Olmesartan medoxomil and amlodipine besilate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about OLMESARTAN/ AMLODIPINE - MYL.
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/ AMLODIPINE - MYL against the benefits he/she expects it will have for
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your tablets.
You may need to read it again.
What OLMESARTAN/ AMLODIPINE - MYL is used for
OLMESARTAN/ AMLODIPINE - MYL is used to treat high blood pressure which is sometimes
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/ AMLODIPINE - MYL works
OLMESARTAN/ AMLODIPINE - MYL 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. OLMESARTAN/ AMLODIPINE
- MYL blocks the action of angiotensin-II and therefore relaxes your blood vessels.
This helps lower your blood pressure.
OLMESARTAN/ AMLODIPINE - MYL also contains amlodipine besilate, a calcium channel
blocker. This reduces the movement of calcium into the cells of the heart and blood
vessels. This also helps to lower blood pressure as it relaxes the blood vessels
and increases the supply of blood and oxygen to the heart.
Your doctor may have prescribed OLMESARTAN/ AMLODIPINE - MYL for another reason.
Ask your doctor if you have any questions about why OLMESARTAN/ AMLODIPINE - MYL has
been prescribed for you.
OLMESARTAN/ AMLODIPINE - MYL is not addictive.
This medicine is available only with a doctor's prescription.
Before you take OLMESARTAN/ AMLODIPINE - MYL
When you must not take it
Do not take OLMESARTAN/ AMLODIPINE - MYL if you have an allergy to:
amlodipine besilate, medicines belonging to a group of chemicals called dihydropyridines
used to treat blood pressure and other heart problems,
or any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to OLMESARTAN/ AMLODIPINE - MYL 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/ AMLODIPINE - MYL 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 had recent serious heart problems
you have low potassium or sodium levels in the blood
Do not take OLMESARTAN/ AMLODIPINE - MYL if you are pregnant or breastfeeding.
OLMESARTAN/ AMLODIPINE - MYL 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/ AMLODIPINE - MYL should be discontinued as
soon as possible.
Do not take OLMESARTAN/ AMLODIPINE - MYL 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/ AMLODIPINE - MYL,
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:
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 OLMESARTAN/ AMLODIPINE - MYL.
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
Some medicines and OLMESARTAN/ AMLODIPINE - MYL may interfere with each other. These
other medicines to treat high blood pressure
any medicines that contain aliskiren
medicines used to treat angina, such as diltiazem
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
lithium or antidepressant medicines
some antibiotics, such as erythromycin or rifampicin
some antifungals, such as ketoconazole or itraconazole
anti-proteases, medicines used to treat HIV infection such as ritonavir
medicines which lower your immune system, such as ciclosporin and tacrolimus
St John's Wort
Grapefruit or grapefruit juice
any medicines that contain colesevelam.
These medicines may be affected by OLMESARTAN/ AMLODIPINE - MYL, or may affect how
well it works. You may need different amounts of your medicine, or you may need to
take different medicines.
Other medicines not listed above may also interfere with OLMESARTAN/ AMLODIPINE -
MYL. Your doctor and pharmacist have more information on medicines to be careful with
or avoid while taking this medicine.
Use in children
The safety and effectiveness of OLMESARTAN/ AMLODIPINE - MYL in children have not
How to take OLMESARTAN/ AMLODIPINE - MYL
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/ AMLODIPINE - MYL 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
How much to take
The dose of OLMESARTAN/ AMLODIPINE - MYL is one tablet to be taken once a day.
How to take it
Swallow OLMESARTAN/ AMLODIPINE - MYL whole with a full glass of water.
Do not chew the tablets.
When to take it
Take OLMESARTAN/ AMLODIPINE - MYL at about the same time each day, with or without
Taking your tablets at the same time each day will have the best effect. It will
also help you remember when to take the tablets. It does not matter whether you take
it with or without food.
How long to take it
OLMESARTAN/ AMLODIPINE - MYL helps control your condition, but does not cure it.
Therefore you must take OLMESARTAN/ AMLODIPINE - MYL 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
If you take too much (overdose)
Immediately telephone your doctor or the 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/ AMLODIPINE - MYL. Do this
even if there are no signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you take too much OLMESARTAN/ AMLODIPINE - MYL, you may feel light-headed, dizzy
or you may faint. You may also have a fast heart beat.
While you are using OLMESARTAN/ AMLODIPINE - MYL
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/ AMLODIPINE - MYL.
If you have excess vomiting and/or diarrhoea while taking OLMESARTAN/ AMLODIPINE -
MYL, 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/ AMLODIPINE
- MYL, 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/ AMLODIPINE - MYL.
Your blood pressure may drop suddenly.
If you become pregnant while taking OLMESARTAN/ AMLODIPINE - MYL, tell your doctor
If you are about to have any blood tests, tell your doctor that you are taking OLMESARTAN/
AMLODIPINE - MYL.
OLMESARTAN/ AMLODIPINE - MYL may interfere with the results of some tests.
Have your blood pressure checked when your doctor says, to make sure OLMESARTAN/ AMLODIPINE
- MYL 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/ AMLODIPINE - MYL to anyone else, even if they have the same
condition as you.
Do not take OLMESARTAN/ AMLODIPINE - MYL to treat any other complaints unless your
doctor or pharmacist tells you to.
Do not stop taking OLMESARTAN/ AMLODIPINE - MYL, 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
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/ AMLODIPINE
- MYL affects you.
As with other medicines in this class, OLMESARTAN/ AMLODIPINE - MYL may cause dizziness,
light-headedness or tiredness in some people. Make sure you know how you react to
OLMESARTAN/ AMLODIPINE - MYL 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
(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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking OLMESARTAN/ AMLODIPINE - MYL.
OLMESARTAN/ AMLODIPINE - MYL 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.
The 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
feeling sick (nausea) or vomiting
unusual tiredness or weakness, fatigue
sore throat and discomfort when swallowing (pharyngitis)
urinary tract infection
swelling of the face, hands, feet or ankles
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
fast heart beat
shortness of breath or tightness in the chest
swelling of the face, 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
If any of the following happen, stop taking OLMESARTAN/ AMLODIPINE - MYL 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
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/ AMLODIPINE - MYL
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/ AMLODIPINE - MYL 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.
If your doctor tells you to stop taking OLMESARTAN/ AMLODIPINE - MYL or the tablets
have passed their expiry date, ask your pharmacist what to do with any that are left
What it looks like
OLMESARTAN/ AMLODIPINE - MYL tablets come in three strengths and each has a different
OLMESARTAN/ AMLODIPINE - MYL 20/5 is a white round tablet, approximately 6mm in diameter,
with C73 debossed on one side.
OLMESARTAN/ AMLODIPINE - MYL 40/5 is a cream round tablet, approximately 8mm in diameter,
with C75 debossed on one side.
OLMESARTAN/ AMLODIPINE - MYL 40/10 is a brownish red round tablet, approximately 8mm
in diameter, with C77 debossed on one side.
The product is presented in blister packs of 10 or 30 film-coated tablets.
OLMESARTAN/ AMLODIPINE - MYL 20/5 - 20 mg olmesartan medoxomil and 5mg amlodipine
OLMESARTAN/ AMLODIPINE - MYL 40/5 - 40 mg olmesartan medoxomil and 5mg amlodipine
OLMESARTAN/ AMLODIPINE - MYL 40/10 - 40 mg olmesartan medoxomil and 10mg amlodipine
colloidal anhydrous silica
pregelatinised maize starch
and iron oxides in OLMESARTAN/ AMLODIPINE - MYL 40/5 and 40/10.
OLMESARTAN/ AMLODIPINE - MYL does not contain sucrose, tartrazine or any other azo
OLMESARTAN/ AMLODIPINE - MYL is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road,
Macquarie Park NSW 2113
Australian Registration Numbers
OLMESARTAN/ AMLODIPINE - MYL 20/5 AUST R 273618
OLMESARTAN/ AMLODIPINE - MYL 40/5 AUST R 273619
OLMESARTAN/ AMLODIPINE - MYL 40/10 AUST R 273620
This leaflet was prepared in July 2017.