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OLMESARTAN MEDOXOMIL 20 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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TEVA UK Ref:

231-30-50073-C LEA OLMESARTAN MEDOXOMIL 10mg, 20mg, 40mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
395 mm
160 mm
-

Colours Used:

OLMESARTAN MEDOXOMIL 10 mg,
20 mg, 40 mg FILM-COATED
TABLETS
Package leaflet: Information for the user

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 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)
• are more than 3 months pregnant (it is also
better to avoid Olmesartan Medoxomil in
early pregnancy – see section 2: Pregnancy,
breast-feeding and fertility)
• suffer from yellowing of the skin and eyes
(jaundice) or problems with drainage of the
bile from the gallbladder (biliary
obstruction e.g. gallstones)
• 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 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’.
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.
Contact your doctor if you experience
diarrhoea that is severe, persistent and
causes substantial weight loss. Your doctor
may evaluate your symptoms and decide on
how to continue your blood pressure
medication.

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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. This medicine 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 section 2: Pregnancy,
breast-feeding and fertility).
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
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 Drugs,
also known as NSAIDs (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. 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’).
• 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 medicines, 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 (see section 3).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy
You must tell your doctor if 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 medicine.

21 June 2016
BLACK

TEVA UK Ref:

231-30-50073-C LEA OLMESARTAN MEDOXOMIL 10mg, 20mg, 40mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

3

No
395 mm
160 mm
-

Version:

2

Template

Colours Used:

How to take Olmesartan Medoxomil • skin rash

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended starting dose for adults is
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 mg
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.
Olmesartan Medoxomil 20 mg and 40 mg
film-coated tablets: The tablet can be divided
into equal doses.
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.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.







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: 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.
Additional side effects in children and
adolescents
In children, side effects are similar to those
reported in adults. However, dizziness and
headache are seen more often in children,
and nose bleeding is a common side effect
seen in children only.
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 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 this medicine out of the sight and reach
of children.
This medicine does not require any special
4 Possible side effects
storage conditions.
Do not use this medicine after the expiry date
Like all medicines this medicine can cause
which is stated on the blister and carton after
side effects, although not everybody gets
EXP. The expiry date refers to the last day of
them. If they do occur, they are often mild
that month.
and do not require treatment to be stopped.
Do not throw away any medicines via
Although not many people may get them,
the following two side effects can be serious: wastewater or household waste. Ask your
On rare occasions (may affect up to 1 in 1,000 pharmacist how to throw away medicines
you no longer use. These measures will help
people) the following allergic reactions, that
protect the environment.
may affect the whole body have been
reported:
of the pack and other
6 Contents
• swelling of the face, mouth and/or larynx
information
(voice box) together with itching and rash
What Olmesartan Medoxomil contains
may occur during treatment with
The active substance is olmesartan
olmesartan. If this happens stop taking
medoxomil. Each Olmesartan Medoxomil
Olmesartan Medoxomil and contact your
film-coated tablet contains 10 mg, 20 mg or
doctor immediately
40 mg olmesartan medoxomil.
• rarely (but more often in older people)
olmesartan can cause the blood pressure to The other ingredients are:
fall too low in susceptible individuals or as Tablet core:
the result of an allergic reaction. This could lactose monohydrate
cause severe light-headedness or fainting. cellulose, microcrystalline
If this occurs stop taking Olmesartan
low-substituted hydroxypropyl cellulose
Medoxomil, contact your doctor
magnesium stearate.
immediately and lie down flat.
Film coating: Opadry II 85F18378 white
These are the other side effects known about [poly(vinyl alcohol) - partly hydrolyzed,
titanium dioxide (E171), macrogol 3350
so far with olmesartan:
(polyethylene glycol), talc].
Common: may affect up to 1 in 10 people
• dizziness
What Olmesartan Medoxomil looks like and
• headache
contents of the pack
• nausea
Olmesartan Medoxomil 10 mg film-coated
• indigestion
tablets: White, round standard convex,
• diarrhoea
film-coated tablets of 6.1 mm, debossed with
• stomach ache
“O” on one side and “10” on the other side.
• gastroenteritis
Olmesartan Medoxomil 20 mg film-coated
• tiredness
tablets: White, round standard convex,
• sore throat
film-coated tablets of 8.2 mm, debossed with
• runny or stuffy nose
“O” on one side, the other side of the tablet is
• bronchitis
scored and debossed with "2" on the left side
• flu-like symptoms
of the score and "0" on the right side.
• cough
• pain
Olmesartan Medoxomil 40 mg film-coated
• pain in the chest, back, bones or joints
tablets: White, oval shaped, film-coated
• infection of the urinary tract
tablets of 15.2 mm in length and 7.1 mm
• swelling of ankles, feet, legs, hands, or
width, debossed with “O” on one side, the
arms
other side of the tablet is scored and
• blood in the urine.
debossed with "4" on the left side of the score
Some changes in blood test results have also and "0" on the right side.
been seen and include the following:
Olmesartan Medoxomil comes in blister
• increased fat levels (hypertriglyceridaemia) packs of: 14, 28, 30, 56, 90 and 98 film-coated
• increased uric acid levels (hyperuricaemia) tablets.
• rise in blood urea
Not all pack sizes may be marketed.
• increases in tests of liver and muscle
function.
Marketing Authorisation Holder
Uncommon: may affect up to 1 in 100 people TEVA UK Limited, Eastbourne, BN22 9AG, UK
• quick allergic reactions that may affect the
Manufacturer
whole body and may cause breathing
Teva Operations Poland Sp. z.o.o, ul.
problems as well as a rapid fall of blood
Mogilska 80. , Krakow, 31-546, Poland
pressure that may even lead to fainting
This leaflet was last revised in 06/2016
(anaphylactic reactions)
PL 00289/1887
• vertigo
PL 00289/1888
• vomiting
PL 00289/1889
• weakness
50073-C
• feeling unwell
395 x 160
• muscular pain

21 June 2016
BLACK

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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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