Osaver Hct

Leaflet accompanying the packaging: patient information

Osaver HCT 20 mg + 12.5 mg film-coated tablets

Osaver HCT 20 mg + 25 mg film-coated tablets

Osaver HCT 40 mg + 12.5 mg film-coated tablets

Osaver HCT 40 mg + 25 mg film-coated tablets

olmesartan medoxomil + hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The full name of the medicine is Osaver HCT, 20 mg + 12.5 mg, 20 mg + 25 mg, 40 mg + 12.5 mg, 40 mg + 25 mg, and throughout the text, it will be referred to as Osaver HCT. Osaver HCT contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists (AIIRA). This medicine lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide lowers blood pressure by removing excess fluids from the body through increased urine production.

Osaver HCT is used to treat patients whose blood pressure is not adequately controlled by taking olmesartan medoxomil alone. The administration of both active substances in Osaver HCT allows for greater blood pressure reduction than when these substances are taken separately. In patients currently taking antihypertensive medications, the doctor may recommend taking Osaver HCT to achieve greater blood pressure reduction. High blood pressure can be controlled with medications such as Osaver HCT. To facilitate blood pressure reduction, the doctor may also recommend lifestyle changes (e.g., weight loss, smoking cessation, reduced alcohol consumption, and reduced salt intake in the diet). The doctor may also encourage regular physical exercise, such as walking or swimming. It is essential to follow the doctor's recommendations.

2. Important information before taking Osaver HCT

When not to take Osaver HCT:

• if you are allergic to olmesartan medoxomil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides),
• after the 3rd month of pregnancy (you should also avoid taking Osaver HCT during early pregnancy - see "Pregnancy and breastfeeding"),
• in case of kidney function disorders,
• if you have low potassium, low sodium, high calcium, or high uric acid levels in your blood (with symptoms of gout or kidney stones) that cannot be treated,
• in case of moderate or severe liver function disorders or yellowing of the skin and eyes (jaundice), or if bile flow from the gallbladder is impaired (bile duct obstruction, e.g., gallstones),
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren. You should not take Osaver HCT if any of the above situations apply to you or if you are in doubt. You should consult your doctor and follow their instructions.

Warnings and precautions

Before starting to take Osaver HCT, you should discuss it with your doctor or pharmacist. Before taking the medicine, you should tell your doctor about any of the following conditions:

• previous kidney transplant;
• liver disease;
• heart failure or heart valve disorders or heart muscle disorders;
• vomiting or diarrhea that is severe or lasts for several days;
• treatment with high doses of diuretics or a low-salt diet;
• adrenal gland disorders (e.g., primary hyperaldosteronism);
• diabetes;
• if you have a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially at high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip tumors (non-melanoma skin cancer). During Osaver HCT treatment, you should protect your skin from sunlight and UV radiation;
• vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure and may occur within a few hours to a few weeks after taking Osaver HCT. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of these symptoms;
• systemic lupus erythematosus (an autoimmune disease);
• allergies or asthma;
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if you have kidney function disorders related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also "When not to take Osaver HCT".

You should contact your doctorif you experience any of the following symptoms:

• severe, persistent diarrhea that causes significant weight loss. Your doctor will assess the symptoms and decide how to continue the blood pressure-lowering treatment.

If you experience any of the above conditions, your doctor may recommend more frequent visits and certain tests. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Osaver HCT, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Osaver HCT on your own. Like any blood pressure-lowering medicine, excessive blood pressure reduction in 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 should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Osaver HCT is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Lab tests

Osaver HCT may cause increased lipid and uric acid levels in the blood (causing gout - a painful joint swelling). Your doctor will likely recommend periodic blood tests to measure lipid and uric acid levels. The use of the medicine may affect the electrolyte balance in your body. Your doctor will likely recommend periodic blood tests to measure electrolyte levels. Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), weakness, lethargy, fatigue, drowsiness, or restlessness, nausea, vomiting, decreased urine output, rapid heartbeat. If you experience such symptoms, you should inform your doctor. You should stop taking Osaver HCT before performing parathyroid function tests.

Important information for athletes

In athletes, the medicine may give a positive result in a doping test.

Children and adolescents

Osaver HCT is not recommended for children and adolescents under 18 years of age.

Osaver HCT and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, you should tell your doctor or pharmacist about taking any of the following medicines. Your doctor may recommend a dose change and/or take other precautions.

• Medicines that may affect potassium levels in the blood when taken with Osaver HCT:
• potassium supplements (including salt substitutes containing potassium),
• diuretics,
• heparin (a blood thinner),
• laxatives,
• corticosteroids,
• adrenocorticotropic hormone (ACTH),
• carbenoxolone (a medicine used to treat mouth and stomach ulcers),
• sodium penicillin G (an antibiotic),
• certain painkillers, such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and some types of depression) - concurrent use with Osaver HCT may increase lithium toxicity. If lithium is necessary, your doctor will recommend measuring lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis), taken concurrently with Osaver HCT, may increase the risk of kidney failure. NSAIDs may also weaken the effect of Osaver HCT.
• Other blood pressure-lowering medicines, as they may enhance the effect of Osaver HCT.
• ACE inhibitor or aliskiren (see also "When not to take Osaver HCT" and "Warnings and precautions").
• Sedatives, tranquilizers, and antidepressants taken concurrently with Osaver HCT may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Amifostine and certain anticancer medicines, such as cyclophosphamide and methotrexate.
• Medicines that lower lipid levels in the blood, such as cholestyramine and colestipol.
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood) - possible weakening of Osaver HCT's effect. Your doctor may recommend taking Osaver HCT at least 4 hours before taking colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and bipiperidine.
• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, or droperidol.
• Certain heart rhythm medicines, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides.
• Medicines that affect heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin given by injection.
• Medicines that lower blood sugar levels, such as metformin or insulin.
• Beta-blockers and diazoxide (used to treat high blood pressure and low blood sugar), as Osaver HCT may enhance their blood sugar-increasing effect.
• Medicines that increase blood pressure and heart rate, such as norepinephrine.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Difemanil, a medicine used in cases of slow heart rate and reduced sweating.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine that prevents organ rejection.
• Certain antibiotics from the tetracycline group or sparfloxacin.
• Amphotericin, used to treat fungal infections.
• Certain antacids, such as aluminum-magnesium hydroxide, as the effect of Osaver HCT may be slightly weakened.
• Cisapride, a medicine that stimulates stomach and intestinal motility.
• Halofantrine, a medicine used to treat malaria.

Osaver HCT with food, drink, and alcohol

Osaver HCT can be taken with or without food. You should be cautious when drinking alcohol while taking Osaver HCT, as dizziness or fainting may occur in some individuals. If such symptoms occur, you should not consume alcohol, including wine, beer, and drinks containing alcohol.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Osaver HCT is slightly weaker in black patients.

Pregnancy and breastfeeding

Pregnancy You should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Your doctor will usually recommend stopping Osaver HCT before planned pregnancy or immediately after confirming pregnancy and recommend taking a different medicine instead of Osaver HCT. Osaver HCT is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus. Breastfeeding You should inform your doctor if you are breastfeeding or plan to breastfeed. Osaver HCT is not recommended during breastfeeding. Your doctor may recommend a different medicine. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

During high blood pressure treatment, drowsiness or dizziness may occur. In such cases, you should not drive vehicles or operate machines until the symptoms have resolved. You should consult your doctor.

Osaver HCT contains lactose

This medicine contains lactose (a type of sugar). If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Osaver HCT

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, you should consult your doctor or pharmacist. Osaver HCT is a combination of two active substances, which means you should take only one tablet per day. The recommended dose of Osaver HCT is one 20 mg + 12.5 mg or one 40 mg + 12.5 mg tablet per day. Your doctor will recommend the appropriate dose, taking into account the doses you have previously taken. If blood pressure control is not sufficient, your doctor may decide to change the dose to one 20 mg + 25 mg or one 40 mg + 25 mg tablet per day. Osaver HCT can be taken with or without food. The tablet should be swallowed with water. If possible, the medicine should be taken at the same time every day, e.g., during breakfast. It is essential to continue taking Osaver HCT for as long as your doctor recommends.

Taking a higher dose of Osaver HCT than recommended

In case of taking a higher dose of the medicine than recommended or accidental ingestion by a child, you should immediately go to a doctor or the emergency department of the nearest hospital and bring the packaging of the medicine with you.

Missing a dose of Osaver HCT

If you accidentally miss a dose, you should take the next dose the following day at the usual time. You should nottake a double dose to make up for the missed dose.

Stopping Osaver HCT treatment

It is essential to continue taking Osaver HCT for as long as your doctor recommends. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Osaver HCT can cause side effects, although not everybody gets them. The following side effects may be serious:

• rarely, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth, and/or throat with accompanying itching and rash.
• less commonly, a sudden allergic reaction may occur, affecting the whole body, which can cause difficulty breathing and a sudden drop in blood pressure, in some cases leading to fainting (anaphylactic reaction).
• less commonly, in sensitive individuals or as a result of an allergic reaction, Osaver HCT may cause excessive blood pressure reduction. This may lead to severe dizziness or fainting.

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

• frequency unknown: if you experience yellowing of the whites of the eyes, dark urine, itching, you should contact your doctor immediately, who will assess the symptoms and decide how to continue the hypertension treatment.

Osaver HCT is a medicine that contains two active substances. The following information refers to side effects that have been reported so far during the use of a combination medicine containing olmesartan medoxomil and hydrochlorothiazide (in addition to those listed above) and those side effects that are observed for each substance separately. The following are other known side effects associated with the use of a combination medicine containing olmesartan medoxomil and hydrochlorothiazide. If you experience any of the following side effects, they are usually mild and do not require treatment discontinuation. Common side effects(may occur in less than 1 in 10 patients):

• dizziness; headache.
• weakness; chest pain; fatigue; swelling of the ankles, feet, legs, hands, or arms.

Less common side effects(may occur in less than 1 in 100 patients):

• feeling of emptiness in the head or dizziness when standing up from a sitting or lying position; drowsiness.
• dizziness of labyrinthine origin.
• awareness of heartbeat (palpitations).
• cough.
• abdominal pain; diarrhea; indigestion; nausea; vomiting.
• rash; eruption.
• joint pain; back pain; muscle cramps; muscle pain: arms and legs.
• blood in the urine.
• erectile dysfunction.
• also, some abnormalities in blood test results have been observed:
• increased lipid or cholesterol levels in the blood,
• increased uric acid or urea levels in the blood,
• increased creatinine levels in the blood,
• increased or decreased potassium levels in the blood,
• increased calcium levels in the blood,
• increased blood sugar levels,
• increased liver enzyme activity. Your doctor will obtain this information from blood tests and inform you about any further action.

Rare side effects(may occur in less than 1 in 1000 patients):

• altered consciousness.
• skin blisters (bubbles).
• acute kidney failure.
• malaise.
• also, some abnormalities in blood test results have been observed:
• increased urea levels in the blood,
• decreased hemoglobin and hematocrit values. Your doctor will obtain this information from blood tests and inform you about any further action.

Other side effects observed during the use of olmesartan medoxomil or hydrochlorothiazide separately, but not observed during the use of a combination medicine containing olmesartan medoxomil and hydrochlorothiazide, or observed with a higher frequency. Olmesartan medoxomil Common side effects(may occur in less than 1 in 10 patients):

• bronchitis; cough; sore throat; cold or nasal congestion.
• abdominal pain; diarrhea; indigestion; gastrointestinal inflammation (gastritis or enteritis); nausea.
• joint pain; back pain; bone pain.
• blood in the urine; urinary tract infection.
• flu-like symptoms; pain.
• also, some abnormalities in blood test results have been observed:
• increased lipid levels in the blood,
• increased urea or uric acid levels in the blood,
• increased liver and muscle enzyme activity.

Less common side effects(may occur in less than 1 in 100 patients):

• angina pectoris (chest pain or discomfort).
• allergic skin rash; skin eruption, itching, blisters (bubbles).
• facial swelling; malaise.
• also, some abnormalities in blood test results have been observed:
• decreased platelet count (thrombocytopenia).

Rare side effects(may occur in less than 1 in 1000 patients):

• kidney function disorders.
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• lack of energy.
• also, some abnormalities in blood test results have been observed:
• increased potassium levels in the blood.

Hydrochlorothiazide Very common side effects(occurring in at least 1 in 10 patients):

• changes in blood test results, including:
• increased lipid or cholesterol levels in the blood,
• increased uric acid levels in the blood.

Common side effects(may occur in less than 1 in 10 patients):

• glucose in the urine.
• confusion.
• abdominal pain; constipation; diarrhea; gastrointestinal inflammation; bloating; nausea; vomiting.
• also, some abnormalities in blood test results have been observed:
• increased creatinine, urea, calcium, and sugar levels in the blood,
• decreased chloride, potassium, magnesium, and sodium levels in the blood,
• increased amylase activity in serum (hyperamylasemia).

Less common side effects(may occur in less than 1 in 100 patients):

• decreased or lost appetite.
• worsening of existing myopia.
• severe breathing difficulties.
• redness; skin reactions to light; itching; purple spots or spots on the skin due to small blood leaks (purpura); blisters (bubbles).

Rare side effects(may occur in less than 1 in 1000 patients):

• swelling and pain in the salivary glands.
• decreased red blood cell count, which can cause pale skin, weakness, or shortness of breath; bone marrow damage; decreased white blood cell count; decreased platelet count.
• indifference; apathy or depression; anxiety; sleep disturbances.
• seizures (convulsions).
• tingling and numbness.
• dry eyes; blurred vision; yellow vision.
• heart rhythm disturbances.
• inflammation of blood vessels; blood clots (thrombosis or embolism).
• shortness of breath; pneumonia; fluid accumulation in the lungs; pulmonary edema.
• pancreatitis.
• inflammation of the gallbladder; jaundice.
• symptoms of lupus, such as rash, joint pain, and finger or toe numbness; skin peeling and blisters.
• muscle weakness; involuntary movements.
• non-infectious kidney inflammation (interstitial nephritis); kidney function disorders.
• fever.

Very rare side effects(may occur in less than 1 in 10,000 patients)

• electrolyte disturbances in the blood, causing excessive reduction of chloride levels in the blood (hypochloremic alkalosis).
• intestinal obstruction (paralytic ileus).

Frequency unknown(cannot be estimated from available data)

• malignant skin tumors and lip tumors (non-melanoma skin cancer)
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera), secondary glaucoma with closed-angle filtration.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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: Al. Jerozolimskie 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 HCT

The medicine should be stored out of sight and reach of children. There are no special storage instructions for the medicine. 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 month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Osaver HCT contains

The active substances of the medicine are olmesartan medoxomil and hydrochlorothiazide. Osaver HCT, 20 mg + 12.5 mg, film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Osaver HCT, 20 mg + 25 mg, film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide. Osaver HCT, 40 mg + 12.5 mg, film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Osaver HCT, 40 mg + 25 mg, film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

Other ingredients are:

Microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

What Osaver HCT looks like and contents of the pack

Osaver HCT, 20 mg + 12.5 mg: very light brown round film-coated tablets. Osaver HCT, 20 mg + 25 mg: pink to light pink round film-coated tablets. Osaver HCT, 40 mg + 12.5 mg: very light brown oval film-coated tablets. Osaver HCT, 40 mg + 25 mg: pink to light pink oval film-coated tablets. 14, 28, 30, 50, 56, 84, 90, 98, 100, and 500 film-coated tablets in aluminum/aluminum (OPA/aluminum/PVC and aluminum foil) blisters, in a cardboard box. 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:

For more information, please contact your local representative of the marketing authorization holder:

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