PACKAGE LEAFLET: INFORMATION FOR THE USER

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

(olmesartan medoxomil)
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Olmetec is and what it is used for.
What you need to know before taking Olmetec.
How to take Olmetec.
Possible side effects.
How to store Olmetec.
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 blood vessels.
Olmetec is used to treat high blood pressure (also known as "hypertension") in adults and in children and adolescents aged 6 to 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 heart attacks, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not cause symptoms. It is important to monitor your blood pressure to help prevent organ damage.
High blood pressure can be controlled with medicines such as Olmetec tablets. Your doctor has likely advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have encouraged 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 taking Olmetec

Do not take Olmetec

if you are allergic to olmesartan medoxomil or to any of the excipients of this medicine (listed in section 6).
if you are more than three months pregnant. Olmetec should also be avoided during early pregnancy – see section “Pregnancy and breastfeeding”.
if you have yellowing of the skin and eyes (jaundice) or disorders affecting bile flow from the gallbladder (biliary obstruction, for example gallstones).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking 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.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also information under the heading “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 heart valves or heart muscle.
Severe vomiting, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet.
Increased potassium levels in the blood.
Adrenal gland disorders.

Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
Contact your doctor if, after taking Olmetec, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Olmetec on your own.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Olmetec is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy and breastfeeding”).
Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmetec is somewhat reduced in patients of black ethnicity.
Elderly
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan to 40 mg daily, your blood pressure should be regularly monitored by your doctor to prevent it from dropping too low.
Children and adolescents
Olmetec has been studied in children and adolescents. For further information, consult your doctor. Olmetec is not recommended for children from 1 year to less than 6 years of age and must not be used in children under 1 year of age due to lack of available information.
Other medicines and Olmetec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform 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 consider it necessary to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Olmetec” and “Warnings and precautions”).
Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (used to thin the blood). Taking these medicines together with Olmetec may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmetec may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) taken 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 reduces cholesterol levels in the blood, which may reduce 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.

Olmetec with food and drink
Olmetec can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Usually, your doctor will advise you to stop taking Olmetec before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Olmetec. Olmetec is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Olmetec is not recommended for women 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 premature.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breast-feeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.
Olmetec contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Olmetec

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

Children and adolescents aged 6 to less than 18 years:
The recommended starting dose is one 10 mg tablet once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to increase the dose to 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more Olmetec than you should
If you take more tablets than you should, or if a child accidentally swallows any tablets, go immediately to your doctor or the nearest emergency department, and bring the medicine pack with you.

If you forget to take Olmetec
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten 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 how to use Olmetec, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If they do occur, they are mostly mild and do not require discontinuation of treatment.
However, although not occurring in everyone, the following side effects can be serious:
In rare cases (which may affect up to 1 in 1,000 people), the following allergic reactions affecting the entire body have been reported:
during treatment with Olmetec, swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur. If this happens, stop taking Olmetec and contact your doctor immediately.
Rarely (but slightly more frequently in elderly people), Olmetec may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could lead to severe dizziness or fainting. If this happens, stop taking Olmetec, contact your doctor immediately and remain lying down.
Frequency not known: if you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Olmetec for a long time, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with treatment for high blood pressure.

The following 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, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, runny or blocked nose, bronchitis, flu-like symptoms, cough, pain, chest, back, bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some laboratory test abnormalities have also been observed, including:
increased blood fats (hypertriglyceridaemia), increased uric acid in blood (hyperuricaemia), increased blood urea, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing problems or a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, rash (exanthema), skin blisters (wheals), angina (pain or discomfort in the chest).

A reduction in the number of a type of blood particle normally present, called platelets (thrombocytopenia), has been observed in blood tests.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure; intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Some laboratory test abnormalities have also been observed. These include increased potassium levels (hyperkalaemia) 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 in 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister (after "Exp."). The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater 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 substance is olmesartan medoxomil.
Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other components are microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose,
low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and
hypromellose (see section 2 “Olmetec contains lactose”).

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Rome, Italy

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany (RMS), Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Luxembourg,
Norway, Netherlands, Portugal, United Kingdom, Spain: Olmetec
Ireland: Benetor