OLMETEC 40 MG FILM-COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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500000/PL1a

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 is will be referred to as
®
Olmetec . Other strengths are 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 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) BEFORE YOU TAKE OLMETEC®
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).
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.
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).

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

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 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.

6) FURTHER INFORMATION
®
What Olmetec contains
The active substance is olmesartan medoxomil
Each film coated
medoxomil.

tablet

contains

40

mg

olmesartan

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.

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

Product Licence Holder and Manufacturer:
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.

On very rare occasions the following allergic reactions have
been reported:

Manufactured by: DAIICHI SANKYO EUROPE GmbH,
Luitpoldstrasse 1, 85276, Pfaffenhofen, Germany

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.

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

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.

®

Olmetec
Limited.

is a registered trademark of Sankyo Company,

Date of last revision of this leaflet: 11th December 2012.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 693000.

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.

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 or uncomfortable feeling in the
chest).
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).
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.
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.
If you notice any sign of discolouration or deterioration of the
tablets consult your pharmacist.

500000/PL1a

500000/PL1a

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 is will be referred
to as Olmesartan Medoxomil. Other strengths are 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 Olmesartan Medoxomil and what it is used for
2) Before you take Olmesartan Medoxomil
3) How to take Olmesartan Medoxomil
4) Possible side effects
5) How to store Olmesartan Medoxomil
6) Further information
1) WHAT IS OLMESARTAN MEDOXOMIL 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) BEFORE YOU TAKE OLMESARTAN MEDOXOMIL
Do not take Olmesartan Medoxomil
• if you are allergic (hypersensitive) to olmesartan
medoxomil or to any other of the ingredients of
Olmesartan Medoxomil
• 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).
Take special care with Olmesartan Medoxomil
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.
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).

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 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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Taking Olmesartan Medoxomil with food and drink
Olmesartan Medoxomil 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)
Olmesartan Medoxomil 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 Olmesartan Medoxomil is somewhat less in black patients.
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
It is unlikely that Olmesartan Medoxomil 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.
Important information about some of the ingredients in
Olmesartan Medoxomil
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 Olmesartan Medoxomil 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.
In patients with mild to moderate kidney disease, your dose
will not be higher than 20 mg once a day.

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 any extra tablets to make up for the
missed dose.

6) FURTHER INFORMATION
What Olmesartan Medoxomil contains
The active substance is olmesartan medoxomil
Each film coated
medoxomil.

tablet

contains

40

mg

olmesartan

If you stop taking Olmesartan Medoxomil
It is important to continue to take Olmesartan Medoxomil
unless your doctor tells you to stop.

Other ingredients are
Microcrystalline
cellulose,
lactose
monohydrate,
hydroxypropylcellulose,
hydroxypropylcellulose
(low
substituted), magnesium stearate, titanium dioxide (E171),
talc,
hypromellose
and
low
substituted
hydroxypropylcellulose.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.

What Olmesartan Medoxomil looks like and contents of the
pack

4) POSSIBLE SIDE EFFECTS
Like all medicines, Olmesartan Medoxomil 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.

Olmesartan Medoxomil 40 mg film coated tablets are white,
oval with C 15 on one side and plain on the reverse.

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

Product Licence Holder and Manufacturer:
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.

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
Olmesartan Medoxomil. If this happens stop taking
Olmesartan Medoxomil and contact your doctor
immediately.

Olmesartan Medoxomil 40 mg is available in packs of 30 film
coated tablets.

Manufactured by: DAIICHI SANKYO EUROPE GmbH,
Luitpoldstrasse 1, 85276, Pfaffenhofen, Germany
Olmesartan Medoxomil 40 mg Film Coated Tablets.
PL No: 18067/0413
POM
Date of last revision of this leaflet: 11th December 2012.

Rarely (but slightly more often in elderly patients) Olmesartan
Medoxomil can cause the blood pressure to fall too low in
susceptible individuals. This could cause severe lightheadedness or fainting. If this occurs stop taking
Olmesartan Medoxomil, contact your doctor immediately
and lie down flat.

To request a copy of this leaflet in Braille, large print or audio
please call 01622 693000.

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.

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 or uncomfortable feeling in the
chest).
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).
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 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 notice any sign of discolouration or deterioration of the
tablets consult your pharmacist.

500000/PL1a

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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