OLMESARTAN/HYDROCHLOROTHIAZIDE KRKA 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide Krka 20 mg/12.5 mg Film-Coated Tablets EFG

olmesartan medoxomil/hydrochlorothiazide

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Olmesartan/Hydrochlorothiazide Krka and what is it used for
2. What you need to know before you take Olmesartan/Hydrochlorothiazide Krka
3. How to take Olmesartan/Hydrochlorothiazide Krka
4. Possible side effects
5. Storage of Olmesartan/Hydrochlorothiazide Krka
6. Contents of the pack and other information

1. What is Olmesartan/Hydrochlorothiazide Krka and what is it used for

Olmesartan/Hydrochlorothiazide Krka contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension) in adults:

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

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

You will only be given Olmesartan/Hydrochlorothiazide Krka if treatment with olmesartan medoxomil alone has not controlled your blood pressure adequately. The combination of both active substances in this medicine helps to lower blood pressure more than either substance alone.

You may already be taking medicines for high blood pressure, but your doctor may want to give you Olmesartan/Hydrochlorothiazide Krka to lower it further.

High blood pressure can be controlled with medicines like Olmesartan/Hydrochlorothiazide Krka tablets. Your doctor may also have recommended that you make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce alcohol consumption, and reduce the amount of salt in your diet). Your doctor may also have advised you to exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

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

Do not takeOlmesartan/Hydrochlorothiazide Krka

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide or any of the other ingredients 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 better to avoid olmesartan/hydrochlorothiazide at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have low potassium, sodium, or high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have severe liver problems or yellowing of the skin and eyes (jaundice) or problems with bile drainage from the gallbladder (bile duct obstruction, e.g., due to gallstones).
• If you have diabetes or kidney problems and are being treated with a medicine that lowers blood pressure and contains aliskiren.

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

Warnings and precautions

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

Before taking the tablets, tell your doctorif you have any of the following health problems:

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or diarrhea, which is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine production (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 if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Olmesartan/Hydrochlorothiazide Krka.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide Krka, seek medical attention 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 pressure in the eye, and can occur within hours to weeks after taking Olmesartan/Hydrochlorothiazide Krka. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing this.
• If you are taking any of the following medicines to treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

Also, read the information under the heading "Do not take Olmesartan/Hydrochlorothiazide Krka".

Your doctor may want to see you more often and do some tests if you have any of these problems.

Contact your doctor if you suffer from severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/hydrochlorothiazide on your own.

Olmesartan/hydrochlorothiazide may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will probably want to do a blood test from time to time to check for these possible changes.

Olmesartan/Hydrochlorothiazide Krka may cause a change in the levels of certain chemicals in the blood called electrolytes. Your doctor will probably want to do a blood test from time to time to check for this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessively low blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. That's why your doctor will closely monitor your blood pressure.

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

Athletes are informed that this medicine may result in a positive doping test.

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. It is not recommended to take olmesartan/hydrochlorothiazide during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after that time.

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 take any other medicines.

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

• Medicines that may increase potassium levels in the blood if taken at the same time as olmesartan/hydrochlorothiazide. These medicines include:

• Potassium supplements (as well as salt substitutes that contain potassium).
• Medicines that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (for the treatment of mouth and stomach ulcers).
• Sodium penicillin G (antibiotic, also called benzylpenicillin sodium).
• Certain pain relievers like aspirin or salicylates.

• Your doctor may need to change your dose and/or take other precautions:
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Olmesartan/Hydrochlorothiazide Krka" and "Warnings and precautions").
• Lithium toxicity (a medicine used to treat mood changes and some types of depression) may increase if taken at the same time as olmesartan/hydrochlorothiazide. If you need to take lithium, your doctor will measure lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken at the same time as olmesartan/hydrochlorothiazide, may increase the risk of kidney problems and reduce the effect of olmesartan/hydrochlorothiazide.

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

• Sedatives, hypnotics, and antidepressants, as they may cause a sudden drop in blood pressure when standing up, when taken with olmesartan/hydrochlorothiazide.

• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.

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

• Colesevelam hydrochloride, a medicine to lower blood cholesterol levels, as it 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, trifluperazine, cyanemazine, 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 erythromycin injection, which can change 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 increase the effect of these medicines on raising blood sugar levels.

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

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

• Difemanil, 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 rejection in transplants.

• Certain antibiotics called tetracyclines, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

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

• Cisapride, used to increase food movement in the stomach and intestines.

• Halofantrine, used for malaria.

Taking Olmesartan/Hydrochlorothiazide Krka with food and drink

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

Be careful when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people feel faint or dizzy. If this happens, do not drink any alcohol, including wine, beer, or drinks with alcohol.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Olmesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after that time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding.

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

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Talk to your doctor.

3. How to take Olmesartan/Hydrochlorothiazide Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose isone Olmesartan/Hydrochlorothiazide Krka 20 mg/12.5 mg tablet per day. If your blood pressure is not controlled adequately, your doctor may change the dose to one Olmesartan/Hydrochlorothiazide Krka 20 mg/25 mg tablet per day.

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

If you take more Olmesartan/Hydrochlorothiazide Krka than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide Krka

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

If you stop taking Olmesartan/Hydrochlorothiazide Krka

It is important to continue taking olmesartan/hydrochlorothiazide unless your doctor tells you to stop.

If you have any further questions on 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 all people suffer from them.

However, the following adverse effects may be serious:

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

• Olmesartan/hydrochlorothiazide may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness may occur. 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, skin itching, even if you started treatment with Olmesartan/Hydrochlorothiazide Krka a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment.

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

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

If these effects occur, they are often mild and it is not necessary to interrupt 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 and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erection problems in men, blood in urine.

Also, some changes in blood test results have been observed, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

Feeling of discomfort, changes in consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have been observed, including:

Increased blood urea nitrogen, decreased hemoglobin, and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with olmesartan/hydrochlorothiazide, or at a higher frequency:

Olmesartan medoxomil:

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

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

Also, some changes in blood test results have been observed, including:

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

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

Rapid allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Also, some changes in blood test results have been observed, including:

Decreased number of a type of blood cells called platelets (thrombocytopenia).

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

Kidney function deterioration, lack of energy, intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Also, some changes in blood test results have been observed, including:

Increased potassium in the blood.

Hydrochlorothiazide:

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

Changes in blood tests, including:

Increased fat in the blood and uric acid levels.

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose in urine.

Also, some changes in blood test results have been observed, including:

Increased creatinine, urea, calcium, and sugar levels in the blood, decreased chloride, potassium, magnesium, and sodium levels in the blood. Increased serum amylase (hyperamylasemia).

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

Decreased or lost appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, 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 number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, infection in the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling, and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

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

Electrolyte imbalance that can cause an abnormally reduced level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

Decreased vision or eye pain due to high blood 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide Krka

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

• The other ingredients 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 Package Contents

Olmesartan/Hydrochlorothiazide Krka 20 mg/12.5 mg film-coated tablets are white to almost white, round, biconvex tablets, marked with a C1 on one face of the tablet, diameter 9 mm.

The film-coated tablets are available in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets.

Not all 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

You can obtain further information on this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: April 2025

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