OLMESARTAN

Main information

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

Documents

Localization

  • Available in:
  • OLMESARTAN SANDOZ 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:
  • 221058
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221058

OLMESARTAN SANDOZ olmesartan medoxomil 20 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

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. OLMESARTAN SANDOZ olmesartan medoxomil 20 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

OLMESARTAN SANDOZ 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. OLMESARTAN SANDOZ 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 01:39:01 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

Olmesartan Sandoz

Olmesartan medoxomil

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Olmesartan Sandoz.

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 Olmesartan

Sandoz 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

Olmesartan Sandoz tablets.

You may need to read it again.

What Olmesartan

Sandoz is used for

Olmesartan Sandoz 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 Olmesartan Sandoz

works

Olmesartan Sandoz 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. Olmesartan

Sandoz blocks the action of

angiotensin-II and therefore relaxes

your blood vessels. This helps lower

your blood pressure.

Your doctor may have prescribed

Olmesartan Sandoz for another

reason. Ask your doctor if you have

any questions about why Olmesartan

Sandoz has been prescribed for you.

Olmesartan Sandoz is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take

Olmesartan Sandoz

When you must not take it

Do not take Olmesartan Sandoz 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

Olmesartan Sandoz should be

discontinued as soon as possible.

Do not take Olmesartan Sandoz

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 Olmesartan

Sandoz, 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

OLMESARTAN SANDOZ

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

Olmesartan Sandoz.

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

any medicines that contain

colesevelam

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

Olmesartan Sandoz in children aged

less than 1 year has not been

established.

How to take

Olmesartan Sandoz

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 Olmesartan Sandoz 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 Olmesartan Sandoz

is 20 mg once a day. The dose may

need to be increased to Olmesartan

Sandoz 40 mg once a day if

necessary.

For children 6-18 years (weighing 35

kg or more):

One Olmesartan Sandoz 20mg tablet

once daily.

For children 6-18 years (weighing

less than 35 kg):

One Olmesartan Sandoz 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 Olmesartan Sandoz whole

with a full glass of water.

Do not chew the tablets.

When to take it

Take Olmesartan Sandoz at about

the same time each day, with or

without food.

Taking Olmesartan Sandoz at the

same time each day will have the

best effect. It will also help you

remember when to take Olmesartan

Sandoz. It does not matter whether

you take it with or without food.

How long to take it

Olmesartan Sandoz helps control

your condition, but does not cure it.

Therefore you must take Olmesartan

Sandoz 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

Olmesartan Sandoz. Do this even if

there are no signs of discomfort or

poisoning.

OLMESARTAN SANDOZ

Keep telephone numbers for these

places handy.

If you take too much Olmesartan

Sandoz, you may feel light-headed,

dizzy or you may faint. You may also

have a fast heartbeat.

While you are using

Olmesartan Sandoz

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 Olmesartan Sandoz.

Make sure you drink enough water

during exercise and hot weather

when you are taking Olmesartan

Sandoz, especially if you sweat a

lot.

If you do not drink enough water

while taking Olmesartan Sandoz, 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 Olmesartan

Sandoz, 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

Olmesartan Sandoz, 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 Olmesartan Sandoz.

Your blood pressure may drop

suddenly.

If you become pregnant while

taking Olmesartan Sandoz, tell

your doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking Olmesartan Sandoz.

Olmesartan Sandoz may interfere

with the results of some tests.

Have your blood pressure checked

when your doctor says, to make

sure Olmesartan Sandoz 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 Olmesartan Sandoz to

anyone else, even if they have the

same condition as you.

Do not take Olmesartan Sandoz to

treat any other complaints unless

your doctor or pharmacist tells you

to.

Do not stop taking Olmesartan

Sandoz, 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

Olmesartan Sandoz affects you.

As with other medicines in this class,

Olmesartan Sandoz may cause

dizziness, light-headedness or

tiredness in some people. Make sure

you know how you react to

Olmesartan Sandoz 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

OLMESARTAN SANDOZ

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

Olmesartan Sandoz.

Olmesartan Sandoz 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 Olmesartan Sandoz 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

Olmesartan Sandoz

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 Olmesartan Sandoz 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-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking Olmesartan

Sandoz 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

Olmesartan Sandoz tablets come in

three strengths and each has a

different appearance:

Olmesartan Sandoz 10 mg -

yellow film coated, round,

biconvex tablets debossed with

'392' on one side and 'L' on other

side

Olmesartan Sandoz 20 mg -

yellow film coated, round,

biconvex tablets debossed with

'323' on one side and 'L' on other

side

OLMESARTAN SANDOZ

Olmesartan Sandoz 40 mg -

yellow film coated, oval shape,

biconvex tablets debossed with

'L324' on one side and plain on

other side

Olmesartan Sandoz is supplied in

packs of 30 tablets.

Ingredients

Active ingredients:

Olmesartan Sandoz 20 mg tablet -

20 mg olmesartan medoxomil per

tablet

Olmesartan Sandoz 40 mg tablet -

40 mg olmesartan medoxomil per

tablet.

Other ingredients:

lactose monohydrate

microcrystalline cellulose

hypromellose

hyprolose

magnesium stearate

Opadry Yellow 03F82788

Olmesartan Sandoz tablets do not

contain sucrose, tartrazine or any

other azo dyes.

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

This leaflet was prepared in March

2017.

Australian Register

Numbers

Olmesartan Sandoz 20 mg tablets

- AUST R 221058

Olmesartan Sandoz 40 mg tablets

- AUST R 221056

OLMESARTAN SANDOZ

There are no news related to this product.