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OLMESARTAN MEDOXOMIL 20 MG FILM-COATED TABLET

Active substance(s): OLMESARTAN MEDOXOMIL

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Olmesartan Medoxomil 10 mg
Film-coated Tablets
Olmesartan Medoxomil 20 mg
Film-coated Tablets
Olmesartan Medoxomil 40 mg
Film-coated Tablets
olmesartan medoxomil

TBC

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.
This medicine 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).
• if you are more than 3 months pregnant. (It is also
better to avoid this medicine 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 have kidney problems
• If you have liver disease
• If you have heart failure or problems with your heart valves
or heart muscle
• If you are diabetic, have severe vomiting, diarrhoea,
treatment with high doses of water tablets (diuretics) or if
you are on a low salt diet
• If you have increased levels of potassium in your blood
• If you have problems with your adrenal glands.
• 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”
During treatment
Contact your doctor if you experience severe, persistent
diarrhoea and substantial weight loss. Your doctor may
evaluate your symptoms and decide on how to continue
your blood pressure medication.

Olmesartan Medoxomil 40 mg,10 mg,20 mg

Description 28 film-coated tablets
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 834332

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 834332
MA No. 04569/1428 1430

Packing Site/Printer

GE Pharmaceuticals
Ltd Botevgrad - BG

Supplier Code TBC

Vendor Job No. 275674
Trackwise Proof No. 5
Glams Proof No. N/A
Kingdom,
Client Market United
Ireland

Keyline/Drawing No. N/A
Barcode Info N/A

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. This medicine 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

This medicine is not recommended for children and
adolescents under the age of 18.

Elderly

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 this medicine is somewhat less in black patients.

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 (NSAIDs) medicines
(medicines used to relieve pain, swelling and other
symptoms of inflammation, including arthritis, e.g.
ibuprofen, aceclofenac) 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 medicine 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.
• Other blood pressure lowering medicines, as the effect of
olmesartan medoxomil can be increased.
• Certain antacids (indigestion remedies), as the effect of
olmesartan medoxomil can be slightly decreased.
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”).

Pregnancy and breast-feeding
Pregnancy

You must tell your doctor if you think you are (or might
become) pregnant or if you are planning to have a baby.
Your doctor will normally advise you to stop taking this
medicine before you become pregnant or as soon as you
know you are pregnant and will advise you to take another
medicine instead.
This medicine 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. This medicine 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.

TBC

Package leaflet: Information for the user

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.

Adults

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 whole with a sufficient amount of water (e.g. one
glass). The tablets should not be chewed. If possible, take
your daily dose at the same time each day, for example at
breakfast time.

Date: 14 Sep 2016
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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 dose.

If you stop taking Olmesartan medoxomil

It is important to continue to take this medicine unless your
doctor tells you to stop.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

TBC

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
side effects can be serious. If you notice any of the
following you should contact your doctor or go to your
nearest hospital emergency department immediately:

Uncommon (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).
• Pain or a tight or heavy feeling in the chest, especially
when exercising. These may be signs of problems with your
heart (angina).

Rare (may affect up to 1 in 1,000 people):

• Swelling of the face, mouth and/or larynx (voice box)
together with itching and rash may occur during treatment
with this medicine. If this happens stop taking this
medicine and contact your doctor immediately.
• Rarely (but slightly more often in older patients), this
medicine can cause the blood pressure to fall too low in
susceptible individuals or as a result of an allergic reaction.
This could cause severe light-headedness or fainting. If this
occurs stop taking this medicine, contact your doctor
immediately and lie down flat.
• Difficulty or pain when urinating, with changes in the
colour and amount of urine passed. Pain in the lower back,
feeling or being sick, feeling generally unwell. These may
be signs of serious problems with your kidneys.
These are the other side effects known about so far with
olmesartan medoxomil:

Common (may affect up to 1 in 10 people):

• Feeling dizzy, headache
• Feeling sick, indigestion, diarrhoea, stomach ache,
gastroenteritis
• Feeling tired
• Sore throat, runny or stuffy nose, bronchitis, flu-like
symptoms, cough
• Pain, particularly in the back, bones or joints
• Infection of the urinary tract
• Blood in the urine
• Swelling of ankles, feet, legs, hands, or arms.
Some changes in blood test results have also been seen:
• Increased fat levels (hypertriglyceridaemia)
• Increased uric acid levels (hyperuricaemia)
• Rise in blood urea
• Increases in tests of liver and muscle function.

Uncommon (may affect up to 1 in 100 people):
• Spinning sensation (vertigo)
• Vomiting, weakness, feeling unwell
• Muscle pain
• Skin rash, allergic skin rash, itching, skin eruption
(exanthema), skin lumps (wheals).

Some changes in blood test results have also been seen:
• A reduction of the number of type of blood cell, known as
platelets (thrombocytopenia),

Rare (may affect up to 1 in 1,000 people):

• Lack of energy
• Muscle cramps
• Reduced kidney function, which may cause you to pass
urine more frequently, especially at night, and will be seen
in a blood test
• Low blood pressure, which may cause you to feel dizzy
or tired
Some changes in blood test results have also been seen:
• Increased potassium levels (hyperkalaemia)
• Increased levels of compounds related to kidney function.

Very rare (may affect up to 1 in 10,000 people):

• Severe persistent diarrhoea and substantial weight loss.

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:

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
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 store above 25°C. Store in the original container in
order to protect from moisture.
Do not use this medicine after the expiry date which is stated
on the carton and blister/bottle. The expiry date refers to the
last day of that month.
For plastic containers, use within 100 days after first opening.
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 film-coated tablet contains 10 mg, 20 mg or 40 mg
olmesartan medoxomil
• The other ingredients in the tablet core are croscarmellose
sodium, mannitol, microcrystalline cellulose, lowsubstituted hydroxypropyl cellulose, collodial anhydrous
silica, magnesium stearate, sodium lauryl sulfate
• The film-coating contains hypromellose, titanium dioxide
(E171), macrogol, talc.

What Olmesartan medoxomil looks like and contents of
the pack
Olmesartan medoxomil 10 mg film-coated tablets are white,
film coated, round, biconvex bevelled edge tablets marked
with 'M' on one side of the tablet and 'O1' on the other side.
Olmesartan medoxomil 20 mg film-coated tablets are white,
film coated, round, biconvex bevelled edge tablets marked
with 'M' on one side of the tablet and 'O2' on the other side.
Olmesartan medoxomil 40 mg film-coated tablets are white,
film coated, oval, biconvex bevelled edge tablets marked
with 'M' on one side of the tablet and 'O4' on the other side.
Olmesartan medoxomil film-coated tablets are available
in blister packs of 14, 28, 28x1, 30, 50x1, 56, 90 and 98 filmcoated tablets. The 20 mg tablets are also available in plastic
bottles of 98 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

UK - Mylan;
Ireland - Generics [UK] Ltd
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
McDermott Laboratories Ltd t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan útca 1, Hungary

This medicinal product is authorised in the Member States
of the EEA under the following names:

Belgium: Olmesartan Mylan 10 mg, 20 mg, 40 mg
filmomhulde tabletten/comprimés
pelliculés/Filmtabletten
France: OLMESARTAN MYLAN 10, 20 & 40 mg,
comprimé pelliculé
Germany: Olmesartanmedoxomil Mylan 10, 20 &
40 mg Filmtabletten
Greece: Olmesartan / Mylan 10 mg, 20 mg &
40 mg
Ireland: Olmesartan medoxomil 10 mg, 20 mg &
40 mg Film-coated tablets
Italy: Olmesartan medoxomil Mylan 10, 20,
40 mg
Luxembourg: Olmesartan Mylan 10 mg, 20 mg, 40 mg
filmomhulde tabletten/comprimés
pelliculés/Filmtabletten
Portugal: Olmesartan medoxomilo Mylan
Spain: Olmesartan MYLAN 10 mg - 20 mg 40 mg comprimidos recubiertos EFG
The Netherlands: Olmesartan medoxomil Mylan
10 mg/20 mg or 40 mg, filmomhulde
tabletten
United Kingdom: Olmesartan medoxomil 10 mg, 20 mg &
40 mg Film-coated tablets

TBC

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

This leaflet was last revised in September 2016.
834332

Olmesartan Medoxomil 40 mg,10 mg,20 mg

Description 28 film-coated tablets
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 834332

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 834332
MA No. 04569/1428 1430

Packing Site/Printer

GE Pharmaceuticals
Ltd Botevgrad - BG

Supplier Code TBC

Vendor Job No. 275674
Trackwise Proof No. 5
Glams Proof No. N/A
Kingdom,
Client Market United
Ireland

Keyline/Drawing No. N/A
Barcode Info N/A

Date: 14 Sep 2016
No. of colours 1
Colours

Time: 11:39
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 190 x 380 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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