General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about OLMETEC.
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
OLMETEC 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
OLMETEC tablets.
You may need to read it
again. What OLMETEC is used for OLMETEC 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 OLMETEC works
OLMETEC
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. OLMETEC blocks
the action of angiotensin-II and therefore relaxes
your blood vessels. This helps lower your blood
pressure.
Your doctor may have prescribed
OLMETEC for another reason. Ask your doctor if you
have any questions about why OLMETEC has been
prescribed for you. OLMETEC is not addictive. This
medicine is available only with a doctor's
prescription. Before you take OLMETEC When you
must not take it
Do not take OLMETEC if:
you have an allergy to OLMETEC or any of the
ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to OLMETEC
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 OLMETEC if you are pregnant or
breastfeeding.
OLMETEC 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 OLMETEC should be
discontinued as soon as possible. Do not take
OLMETEC 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 OLMETEC, 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.
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
OLMETEC.
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 OLMETEC 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.
These medicines may
be affected by OLMETEC, 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, OLMETEC 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
OLMETEC in children has not been established.
How to take OLMETEC 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 OLMETEC 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 patients, the usual starting dose of
OLMETEC is 20 mg once a day. The dose may need to
be increased to OLMETEC 40 mg once a day if
necessary.
How to take it
Swallow
OLMETEC whole with a full glass of water.
Do not chew the tablets. When to take it
Take OLMETEC at about the same time each day,
with or without food.
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
OLMETEC helps control your condition,
but does not cure it. Therefore you must take
OLMETEC 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 OLMETEC. Do this even if there are no
signs of discomfort or poisoning.
Keep
telephone numbers for these places handy.
If you take too much OLMETEC, you may feel
light-headed, dizzy or you may faint. You may also
have a fast heartbeat. While you are using OLMETEC
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 OLMETEC.
Make sure you drink enough water during
exercise and hot weather when you are taking
OLMETEC, especially if you sweat a lot.
If
you do not drink enough water while taking
OLMETEC, 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 OLMETEC, 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 OLMETEC, 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
OLMETEC.
Your blood pressure may drop
suddenly. If you become pregnant while taking
OLMETEC, tell your doctor immediately.
If
you are about to have any blood tests, tell your
doctor that you are taking OLMETEC.
OLMETEC may interfere with the results of some
tests. Have your blood pressure checked when your
doctor says, to make sure OLMETEC 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 OLMETEC to anyone else, even
if they have the same condition as you.
Do
not take OLMETEC to treat any other complaints
unless your doctor or pharmacist tells you to.
Do not stop taking OLMETEC, 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 OLMETEC affects you.
As
with other medicines in this class, OLMETEC may
cause dizziness, light-headedness or tiredness in
some people. Make sure you know how you react to
OLMETEC 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 OLMETEC.
OLMETEC
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)
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
OLMETEC 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 OLMETEC 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 OLMETEC 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
OLMETEC 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
OLMETEC tablets come in two
strengths and each has a different appearance:
OLMETEC 20 mg - White, circular film coated
tablet with characteristic odour approximately 8.5
mm in diameter, with C14 embossed on one side
OLMETEC 40 mg - White, oval film coated tablet
with characteristic odour approximately 15 x 7 mm
in size, with C15 embossed on one side.
A
box of OLMETEC contains 10 or 30 tablets.
Ingredients
Active ingredients:
OLMETEC
20 mg - 20 mg olmesartan medoxomil per tablet
OLMETEC 40 mg - 40 mg olmesartan medoxomil per
tablet.
Other ingredients:
microcrystalline cellulose
low-substituted
hydroxypropylcellulose
lactose
hydroxypropylcellulose
magnesium stearate
Opadry OY-S-38956 that contains titanium
dioxide, talc and hydroxypropylmethylcellulose.
OLMETEC does not contain sucrose,
tartrazine or any other azo dyes. Supplier
OLMETEC is supplied in Australia by:
Schering-Plough Pty Limited
Level 4, 66
Waterloo Road
North Ryde NSW 2113
Australian Registration Numbers
OLMETEC
20 mg - AUST R 102138
OLMETEC 40 mg - AUST R
102139
This leaflet was prepared in
November 2007.
© Schering-Plough Pty
Limited 2007
All rights reserved
® Registered trademark of Daiichi Sankyo
Company Ltd