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OLMETEC 10 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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Olmetec®
10 mg film-coated tablets
Olmetec®
40 mg film-coated tablets
(olmesartan medoxomil)
PATIENT INFORMATION LEAFLET
This medicine is called Olmetec 10 mg film-coated tablets or
Olmetec 40 mg film-coated tablets but will be referred to as
Olmetec throughout this leaflet.
Another strength (20 mg) is also available.
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)
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 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 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. 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 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 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.
See also information under the heading “Do not take 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.
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
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:
 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 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.
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.
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.

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.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney
failure.

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
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.

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
children only.
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.
This medicinal product does not require any special storage
conditions.
Do not use Olmetec after the expiry date (“EXP”) which is
stated on the box and on the blister strip. The expiry date
refers to the last day of that month.
If the tablets show any signs of deterioration, seek the
advice of your pharmacist.
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.

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.

6) CONTENTS OF THE PACK AND OTHER
INFORMATION

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),
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).

What Olmetec contains
The active substance is olmesartan medoxomil
Each film-coated tablet contains 10 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 contains
lactose”).
What Olmetec looks like and contents of the pack
Olmetec 10 mg film-coated tablets are white, circular, film-coated
tablets with C 13 embossed on one side and plain on the
reverse.
Olmetec 40 mg film-coated tablets are white, oval, film-coated
tablets with C 15 embossed on one side and plain on the
reverse.
Olmetec film-coated tablets are available in packs of 30 and 90
film-coated tablets.

Manufacturer
This product is manufactured by
DAIICHI SANKYO EUROPE GmbH,
Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany.
Procured within the EU and repackaged by
Mediwin Limited, PL Holder Mediport Limited,
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton,
West Sussex, BN17 7PA, United Kingdom.
PL 18980/0844 – Olmetec 10 mg film-coated tablets
PL 18980/0845 – Olmetec 40 mg film-coated tablets

POM
Date of leaflet preparation: 20/06/2016.
Olmetec® is a registered Trademark of Daiichi Sankyo
Company Limited.

PIL-0844-0845-S0004

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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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