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OLMESARTAN MEDOXOMIL 20 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL / OLMESARTAN MEDOXOMIL / OLMESARTAN MEDOXOMIL

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ZINC Ref:

EAS723 LEA OLMESARTAN MEDOXOMIL 10mg, 20mg, 40mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
395 mm
160 mm
N/A
N/A

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

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What Olmesartan Medoxomil is and
what it is used for

19 April 2017

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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 has been studied in
children and adolescents. For more
information, talk to your doctor. Olmesartan
Medoxomil is not recommended for children
from 1 year to less than 6 years and should
not be used in children under the age of
1 year as no experience is available.
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.

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’) in adults and in children and
adolescents aged 6 to less than 18 years. 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
Older people
advice from your doctor.
If you are over 65 years of age and your doctor
to increase your dose of olmesartan
2 What you need to know before you decides
medoxomil to 40 mg daily, then you need to
take Olmesartan Medoxomil
have your blood pressure regularly checked by
Do not take Olmesartan Medoxomil if you:
your doctor to make sure that your blood
• are allergic to olmesartan medoxomil or
pressure does not become too low.
any of the other ingredients of this
Black patients
medicine (listed in section 6)
• are more than 3 months pregnant (it is also As with other similar medicines, the blood
pressure lowering effect of olmesartan
better to avoid Olmesartan Medoxomil in
early pregnancy – see section 2: Pregnancy, medoxomil is somewhat less in black patients.
breast-feeding and fertility)
Olmesartan Medoxomil with food and drink
• suffer from yellowing of the skin and eyes
Olmesartan Medoxomil can be taken with or
(jaundice) or problems with drainage of the without food (see section 3).
bile from the gallbladder (biliary
Pregnancy, breast-feeding and fertility
obstruction e.g. gallstones)
If you are pregnant or breast-feeding, think
• have diabetes or impaired kidney function
you may be pregnant or are planning to have
and you are treated with a blood pressure
a baby, ask your doctor or pharmacist for
lowering medicine containing aliskiren.
advice before taking this medicine.
Warnings and precautions
Pregnancy
Talk to your doctor or pharmacist before
You must tell your doctor if you are or might
taking Olmesartan Medoxomil.
become pregnant. Your doctor will normally
• if you are taking any of the following
medicines used to treat high blood pressure: advise you to stop taking Olmesartan
Medoxomil before you become pregnant or
• an ACE-inhibitor (for example enalapril,
as soon as you know you are pregnant and
lisinopril, ramipril), in particular if you
will advise you to take another medicine
have diabetes-related kidney problems.
instead of Olmesartan Medoxomil.
• aliskiren.
Olmesartan Medoxomil is not recommended
Your doctor may check your kidney function, in early pregnancy, and must not be taken
blood pressure, and the amount of
when more than 3 months pregnant, as it
electrolytes (e.g. potassium) in your blood at may cause serious harm to your baby if used
regular intervals.
after the third month of pregnancy.
See also information under the heading ‘Do
Breast-feeding
not take Olmesartan Medoxomil’.
Tell your doctor if you are breast-feeding or
Tell your doctor if you have any of the
about to start breast-feeding. Olmesartan
following health problems:
Medoxomil is not recommended for mothers
• kidney problems
who are breast-feeding and your doctor may
• liver disease
choose another treatment for you if you wish
• heart failure or problems with your heart
to breast-feed, especially if your baby is
valves or heart muscle
newborn, or was born prematurely.
• severe vomiting, diarrhoea, treatment with
high doses of water tablets (diuretics) or if Ask your doctor or pharmacist for advice
before taking any medicine.
you are on a low salt diet
• increased levels of potassium in your blood Driving and using machines
• problems with your adrenal glands.
You may feel sleepy or dizzy while being
treated for your high blood pressure. If this
Contact your doctor if you experience
diarrhoea that is severe, persistent and causes happens, do not drive or use machines until the
symptoms wear off. Ask your doctor for advice.
substantial weight loss. Your doctor may
evaluate your symptoms and decide on how
Olmesartan Medoxomil contains lactose
to continue your blood pressure medication.
This medicine contains lactose (a type of

REG0156563

Version 3.2

Approved

Page 1 of 4

ZINC Ref:

EAS723 LEA OLMESARTAN MEDOXOMIL 10mg, 20mg, 40mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
395 mm
160 mm
N/A
N/A

Version:

1

Colours Used:

19 April 2017

BLACK
Template

pressure that may even lead to fainting
sugar). If you have been told by your doctor
(anaphylactic reactions)
that you have an intolerance to some sugars,
contact your doctor before taking this medicine. • vertigo
• vomiting
3 How to take Olmesartan Medoxomil • weakness
• feeling unwell
Always take this medicine exactly as your
• muscular pain
doctor or pharmacist has told you. Check with • skin rash
your doctor or pharmacist if you are not sure. • allergic skin rash
The recommended starting dose for adults is • itching
• exanthema (skin eruption)
10 mg tablet once a day. However, if your
blood pressure is not controlled, your doctor • skin lumps (wheals)
may decide to change your dose up to 20 mg • angina (pain or uncomfortable feeling in
the chest).
or 40 mg once a day, or prescribe additional
medicines.
In blood tests a reduction of the numbers of a
In patients with mild to moderate kidney
type of blood cell, known as platelets has
disease, your dose will not be higher than
been seen (thrombocytopenia).
20 mg once a day.
Rare: may affect up to 1 in 1,000 people
Children and adolescents from 6 to less than • lack of energy
18 years of age:
• muscle cramps
The recommended starting dose is 10 mg
• impaired kidney function
once daily. If the patient’s blood pressure is
• kidney failure.
not adequately controlled, the doctor may
decide to change the dose up to 20 or 40 mg Some changes in blood test results have also
been seen. These include increased potassium
once a day.
levels (hyperkalaemia) and increased levels of
In children who weigh less than 35 kg, the
dose will not be higher than 20 mg once a day. compounds related to kidney function.
The tablets can be taken with or without food. Additional side effects in children and
Swallow the tablets with a sufficient amount adolescents:
of water (e.g. one glass). If possible, take your In children, side effects are similar to those
reported in adults. However, dizziness and
daily dose at the same time each day, for
headache are seen more often in children,
example at breakfast time.
and nose bleeding is a common side effect
Olmesartan Medoxomil 20 mg and 40 mg
seen in children only.
film-coated tablets: The tablet can be divided
Reporting of side effects
into equal doses.
If you get any side effects, talk to your doctor
If you take more Olmesartan Medoxomil than or pharmacist. This includes any possible side
you should
effects not listed in this leaflet. You can also
If you take more tablets than you should or if report side effects directly via the Yellow Card
a child accidentally swallows some, go to
Scheme at: www.mhra.gov.uk/yellowcard
your doctor or nearest emergency
By reporting side effects you can help provide
department immediately and take your
more information on the safety of this medicine.
medicine pack with you.
5 How to store Olmesartan Medoxomil
If you forget to take Olmesartan Medoxomil
If you forget a dose, take your normal dose
Keep this medicine out of the sight and reach
on the following day as usual. Do not take a
of children.
double dose to make up for a forgotten tablet.
This medicine does not require any special
If you stop taking Olmesartan Medoxomil
storage conditions.
It is important to continue to take Olmesartan
Medoxomil unless your doctor tells you to stop. Do not use this medicine after the expiry date
which is stated on the blister and carton after
If you have any further questions on the use of EXP. The expiry date refers to the last day of
this medicine, ask your doctor or pharmacist. that month.
Do not throw away any medicines via
4 Possible side effects
wastewater or household waste. Ask your
Like all medicines this medicine can cause
pharmacist how to throw away medicines
side effects, although not everybody gets
you no longer use. These measures will help
them. If they do occur, they are often mild
protect the environment.
and do not require treatment to be stopped.
of the pack and other
6 Contents
Although not many people may get them,
information
the following two side effects can be serious:
On rare occasions (may affect up to 1 in 1,000 What Olmesartan Medoxomil contains
The active substance is olmesartan
people) the following allergic reactions, that
may affect the whole body have been reported: medoxomil. Each Olmesartan Medoxomil
film-coated tablet contains 10 mg, 20 mg or
• swelling of the face, mouth and/or larynx
(voice box) together with itching and rash may 40 mg olmesartan medoxomil.
occur during treatment with olmesartan. If this The other ingredients are:
happens stop taking Olmesartan Medoxomil Tablet core:
and contact your doctor immediately
lactose monohydrate
• rarely (but more often in older people)
cellulose, microcrystalline
olmesartan can cause the blood pressure to low-substituted hydroxypropyl cellulose
fall too low in susceptible individuals or as magnesium stearate.
the result of an allergic reaction. This could Film coating: Opadry II 85F18378 white
cause severe light-headedness or fainting. [poly(vinyl alcohol) - partly hydrolyzed,
If this occurs stop taking Olmesartan
titanium dioxide (E171), macrogol 3350
Medoxomil, contact your doctor
(polyethylene glycol), talc].
immediately and lie down flat.
What Olmesartan Medoxomil looks like and
These are the other side effects known about contents of the pack
so far with olmesartan:
Olmesartan Medoxomil 10 mg film-coated
Common: may affect up to 1 in 10 people
tablets: White, round standard convex,
• dizziness
film-coated tablets of 6.1 mm, debossed with
• headache
“O” on one side and “10” on the other side.
• nausea
Olmesartan Medoxomil 20 mg film-coated
• indigestion
tablets: White, round standard convex,
• diarrhoea
film-coated tablets of 8.2 mm, debossed with
• stomach ache
“O” on one side, the other side of the tablet is
• gastroenteritis
scored and debossed with "2" on the left side of
• tiredness
the score and "0" on the right side.
• sore throat
• runny or stuffy nose
Olmesartan Medoxomil 40 mg film-coated
• bronchitis
tablets: White, oval shaped, film-coated tablets
• flu-like symptoms
of 15.2 mm in length and 7.1 mm width,
• cough
debossed with “O” on one side, the other side of
• pain
the tablet is scored and debossed with "4" on the
• pain in the chest, back, bones or joints
left side of the score and "0" on the right side.
• infection of the urinary tract
• swelling of ankles, feet, legs, hands, or arms Olmesartan Medoxomil comes in blister packs
of: 14, 28, 30, 56, 90 and 98 film-coated tablets.
• blood in the urine.
Some changes in blood test results have also Not all pack sizes may be marketed.
Marketing Authorisation Holder
been seen and include the following:
• increased fat levels (hypertriglyceridaemia) TEVA UK Limited, Eastbourne, BN22 9AG, UK
• increased uric acid levels (hyperuricaemia) Manufacturer
• rise in blood urea
Teva Operations Poland Sp. z.o.o, ul.
• increases in tests of liver and muscle function. Mogilska 80. , Krakow, 31-546, Poland
Uncommon: may affect up to 1 in 100 people This leaflet was last revised in 04/2017
• quick allergic reactions that may affect the
PL 00289/1887
EAS723
whole body and may cause breathing
395 x 160
PL 00289/1888
problems as well as a rapid fall of blood
PL 00289/1889

REG0156563

Version 3.2

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Expand Transcript

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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