OLMETEC 40 MG FILM-COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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504054/PL1b

®

Olmetec 40 mg Film Coated Tablets
(olmesartan medoxomil)

Patient Information Leaflet
®
The name of your medicine is Olmetec 40 mg Film Coated
Tablets. Throughout this leaflet it will be referred to as
®
Olmetec . Other strengths are 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 angiotensinII 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
®
tablets. Your doctor has probably also
Olmetec
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 to any
other of the 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 or 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 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 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.

Continued overleaf

®

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.

6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Olmetec contains
The active substance is olmesartan medoxomil
Each film coated
medoxomil.

tablet

contains

40

mg

olmesartan

The other ingredients are microcrystalline cellulose, lactose
monohydrate, hydroxypropylcellulose, magnesium stearate,
titanium dioxide (E171), talc, hypromellose and low
substituted hydroxypropylcellulose.
®

What Olmetec looks like and contents of the pack
®

Olmetec 40 mg film coated tablets are white, oval with C 15
on one side and plain on the other side.
®

Olmetec 40 mg is available in packs of 30 film coated tablets.
Product Licence Holder:
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at St James’
House, 8 Overcliffe, Gravesend, Kent DA11 0HJ.
Manufacturer:
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1, 85276,
Pfaffenhofen, Germany
®

Olmetec 40 mg Film Coated Tablets.
PL No: 18067/0413
POM
Olmetec
Limited.

®

is a registered trademark of Sankyo Company,
rd

Date of last revision of this leaflet: 23 January 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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.
Do not use this medicine after the expiry date which is stated
on the box and on the blister strip (“EXP”). The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
If you notice any sign of discolouration or deterioration of the
tablets consult your pharmacist.

504054/PL1b

500000/PL1b

Olmesartan Medoxomil 40 mg Film Coated Tablets

Patient Information Leaflet
The name of your medicine is Olmesartan Medoxomil 40 mg
Film Coated Tablets. Throughout this leaflet it will be referred
to as Olmesartan Medoxomil. Other strengths are 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 Olmesartan Medoxomil is and what it is used for
2) What you need to know before you take 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 to any
other of the 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 or 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.

Continued overleaf

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.
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
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 light-headedness 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

6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Olmesartan Medoxomil contains
The active substance is olmesartan medoxomil
Each film coated
medoxomil.

tablet

contains

40

mg

olmesartan

The other ingredients are microcrystalline cellulose, lactose
monohydrate, hydroxypropylcellulose, magnesium stearate,
titanium dioxide (E171), talc, hypromellose and low
substituted hydroxypropylcellulose.
What Olmesartan Medoxomil looks like and contents of the
pack
Olmesartan Medoxomil 40 mg film coated tablets are white,
oval with C 15 on one side and plain on the other side.
Olmesartan Medoxomil 40 mg is available in packs of 30 film
coated tablets.
Product Licence Holder:
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at St James’
House, 8 Overcliffe, Gravesend, Kent DA11 0HJ.
Manufacturer:
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1, 85276,
Pfaffenhofen, Germany
Olmesartan Medoxomil 40 mg Film Coated Tablets.
PL No: 18067/0413
POM
rd

Date of last revision of this leaflet: 23 January 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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 OLMESARTAN MEDOXOMIL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the box and on the blister strip (“EXP”). The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
If you notice any sign of discolouration or deterioration of the
tablets consult your pharmacist.

500000/PL1b

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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