OLMETEC 40MG TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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OLMETEC® 40mg Tablets /
OLMESARTAN MEDOXOMIL 40mg Tablets

T03593

(olmesartan medoxomil)

Patient Information Leaflet
This product is available using either of the
above names but will be referred to as Olmetec
throughout the leaflet.
Other strengths of this product are also
available.
Read all of this leaflet carefully before you
start taking this medicine.
• 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 symptoms are the same as
yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Olmetec and what it is used for
2. Before you take Olmetec
3. How to take Olmetec
4. Possible side effects
5. How to store Olmetec
6. Further information

1. What is Olmetec 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.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken 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.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Taking Olmetec with food and drink
Olmetec can be taken with or without food.
Swallow the tablets with a little water. If
possible, take your daily dose at the same time
each day, for example at breakfast time.
Children and adolescents (under 18)
Olmetec is not recommended for children and
adolescents under the age of 18.
Elderly patients
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.

2. Before you take Olmetec

Pregnancy and breast-feeding

Do not take Olmetec
• if you are allergic (hypersensitive) to
olmesartan medoxomil or to any other of the
ingredients of Olmetec
• 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).

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.

Take special care with Olmetec
Before you take the tablets, 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.

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

Your doctor will therefore check your blood
pressure carefully.

Driving and using machines
It is unlikely that Olmetec will affect your ability
to drive or operate machinery. However,
dizziness or fatigue can occasionally occur
during the treatment of high blood pressure. If
you notice such effects, do not drive or use
machines until the symptoms wear off. Ask your
doctor for advice.

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).

Important information about some of the
ingredients in Olmetec
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.

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.

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3. How to take Olmetec
Always take Olmetec exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The tablets can be taken with or without food.
Swallow the tablets with a little water. If
possible, take your daily dose at the same time
each day, for example at breakfast time.
The usual 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.

Some changes in blood test results have also
been seen. These include increased levels of
compounds related to kidney function and
reduced numbers of a type of blood cell, known
as platelets (thrombocytopenia).
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Olmetec
Keep out of the sight and reach of children.
This medicinal product does not require any
special storage conditions.

In patients with mild to moderate kidney
disease, your dose will not be higher than 20
mg once a day.

Do not use Olmetec after the expiry date
(“EXP”) which is stated on the box and on the
blister strip.

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 the tablets become discoloured or show signs
of any deterioration, you should seek the advice
of your pharmacist who will advise you what to
do.

If you forget to take Olmetec
If you forget a dose, take your normal dose on
the following day as usual. Do not take any
extra tablets to make up for the missed dose.
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, Olmetec 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 very rare occasions the following allergic
reactions 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
patients) Olmetec can cause the blood pressure
to fall too low in susceptible individuals. This
could cause severe light-headedness or
fainting. If this occurs stop taking Olmetec,
contact your doctor immediately and lie
down flat.
To give you an idea of how many patients might
get side effects, they have been listed as
common, uncommon, rare and very rare. These
mean the following:
Common
Uncommon
Rare
Very rare

less than 1 in 10 people.
less than 1 in 100 people.
less than 1 in 1,000 people.
less than 1 in 10,000
people.

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.

6. Further information
What Olmetec contains
The active substance is olmesartan
medoxomil
Each film-coated tablet contains 40 mg
olmesartan medoxomil.
Other ingredients are
Microcrystalline
cellulose,
lactose
monohydrate,
hydroxypropylcellulose,
magnesium stearate, titanium dioxide (E171),
talc and hypromellose.
What Olmetec looks like and contents of the
pack
Olmetec 40mg Tablets are white, oval,
film-coated tablets marked C15 embossed on
one side and plain on the reverse.
Olmetec tablets are supplied in blister packs of
30 film-coated tablets.
Manufacturer and Product Licence holder
This medicine is manufactured by Daiichi
Sankyo Europe GmbH, Luitpoldstrasse 1,
85276 Pfaffenhofen, Germany. It is procured
from within the EU by the Product Licence
Holder: Swinghope Ltd, Marlowe Way, Croydon
CR0 4XS and repackaged by Interport Ltd,
Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1082
Leaflet revision date: 14/08/12
Olmetec® is a registered trademark of Sankyo
Company Limited, Japan.

Common side effects:
Dizziness, nausea, indigestion, diarrhoea,
stomach ache, gastroenteritis, tiredness, sore
throat, runny or stuffy nose, bronchitis, flu-like
symptoms, cough, 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),
increases in tests of liver and muscle function.
Uncommon side effects:
Vertigo, skin rash, angina (pain
uncomfortable feeling in the chest).

or

Rare side effects:
Rarely, blood test results have shown increased
potassium levels (hyperkalaemia).
Very rare side effects:
Headache, muscle cramps and muscular pain,
impaired kidney function, kidney failure,
weakness, lack of energy, feeling unwell,
vomiting, itching, exanthema (skin eruption).

T03593

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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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