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OLMESARTAN MEDOXOMIL 40 MG FILM-COATED TABLET

Active substance(s): OLMESARTAN MEDOXOMIL

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170mm

Olmesartan medoxomil 10 mg
Film-coated Tablets
Olmesartan medoxomil 20 mg
Film-coated Tablets
Olmesartan medoxomil 40 mg
Film-coated 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 only.
Do not pass it on 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.
This medicine 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

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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 this medicine 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).
• if you have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking
olmesartan medoxomil
• If you have kidney problems
• If you have liver disease
• If you have heart failure or problems with your
heart valves or heart muscle
• If you are diabetic, have severe vomiting,
diarrhoea, treatment with high doses of water
tablets (diuretics) or if you are on a low salt diet
• If you have increased levels of potassium in your
blood
• If you have problems with your adrenal glands.
• If you are taking any of the following medicines
used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril,
ramipril), in particular if you have
diabetes-related kidney problems.
- aliskiren
Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading “Do not
take Olmesartan medoxomil”

Children and adolescents
This medicine is not recommended for children
and adolescents under the age of 18.
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 this medicine is somewhat less
in black patients.
Other medicines and Olmesartan medoxomil
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
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, e.g. ibuprofen, aceclofenac)
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.

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Package leaflet: Information for the user

Your doctor may need to change your dose and/or
to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see
also information under the headings “Do not take
Olmesartan medoxomil” and “Warnings and
precautions”).
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or
might become) pregnant or if you are planning to
have a baby. Your doctor will normally advise you
to stop taking this medicine before you become
pregnant or as soon as you know you are pregnant
and will advise you to take another medicine
instead.
This medicine 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. This medicine 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.
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.
Adults
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.

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.

The tablets can be taken with or without food.
Swallow the tablets whole with a sufficient
amount of water (e.g. one glass). The tablets
should not be chewed. If possible, take your daily
dose at the same time each day, for example at
breakfast time.

You must tell your doctor if you think you are (or
might become) pregnant. This medicine 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).

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.

Black

ARTWORK FOR SUBMISSION ONLY, DUMMY KEYLINES IN USE. NO KEYLINE AVAILABLE AT THE TIME OF ARTWORK
CREATION AS PACK SITE TO BE DEFINED. UPDATE REQUIRED ONCE ACTUAL PACKAGING SITE IS CONFIRMED.

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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 dose.
If you stop taking Olmesartan medoxomil
It is important to continue to take this medicine
unless your doctor tells you to stop.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

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

By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

5. How to store Olmesartan medoxomil

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.

Keep this medicine out of the sight and reach of
children.
Do not store above 25°C. Store in the original
container in order to protect from moisture.
Do not use this medicine after the expiry date
which is stated on the carton and blister/bottle.
The expiry date refers to the last day of that
month.
For plastic containers, use within 100 days after
first opening.
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 protect the environment.

Although not many people may get them, the
following side effects can be serious. If you
notice any of the following you should contact
your doctor or go to your nearest hospital
emergency department immediately:
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).
• Pain or a tight or heavy feeling in the chest,
especially when exercising. These may be signs
of problems with your heart (angina).
Rare side effects (may affect up to 1 in 1,000
people):
• Swelling of the face, mouth and/or larynx (voice
box) together with itching and rash may occur
during treatment with this medicine. If this
happens stop taking this medicine and
contact your doctor immediately.
• Rarely (but slightly more often in older patients),
this medicine can cause the blood pressure to
fall too low in susceptible individuals or as a
result of an allergic reaction. This could cause
severe light-headedness or fainting. If this
occurs stop taking this medicine, contact your
doctor immediately and lie down flat.
• Difficulty or pain when urinating, with changes
in the colour and amount of urine passed. Pain in
the lower back, feeling or being sick, feeling
generally unwell. These may be signs of serious
problems with your kidneys.
These are the other side effects known about so
far with olmesartan medoxomil:
Common side effects (may affect up to 1 in 10
people):
• Feeling dizzy, headache
• Feeling sick, indigestion, diarrhoea, stomach
ache, gastroenteritis
• Feeling tired
• Sore throat, runny or stuffy nose, bronchitis,
flu-like symptoms, cough
• Pain, particularly in the back, bones or joints
• Infection of the urinary tract
• Blood in the urine
• Swelling of ankles, feet, legs, hands, or arms.
Some changes in blood test results have also been
seen:
• 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):
• Spinning sensation (vertigo)
• Vomiting, weakness, feeling unwell
• Muscle pain
• Skin rash, allergic skin rash, itching, skin eruption
(exanthema), skin lumps (wheals).
Some changes in blood test results have also been
seen:
• A reduction of the number of type of blood cell,
known as platelets (thrombocytopenia),
Rare side effects (may affect up to 1 in 1,000
people):
• Lack of energy
• Muscle cramps
• Reduced kidney function, which may cause you
to pass urine more frequently, especially at night,
and will be seen in a blood test
• Low blood pressure, which may cause you to feel
dizzy or tired
Some changes in blood test results have also been
seen:
• Increased potassium levels (hyperkalaemia)
• Increased levels of compounds related to kidney
function.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via:

6. Contents of the pack and other information
What Olmesartan medoxomil contains
• The active substance is olmesartan medoxomil
• Each film-coated tablet contains 10 mg, 20 mg or
40 mg olmesartan medoxomil
• The other ingredients in the tablet core are
croscarmellose sodium, mannitol,
microcrystalline cellulose, low-substituted
hydroxypropyl cellulose, collodial anhydrous
silica, magnesium stearate, sodium lauryl sulfate
• The film-coating contains hypromellose,
titanium dioxide (E171), macrogol, talc.
What Olmesartan medoxomil looks like and
contents of the pack
Olmesartan medoxomil 10 mg film-coated tablets
are white, film coated, round, biconvex bevelled
edge tablets marked with 'M' on one side of the
tablet and 'O1' on the other side.
Olmesartan medoxomil 20 mg film-coated tablets
are white, film coated, round, biconvex bevelled
edge tablets marked with 'M' on one side of the
tablet and 'O2' on the other side.
Olmesartan medoxomil 40 mg film-coated tablets
are white, film coated, oval, biconvex bevelled
edge tablets marked with 'M' on one side of the
tablet and 'O4' on the other side.
Olmesartan medoxomil film-coated tablets are
available in blister packs of 14, 28, 30, 50x1, 56, 90
and 98 film-coated tablets. The 20 mg tablets are
also available in plastic bottles of 98 and 500
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics UK [Ltd], Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6
1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan útca
1, Hungary
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Belgium: Olmesartan Mylan 10 mg, 20 mg, 40 mg
filmomhulde tabletten/comprimés
pelliculés/Filmtabletten
France: OLMESARTAN MYLAN 10, 20 & 40 mg,
comprimé pelliculé
Germany: Olmesartanmedoxomil Mylan 10, 20 &
40 mg Filmtabletten
Greece: Olmesartan / Mylan 10 mg, 20 mg & 40 mg
Ireland: Olmesartan medoxomil 10 mg, 20 mg &
40 mg Film-coated tablets
Italy: Olmesartan medoxomil Mylan 10, 20, 40 mg
Luxembourg: Olmesartan Mylan 10 mg, 20 mg,
40 mg filmomhulde tabletten/comprimés
pelliculés/Filmtabletten
Portugal: Olmesartan medoxomilo Mylan
Spain: Olmesartan MYLAN 10 mg - 20 mg - 40 mg
comprimidos recubiertos EFG
The Netherlands: Olmesartan medoxomil Mylan
10 mg/20 mg or 40 mg, filmomhulde tabletten
United Kingdom: Olmesartan medoxomil 10 mg,
20 mg & 40 mg Film-coated tablets
This leaflet was last revised in: November 2014.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
525790

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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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