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OLMESARTAN MEDOXOMIL 40MG FILM COATED TABLETS
Active substance(s): OLMESARTAN MEDOXOMIL
OLMETEC® 40MG FILM-COATED TABLETS/
OLMESARTAN MEDOXOMIL 40MG
Olmetec/Olmesartan Medoxomil is available in the following
strengths: 10mg, 20mg and 40mg.
This leaflet only applies to Olmetec 40mg Film-Coated Tablets
/Olmesartan Medoxomil 40mg Film-Coated Tablets which will
be referred to as Olmetec throughout this leaflet.
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
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.
What is in this leaflet
What Olmetec is and what it is used for
What you need to know before you take Olmetec
How to take Olmetec
Possible side effects
How to store Olmetec
Contents of the pack and other information
1. What Olmetec is and what it is used for
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. 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
2. What you need to know before you take
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 in early pregnancy – see
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
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 diabetes-related
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 take Olmetec”.
Tell your doctor if you have any of the following health
Heart failure or problems with your heart valves or heart
Severe vomiting, diarrhoea, treatment with high doses
of water tablets (diuretics) or if you are on a low salt
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).
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.
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.
Olmetec contains lactose monohydrate
As with other similar drugs the blood pressure lowering effect
of Olmetec is somewhat less in black patients.
This medicine contains lactose monohydrate (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 Olmetec
If you are 65 years or over and your doctor decides to
increase your dose of olmesartan medoxomil to 40mg 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 medicines.
In particular, tell your doctor or pharmacist about any of the
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
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
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 NSAIDs.
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
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.
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Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
The recommended starting dose is one 10mg tablet once a
day. However, if your blood pressure is not controlled, your
doctor may decide to change your dose up to 20mg or 40mg
once a day, or prescribe additional medicines.
In patients with mild to moderate kidney disease, your dose
will not be higher than 20mg once a day.
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.
Children and adolescents from 6 to less than
18 years of age:
The recommended starting dose is 10mg once daily. If the
patient’s blood pressure is not adequately controlled, the
doctor may decide to change the dose up to 20mg or 40mg
once a day. In children who weigh less than 35kg, the dose
will not be higher than 20mg 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
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 immediately.
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
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
If the tablets become discoloured or show any other signs of
deterioration, you should consult your pharmacist who will
advise you what to do.
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
What Olmetec contains
Each film-coated tablet contains 40mg of
Also contains: microcrystalline cellulose,
lactose monohydrate, hydroxypropylcellulose,
low substitute hydroxypropylcellulose, magnesium stearate,
titanium dioxide (E171), talc and hypromellose (See section 2
“Olmetec contains lactose monohydrate”).
What Olmetec looks like and contents of the pack
Your tablets are white, oval, film-coated tablets with ‘C15’
embossed on one side and plain on the reverse.
Olmetec is available in packs of 30 film-coated tablets.
Your tablets are manufactured by:
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1,
85276 Pfaffenhofen, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
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.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
Uncommon side effects (may affect up to 1 in
Leaflet revision & issue date (Ref): 14.06.17
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, 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).
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
Lack of energy, muscle cramps, impaired kidney function,
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.
PL No: 08929/0261
Olmetec® is a registered trademark of Daiichi Sankyo
Blind or partially sighted?
Is this leaflet hard to see or
Call +44 (0) 1302 365000
Please be ready to give the
Product name: Olmetec /
40mg Film-Coated Tablets
Reference No: 08929/0261
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Olmetec
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
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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.