Olmesartan/hydrochlorothiazide Krka 20 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán/Hidroclorotiazida Krka 20 mg/12.5 mg film-coated tablets EFG

olmesartán medoxomilo/hidroclorotiazida

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olmesartán/Hidroclorotiazida Krka is and what it is used for
2. What you need to know before taking Olmesartán/Hidroclorotiazida Krka
3. How to take Olmesartán/Hidroclorotiazida Krka
4. Possible adverse effects
5. How to store Olmesartán/Hidroclorotiazida Krka
6. Contents of the pack and other information

1. What Olmesartán/Hidroclorotiazida Krka is and what it is used for

Olmesartán/Hidroclorotiazida Krka contains two active substances, olmesartán medoxomilo and hidroclorotiazida, which are used to treat high blood pressure (hypertension) in adults:

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics ("medicines that increase urine elimination"). It lowers blood pressure by helping the body get rid of excess fluid, by making the kidneys produce more urine.

You will only be prescribed Olmesartán/Hidroclorotiazida Krka if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in this medicine contributes to a greater reduction in blood pressure than each substance given separately.

You may already be taking medicines to treat high blood pressure, but your doctor may wish to prescribe Olmesartán/Hidroclorotiazida Krka to lower it further.

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida Krka tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Krka

Do not take Olmesartan/Hydrochlorothiazide Krka

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant (it is also best to avoid olmesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have low levels of potassium or sodium, or high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these situations apply to you, or you are unsure, do not take the tablets. Speak to your doctor first and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartan/Hydrochlorothiazide Krka.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Mild to moderate kidney problems or if you have recently had a kidney transplant.

• Liver disease.

• Heart failure or problems with heart valves or heart muscle.

• Severe or prolonged vomiting or diarrhoea lasting several days.

• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.

• Problems with the adrenal glands (e.g., primary hyperaldosteronism).

• Diabetes.

• Lupus erythematosus (an autoimmune disease).

• Allergy or asthma.

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Olmesartan/Hydrochlorothiazide Krka.

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide Krka, seek medical help immediately.

• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks of taking Olmesartan/Hydrochlorothiazide Krka. This may lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may have a higher risk of developing this condition.

• If you are taking any of the following medicines for high blood pressure:

• An ACE inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• Aliskiren.

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.

Also refer to the information under the section “Do not take Olmesartan/Hydrochlorothiazide Krka”.

Your doctor may want to see you more often and carry out some tests if you have any of these conditions.

Contact your doctor if you experience severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.

Olmesartan/hydrochlorothiazide may increase levels of fats and uric acid (which causes gout – painful swelling of the joints) in the blood. Your doctor may want to carry out blood tests from time to time to monitor these possible changes.

Olmesartan/Hydrochlorothiazide Krka may alter blood levels of certain chemicals called electrolytes. Your doctor may want to carry out blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, or rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other 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 closely monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking olmesartan/hydrochlorothiazide before the test.

Athletes should be aware that this medicine may lead to a positive analytical result in doping controls.

Inform your doctor if you think you are (or might become) pregnant. Use of olmesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents

Olmesartan/hydrochlorothiazide is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan/Hydrochlorothiazide Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist about any of the following medicines:

• Medicines that may increase potassium levels in the blood when used together with olmesartan/hydrochlorothiazide. These include:

• Potassium supplements (as well as salt substitutes containing potassium)

• Medicines that increase urine output (diuretics)

• Heparin (a blood thinner)

• Laxatives

• Steroids

• Adrenocorticotropic hormone (ACTH)

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers)

• Sodium penicillin G (an antibiotic, also known as sodium benzylpenicillin)

• Some painkillers such as aspirin or salicylates

• Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan/Hydrochlorothiazide Krka” and “Warnings and precautions”).

• The toxicity of lithium (a medicine used to treat mood disorders and certain types of depression) may increase when taken together with olmesartan/hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartan/hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide.

• Other blood pressure-lowering medicines (antihypertensives), as they may increase the effect of olmesartan/hydrochlorothiazide.

• Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure when standing up when used with olmesartan/hydrochlorothiazide.

• Certain muscle relaxants such as baclofen and tubocurarine.

• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.

• Cholestyramine and colestipol, medicines used to lower blood fat levels.

• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take olmesartan/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.

• Anticholinergic medicines such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, zuclopenthixol, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as olmesartan/hydrochlorothiazide may enhance their blood sugar-raising effect.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemanyl, used to treat slow heart rate or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Certain antibiotics known as tetracyclines, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of olmesartan/hydrochlorothiazide.

• Cisapride, used to increase movement of food through the stomach and intestine.

• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Krka with food, drinks, and alcohol

Olmesartan/Hydrochlorothiazide Krka can be taken with or without food.

Be cautious when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of olmesartan/hydrochlorothiazide is somewhat lower in patients of Black race.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking olmesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of olmesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of olmesartan/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to continue breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

3. How to take Olmesartán/Hidroclorotiazida Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Krka 20 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida Krka 20 mg/25 mg daily.

Take the tablet with water. If possible, you should take your dose at the same time each day, for example, with breakfast. It is important that you continue taking olmesartán/hidroclorotiazida until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Krka than you should

If you take more tablets than you should, or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and bring the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida Krka

If you forget to take a dose, take your usual dose the next day as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán/Hidroclorotiazida Krka

It is important to continue taking olmesartán/hidroclorotiazida unless your doctor tells you to stop treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

• In rare cases, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.

• Olmesartan/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens to you, stop taking olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.

• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itchy skin, even if you have been taking olmesartan/hydrochlorothiazide for some time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide Krka is a combination of two active substances. The following information first describes adverse effects reported so far with the combination olmesartan/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances when used separately.

These are other known adverse effects reported so far with olmesartan/hydrochlorothiazide:

If these effects occur, they are often mild and it is usually not necessary to discontinue treatment.

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

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

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

Rapid or strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:

Increased levels of fat in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased levels of potassium in blood, increased levels of calcium in blood, increased blood glucose, increased liver function test values. Your doctor will monitor you through a blood test and advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

Rarely, the following changes in blood test results have also been observed:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values.

Your doctor will monitor you through a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with olmesartan/hydrochlorothiazida, or reported more frequently:

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion or discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Commonly observed changes in blood test results include:

Increased levels of fat in blood, increased blood urea or uric acid, increased liver or muscle enzyme levels.

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

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommonly, the following changes in blood test results have also been observed:

Reduction in the number of a type of blood cell called platelets (thrombocytopenia).

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

Worsening of kidney function, lack of energy.

Rarely, the following changes in blood test results have also been observed:

Increased potassium levels in blood.

Hydrochlorothiazide:

Very common adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increased blood fat levels and increased uric acid levels.

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

Confusion, abdominal pain, stomach discomfort, bloated feeling, diarrhea, nausea, vomiting, constipation, glucose in urine.

Changes in blood test results may also include:

Increased levels of creatinine, urea, calcium and blood glucose; decreased levels of chloride, potassium, magnesium and sodium in blood; increased serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes affect movement).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that may cause abnormally low chloride levels in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Adverse effects of unknown frequency (cannot be estimated from available data):

Reduced vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Krka

• The active substances are olmesartan medoxomilo and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomilo and 12.5 mg of hydrochlorothiazide.

• The other components are microcrystalline cellulose, magnesium stearate and low-substituted hydroxypropylcellulose in the core, and titanium dioxide, talc, poly(vinyl alcohol) and macrogol 3000 in the coating.

Appearance of the product and contents of the pack

Olmesartan/Hydrochlorothiazide Krka 20 mg/12.5 mg film-coated tablets are white to almost white, round, biconvex tablets, marked with "C1" on one side, 9 mm in diameter.

Film-coated tablets are available in boxes containing 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of last review of this leaflet: January 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/