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OLMETEC 10 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL / OLMESARTAN MEDOXOMIL

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Package Leaflet: Information for the User
®

Olmetec 10 mg film-coated tablets
®
Olmetec 40 mg film-coated tablets
(olmesartan medoxomil)
This medicine is called Olmetec 10 mg film-coated tablets or Olmetec
40 mg film-coated tablets but will be referred to as Olmetec throughout
this leaflet. Another strength (20 mg) is also available.
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 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’) 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 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 using Olmetec. Tell your doctor if you are
using 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).
Black patients
As with other similar drugs the blood pressure lowering effect of
Olmetec is somewhat less in black patients.
Elderly people
If you are 65 years or over 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.
Children and adolescents
Olmetec has been studied in children and adolescents. For more
information, talk to your doctor. Olmetec is not recommended for
children from 1 year to less than 6 years and should not be used in
children under the age of 1 year as no experience is available.
Other medicines and Olmetec:
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
In particular, tell your doctor or pharmacist about any of the following:
• 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.
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 breastfeeding. Olmetec is not recommended for mothers who are breastfeeding, 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. If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this 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.

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.
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.
Children and adolescents from 6 to less than 18 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 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 elderly 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,
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), swelling of the face,
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 1000 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.
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 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 this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Olmetec after the expiry date (“EXP”) which is stated on the
box and on the blister strip. The expiry date refers to the last day of that
month.
If the tablets show any signs of deterioration, seek the advice of your
pharmacist.
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.
6. Contents of the pack and other information
What Olmetec contains
The active substance is olmesartan medoxomil
Each film-coated tablet contains 10 mg or 40 mg olmesartan
medoxomil.
The other ingredients are microcrystalline cellulose, lactose
monohydrate, hydroxypropylcellulose, low substituted
hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171),
talc and hypromellose (See section 2 “Olmetec contains lactose”).
What Olmetec looks like and contents of the pack
Olmetec 10 mg film-coated tablets are white, circular, film-coated
tablets with C 13 embossed on one side and plain on the reverse.
Olmetec 40 mg film-coated tablets are white, oval, film-coated tablets
with C 15 embossed on one side and plain on the reverse.
Olmetec film-coated tablets are available in packs of 30 and 90 filmcoated tablets.
Manufacturer
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1,
85276 Pfaffenhofen, Germany
Procured from within the EU and repackaged by Mediwin Limited,
Product Licence Holder: Mediport Limited, 13 Martello Enterprise Centre,
Courtwick Lane, Littlehampton, West Sussex, BN17 7PA,
United Kingdom.
POM

PL 18980/0844 – Olmetec 10 mg film-coated tablets
PL 18980/0845 – Olmetec 40 mg film-coated tablets

Date of leaflet preparation: 12/06/2017
Olmetec® is a Registered Trademark of Daiichi Sankyo Company
Limited.

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PIL-0844-0845-S0006

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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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