2. What should I know before I use OLSETAN?
Do not use if you have ever had an allergic reaction to OLSETAN or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with OLSETAN and affect how it works.
4. How do I use OLSETAN?
Follow all directions given to you by your doctor or pharmacist carefully. Take OLSETAN
at the same time each day.
Swallow OLSETAN tablets whole with a full glass of water.
5. What should I know while using OLSETAN?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using OLSETAN.
If you become pregnant while taking OLSETAN, tell your doctor immediately.
Go to your doctor regularly for a check-up.
|
|
Things you should not do
|
Do not stop using this medicine suddenly, or lower the dosage, or take it to treat
any other complaints, unless your doctor tells you to.
Do not give OLSETAN to anyone else, even if they have the same condition as you.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how OLSETAN affects you.
OLSETAN may cause dizziness, light-headedness or tiredness in some people.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol.
Your doctor may advise you to limit your alcohol intake.
|
|
Looking after your medicine
|
Keep your tablets in the box until it is time to take them. Keep your tablets in a
cool dry place where the temperature stays below 25 °C.
|
6. Are there any side effects?
Common side effects may include dizziness, feeling light-headed, cough, headache,
feeling nauseous or vomiting, diarrhoea, tiredness, 'flu-like' symptoms, sore throat
and difficulty swallowing, back pain, swelling of the face or body and urinary infection.
Serious side effects may include swelling of the face, lips tongue or throat which
causes difficulty swallowing or breathing, muscle or joint pain, fast heartbeat and
chest pain. For more information, including what to do if you have any side effects,
see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): olmesartan medoxomil
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using OLSETAN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using OLSETAN.
Where to find information in this leaflet:
1. Why am I using OLSETAN?
OLSETAN contains the active ingredient olmesartan medoxomil. OLSETAN contains olmesartan medoxomil, which 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. OLSETAN blocks the action of angiotensin-II
and therefore relaxes your blood vessels. This helps lower your blood pressure.
OLSETAN 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.
OLSETAN is not addictive.
2. What should I know before I use OLSETAN?
Warnings
Do not use OLSETAN if:
you have an allergy to OLSETAN or any of the ingredients listed at the end of this
leaflet. Symptoms of an allergic reaction to OLSETAN may include skin rash, itchiness, shortness
of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint
pain.
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 are pregnant or breast-feeding
the expiry date on the pack has passed or if the packaging is torn or shows signs
of tampering
Tell your doctor if:
you have allergies to any other medicines, or any other substances, such as foods,
preservatives or dyes
you have or have had any other 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 are following a very low salt diet
you are or intend to become pregnant or plan to breastfeed
you are taking potassium supplements, potassium-sparing agents, potassium-containing
salt substitutes or other medicines that may increase serum potassium (e.g., trimethoprim-containing
products)
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take OLSETAN if you are pregnant or breastfeeding.
OLSETAN 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 OLSETAN should be discontinued as soon as possible.
Use in children
The safety and effectiveness of OLSETAN in children aged less than 1 year has not
been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and OLSETAN may interfere with each other. These include:
other medicines to treat high blood pressure
other diuretics, also known as fluid or water tablets
non-steroid 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
other medicines that may increase serum potassium (e.g., trimethoprim-containing products)
lithium, a medicine used to treat mood swings and some types of depression
any medicines that contain colesevelam
any medicines that contain aliskiren
These medicines may be affected by OLSETAN, 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OLSETAN.
4. How do I use OLSETAN?
How much to take
For most adult patients, the usual starting dose of OLSETAN is 20 mg once a day. The
dose may need to be increased to OLSETAN 40 mg once a day if necessary.
How to take OLSETAN
Swallow OLSETAN whole with a full glass of water.
Do not chew the tablets.
When to take OLSETAN
Take OLSETAN at about the same time each day. Taking OLSETAN at the same time each day will have the best effect. It will also
help you remember when to take OLSETAN.
It does not matter whether you take it with or without food.
OLSETAN helps control your condition, but does not cure it. Therefore you must take
OLSETAN every day. Continue taking your medicine for as long as your doctor tells
you.
If you forget to take OLSETAN
OLSETAN should be used regularly at the same time each day If you miss your dose at
the usual time take it as soon as you remember and then go back to taking your medicine
as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
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 take too much OLSETAN (overdose)
If you think that you have used too much OLSETAN, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you take too much OLSETAN, you may feel light-headed, dizzy, or you may faint.
You may also have a fast heartbeat.
5. What should I know while using OLSETAN?
Things you should do
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking OLSETAN.
Have your blood pressure checked when your doctor says, to make sure OLSETAN 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.
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.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking OLSETAN.
Your blood pressure may suddenly drop.
If you are about to have any blood tests, tell your doctor that you are taking OLSETAN.
OLSETAN may interfere with the results of some tests.
Make sure you drink enough water during exercise and hot weather when you take OLSETAN,
especially if you sweat a lot.
If you do not drink enough water while taking OLSETAN, 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.
Call your doctor straight away if you:
have excess vomiting and/or diarrhoea while taking OLSETAN.
You may lose too much water and salt and your blood pressure may drop too much.
feel light-headed or dizzy after taking your first dose of OLSETAN, or when your dose
is increased.
become pregnant while taking OLSETAN.
Remind any doctor, dentist or pharmacist you visit that you are using OLSETAN.
Things you should not do
Do not give OLSETAN to anyone else, even if they have the same condition as you.
Do not take OLSETAN to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking OLSETAN, or lower the dosage, without checking with your doctor.
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
(preferably wholegrain), cereals and fish. Also eat less sugar and fat (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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how OLSETAN
affects you.
As with other medicines in this class, OLSETAN may cause dizziness, light-headedness
or tiredness in some people. Make sure you know how you react to OLSETAN 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Your doctor may advise you to limit your alcohol intake.
Looking after your medicine
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 your medicine:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking OLSETAN or it is out of date, take it to any
pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that is making you feel
unwell.
Serious side effects are rare.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What OLSETAN contains
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Active ingredient
(main ingredient)
|
Olmesartan medoxomil 10, 20 or 40 mg per tablet
|
|
Other ingredients
(inactive ingredients)
|
- Hydroxypropylcellulose
- Low-substituted hydroxypropyl cellulose (LH-21)
- Cellulose microcrystalline (Avicel PH 101)
- Cellulose microcrystalline (Avicel PH 102)
- Hypromellose 6CPS
- Talc
- Titanium dioxide
- Magnesium stearate
|
|
Potential allergens
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Lactose monohydrate
|
Do not take this medicine if you are allergic to any of these ingredients.
What OLSETAN looks like
*OLSETAN 10 mg is white to off-white, round, biconvex, film coated tablets, debossed
with "IO2" on one side and plain on other side (AUST R 358593).
OLSETAN 20 mg is white to off-white, round, biconvex, film coated tablets, debossed
with "IO3" on one side and plain on other side (AUST R 358608).
OLSETAN 40 mg is w White to off-white, oval, biconvex, film coated tablets, debossed
with "IO4" on one side and plain on other side (AUST R 358594).
The tablets are supplied in blister packs of 30 film-coated tablets.
*Currently not available in Australia
Who sponsors OLSETAN
Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne VIC 3000
Phone: 1800 134 988
Who distributes OLSETAN
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2026.