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OLMESARTAN MEDOXOMIL 10MG FILM COATED TABLET

Active substance(s): OLMESARTAN MEDOXOMIL

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Olmesartan

Market

UK-IE

Language

English

Tentative Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

2 (Page 1 of 2)

Date

11.01.16 (Olmesartan (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

baby if used at that stage (see pregnancy
section).
PACKAGE LEAFLET: INFORMATION FOR THE
USER

Olmesartan Medoxomil
10 mg film coated tablets
Olmesartan Medoxomil
20 mg film coated tablets
Olmesartan Medoxomil
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 sign of illness are the same as
yours.
- If you get any side effects, talk to your doctor or
pharmacist or nurse. 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.
Olmesartan Medoxomil are 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. 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 (hypersensitive) to
Olmesartan Medoxomil or to any other of the
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 before taking Olmesartan
Medoxomil.
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 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
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

Children and adolescents
Olmesartan Medoxomil is not recommended for
children and adolescents under the age of 18.
Other medicines and Olmesartan Medoxomil
Please tell your doctor or pharmacist if you are
taking or have recently taken or might take any of
the following medicines:
- Other blood pressure lowering medicines, as
the effect of Olmesartan Medomoxil Tablets can
be increased and as the frequency of adverse
events can be higher.
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 Medomoxil Tablets may be
decreased. Your doctor may advise you to take
Olmesartan Medomoxil Tablets 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 Medomoxil Tablets
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
Medomoxil Tablets before you become pregnant
or as soon as you know you are pregnant and will
advise you to take another medicine instead of
Olmesartan Medomoxil Tablets. Olmesartan
Medomoxil Tablets 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 Medomoxil
Tablets 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.
Important information about some of the
ingredients in Olmesartan Medoxomil
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 described in
this leaflet or as your doctor or pharmacist or
nurse has told you. Check with your doctor or
pharmacist or nurse 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.
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

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Olmesartan

Market

UK-IE

Language

English

Tentative Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

2 (Page 2 of 2)

Date

11.01.16 (Olmesartan (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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 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
Medomoxil Tablets 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 light-headedness 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:
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), 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 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 or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the national
reporting system (see contact details below).
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

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 label and on the blister
strip. 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 ingredient is Olmesartan Medoxomil.
Each film-coated tablet contains 10 mg
Olmesartan Medoxomil.
Each film-coated tablet contains 20 mg
Olmesartan Medoxomil.
Each film-coated tablet contains 40 mg
Olmesartan Medoxomil.

Approved By
Quality Assurance

Other ingredients are:
Cellulose microcrystalline, lactose monohydrate,
hydroxypropylcellulose, low substituted
hydroxypropylcellulose, magnesium stearate,
titanium dioxide (E171), talc and hypromellose.
What Olmesartan Medoxomil looks like and
contents of the pack
Olmesartan Medoxomil 10 mg film-coated tablets
are White to off-white, round, biconvex, film
coated tablets, debossed with “IO2” on one side
and plain on other side.
Olmesartan Medoxomil 20 mg film-coated tablets
are White to off-white, round, biconvex, film
coated tablets, debossed with “IO3” on one side
and plain on other side.
Olmesartan Medoxomil 40 mg film-coated tablets
are White to off-white, oval, biconvex, film coated
tablets, debossed with “IO4” on one side and
plain on other side.
Olmesartan Medoxomil are available in packs of
14, 28, 30, 56, 84, 90, 98 and 280 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House,
319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House,
319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56 , Budapest
1047 Hungary
The medicinal product is authorized in the
Member States of the EEA under the following
names:
Name of the
Member State
Austria

Name of the medicinal
product
Olmesartan Medoxomil Accord
10 mg/20 mg/40 mg
filmtabletten
Germany
Olmesartan Medoxomil Accord
10 mg/20 mg/40 mg
Filmtabletten
Estonia
Olmesartan Medoxomil Accord
Finland
Olmesartan Medoxomil Accord
10 mg/20 mg/40 mg
tabletti, kalvopäällysteinen
France
Olmesartan Medoxomil Accord
10 mg/20 mg/40 mg comprimé
pelliculé
Ireland
Olmesartan Medoxomil
10 mg/20 mg/40 mg
film coated tablets
Italy
Olmesartan Medoxomil Accord
The Netherlands Olmesartan Medoxomil Accord
10 mg/20 mg/40 mg
filmomhulde tabletten
United Kingdom Olmesartan Medoxomil
10 mg/20 mg/40 mg
film coated tablets
This leaflet was last approved in 01/2016

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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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