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OLMETEC 40MG FILM COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OLMETEC® 40MG FILM-COATED TABLETS /
OLMESARTAN MEDOXOMIL 40MG
FILM-COATED TABLETS
(olmesartan medoxomil)

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
pharmacist.
This medicine has been prescribed for you. Do not pass it 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:

1.
2.
3.
4.
5.
6.

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’). 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
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 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 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).

Warnings and precautions

Talk to your doctor before taking Olmetec. 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, 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.
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.
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).

Children and adolescents

Olmetec is not recommended for children and adolescents under
the age of 18.

Other medicines and Olmetec:

Tell your doctor or pharmacist if you are taking have recently
taken or might take any of the following medicines:
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
NSAIDs.
Other blood pressure lowering medicines, as the effect of
Olmetec can be increased.
Certain antacids (indigestion remedies), as the effect of
Olmetec can be slightly decreased.
Page 1 of 2

Older people

If you are over 65 years of age 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.

Black patients

As with other similar drugs the blood pressure lowering effect of
Olmetec is somewhat less in black patients.

Olmetec with food and drink

Olmetec can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy

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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breastfeeding. 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.
Ask your doctor or pharmacist for advice before taking any
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

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 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 10mg tablet once a day.
However, if your blood pressure is not controlled, your doctor may
decide to change your dose up to 20 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.

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 immediately.
Rarely (but slightly more often in older 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 10
people):

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 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), 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).

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Olmetec contains

Each film-coated tablet contains 40mg of olmesartan medoxomil.
Also contains: microcrystalline cellulose, lactose monohydrate,
hydroxypropylcellulose, low substitute hydroxypropylcellulose,
magnesium stearate, titanium dioxide (E171), talc and
hypromellose (See section 2 “Olmetec contains lactose”).

What Olmetec looks like and the 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.

Rare side effects (may affect up to 1 in 1000
people):

Manufacturer

Lack of energy, muscle cramps, impaired kidney function, kidney
failure.

Your tablets are manufactured by:
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1,
85276 Pfaffenhofen, Germany.

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.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Reporting of side effects

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

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 (see details below). By reporting
side effects you can help provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Tel: Free phone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE OLMETEC
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use the medicine after the expiry date printed on the
carton and blister label. 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.
If the tablets become discoloured or show any other signs of
deterioration, you should consult your pharmacist who will advise
you what to do.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Page 2 of 2

PL No: 08929/0261

POM

Leaflet revision & issue date (Ref): 26.09.13
Olmetec® is a registered trademark of Daiichi Sankyo Company
Limited.
To listen to or request a copy of this leaflet in Braille, large print
or audio, please contact 01302 552940 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name:
Olmetec 40mg Film-Coated Tablets /
Olmesartan Medoxomil 40mg Film-Coated
Tablets
Reference number: 08929/0261

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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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