OLMETEC 20MG FILM COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

View full screen / Print PDF » Download PDF ⇩

Transcript
FRONT PAGE
Olmetec® 20 mg Film-coated Tablets/
Olmesartan medoxomil 20 mg Film-coated Tablets

T04635

(olmesartan medoxomil)

Patient Information Leaflet
Your medicine is available using one of the
above names but will be referred to as Olmetec
throughout this Patient Information Leaflet.
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).
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
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.

BACK PAGE
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.

5.

HOW TO STORE OLMETEC

Keep out of the sight and reach of children.
Do not take this medicine after the expiry date
shown on the pack.
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.
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
OTHER INFORMATION

PACK AND

What Olmetec contains
Olmetec 20 mg Tablets contain 20mg of
olmesartan medoxomil as the active ingredient.
Olmetec 20 mg Tablets also contain the
following inactive ingredients:
Tablet core - microcrystalline cellulose, lactose
monohydrate, hydroxypropylcellulose, and
magnesium stearate.
Tablet coat - titanium dioxide (E171), talc and
hypromellose.
What Olmetec looks like and contents of
pack
Olmetec 20 mg Tablets are white, circular,
film-coated tablets with C14 embossed on one
side and plain on the reverse.
They are supplied in calendar blister strips
containing 28 tablets.
Manufacturer and Product Licence Holder
This medicine is manufactured by Sankyo
Pharma 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: 10380/1150
Leaflet revision date: 05/11/2013
Olmetec® is a registered trademark of Daiichi
Sankyo Company Limited, Japan.

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 1,000
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 or
Tel: Free phone 0808 100 3352
By reporting side effects, you can help provide
more information on the safety of this medicine.
T04635

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.

Hide
(web3)