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OLMESARTAN MEDOXOMIL 10 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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Package leaflet: Information for the patient
Olmesartan medoxomil 10 mg, 20 mg and 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.
The tablets are used for treating high blood pressure
(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 . 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)
• if you are more than 3 months pregnant. (It is also better
to avoid Olmesartan medoxomil 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 are taking any of the following medicines used to
treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril,
ramipril), in particular if you have diabetes- related
kidney problems
o 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.
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



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might become) pregnant. Olmesartan medoxomil 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 medoxomil should not be used in children
under the age of 1 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 of the following
medicines:
 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”).
 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) 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.
 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 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 drugs 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.
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 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
medicinal product.
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.

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Dosage:
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.
Use in children and adolescents with high blood
pressure
Children and adolescents from 6 to 17 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 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
product, 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 medoxomil.
If this happens stop taking Olmesartan medoxomil
and contact your doctor immediately.
Rarely (but slightly more often in older 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 medoxomil:
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:
o increased fat levels (hypertriglyceridaemia)
o increased uric acid levels (hyperuricaemia)
o rise in blood urea
o 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), 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).

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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.
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.
co.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.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
of that month.
This medicinal product does not require any special
storage conditions.
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 medoxomil contains
- The active substance is olmesartan medoxomil
- Each tablet contains 10 mg, 20 mg or 40 mg olmesartan
medoxomil.
- The other ingredient are cellulose microcrystalline,
low substituted hydroxypropyl cellulose, lactose
monohydrate, hydrogenated  castor  oil, magnesium
Stearate, hypromellose, hydroxypropyl cellulose,
Titanium Dioxide and talc
What Olmesartan medoxomil looks like and contents
of the pack
Olmesartan medoxomil 10 mg tablets are white to off
white, round film-coated tablets, debossed with 476 on
one side and plain on the other side with a characteristic
odour, approx. 6.3 mm in diameter.
Olmesartan medoxomil 20 mg tablets are white to off
white, round film-coated tablets, debossed with 437 on
one side and plain on the other side with a characteristic
odour, approx. 8.6 mm in diameter.
Olmesartan medoxomil 40 mg tablets are white to off
white, oval-shaped film-coated tablets debossed with 438
on one side and plain on the other side with a characteristic
odour approx.15.3 mm in length and 7.2 mm in breadth.
Olmesartan medoxomil tablets are available in packs of
28, 30, 56, 90 and 98 film-coated tablets and packed in
PVC/Alu/OPA – Alu blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex, HA3 0BU
United Kingdom.
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom.
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
56617 Vysoke Myto
Czech Republic.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Netherlands
Olmesartan medoxomil Glenmark
10 mg/20mg/40mg filmomhulde
tabletten
Spain
Olmesartan Glenmark 10
mg/20mg/40mg Comprimidos
Recubiertos
Germany
Olmesartan Glenmark 10
mg/20mg/40mg Filmtablette
United Kingdom Olmesartan medoxomil 10
mg/20mg/40mg Film-coated
Tablets
Ireland Olmesartan medoxomil 10
mg/20mg/40mg Film-coated
Tablets
This leaflet was last revised in 04/2015.

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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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