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OLMESARTAN 20MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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PACKAGE LEAFLET: INFORMATION FOR
THE USER

See also information under the heading
“Do not take olmesartan”.

Olmesartan 10 mg
Olmesartan 20 mg
Olmesartan 40 mg
Film-coated tablets

As with any medicine which reduces
blood pressure, an excessive drop in
blood pressure in patients with blood
flow disturbances of the heart or brain
could lead to a heart attack or stroke.
Your doctor will therefore check your
blood pressure carefully.

What is in this leaflet:
1. What olmesartan is and what it is used for
2. What you need to know before you take
olmesartan
3. How to take olmesartan
4. Possible side effects
5. How to store olmesartan
6. Contents of the pack and other information
1. What olmesartan is and what it is
used for

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The name of your medicine is called
Olmesartan10mg, 20mg or 40mg
Film-coated tablets (referred to as
olmesartan throughout this leaflet).
Olmesartan belongs to a group of medicines
called angiotensin-II receptor antagonists.
They lower blood pressure by relaxing
the blood vessels.
Olmesartan is used for the treatment of
high blood pressure (also known as
‘hypertension’). High blood pressure can
damage blood vessels in organs such as
the heart, kidneys, brain and eyes. In
some cases this may lead to a heart
attack, heart or kidney failure, stroke or
blindness. Usually high blood pressure
has no symptoms. It is important to have
your blood pressure checked to prevent
damage occurring.
High blood pressure can be controlled with
medicines such as olmesartan tablets.
Your doctor has probably also recommended
that you make some changes in your
lifestyle to help lower your blood pressure
(for example losing weight, giving up
smoking, reducing the amount of alcohol
you drink and reducing the amount of salt in
your diet). Your doctor may also have urged
you to take regular exercise, such as
walking or swimming. It is important to
follow this advice from your doctor.

Do not take olmesartan
• if you are allergic to olmesartan medoxomil
or any of the other ingredients of this
medicine (listed in section 6)
• if you are more than 3 months pregnant.
(It is also better to avoid olmesartan
tablets in early pregnancy - see
pregnancy section.)
• if you suffer from yellowing of the skin
and eyes (jaundice) or problems with
drainage of the bile from the gallbladder
(biliary obstruction e.g. gallstones).
• if you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before
taking olmesartan.
Before you take the tablets, tell your
doctor if you have any of the following
health problems:
• kidney problems
• liver disease
• heart failure or problems with your heart
valves or heart muscle
• severe vomiting or diarrhoea
• treatment with high doses of water tablets
(diuretics) or if you are on a low salt diet
• increased levels of potassium in your
blood
• problems with your adrenal glands
(e.g. primary aldosteronism).
• if you are taking any of the following
medicines used to treat high blood
pressure:
• an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
• aliskiren.
Your doctor may check your kidney
function, blood pressure, and the amount
of electrolytes (e.g. potassium) in your
blood at regular intervals.

Children and adolescents
Olmesartan is not recommended for children
and adolescents under the age of 18.
Other medicines and olmesartan
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist
if you are taking or have recently taken any
of the following medicines. Your doctor
may need to change your dose and/or to
take other precautions.
• Potassium supplements, a salt substitute
which contains potassium, water tablets
(diuretics) or heparin (for thinning the
blood). Using these medicines at the
same time as olmesartan may raise the
levels of potassium in your blood.
• Lithium (a medicine used to treat mood
swings and some types of depression)
used at the same time as olmesartan
may increase the toxicity of lithium.
If you have to take lithium, your doctor
will measure your lithium blood levels.
• Non-Steroidal Anti-Inflammatory (NSAIDs)
medicines (medicines used to relieve pain,
swelling and other symptoms of
inflammation, including arthritis) used at
the same time as olmesartan may increase
the risk of kidney failure and the effect of
olmesartan can be decreased by NSAIDs.
• Other blood pressure lowering medicines,
as the effect of olmesartan can be
increased.
• Certain antacids (indigestion remedies),
as the effect of olmesartan can be
slightly decreased.
• An ACE-inhibitor or aliskiren (see also
information under the headings “Do not
take olmesartan” and “Warnings and
precautions”).
Older people
If you are over 65 years of age and your
doctor decides to increase your dose of
olmesartan medoxomil to 40 mg daily,
then you need to have your blood
pressure regularly checked by your doctor
to make sure that your blood pressure
does not become too low.
Black patients
As with other similar drugs the blood
pressure lowering effect of Olmesartan is
somewhat less in black patients.
Pregnancy, breast-feeding and fertility
Pregnancy
You must tell your doctor if you think you
are (or might become) pregnant. Your
doctor will normally advise you to stop
taking olmesartan before you become
pregnant or as soon as you know you are
pregnant and will advise you to take
another medicine instead of olmesartan.
Olmesartan is not recommended in early
pregnancy, and must not be taken when
more than 3 months pregnant, as it may
cause serious harm to your baby if used
after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or
about to start breast-feeding. Olmesartan is
not recommended for mothers who are
breast-feeding, and your doctor may
choose another treatment for you if you
wish to breast-feed, especially if your baby
is newborn, or was born prematurely.
Driving and using machines
You may feel sleepy or dizzy while being
treated for your high blood pressure.
If this happens, do not drive or use
machines until the symptoms wear off.
Ask your doctor for advice.
Olmesartan contains lactose
This medicine contains lactose (a type of
sugar). If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.
3. How to take olmesartan
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

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2. What you need to know before you
take olmesartan

You must tell your doctor if you think you
are (or might become) pregnant.
Olmesartan is not recommended in early
pregnancy, and must not be taken if you
are more than 3 months pregnant, as it
may cause serious harm to your baby if
used at that stage (see pregnancy section).

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olmesartan medoxomil
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.

The recommended starting dose is one
10 mg tablet once a day. However, if your
blood pressure is not controlled, your
doctor may decide to change your dose
up to 20 or 40 mg once a day, or
prescribe additional medicines.
The tablets can be taken with or without
food. Swallow the tablets with a sufficient
amount of water (e.g. one glass). If possible,
take your daily dose at the same time
each day, for example at breakfast time.
In patients with mild to moderate kidney
disease, your dose will not be higher than
20 mg once a day.
If you take more olmesartan than you
should
If you take more tablets than you should
or if a child accidentally swallows some,
go to your doctor or nearest accident and
emergency department immediately and
take your medicine pack with you.
If you forget to take olmesartan
If you forget a dose, take your normal dose
on the following day as usual. Do not take
a double dose to make up for a forgotten
tablet.
If you stop taking olmesartan
It is important to continue to take olmesartan
unless your doctor tells you to stop.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If they do occur, they are often mild and
do not require treatment to be stopped.
Although not many people may get them,
the following two side effects can be
serious:
On rare occasions (may affect up to 1 in
1,000 people) the following allergic
reactions, that may affect the whole body
have been reported:
Swelling of the face, mouth and/or larynx
(voice box) together with itching and rash
may occur during treatment with
olmesartan. If this happens, stop taking
olmesartan and contact your doctor
immediately.
Rarely (but slightly more often in older
people) olmesartan can cause the blood
pressure to fall too low in susceptible
individuals or as the result of an allergic
reaction. This could cause severe
light-headedness or fainting. If this
happens, stop taking olmesartan,
contact your doctor immediately and
lie down flat.
These are the other side effects known
about so far with olmesartan:
Common side effects (may affect up to
1 in 10 people):
• dizziness, headache
• nausea
• indigestion
• diarrhoea
• stomach ache, gastroenteritis
(inflammation of the stomach or
intestines)
• tiredness
• sore throat
• runny or stuffy nose
• bronchitis
• flu-like symptoms
• cough
• pain, pain in the chest, back, bones
or joints
• infection of the urinary tract
• swelling of ankles, feet, legs, hands
or arms
• blood in the urine.
Some changes in blood test results have
also been seen and include the following:
• increased fat levels
(hypertriglyceridaemia)
• increased uric acid levels
(hyperuricaemia)
• rise in blood urea
• increases in tests of liver and
muscle function.
Uncommon side effects (may affect up
to 1 in 100 people):
• quick allergic reactions that may
affect the whole body and may
cause breathing problems as well as
a rapid fall of blood pressure that
may even lead to fainting
(anaphylactic reactions)
• swelling of the face
• a feeling of dizziness or spinning
(vertigo)
• vomiting
• lack of strength, feeling unwell
• muscle pain
• skin rash, allergic skin rash, itching,
exanthema (skin eruption), skin
lumps (wheals)
• angina (pain or uncomfortable
feeling in the chest)

• In blood tests a reduction of the
numbers of a type of blood cell,
known as platelets has been seen
(thrombocytopenia)
Rare side effects (may affect up to 1 in
1,000 people):
• lack of energy
• muscle cramps
• impaired kidney function, kidney
failure
• Some changes in blood test results
have also been seen. These include
increased potassium levels
(hyperkalaemia) and increased levels
of compounds related to kidney
function.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store olmesartan
Keep this medicine out of the sight and
reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry
date which is stated on the box and on
the blister after (“EXP”). The expiry date
refers to the last day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other
information
What olmesartan contains
The active substance is olmesartan
medoxomil.
Each film-coated tablet contains 10 mg,
20 mg or 40 mg olmesartan medoxomil.
The other ingredients are:
microcrystalline cellulose, lactose
monohydrate, hydroxypropyl cellulose,
low-hydroxypropyl cellulose-11, magnesium
stearate, colloidal anhydrous silica,
hypromellose, talc, titanium dioxide (E171).
What olmesartan looks like and contents
of the pack
Olmesartan 10 and 20 mg are white,
circular film-coated tablets.
Olmesartan 40 mg are white, oval,
film-coated tablets.
Olmesartan film-coated tablets are
available in blister packs of 14, 28, 30, 50,
56, 84, 90, 98, 100 and 500 film-coated
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Manufacturer
S.C. Zentiva, S.A., B-dul Theodor Pallady
nr.50, sector 3, 032266 Bukuresti,
Romania
This leaflet was last revised in
December 2015
‘Zentiva’ is a registered trademark.
© 2015 Zentiva.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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