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OLMESARTAN 10MG TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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S0729 LEAFLET Olmetec 20150706

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMETEC 10mg TABLETS
(olmesartan medoxomil)
Your medicine is known as Olmetec 10mg Tablets but will be
referred to as Olmetec throughout the following leaflet.
Information regarding other strengths of Olmetec also may be
present throughout the 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).

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.

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 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

What is in this leaflet:
1. What Olmetec is and what it is used for

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

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

Other medicines and Olmetec:
Tell your doctor or pharmacist if you are taking have recently taken
or might take any of the following medicines:


Other blood pressure lowering medicines, as the effect of
Olmetec can be increased.

1. WHAT OLMETEC IS AND WHAT IT IS USED FOR

Your doctor may need to change your dose and/or to take
other precautions:

Olmetec belongs to a group of medicines called angiotensin-II
receptor antagonists. They lower blood pressure by relaxing the
blood vessels.

If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take Olmetec” and
“Warnings and precautions”).

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 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.



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.



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.

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. gallstones).



if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.

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
Olmetec is somewhat less in black patients.

Warnings and precautions
Talk to your doctor before taking Olmetec. Tell your doctor 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 diabetesrelated 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. See also information under the heading “Do not take
Olmetec”.

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

Uncommon side effects (may affect up to 1 in 100 people):

Tell your doctor if you are breast-feeding or about to start breastfeeding. Olmetec is not recommended for mothers who are breastfeeding, 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.

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).

Ask your doctor or pharmacist for advice before taking any
medicine.

In blood tests a reduction of the numbers of a type of blood cell,
known as platelets has been seen (thrombocytopenia).

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 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 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

Rare side effects (may affect up to 1 in 1000 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 OLMETEC


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

If you forget to take Olmetec

What Olmetec contains

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.



Each film-coated tablet contains 10mg of the active ingredient,
olmesartan medoxomil.

If you stop taking Olmetec



Olmetec Tablets also contain the following inactive ingredients:
microcrystalline cellulose, lactose monohydrate, hydroxypropyl
cellulose, low substituted hydroxypropyl cellulose, magnesium
stearate, titanium dioxide, hypromellose and talc.

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.

What Olmetec looks like and contents of the pack
4. POSSIBLE SIDE EFFECTS

Olmetec tablet is a white, round tablet with ‘C13’ embossed on one
side and plain on the other

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.

Olmetec Tablets are available as blister packs of 28 tablets.

Although not many people may get them, the following two side
effects can be serious:

Product Licence holder

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 lightheadedness 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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by DAIICHI SANKYO EUROPE
GMBH, LUITPOLDSTRASSE 1, 85276 PFAFFENHOFEN,
GERMANY.
POM

PL 19488/0729

Olmetec 10mg tablets

Leaflet revision date: 06 July 2015
Olmetec is a registered trade mark of Sankyo Company Ltd, Japan.
S0729 LEAFLET Olmetec 20150706

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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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