Osaver

Package Leaflet: Information for the Patient

Osaver 10 mg Film-Coated Tablets

Osaver 20 mg Film-Coated Tablets

Osaver 40 mg Film-Coated Tablets

Olmesartan Medoxomil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Osaver and what is it used for
• 2. Important information before taking Osaver
• 3. How to take Osaver
• 4. Possible side effects
• 5. How to store Osaver
• 6. Contents of the pack and other information

1. What is Osaver and what is it used for

Osaver belongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by widening the blood vessels.
Osaver is used to treat high blood pressure, also known as hypertension, in adults and children and adolescents from 6 to less than 18 years of age. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause any symptoms. Monitoring blood pressure helps prevent these damages.
Hypertension can be controlled by taking medicines such as Osaver, film-coated tablets. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g., weight loss, smoking cessation, reduced alcohol consumption, and reduced salt intake in the diet). Your doctor may also encourage regular physical exercise, such as walking or swimming. It is essential to follow your doctor's advice.

2. Important information before taking Osaver

When not to take Osaver:

• if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6),
• after the third month of pregnancy (you should also avoid taking Osaver during early pregnancy - see section "Pregnancy"),
• if you have jaundice (yellowing of the skin and eyes) or obstruction of bile flow from the gallbladder (bile duct obstruction, e.g., due to gallstones),
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

blood pressure.

Warnings and precautions

Before taking Osaver, discuss it with your doctor or pharmacist.
Tell your doctorif you have any of the following health problems:

• kidney disease,
• liver disease,
• heart failure, valve problems, or heart muscle disease,
• severe vomiting, diarrhea, taking high doses of diuretics, or a low-salt diet,
• high potassium levels in the blood,
• adrenal gland problems (e.g., primary aldosteronism),
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When not to take Osaver".
You should contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your condition and decide how to continue blood pressure treatment.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Osaver, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Osaver on your own.
As with any blood pressure-lowering medicine, excessive lowering of blood pressurein patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
You must inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. Osaver is not recommended during early pregnancy. You should not take Osaver after the third month of pregnancy, as it may seriously harm your baby (see section "Pregnancy").

Children and adolescents

Olmesartan medoxomil has been studied in children and adolescents. For more information, ask your doctor.
Osaver is not recommended for children under 6 years of age and should not be used in children under 1 year of age, as there is no experience with the use of the medicine in this age group.

Osaver and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is especially important for the following medicines:

• Other blood pressure-lowering medicines, as they may enhance the effect of Osaver. Your doctor may recommend a dose change and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also sections "When not to take Osaver" and "Warnings and precautions").
• Potassium supplements, salt substitutes containing potassium, diuretics (water pills), or heparin (a blood thinner).

These medicines may increase potassium levels in the blood when taken with Osaver.

• Lithium (a medicine used to treat mood changes and some types of depression). Taking lithium with Osaver may increase the toxic effects of lithium. If lithium is necessary, your doctor will recommend monitoring lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken with Osaver may increase the risk of kidney failure. The effect of Osaver may be reduced by NSAIDs.
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood) - possible reduction of Osaver effect. Your doctor may recommend taking Osaver at least 4 hours before taking colesevelam hydrochloride.
• Certain antacids (medicines used to neutralize stomach acid), as they may slightly reduce the effect of Osaver.

Elderly patients

In patients over 65 years of age, whose dose of Osaver is increased to 40 mg per day, the doctor will recommend regular monitoring of blood pressure to ensure that it does not drop too low.

Black patients

As with similar medicines, the blood pressure-lowering effect of Osaver may be slightly weaker in black patients.

Osaver with food and drink

Osaver can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. Your doctor will usually recommend stopping Osaver before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine. Osaver is not recommended during early pregnancy. You should not take Osaver after the third month of pregnancy, as it may seriously harm your baby.
Breastfeeding
Inform your doctor about breastfeeding or intending to breastfeed. Osaver is not recommended during breastfeeding. Your doctor may choose another medicine if you intend to breastfeed, especially if you are breastfeeding a newborn or premature baby.
If you are pregnant or breastfeeding, 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

During treatment for high blood pressure, drowsiness or dizziness may occasionally occur. In such cases, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

Osaver contains lactose

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

3. How to take Osaver

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 10 mg once daily. However, if adequate blood pressure control is not achieved, your doctor may increase the dose to 20 mg or 40 mg once daily or prescribe additional medicines.
In patients with mild to moderate kidney disease, the dose of Osaver must not exceed 20 mg once daily.

Use in children and adolescents from 6 to less than 18 years of age.

The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose to 20 or 40 mg once daily. In children weighing less than 35 kg, the dose will not exceed 20 mg once daily.
Tablets can be taken with or without food. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water). If possible, take the medicine at the same time every day, e.g., during breakfast.

Take more Osaver than prescribed

If you have taken more Osaver than prescribed or if a child has accidentally taken the medicine, seek medical attention immediately and take the package leaflet with you to the doctor or hospital.

Forget to take Osaver

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stop taking Osaver

It is important to continue taking Osaver for as long as your doctor prescribes it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Osaver can cause side effects, although not everybody gets them.
If they do occur, they are usually mild and do not require treatment to be stopped.
The following side effects may occur, although they are rare and may be serious:

• Uncommon (may affect up to 1 in 100 people): may cause a sudden allergic reaction that can cause difficulty breathing and a sudden drop in blood pressure, leading to fainting (anaphylactic reaction).
• Rare (may affect up to 1 in 1,000 people): during treatment with Osaver, swelling of the face, mouth, and/or throat may occur with itching and rash. Rarely (but more frequently in elderly people): Osaver may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This can lead to severe dizziness or fainting.
• Frequency not known (cannot be estimated from the available data): if yellowing of the eyes occurs, dark urine, itching of the skin, even if Osaver was started much earlier, you should contact your doctor immediately, who will assess the symptoms and decide how to continue the treatment of high blood pressure.

If you experience any of the above symptoms, stop taking Osaver and contact your doctor immediately.

Lie down.

Other known side effects associated with olmesartan medoxomil are:

Common side effects (may affect up to 1 in 10 people):

• Dizziness, headache
• Bronchitis, sore throat, cough, cold, or runny nose
• Gastroenteritis (inflammation of the stomach and intestines), diarrhea, stomach pain, nausea, indigestion
• Back, joint, or bone pain
• Blood in the urine, urinary tract infection
• Pain, chest pain, swelling of the ankles, feet, legs, hands, or arms, flu-like symptoms, fatigue
• Abnormal blood test results:
• increased triglycerides (hypertriglyceridemia),
• increased uric acid (hyperuricemia),
• increased urea in the blood,
• increased liver enzyme activity and muscle function parameters.

Uncommon side effects (may affect up to 1 in 100 people):

• Dizziness or spinning sensation (vertigo)
• Chest pain (angina pectoris)
• Vomiting
• Skin rash, allergic skin rash, hives, itching, urticaria (hives), skin bumps (papules)
• Muscle pain
• Facial swelling
• Weakness, malaise
• Abnormal blood test results showed a decrease in the number of blood cells called platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):

• Acute kidney failure, kidney problems
• Muscle spasms
• Angioedema of the intestine: intestinal swelling with symptoms such as stomach pain, nausea, vomiting, and diarrhea
• Lack of energy
• Abnormal blood test results:
• increased potassium levels (hyperkalemia),
• increased levels of substances that indicate kidney function.

Additional side effects in children and adolescents

In children, similar side effects occur as in adults. However, dizziness and headache are more common in children, while nosebleeds are a common side effect that occurs only in children.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Osaver

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP". 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 protect the environment.

6. Contents of the pack and other information

What Osaver contains

The active substance 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, hydroxypropylcellulose with a low degree of substitution, magnesium stearate, colloidal anhydrous silica, hypromellose, talc, titanium dioxide (E171).

What Osaver looks like and contents of the pack

Osaver 10 mg are white, round film-coated tablets with a diameter of 5.9 - 6.5 mm.
Osaver 20 mg are white, round film-coated tablets with a diameter of 7.9 - 8.7 mm.
Osaver 40 mg are white, oval film-coated tablets with a length of 13.9 - 14.7 mm and a width of 7.9 - 8.7 mm.
Osaver, film-coated tablets are available in Al/Al (OPA/Al/PVC and aluminum foil) blisters.
Osaver, film-coated tablets are available in blisters, in a box of 14, 28, 30, 50, 56, 84, 90, 98, 100, and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s. U kabelovny 130, 102 37, Prague 10 - Dolní Měcholupy, Czech Republic

Manufacturer

Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Zeota
Italy: Olmesartan Medoxomil Zentiva
Portugal: Olmesartan medoxomilo Zentiva
Poland: Osaver

For more information, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:June 2025