLMERTAN helps control your

condition, but does not cure it.

Therefore you must take

OLMERTAN 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 OLMERTAN. Do this even

if there are no signs of discomfort

or poisoning.

Keep telephone numbers for

these places handy.

If you take too much

OLMERTAN, you may feel

light-headed, dizzy or you may

faint. You may also have a fast

heartbeat.

While you are using

OLMERTAN

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

OLMERTAN.

Make sure you drink enough

water during exercise and hot

weather when you are taking

OLMERTAN, especially if you

sweat a lot.

If you do not drink enough water

while taking OLMERTAN, 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

OLMERTAN, 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

OLMERTAN, 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

OLMERTAN.

Your blood pressure may

drop suddenly.

If you become pregnant

while taking OLMERTAN,

tell your doctor

immediately.

If you are about to have any

blood tests, tell your doctor that

you are taking OLMERTAN.

OLMERTAN may interfere with

the results of some tests.

Have your blood pressure

checked when your doctor says,

to make sure OLMERTAN 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 OLMERTAN to

anyone else, even if they have

the same condition as you.

Do not take OLMERTAN to

treat any other complaints

unless your doctor or

pharmacist tells you to.

Do not stop taking

OLMERTAN, 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 OLMERTAN

affects you.

As with other medicines in this

class, OLMERTAN may cause

dizziness, light-headedness or

tiredness in some people. Make

sure you know how you react to

OLMERTAN 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 pharmacist

as soon as possible if you do not

feel well while you are taking

OLMERTAN.

OLMERTAN 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 OLMERTAN 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 OLMERTAN

Storage

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 OLMERTAN 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 OLMERTAN

or the tablets have passed their

expiry date, ask your pharmacist

what to do with any that are left

over.

Product description

What it looks like

OLMERTAN tablets come in

three strengths and each has a

different appearance:

OLMERTAN 10 mg - yellow

film coated, round, biconvex

tablets debossed with ‘392’ on

one side and ‘L’ on other side

OLMERTAN 20 mg - yellow

film coated, round, biconvex

tablets debossed with ‘323’ on

one side and ‘L’ on other side

OLMERTAN 40 mg - yellow

film coated, oval shape,

biconvex tablets debossed with

‘L324’ on one side and plain on

other side

A box of OLMERTAN contains 30

tablets.

Ingredients

Active ingredients:

OLMERTAN 10 mg tablet - 10

mg olmesartan medoxomil per

tablet

OLMERTAN 20 mg tablet - 20

mg olmesartan medoxomil per

tablet

OLMERTAN 40 mg tablet - 40

mg olmesartan medoxomil per

tablet.

Other ingredients:

lactose monohydrate

microcrystalline cellulose

low-substituted

hydroxypropylcellulose

hydroxypropylcellulose

magnesium stearate

Opadry Yellow 03F82788

OLMERTAN tablets do not

contain sucrose, tartrazine or any

other azo dyes.

OLMERTAN

Supplier

OLMERTAN is supplied in

Australia by:

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne VIC 3121

Australian Registration

Numbers

OLMERTAN 10 mg tablets -

AUST R 221062

OLMERTAN 20 mg tablets -

AUST R 221051

OLMERTAN 40 mg tablets -

AUST R 221050

This leaflet was prepared in

October 2016.

There are no news related to this product.