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OLMESARTAN 20 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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Olmesartan 10 mg film-coated
tablets
Olmesartan 20 mg film-coated
tablets
Olmesartan 40 mg film-coated
tablets
Olmesartanmedoxomil
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 is and what it is used
for
2. What you need to know before you take
Olmesartan
3. How to take Olmesartan
4. Possible side effects
5. How to store Olmesartan
6. Contents of the pack and other
information
1.

What Olmesartan is and what it is
used for

Olmesartan belongs to a group of medicines
called angiotensin-II receptor antagonists.
They lower blood pressure by relaxing the
blood vessels.
Olmesartan 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 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

Do not take Olmesartan:
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 Olmesartan
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).
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 using
Olmesartan.
Tell your doctor 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”
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

Black
A/s: 147 x 440 mm

may evaluate your symptoms and decide
on how to continue your blood pressure
medication.
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 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).
Black patients
As with other similar drugs the blood pressure
lowering effect of Olmesartan is somewhat
less in black patients.
Elderly people
If you are 65 years or over 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.
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:
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
In particular, tell your doctor or pharmacist
about any of the following:
• Other blood pressure lowering medicines,
as the effect of Olmesartan 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” and
“Warnings and precautions”).
• 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 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 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 may
increase the risk of kidney failure and the
effect of Olmesartan can be decreased by
NSAIDs.
• Colesevelam hydrochloride, a drug
that lowers the level of cholesterol in
your blood, as the effect of olmesartan
medoxomil may be decreased. Your
doctor may advise you to take olmesartan
medoxomil at least 4 hours before
colesevelam hydrochloride.
• Certain antacids (indigestion remedies),
as the effect of Olmesartan can be slightly
decreased.
Olmesartan with food and drink
Olmesartan 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 Olmesartan
before you become pregnant or as soon as
you know you are pregnant and will advise
you to take another medicine instead of
Olmesartan. Olmesartan 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 is
not recommended for mothers who are breastfeeding, 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.
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.
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 contains lactose
This medicine contains lactose
(a type of sugar). If you have been told

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Package Leaflet: Information for
the User

by your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this
medicinal product.
3. How to take Olmesartan
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.
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.
Children and adolescents from 6 to less
than 18 years of age:
The recommended starting dose is 10 mg
once daily. If the patient’s blood pressure is not
adequately controlled, the doctor may decide
to change the dose up to 20 or 40 mg once a
day. In children who weigh less than 35 kg, the
dose will not be higher than 20 mg once a day.
If you take more Olmesartan 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
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
It is important to continue to take Olmesartan
unless your doctor tells you to stop.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4.

Possible side effects

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

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label, carton, bottle after
EXP. The expiry date refers to the last day of
that month.
Store below 30°C.
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.
6.

Contents of the pack and other
information

What Olmesartan contains
The active substance is Olmesartan
medoxomil.
Each film-coated tablet contains 10 mg of
Olmesartan medoxomil.
Each film-coated tablet contains 20 mg of
Olmesartan medoxomil.
Each film-coated tablet contains 40 mg of
Olmesartan medoxomil.
The other ingredients are
Tablet core: Lactose monohydrate, cellulose
microcrystalline, hydroxy propyl cellulose,
low substituted hydroxy propyl cellulose,
magnesium stearate.

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.

Tablet coating: Hydroxy propyl cellulose,
titanium dioxide, talc, iron oxide red (E172) (for
10 mg tablets only), iron oxide yellow (E172)
(for 10 mg tablets only).

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

What Olmesartan looks like and contents of
the pack
Film-coated tablet.

Rarely (but slightly more often in elderly
people) olmesartan medoxomil can cause the
blood pressure to fall too low in susceptible
individuals or as the result of an allergic
reaction. This could cause severe lightheadedness or fainting. If this occurs stop
taking Olmesartan medoxomil, contact your
doctor immediately and lie down flat.
These are the other side effects known about
so far with Olmesartan:
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.
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), swelling of the face,
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

Olmesartan 10 mg film-coated tablets:
Orange coloured, round shaped, biconvex,
film-coated tablets debossed with ‘K’ on one
side and ‘17’ on the other side.
Olmesartan 20 mg film-coated tablets
White coloured, round shaped, biconvex, filmcoated tablets debossed with ‘K’ on one side
and ‘18’ on the other side.
Olmesartan 40 mg film-coated tablets
White coloured, oval shaped, biconvex filmcoated tablets debossed with ‘K’ on one side
and ‘19’ on the other side.
Olmesartan film-coated tablets are available
in polyamide/ aluminium foil/ PVC - aluminium
foil blister pack and HDPE bottle packs with
polypropylene closure.
Pack sizes:
Blister pack: 7, 14, 28, 30, 56, 60, 90, 98, 100,
280 and 500 film-coated tablets
Unit dose blister packs: 10, 50 and 500 filmcoated tablets.
HDPE bottle pack:
10 mg: 30, 100, 250 and 500 film-coated
tablets
20 mg & 40 mg: 30, 100, 250 and 1000
film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 06/2017.

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

+ 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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