OLMETEC 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. OLMETEC 10mg, 20 mg, 40 mg film-coated tablets
   1. What is Olmetec and what is it used for
   2. What you need to know before using Olmetec
   3. How to use Olmetec
   4. Possible side effects
   5. How to store Olmetec
   6. Package Contents and Other Information

OLMETEC 10mg, 20 mg, 40 mg film-coated tablets

olmesartan medoxomil
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Olmetec and what is it 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 to treat high blood pressure (also called “arterial hypertension”). High
blood pressure can damage the blood vessels in organs such as the heart, kidneys, brain and
eyes. In some cases, this can lead to heart attacks, heart or kidney failure, stroke
or blindness. Usually, high blood pressure has no symptoms. It is important to check your
blood pressure to prevent damage.
High blood pressure can be controlled with medicines such as Olmetec tablets. Your doctor has probably recommended that you also make some changes to your lifestyle to
help lower your blood pressure (for example, lose weight, quit smoking,
reduce alcohol intake and reduce salt intake in your diet). Your doctor may have also
advised you to exercise regularly, such as walking or swimming. It is important that you
follow your doctor's advice.

2. What you need to know before using 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 pregnant for more than three months, it is best to avoid Olmetec even in the early stages of pregnancy, see section “Pregnancy and breastfeeding”.
• if you suffer from yellowing of the skin and eyes (jaundice) or from impaired bile flow from the gallbladder (biliary obstruction, for example gallstones).
• if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor before using Olmetec.
Consult 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), especially if you have kidney problems related to diabetes.
• Aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “Do not take Olmetec”.
Consult your doctor if you also have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• Increased levels of potassium in your blood.
• Problems with the adrenal glands.

Tell your doctor if you experience severe and prolonged diarrhea with significant weight loss. Your
doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, an excessive reduction in blood pressure in patients with circulatory disorders of the heart or brain could lead to a
heart attack or stroke. Your doctor will therefore carefully monitor your blood
pressure.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Olmetec is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents
Olmetec is not recommended in children and adolescents under the age of 18 years.

Other medicines and Olmetec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist about each of the following medicines:

• Other medicines that lower blood pressure may increase the effect of Olmetec. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmetec” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diuretics or heparin (to thin the blood). Taking these medicines together with Olmetec may increase potassium levels in your blood.
• Lithium (a medicine used to treat mood swings and some types of depression) used together with Olmetec may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used together with Olmetec may increase the risk of kidney failure and the effectiveness of Olmetec may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may decrease the effect of Olmetec. Your doctor may advise you to take Olmetec at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmetec.

Elderly
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan to 40
mg per day, your blood pressure should be regularly monitored by your doctor to
avoid it falling too low.

Patients of black ethnicity
As with other similar medicines, the blood pressure lowering effect of Olmetec is, to some
extent, reduced in patients of black ethnicity.

Olmetec with food and drink
Olmetec can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking
Olmetec before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Olmetec. Olmetec is not
recommended in the early stages of pregnancy and must not be taken if you are pregnant
for more than three months as it can cause serious harm to the baby if taken after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Olmetec is not
recommended for women who are breastfeeding, and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newly born or premature.
If you are pregnant, suspect you are pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You may feel drowsy or dizzy during treatment for high blood pressure. If this happens,
do not drive or use machines until the symptoms have disappeared. Ask your doctor for advice.

Olmetec contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you have
an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Olmetec

Always take this medicine exactly as your doctor has instructed. If you have any doubts,
consult your doctor or pharmacist.
The recommended initial dose is one 10 mg tablet once a day. However, if your
blood pressure is not controlled, your doctor may decide to increase the dose to 20 or 40
mg once a day, or they may prescribe other medicines.
In patients with mild to moderate renal impairment, the dose should not exceed 20 mg once
a day.
The tablets can be taken with or without food. Swallow the tablets with a
sufficient amount of water (for example, a glass). If possible, take your daily
dose every day at the same time, for example with breakfast.

If you take more Olmetec than you should
If you take more tablets than you should, or if a child accidentally swallows any,
go to your doctor or the nearest emergency room immediately, bringing the
medicine packaging with you.

If you forget to take Olmetec
If you forget to take a dose, take your normal dose the next day. Do not take
a double dose to make up for the missed tablet.

If you stop taking Olmetec
It is important to continue taking Olmetec unless your doctor tells you to stop.
If you have any doubts about using Olmetec, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not appear in all people, the following two side effects can be serious:
In rare cases (which may affect up to 1 in 1000 people), the following allergic reactions that can affect the whole body have been reported:
during treatment with Olmetec, swelling of the face, mouth and/or larynx (the seat of the vocal cords) may occur, associated with itching and skin rash. If this happens, stop taking Olmetec and contact your doctor immediately.
Rarely (but slightly more often in elderly people) Olmetec can cause excessive reductions in blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting. If this happens, stop taking Olmetec, contact your doctor immediately and remain lying down.
These are the other side effects known so far with Olmetec:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.
Some changes in laboratory tests have also been observed, including the following:
increased blood fats (hypertriglyceridemia), increased uric acid in the blood (hyperuricemia), increased urea in the blood, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions that can affect the whole body and can cause breathing problems or a rapid drop in blood pressure that can also cause fainting (anaphylactic reactions), swelling of the face, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, rash (skin eruption), skin blisters (urticaria), angina (chest pain or discomfort).
A decrease in the number of a type of particle normally present in the blood, called platelets (thrombocytopenia), has been observed in blood tests.

Rare side effects (may affect up to 1 in 1000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure
Some changes in laboratory tests have also been observed. These include increased levels of potassium (hyperpotassemia) and increased levels of substances related to kidney function.

Additional side effects in children and adolescents:
In children, side effects are similar to those reported for adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a common side effect only in children.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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.
Do not use this medicine after the expiry date which is stated on the package and on the blister (after
“Exp.”). The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Olmetec contains
The active ingredient is olmesartan medoxomil.
Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other ingredients are microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose,
low substitution hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and
hypromellose (see section 2 “Olmetec contains lactose”).

Description of the appearance of Olmetec and package contents
Olmetec 10 mg, film-coated tablets, round, white in colour, with the letters C13 imprinted on one side;
Olmetec 20 mg, film-coated tablets, round, white in colour, with the letters C14 imprinted on one side;
Olmetec 40 mg, film-coated tablets, oval, white in colour, with the letters C15 imprinted on one side.
Olmetec is available in packs of 14, 28, 30, 56, 84, 90, 98 and 10x28 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets with a pre-cut blister for
single dose.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Roma

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen (Germany)
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany (RMS), Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Luxembourg,
Norway, Netherlands, Portugal, United Kingdom, Spain: Olmetec
Ireland: Benetor

Other sources of information
Detailed and up-to-date information on this medicinal product is available by
scanning the QR code printed on the inside of the package leaflet with a smartphone.
The same information is also available at the following address: www.olmesartanpatient.eu