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OLMESARTAN 40MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL / OLMESARTAN MEDOXOMIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olmesartan 10 mg
Olmesartan 20 mg
Olmesartan 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 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

The name of your medicine is called Olmesartan10mg, 20mg or 40mg Film-coated tablets
(referred to as olmesartan throughout this leaflet).
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 taking olmesartan.
Before you take the tablets, 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 or 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 (e.g. primary aldosteronism).

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”.
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).
Children and adolescents
Olmesartan medoxomil has been studied in children and adolescents. For more information, talk
to your doctor. Olmesartan 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 taking, have recently taken or might take any other
medicines.
In particular, tell your doctor or pharmacist if you are taking or have recently taken any of the
following medicines. Your doctor may need to change your dose and/or to take other 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.

Other blood pressure lowering medicines, as the effect of olmesartan can be increased.

Certain antacids (indigestion remedies), as the effect of olmesartan can be slightly
decreased.

An ACE-inhibitor or aliskiren (see also information under the headings “Do not take
olmesartan” and “Warnings and precautions”).
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 Olmesartan is somewhat less in
black patients.
Pregnancy, breast-feeding and fertility
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 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.

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 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 or pharmacist 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.
Use in children and adolescents from 6 to less than18 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.
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 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 accident and 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

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 olmesartan. If this happens, stop taking olmesartan and contact your
doctor immediately.
Rarely (but slightly more often in older people) olmesartan 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 happens, stop taking olmesartan, 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 (inflammation of the stomach or intestines)
• 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
a feeling of dizziness or spinning (vertigo)
vomiting
lack of strength, feeling unwell
muscle 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.
Additional side effect 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 store above 25ºC.
Do not use this medicine after the expiry date which is stated on the box and on the blister after
(“EXP”). The expiry date refers to the last day of that month.
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, 20 mg or 40 mg olmesartan medoxomil.
The other ingredients are:
microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low-hydroxypropyl
cellulose-11, magnesium stearate, colloidal anhydrous silica, hypromellose, talc, titanium dioxide
(E171).
What olmesartan looks like and contents of the pack
Olmesartan 10 and 20 mg are white, circular film-coated tablets.
Olmesartan 40 mg are white, oval, film-coated tablets.
Olmesartan film-coated tablets are available in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 100
and 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Manufacturer
S.C. Zentiva, S.A., B-dul Theodor Pallady nr.50, sector 3, 032266 Bukuresti, Romania

This leaflet was last revised in July 2017
‘Zentiva’ is a registered trademark. © 2017 Zentiva.

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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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