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OLMETEC 20MG FILM COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL

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Olmetec® 10mg Film coated Tablets/
Olmetec® 20mg Film coated Tablets/
Olmetec® 40mg Film coated Tablets
(olmesartan medoxomil)
Your medicine is known by the above names, but will be referred to as
Olmetec throughout this:
Patient Information Leaflet
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. Do not pass it 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 Olmetec is and what it is used for
2) What you need to know before you take Olmetec
3) How to take Olmetec
4) Possible side effects
5) How to store Olmetec
6) Contents of the pack and other information

1) What Olmetec is and what it is used for
Olmetec belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood pressure by relaxing the blood vessels.
Olmetec 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 Olmetec
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 Olmetec
Do not take Olmetec
 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 Olmetec
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 before taking Olmetec. 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 Olmetec”.
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.
Olmetec 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
Olmetec is not recommended for children and adolescents under the age of
18.
Other medicines and Olmetec:
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 Olmetec 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 Olmetec” 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 Olmetec 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 Olmetec 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 Olmetec may increase the risk of kidney
failure and the effect of Olmetec can be decreased by NSAIDs.
 Colesevelam hydrochloride, a drug that lowers the level of cholesterol in
your blood, as the effect of Olmetec may be decreased. Your doctor may
advise you to take Olmetec at least 4 hours before colesevelam
hydrochloride.
 Certain antacids (indigestion remedies), as the effect of Olmetec 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 Olmetec is
somewhat less in black patients.
Olmetec with food and drink
Olmetec 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 Olmetec before you
become pregnant or as soon as you know you are pregnant and will advise
you to take another medicine instead of Olmetec. Olmetec 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.
Olmetec 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.
Olmetec 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.

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).

3) How to take Olmetec
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

Rare side effects (may affect up to 1 in 1000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure.

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.

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.

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.
The translation of the days of the week on the blister label is listed as follows:
Seg
→ Ter
→ Qua → Qui
→ Sex → Sab → Dom
Mon
→ Tue → Wed →Thur → Fri
→ Sat
→ Sun
If you take more Olmetec 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 Olmetec
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 Olmetec
It is important to continue to take Olmetec 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 Olmetec. If this happens stop
taking Olmetec and contact your doctor immediately.
Rarely (but slightly more often in older people) Olmetec 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 Olmetec, contact your doctor immediately and lie down flat.
These are the other side effects known about so far with Olmetec
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, flulike 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Olmetec
 KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
 This medicinal product does not require any special storage conditions.
 Do not use Olmetec Tablets after the expiry date (“EXP”) which is stated
on the carton and the blister label. The expiry date refers to the last day of
that month.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.

6) Contents of the pack and other information
What Olmetec contains:
The active substance is olmesartan medoxomil
10mg: Each film-coated tablet contains 10 mg of olmesartan medoxomil.
20mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil.
40mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil.
Other ingredients are; Microcrystalline cellulose, lactose monohydrate,
hydroxypropylcellulose, low substituted hydroxypropylcellulose, magnesium
stearate, titanium dioxide (E171), talc and hypromellose.
What Olmetec looks like and contents of the pack
10 mg: White, circular film-coated tablets with C 13 on one side and available
in calendar packs of 14 Tablets.
20 mg: White, circular film-coated tablets with C 14 on one side and available
in calendar packs of 28 and 56 Tablets.
40 mg: White, oval film-coated tablets with C 15 on one side and available in
calendar packs of 28 and 56 Tablets.
Who makes and repackages your medicine?
PL 10383/1475
Olmetec® 10mg film coated tablets POM
PL 10383/1476
Olmetec® 20mg film coated tablets POM
PL 10383/1477
Olmetec® 40mg film coated tablets POM
Your medicine is manufactured by Sankyo Pharma GmbH Luitpoldstrasse 1
85276 Pfaffenhofen Germany. Procured from within the EU and repackaged
by the Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 28.09.2015
Olmetec® is a registered trademark of Daiichi Sankyo Company Ltd., Tokyo,
Japan.

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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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