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PACKAGE LEAFLET: INFORMATION FOR THE USER

OLPRESS 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Olpress is and what it is used for
2. What you need to know before you use Olpress
3. How to use Olpress
4. Possible side effects
5. How to store Olpress
6. Contents of the pack and other information

1. What Olpress is and what it is used for

Olpress belongs to a group of medicines called angiotensin II receptor antagonists.
They reduce blood pressure by relaxing blood vessels.
Olpress is used to treat 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 heart attacks, heart or kidney failure, stroke, or blindness.
High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure regularly to prevent damage from occurring.
High blood pressure can be controlled with medicines such as Olpress tablets. Your doctor has likely also 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 OLPRESS

Do not take Olpress

• if you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than three months pregnant. It is better to avoid Olpress tablets during the early stages of 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 Olpress.
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 the section "Do not take Olpress".
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 levels of potassium in the blood.
• Problems with the adrenal glands.

Your doctor may want to examine you more frequently and may prescribe tests if you have any of the above conditions.
Inform your doctor if you develop severe and prolonged diarrhoea 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, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to a 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). Olpress 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”).

Children and adolescents
Olpress is not recommended for children and adolescents under 18 years of age.

Other medicines and Olpress
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines:
In particular, inform your doctor or pharmacist about each of the following:

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

Elderly
If you are 65 years of age or older and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your blood pressure should be regularly monitored by your doctor to avoid excessive lowering.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olpress is somewhat reduced in patients of Black ethnicity.

Olpress with food and drink
Olpress 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). Your doctor will usually advise you to stop taking Olpress before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olpress. Olpress 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 breast-feed. Olpress 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, think you may be pregnant, are planning a pregnancy, or are breast-feeding, ask your doctor or pharmacist for advice 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.

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

3. How to use OLPRESS

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
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 or 40
mg once daily, or may prescribe other 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 water (for example, a glass). If possible, take your daily dose at the same time each day, for example with breakfast.
If you take more Olpress than you should
If you take more tablets than prescribed or if a child accidentally swallows any,
go immediately to your doctor or nearest emergency department, taking the
medicine pack with you.
If you forget to take Olpress
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 Olpress
It is important to continue taking Olpress unless your doctor tells you to stop.
If you have any doubts about using Olpress, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they do occur, they are mostly mild and do not require discontinuation of treatment.

Although they do not occur in all people, the following two side effects can be serious:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions involving the whole body have been reported:

During treatment with Olpress, 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 Olpress and contact your doctor immediately.

Rarely (but slightly more frequently in elderly people), Olpress may cause excessive lowering of 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 Olpress, contact your doctor immediately, and remain lying down.

The following are the other side effects known so far with Olpress:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal discharge, bronchitis, influenza-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 laboratory test abnormalities have also been observed, including the following:
increase in blood fats (hypertriglyceridaemia), increase in blood uric acid (hyperuricaemia), increase in blood urea, increase in 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 difficulties or a rapid drop in blood pressure that may even 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 in the blood, called platelets (thrombocytopenia), has also been observed in blood tests.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, reduced kidney function, kidney failure.
Some blood test abnormalities have also been observed, including 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 side effect commonly seen only in children.

Reporting of side effects
If you experience any side effects, 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 OLPRESS

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 does not require any special storage conditions.
Do not dispose of any medicine 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 Olpress 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 “Olpress contains lactose”).

Description of the appearance of Olpress and contents of the pack
Olpress 10 mg film-coated tablets, round, white, marked on one side with the code C13;
Olpress 20 mg film-coated tablets, round, white, marked on one side with the code C14;
Olpress 40 mg film-coated tablets, oval, white, marked on one side with the code C15.
Olpress 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 pre-scored blisters for single doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611 Luxembourg.
Under licence from Daiichi Sankyo Europe GmbH
Marketing Authorisation Holder for distribution: Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7, Bagno a Ripoli - Florence, Italy.
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen (Germany)
Berlin Chemie AG
Glienicker Weg, 125
12489 Berlin (Germany)
Laboratorios Menarini, S.A.
Alfons XII, 587 - E 08918 Badalona, Barcelona (Spain)

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Mencord
Belgium: Belsar
Cyprus: Olartan
Denmark: Benetor
Germany: Votum
Greece: Olartan
Finland: Benetor
France: Alteis
Ireland: Omesar
Iceland: Benetor
Italy: Olpress
Luxembourg: Belsar
Malta: Omesar
Norway: Benetor
Poland: Revival
Portugal: Olsar
Czech Republic: Sarten
Slovenia: Tensiol
Spain: Ixia