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OLMETEC 40 MG TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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Package Leaflet: Information for the User

Olmetec® 40 mg Tablets
(olmesartan medoxomil)
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).
 The name of your medicine is Olmetec® 40 mg
Tablets but it will be referred as Olmetec
throughout this leaflet. This product is available
in other strengths also.

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).
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.
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 breast-feeding. 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.
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 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.
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).

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,
pharmacist or nurse. 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.
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. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Olmetec contains
The active substance is olmesartan medoxomil
Each film-coated tablet contains 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 40 mg tablets are white, oval, filmcoated tablets with “C15” embossed on one
side and plain on the reverse.
Olmetec film-coated tablets are available in
blister packs of 28.
Manufacturer
Daiichi Sankyo Europe GmbH,
Luitpoldstrasse 1, 85276 Pfaffenhofen,
Germany.
Or
Berlin Chemie AG,
Glienicker Weg, 125,
12489 Berlin, Germany.
Or
Laboratorios Menarini, S.A.,
Alfons XII, 587 – E 08918,
Barcelona, Spain.
Procured from within the EU and
repackaged by Product Licence holder:
Kosei Pharma UK Limited,
956 Buckingham Avenue,
Slough Trading Estate,
Slough, SL1 4NL.
Olmetec® 40 mg Tablets
PL: 39352/0262

POM

Olmetec® is a registered trademark of Daiichi
Sankyo Company Limited.
Leaflet date: 17.09.2014
Reporting of side effects:
United Kingdom
Yellow Card Scheme
Tel: Free phone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard

Package Leaflet: Information for the User

Olmesartan Medoxomil 40 mg film-coated tablets
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).
 The name of your medicine is Olmesartan
Medoxomil 40 mg Tablets but it will be referred
as Olmesartan Medoxomil throughout this
leaflet. This product is available in other
strengths also.

What is in this leaflet:
1. What Olmesartan Medoxomil is and what it is
used for
2. What you need to know before you use
Olmesartan Medoxomil
3. How to take Olmesartan Medoxomil
4. Possible side effects
5. How to store Olmesartan Medoxomil
6. Contents of the pack and other information

1. WHAT OLMESARTAN MEDOXOMIL
IS AND WHAT IT IS USED FOR
Olmesartan Medoxomil belongs to a group of
medicines called angiotensin-II receptor
antagonists. They lower blood pressure by
relaxing the blood vessels.
Olmesartan Medoxomil 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 Olmesartan Medoxomil
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 OLMESARTAN
MEDOXOMIL
Do not take Olmesartan Medoxomil
 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 Olmesartan Medoxomil
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).
Warnings and precautions
Talk to your doctor before taking Olmesartan
Medoxomil. 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. Olmesartan
Medoxomil 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
Olmesartan Medoxomil is not recommended for
children and adolescents under the age of 18.

Other medicines and Olmesartan
Medoxomil:
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
Olmesartan Medoxomil 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 Olmesartan Medoxomil
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
Olmesartan Medoxomil may increase the risk
of kidney failure and the effect of Olmesartan
Medoxomil can be decreased by NSAIDs.
 Other blood pressure lowering medicines, as
the effect of Olmesartan Medoxomil can be
increased.
 Certain antacids (indigestion remedies), as
the effect of Olmesartan Medoxomil 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 Olmesartan Medoxomil is
somewhat less in black patients.
Olmesartan Medoxomil with food and drink
Olmesartan Medoxomil 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 Olmesartan
Medoxomil before you become pregnant or as
soon as you know you are pregnant and will
advise you to take another medicine instead of
Olmesartan Medoxomil. Olmesartan Medoxomil
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 breast-feeding. Olmesartan
Medoxomil 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.
Olmesartan Medoxomil 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 OLMESARTAN
MEDOXOMIL
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 Olmesartan Medoxomil
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 Olmesartan Medoxomil
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 Olmesartan Medoxomil
It is important to continue to take Olmesartan
Medoxomil unless your doctor tells you to stop.

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,
pharmacist or nurse. 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 OLMESARTAN
MEDOXOMIL
Keep out of the sight and reach of children.
This medicinal product does not require any
special storage conditions.
Do not use Olmesartan Medoxomil 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.
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 have any further questions on the use of
this product, ask your doctor or pharmacist.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Olmesartan Medoxomil contains

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.

The active substance is olmesartan medoxomil
Each film-coated tablet contains 40 mg
olmesartan medoxomil.

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 Olmesartan Medoxomil. If
this happens stop taking Olmesartan
Medoxomil and contact your doctor
immediately.
Rarely (but slightly more often in older people)
Olmesartan Medoxomil 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 Olmesartan Medoxomil, contact your
doctor immediately and lie down flat.
These are the other side effects known
about so far with Olmesartan Medoxomil
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).

The other ingredients are microcrystalline
cellulose, lactose monohydrate,
hydroxypropylcellulose, low substituted
hydroxypropylcellulose, magnesium stearate,
titanium dioxide (E171), talc and hypromellose
(See section 2 “Olmesartan Medoxomil
contains lactose”).
What Olmesartan Medoxomil looks like and
contents of the pack
Olmesartan Medoxomil 40 mg tablets are white,
oval, film-coated tablets with “C15” embossed
on one side and plain on the reverse.
Olmesartan Medoxomil film-coated tablets are
available in blister packs of 28.
Manufacturer
Daiichi Sankyo Europe GmbH,
Luitpoldstrasse 1, 85276 Pfaffenhofen,
Germany.
Or
Berlin Chemie AG,
Glienicker Weg, 125,
12489 Berlin, Germany.
Or
Laboratorios Menarini, S.A.,
Alfons XII, 587 – E 08918,
Barcelona, Spain.
Procured from within the EU and
repackaged by Product Licence holder:
Kosei Pharma UK Limited,
956 Buckingham Avenue,
Slough Trading Estate,
Slough, SL1 4NL.
Olmesartan Medoxomil 40 mg film-coated
tablets

POM

PL: 39352/0262
Leaflet date: 17.09.2014
Reporting of side effects:
United Kingdom
Yellow Card Scheme
Tel: Free phone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard

Expand view ⇕

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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