Osaver

Patient Information Leaflet

Osaver 10 mg coated tablets
Osaver 20 mg coated tablets
Osaver 40 mg coated tablets
Olmesartan medoxomil
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Osaver is and what it is 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 Osaver is and what it is used for

Osaver belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by widening blood vessels.
Osaver is used to treat high blood pressure, also known as hypertension, in adults and in children and adolescents aged 6 to below 18 years. High blood pressure can damage blood vessels in vital organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually causes no symptoms. Monitoring blood pressure helps prevent such damage.
Hypertension can be controlled with medicines such as Osaver coated tablets. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g. weight reduction, quitting smoking, reducing alcohol intake, and decreasing dietary salt). Your doctor may also encourage regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. Important information before using Osaver

When not to use Osaver:

• if the patient is allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (use of Osaver should also be avoided in early pregnancy - see section "Pregnancy"),
• if the patient develops yellowing of the skin or eyes (jaundice) or impaired bile flow from the gallbladder (biliary obstruction, e.g. due to gallstones),
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Osaver, discuss this with your doctor or pharmacist.

Tell your doctor if the patient has any of the following health conditions:

• kidney disease,
• liver disease,
• heart failure, heart valve or heart muscle disorders,
• severe vomiting, diarrhoea, use of high doses of diuretics ("water pills") or a low-salt diet,
• increased potassium levels in the blood,
• adrenal gland disorders (e.g. primary hyperaldosteronism),
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).

See also the section "When not to use Osaver".

Contact your doctor if the patient develops severe, persistent diarrhoea leading to significant weight loss. The doctor will assess the patient's condition and decide how to continue blood pressure-lowering treatment.

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Osaver, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Osaver on your own.

As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor the patient's blood pressure.

Always inform your doctor if you are pregnant, suspect pregnancy or are planning pregnancy. Use of Osaver is not recommended during early pregnancy. Do not take Osaver after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").

Children and adolescents

Olmesartan medoxomil has been studied in children and adolescents. More information is available from your doctor.

Osaver is not recommended for children aged 1 year to less than 6 years and should not be used in children under 1 year of age, as there is no experience with use of the medicine in this age group.

Osaver with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This especially includes the following medicines:

• Other blood pressure-lowering medicines, as they may enhance the effect of Osaver. Your doctor may recommend a dose adjustment and/or additional precautions if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Osaver" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics ("water pills") or heparin (a medicine that reduces blood clotting). Taking these medicines together with Osaver may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression). Taking lithium together with Osaver may increase the toxic effects of lithium. If lithium treatment is necessary, your doctor will recommend monitoring lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis), which when taken together with Osaver may increase the risk of kidney failure. The effect of Osaver may be reduced by NSAIDs.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – may reduce the effectiveness of Osaver. Your doctor may recommend taking Osaver at least 4 hours before taking colesevelam hydrochloride.
• Some medicines that neutralize stomach acid (medicines used for indigestion), as they may slightly reduce the effect of Osaver.

Elderly patients

In patients over 65 years of age whose dose has been increased to 40 mg once daily, the doctor will recommend regular monitoring of blood pressure to ensure that blood pressure is not lowered too much.

Black patients

As with similar medicines, the antihypertensive effect of Osaver may be somewhat weaker in black patients.

Osaver with food and drink

Osaver can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect pregnancy or are planning pregnancy. Your doctor will usually recommend stopping Osaver before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Use of Osaver is not recommended in early pregnancy. Do not take Osaver after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Osaver is not recommended during breastfeeding. Your doctor may choose an alternative medicine if you plan to breastfeed, especially if breastfeeding a newborn or premature infant.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Osaver

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult 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 renal impairment, the dose should not exceed 20 mg once daily.
Use in children and adolescents aged 6 to under 18 years.
The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately
controlled, the doctor may decide to adjust the dose to 20 mg or 40 mg once daily. In children
weighing less than 35 kg, the dose will not exceed 20 mg once daily.
Tablets may be taken with food or independently of meals. Swallow the tablet with an adequate
amount of liquid (e.g. a glass of water). If possible, the medicine should be taken at the same time every day, for example during breakfast.
Taking more Osaver than prescribed
If you take more Osaver than prescribed, or if a child accidentally swallows the medicine, seek
immediate medical advice at the nearest hospital emergency department and bring the medicine
packaging with you.
Missing a dose of Osaver
If a dose is missed, take the next dose at the usual time the following day. Do not take a double dose
to make up for a missed dose.
Stopping Osaver treatment
It is important to continue taking Osaver for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If they do occur, they are often mild and do not require discontinuation of treatment.
The following adverse reactions, although not common, may be serious:

• Uncommon (may occur in less than 1 in 100 patients): a sudden, whole-body allergic reaction may occur, which can cause difficulty breathing and a sudden drop in blood pressure, in some cases leading to fainting (anaphylactic reaction).
• Rare (may occur in less than 1 in 1000 patients): when taking Osaver, swelling of the face, mouth, and (or) larynx, accompanied by itching and rash, may occur. Rarely (but somewhat more frequently in elderly patients): Osaver may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This may lead to severe dizziness or fainting.
• Frequency not known (cannot be estimated from available data): if yellowing of the whites of the eyes, dark urine, or skin itching occurs, even if Osaver treatment was started significantly earlier, contact a doctor immediately. The doctor will assess the symptoms and decide how to continue treatment for hypertension.
  If any of the above symptoms occur, discontinue use of the medicine Osaver immediately, contact a doctor, and lie down.

The following are other known adverse reactions associated with olmesartan medoxomil:

Common adverse reactions (may occur in less than 1 in 10 patients):

• Dizziness, headache
• Bronchitis, sore throat, cough, runny or stuffy nose
• Gastritis and enteritis (inflammation of the stomach or intestines), diarrhea, stomach pain, nausea, indigestion
• Joint, back, or bone pain
• Blood in 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 fat levels (hypertriglyceridemia),
• increased uric acid levels (hyperuricemia),
• increased blood urea levels,
• increased liver enzyme activity and muscle function parameters.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• Dizziness or sensation of spinning (vertigo)
• Angina (chest pain or discomfort)
• Vomiting
• Skin rash, allergic skin rash, urticaria, itching, exanthema (skin eruptions), skin nodules (blisters)
• Muscle pain
• Facial swelling
• Weakness, malaise
• Blood tests have shown a decrease in the number of blood cells called platelets (thrombocytopenia).

Rare adverse reactions (may occur in less than 1 in 1000 patients):

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

Additional adverse reactions in children and adolescents
In children, similar adverse reactions occur as those reported in adult patients. However, dizziness and headache occur more frequently in children, while nosebleeds are a common adverse reaction occurring only in children.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Osaver

Keep this medicine out of sight and reach of children.
Do not store above 25 ºC.
Do not use this medicine after the expiry date stated on the packaging after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the Package and Other Information

What Osaver Contains
The active substance is olmesartan medoxomil.
Each coated tablet contains 10 mg, 20 mg, or 40 mg of olmesartan medoxomil.
The other ingredients are:
microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose,
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 coated tablets with a diameter of 5.9 – 6.5 mm.
Osaver 20 mg are white, round coated tablets with a diameter of 7.9 – 8.7 mm.
Osaver 40 mg are white, oval coated tablets with a length of 13.9 – 14.7 mm and width of 7.9 – 8.7 mm.

Osaver, coated tablets, are available in Al/Al blisters (OPA/Al/PVC and Al foil).
Osaver, coated tablets, are available in blister packs in the following pack sizes: 14, 28, 30, 50, 56, 84, 90, 98, 100 and 500 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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 further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00