Osaver hct

Package leaflet: Information for the user

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
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Osaver HCT is and what it is 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 will be referred to as Osaver HCT throughout this text.
Osaver HCT contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which
are used in the treatment of high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists (AIIRAs). 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 fluid from the body, increasing the amount of urine produced.

Osaver HCT is used to treat patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone. Using both active substances in Osaver HCT provides a greater reduction in blood pressure than using either substance alone.
If you are currently taking antihypertensive medicines, your doctor may prescribe Osaver HCT to achieve better blood pressure control.
High blood pressure can be managed with medicines such as Osaver HCT. To help lower your blood pressure, your doctor may also recommend lifestyle changes (e.g. weight reduction, stopping smoking, reducing alcohol intake, and reducing salt in the diet). Your doctor may also encourage you to engage in regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. Important information before using Osaver HCT

When not to use Osaver HCT:

• if the patient is 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 (use of Osaver HCT should also be avoided in early pregnancy – see section “Pregnancy and breastfeeding”),
• in case of kidney function disorders,
• if there is low potassium, low sodium, high calcium, or high uric acid levels in the blood (with symptoms of gout or kidney stones) that are not responding to treatment,
• in cases of moderate or severe liver dysfunction or jaundice (yellowing of the skin and eyes), or if bile flow from the gallbladder is obstructed (biliary obstruction, e.g. gallstones),
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren. Osaver HCT should not be used if any of the above conditions apply to the patient or if the patient has any doubts about them. The patient should consult a doctor first and follow the advice given.

Warnings and precautions
Before starting treatment with Osaver HCT, discuss this with your doctor or pharmacist.
Before taking the medicine, tell your doctor if any of the following conditions apply:

• previous kidney transplant;
• liver disease;
• heart failure or heart valve or myocardial disorders;
• vomiting or diarrhoea that are severe or last for several days;
• treatment with high doses of diuretics ("water pills") or following a low-salt diet;
• adrenal gland disorders (e.g. primary hyperaldosteronism);
• diabetes;
• previous history of skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer (including lip cancer). While taking Osaver HCT, protect your skin from sunlight and UV radiation;
• visual disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure and may occur within hours to weeks after starting Osaver HCT. If left untreated, they may lead to permanent vision loss. If the patient has previously had an allergic reaction to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• systemic lupus erythematosus (an autoimmune disease);
• allergies or asthma;
• taking any of the following medicines for high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes,
  • aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section “When not to use Osaver HCT”.

Contact your doctor if the patient experiences any of the following symptoms:

• severe, persistent diarrhoea leading to significant weight loss. The doctor will assess the symptoms and decide how to continue antihypertensive treatment.

If any of the above conditions apply, the doctor may recommend more frequent visits and certain tests.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Osaver HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Osaver HCT 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, the doctor will carefully monitor the patient's blood pressure.
Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. Use of Osaver HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).

Laboratory tests
Osaver HCT may increase blood lipid and uric acid levels (a cause of gout – painful joint swelling). The doctor may recommend periodic blood tests to monitor lipid and uric acid levels.
The medicine may affect the patient's electrolyte balance. The doctor may recommend periodic blood tests to monitor electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, drowsiness, fatigue, sleepiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform the doctor.
Stop taking Osaver HCT before undergoing parathyroid function tests.

Important information for athletes
This medicine may cause a positive result in anti-doping tests.

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

Osaver HCT and 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.
In particular, inform the doctor or pharmacist if any of the following medicines are being used. The doctor may recommend a dose adjustment and/or additional precautions.

• Medicines that may affect blood potassium levels when used together with Osaver HCT:
  • potassium supplements (including potassium-containing salt substitutes),
  • diuretics ("water pills"),
  • heparin (a medicine that reduces blood clotting),
  • laxatives,
  • steroids,
  • adrenocorticotropic hormone (ACTH),
  • carbenoxolone (used to treat mouth and stomach ulcers),
  • sodium G penicillin (sodium salt of benzylpenicillin, an antibiotic),
  • certain painkillers such as aspirin or salicylates.
• Lithium (used to treat mood disorders and certain types of depression) – concomitant use with Osaver HCT may increase lithium toxicity. If lithium treatment is necessary, the doctor may recommend monitoring lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, used to reduce pain, swelling, and other inflammatory symptoms, including joint inflammation), when taken together with Osaver HCT, may increase the risk of kidney failure. NSAIDs may also reduce the effectiveness of Osaver HCT.
• Other blood pressure-lowering medicines, as they may enhance the effect of Osaver HCT.
• ACE inhibitors or aliskiren (see also sections “When not to use Osaver HCT” and “Warnings and precautions”).
• Sleeping pills, sedatives, and antidepressants taken together with Osaver HCT may cause sudden drops in blood pressure upon standing.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and certain other anticancer medicines such as cyclophosphamide and methotrexate.
• Medicines that lower blood lipid levels, such as cholestyramine and colestipol.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol) – may reduce the effectiveness of Osaver HCT. The doctor may recommend taking Osaver HCT at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, e.g. atropine, biperiden.
• Medicines used to treat certain psychiatric disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, or droperidol.
• Certain medicines used for heart disorders, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or cardiac glycosides.
• Medicines affecting heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin.
• Medicines that lower blood glucose 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 glucose-raising effects.
• Medicines that increase blood pressure and heart rate, such as noradrenaline.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines used for gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Difemanyl, a medicine used for slow heart rate and reduced sweating.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent rejection of transplanted organs.
• Certain tetracycline antibiotics or sparfloxacin.
• Amphotericin, used to treat fungal infections.
• Certain antacids, e.g. aluminium-magnesium hydroxide, as they may slightly reduce the effectiveness of Osaver HCT.
• Cisapride, a medicine that stimulates gastrointestinal motility.
• Halofantrine, a medicine used to treat malaria.

Osaver HCT with food, drink, and alcohol
Osaver HCT can be taken with or without food.
Exercise caution when drinking alcohol while taking Osaver HCT, as some people may experience fainting or dizziness. If such symptoms occur, do not consume alcohol, including wine, beer, and alcoholic beverages.

Patients of Black race
As with other similar medicines, the blood pressure-lowering effect of Osaver HCT is somewhat weaker in patients of Black race.

Pregnancy and breastfeeding
Pregnancy
Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. The doctor will usually recommend discontinuing Osaver HCT before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Osaver HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to start breastfeeding. Osaver HCT is not recommended during breastfeeding. The doctor may recommend an alternative medicine.

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Treatment for high blood pressure may cause drowsiness or dizziness. In such cases, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Osaver HCT contains lactose
This medicine contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Osaver HCT

This medicine should always be taken as advised by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Osaver HCT is a combination of two active substances, meaning only one tablet per day should be
taken.
The recommended dose of Osaver HCT is one tablet of Osaver HCT 20 mg + 12.5 mg or one tablet of
Osaver HCT 40 mg + 12.5 mg daily. Your doctor will recommend the appropriate dose, taking into
account the doses previously taken.
If blood pressure is not adequately controlled, your doctor may decide to change the dose to –
accordingly – one tablet of Osaver HCT 20 mg + 25 mg or one tablet of Osaver HCT 40 mg + 25 mg
daily.
Osaver HCT may be taken with food or independently of meals. Swallow the tablet with water. If
possible, take the medicine at the same time every day, for example during breakfast. It is important
to continue taking Osaver HCT for as long as your doctor advises.
Taking more Osaver HCT than recommended
If you take more medicine than recommended, or if a child accidentally swallows the medicine,
seek immediate medical attention at the nearest hospital emergency department and bring the
medicine packaging with you.
Missing a dose of Osaver HCT
If a dose is accidentally missed, take the next dose the following day at the usual time. Do not take a
double dose to make up for the missed dose.
Stopping Osaver HCT treatment
It is important to continue taking Osaver HCT for as long as your doctor advises.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may be serious:

• allergic reactions affecting the whole body may rarely occur, with facial swelling, swelling of the mouth and (or) larynx, accompanied by itching and rash.
• anaphylactic reaction (sudden allergic reaction affecting the whole body) may not infrequently occur, causing breathing difficulties and sudden drop in blood pressure, sometimes leading to fainting.
• not infrequently, in sensitive individuals or as a result of an allergic reaction, Osaver HCT may cause excessive lowering of blood pressure. This may lead to severe dizziness or fainting. If any of the above symptoms occur, treatment with Osaver HCT should be discontinued immediately, contact a doctor without delay, and lie down.
• frequency not known: if yellowing of the whites of the eyes occurs, dark urine, or skin itching, even if Osaver HCT was started significantly earlier, seek medical advice immediately. The doctor will assess the symptoms and decide how to continue antihypertensive treatment.

Osaver HCT is a medicine containing two active substances. The information below refers to adverse reactions reported so far during treatment with a combination medicine containing olmesartan medoxomil and hydrochlorothiazide (in addition to those listed above), as well as adverse reactions observed with each substance individually.
Below are other known adverse reactions associated with the use of the combination medicine containing olmesartan medoxomil and hydrochlorothiazide. If the following adverse reactions occur, they are often mild and do not require discontinuation of treatment.
Common adverse reactions (may occur in fewer than 1 in 10 patients):

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

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

• feeling of "emptiness" in the head or dizziness when standing up from a sitting or lying position; drowsiness.
• vertigo.
• palpitations (awareness of heartbeats).
• cough.
• abdominal pain; diarrhoea; indigestion; nausea; vomiting.
• rash, skin eruption.
• joint pain; back pain; muscle cramps; muscle pain in arms and legs.
• blood in urine.
• erectile dysfunction.
• certain abnormalities in blood test results have also been observed:
  • increased blood levels of fats or cholesterol,
  • increased blood levels of urea or uric acid,
  • increased blood creatinine levels,
  • increased or decreased blood potassium levels,
  • increased blood calcium levels,
• increased blood glucose levels,
• increased liver enzyme activity. Your doctor will obtain the above information from blood tests and inform you about any further necessary steps.

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

• disturbances of consciousness.
• skin nodules (blisters).
• acute renal failure.
• malaise.
• certain abnormalities in blood test results have also been observed:
  • increased blood urea nitrogen (BUN) levels,
  • decreased haemoglobin levels and haematocrit values. Your doctor will obtain the above information from blood tests and inform you about any further necessary steps.

Other adverse reactions observed during treatment with olmesartan medoxomil or hydrochlorothiazide alone, but not observed or observed with different frequency during treatment with the combination medicine containing olmesartan medoxomil and hydrochlorothiazide.
Olmesartan medoxomil
Common adverse reactions (may occur in fewer than 1 in 10 patients):

• bronchitis; cough; sore throat; nasal congestion or runny nose.
• abdominal pain; diarrhoea; indigestion; gastroenteritis (inflammation of the stomach or intestines); nausea.
• joint pain; back pain; bone pain.
• blood in urine; urinary tract infection.
• influenza-like symptoms; pain.
• certain abnormalities in blood test results have also been observed:
  • increased blood lipid levels,
  • increased blood levels of urea or uric acid,
  • increased liver and muscle enzyme activity.

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

• angina (chest pain or discomfort).
• allergic skin rash; urticaria, itching, skin nodules (blisters).
• facial swelling; malaise.
• certain abnormalities in blood test results have also been observed:
  • decreased number of platelets (thrombocytopenia).

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

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

Hydrochlorothiazide
Very common adverse reactions (occur in at least 1 in 10 patients):

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

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

• glucose excretion in urine.
• confusion.
• abdominal pain; constipation; diarrhoea; gastritis; bloating; nausea; vomiting.
• certain abnormalities in blood test results have also been observed:
  • increased blood levels of creatinine, urea, calcium, and glucose,
  • decreased blood chloride, potassium, magnesium, and sodium levels,
  • increased serum amylase activity (hyperamylasemia).

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

• decreased or loss of appetite.
• worsening of existing myopia.
• severe breathing difficulties.
• erythema; photosensitivity reactions; itching; purpura (purple spots or patches on the skin due to minor bleeding); skin nodules (blisters).

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

• swelling and pain of salivary glands.
• decreased number of red blood cells causing pallor, weakness, or shortness of breath; bone marrow damage; decreased number of white blood cells; decreased number of platelets.
• feeling of indifference; apathy or depression; anxiety; sleep disturbances.
• convulsions (seizures).
• tingling and numbness.
• dry eyes; blurred vision; yellow vision.
• cardiac arrhythmias.
• vasculitis, blood clots (thrombosis or embolism).
• dyspnoea; pneumonia; fluid accumulation in the lungs; pulmonary oedema.
• pancreatitis.
• cholecystitis; jaundice.
• symptoms of systemic lupus erythematosus, such as rash, joint pain, cold hands and fingers; skin peeling and blisters.
• muscle weakness; involuntary movements.
• non-infectious kidney inflammation (interstitial nephritis); kidney function disorders.
• fever.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):

• electrolyte imbalances in blood causing excessive reduction in blood chloride levels (hypochloremic alkalosis).
• intestinal obstruction (paralytic ileus).

Frequency not known (cannot be estimated from available data):

• skin and lip malignancies (non-melanoma skin cancers).
• visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive accumulation of fluid between choroid and sclera), secondary angle-closure glaucoma.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Osaver HCT

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the container following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Osaver HCT contains
The active substances in Osaver HCT 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, colloidal anhydrous 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 aluminium/aluminium blisters (OPA/aluminium/PVC and aluminium foil), packed in a cardboard box.
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 European Economic Area under the following names:

For more detailed information, please contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00