UK Edition. Click here for US version.
OLMETEC 20MG FILM-COATED TABLET
Active substance(s): OLMESARTAN MEDOXOMIL
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Package Leaflet: Information for the user
Olmetec® 10 mg, 20 mg, 40 mg
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
• 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.
What is in this leaflet
1. What Olmetec is and what it is used for
2. What you need to know before you take Olmetec
3. How to take Olmetec
4. Possible side effects
5. How to store Olmetec
6. Contents of the pack and other information
1. WHAT OLMETEC IS AND WHAT IT IS
Olmetec belongs to a group of medicines called
angiotensin-II receptor antagonists. They lower
blood pressure by relaxing the blood vessels.
Olmetec is used for the treatment of high blood
pressure (also known as ‘hypertension’) in adults
and in children and adolescents aged 6 to less
than 18 years. 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
High blood pressure can be controlled with
medicines such as Olmetec 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.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OLMETEC:
Do not take Olmetec
• 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 Olmetec 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.
• 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 before using Olmetec. Tell
your doctor if you are using any of the following medicines used to treat high blood pressure:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
Your doctor may check your kidney function,
blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not
Tell your doctor if you have any of the following
• Kidney problems
• Liver disease
• Heart failure or problems with your heart valves
or heart muscle
• Severe vomiting, 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.
Contact your doctor if you experience diarrhoea
that is severe, persistent and causes substantial
weight loss. Your doctor may evaluate your
symptoms and decide on how to continue your
blood pressure medication.
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
You must tell your doctor if you think you are
(or might become) pregnant. Olmetec 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).
As with other similar drugs the blood pressure
lowering effect of Olmetec is somewhat less in
If you are 65 years or over 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.
Children and adolescents
Olmetec has been studied in children and adolescents. For more information, talk to your doctor. Olmetec is not recommended for children
from 1 year to less than 6 years and should not be
used in children under the age of 1 year as no
experience is available.
Other medicines and Olmetec:
Tell your doctor or pharmacist if you are using
have recently used or might use any other
In particular, tell your doctor or pharmacist about
any of the following:
• Other blood pressure lowering medicines, as the
effect of Olmetec can be increased.
• Your doctor may need to change your dose
and/or to take other precautions:
• If you are taking an ACE-inhibitor or aliskiren (see
also information under the headings “Do not take
Olmetec” and “Warnings and 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 Olmetec 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 Olmetec 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
Olmetec may increase the risk of kidney failure
and the effect of Olmetec can be decreased by
• Colesevelam hydrochloride, a drug that lowers
the level of cholesterol in your blood, as the
effect of Olmetec may be decreased. Your doctor may advise you to take Olmetec at least
4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as the
effect of Olmetec can be slightly decreased.
Olmetec with food and drink
Olmetec can be taken with or without food.
Pregnancy and breast-feeding
You must tell your doctor if you think you are
(or might become) pregnant. Your doctor will
normally advise you to stop taking Olmetec
before you become pregnant or as soon as you
know you are pregnant and will advise you to take
another medicine instead of Olmetec. Olmetec 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.
Tell your doctor if you are breast-feeding or
about to start breast-feeding. Olmetec 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.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
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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.
of the face, vertigo, vomiting, weakness, feeling
unwell, muscular pain, skin rash, allergic skin
rash, itching, exanthema (skin eruption), skin
lumps (wheals), angina (pain or uncomfortable
feeling in the chest).
Olmetec 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.
In blood tests a reduction of the numbers of a
type of blood cell, known as platelets has been
3. HOW TO TAKE OLMETEC
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not sure.
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.
In patients with mild to moderate kidney disease,
your dose will not be higher than 20 mg once a
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
Children and adolescents from 6 to less than
18 years of age:
The recommended starting dose is 10 mg once
daily. If the patient’s blood pressure is not
adequately controlled, the doctor may decide to
change the dose up to 20 or 40 mg once a day.
In children who weigh less than 35 kg, the dose
will not be higher than 20 mg once a day.
If you take more Olmetec than you should
If you take more tablets than you should or if a child
accidentally swallows some, go to your doctor or
nearest emergency department immediately and
take your medicine pack with you.
If you forget to take Olmetec
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 Olmetec
It is important to continue to take Olmetec unless
your doctor tells you to stop.
If you have any further questions on the use of
this product, 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 Olmetec. If this happens
stop taking Olmetec and contact your doctor
Rarely (but slightly more often in elderly people)
Olmetec 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 occurs stop
taking Olmetec, contact your doctor immediately and lie down flat.
These are the other side effects known about
so far with Olmetec
Common side effects (may affect up to 1 in
Dizziness, headache, nausea, indigestion, diarrhoea,
stomach ache, gastroenteritis, 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
Uncommon side effects (may affect up to 1 in
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
Rare side effects (may affect up to 1 in 1000
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.
Additional side effects in children and adolescents:
In children, side effects are similar to those
reported in adults. However, dizziness and
headache are seen more often in children, and
nose bleeding is a common side effect seen in
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 OLMETEC
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the carton and on the blister
strip after "EXP". The expiry date refers to the last
day of that month.
This medicinal product does not require any
special storage conditions.
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
6. CONTENTS OF THE PACK AND OTHER
What Olmetec 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, hydroxypropylcellulose, low substituted hydroxypropylcellulose,
magnesium stearate, titanium dioxide (E171),
talc and hypromellose (See section 2 “Olmetec
What Olmetec looks like and contents of the
Olmetec 10 mg film-coated tablets are white,
circular with C 13 on one side.
Olmetec 20 mg film-coated tablets are white,
circular with C 14 on one side.
Olmetec 40 mg film-coated tablets are white,
oval with C 15 on one side.
Olmetec film-coated tablets are available in
packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28
film-coated tablets and in packs with perforated
unit dose blisters of 10, 50 and 500 film-coated
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation Holder
DAIICHI SANKYO UK LTD
Chalfont Park, Gerrards Cross
England SL9 0GA, UK
DAIICHI SANKYO EUROPE GmbH
85276 Pfaffenhofen, Germany
This leaflet was last revised in July 2017.
UK: Olmetec 10 mg, 20 mg, 40 mg
The following pack sizes are registered:
14, 28, 56 and 98 film-coated tablets.
The following pack sizes are currently marketed:
28 film-coated tablets (10 mg, 20 mg, 40 mg)
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audio, please call, free of charge 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Olmetec 10 mg Film-Coated Tablets
Reference number: PL 08265/0015
This is a service provided by the Royal National Institute of Blind
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.