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OLMESARTAN 10MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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Package leaflet: Information for the user

Olmesartan 10 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.
Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your doctor or pharmacist.
Ÿ 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.
Ÿ 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'). 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:
Ÿ if you are allergic to Olmesartan or any of the other ingredients of this
medicine (listed in section 6)
Ÿ if you are more than 3 months pregnant. (It is also better to avoid
Olmesartan tablets in early pregnancy – see pregnancy section.)
Ÿ 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).

Ÿ 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.
Tell your doctor if you have any of the following health problems:
Ÿ
Ÿ
Ÿ
Ÿ

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.
Ÿ Increased levels of potassium in your blood.
Ÿ Problems with your adrenal glands.
Ÿ 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”
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 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 is not recommended for children and adolescents under the age of 18.
Other medicines and Olmesartan:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any of the following medicines:
Ÿ 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.
Ÿ 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.

Ÿ 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.
Ÿ Other blood pressure lowering medicines, as the effect of Olmesartan can
be increased.
Ÿ Colesevelam hydrochloride, a drug that lowers the level of cholesterol in
your blood, as the effect of Olmesartan may be decreased. Your doctor
may advise you to take Olmesartan at least 4 hours before colesevelam
hydrochloride.
Ÿ Certain antacids (indigestion remedies), as the effect of Olmesartan 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” 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.
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. 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.
Olmesartan s 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.

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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). The tablet should be swallowed
whole without chewing. 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 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
occurs 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, 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.
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 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.

6. Contents of the pack and other information
What Olmesartan contains
The active substance is Olmesartan medoxomil
Each film-coated tablet contains 10 mg Olmesartan medoxomil.
The other ingredients are Lactose Monohydrate, Microcrystalline cellulose
(PH 101), Sodium starch glycolate (Type B), Hydroxypropyl Cellulose,
Colloidal Silicon Dioxide, Magnesium Stearate and Instacoat universal White
(A05G10022) [HPMC 2910 / Hypromellose 6cPs, Hydroxy Propyl Cellulose,
Talc and Titanium dioxide]. (See section 2 “Olmesartan contains lactose”)
What Olmesartan looks like and contents of the pack
Olmesartan 10 mg film-coated tablets are White, round, biconvex, film coated
tablets debossed with "C 52" on one side and plain on other side.
Olmesartan film-coated tablets are available in Blister pack comprises of Cold
formable film consisting of 25µ OPA / 45µ Aluminum foil /60µ PVC as
forming material and Plain 30µ Aluminum Foil/ 6 - 8 gsm HSL as lidding
Material
Pack size: 14, 28, 30, 56, 90, 98, 280 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue,
Wynyard, Billingham,
TS22 5TB
United Kingdom
Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park,
Wheatley Hall Road,
Doncaster,
DN2 4LT,
United Kingdom.
This leaflet was last revised in 06/2016

Do not use this medicine after the expiry date which is stated on the box and
on the blister strip after (“EXP”). 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 to protect the environment.

ARTWORK CODE 02

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.

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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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