Olmesartan/hydrochlorothiazide Krka 40 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg film-coated tablets EFG

olmesartan medoxomil/hydrochlorothiazide

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 Olmesartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know before taking Olmesartan/Hydrochlorothiazide Krka
3. How to take Olmesartan/Hydrochlorothiazide Krka
4. Possible side effects
5. How to store Olmesartan/Hydrochlorothiazide 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, 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 ("medicines that increase urine elimination"). It reduces blood pressure by helping the body get rid of excess fluid, causing the kidneys to increase urine production.

You will be given Olmesartán/Hidroclorotiazida Krka only if treatment with olmesartan medoxomil 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 either 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 has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing 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 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 advisable to avoid olmesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have 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 moderate or 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 renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these situations apply to you, or 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:

• Kidney transplant

• Liver disease

• Heart failure or problems with heart valves or heart muscle

• Severe or prolonged vomiting (feeling sick) or diarrhea 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 lung 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 vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking Olmesartan/Hydrochlorothiazide Krka. This may lead to permanent vision loss if untreated. If you previously had an allergy 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), especially 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 in the section “Do not take Olmesartan/Hydrochlorothiazide Krka”.

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

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

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

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

As with any other medicine that lowers blood pressure, excessive reduction in 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 must stop taking olmesartan/hydrochlorothiazide before the test.

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

Inform your doctor if you think you are (or might become) pregnant. Olmesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be taken after the third month of pregnancy, 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

Inform 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 taken together with olmesartan/hydrochlorothiazide. These include:

• Potassium supplements (including potassium-containing salt substitutes)

• Medicines that increase urine production (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”).

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

• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other inflammatory symptoms, including arthritis), when taken 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 enhance the effect of olmesartan/hydrochlorothiazide.

• Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure upon standing when taken 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 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, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

• Certain heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.

• 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 intensify 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 aluminum and magnesium hydroxide, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.

• Cisapride, used to increase stomach and intestinal motility.

• 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 reduced 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. Olmesartan/hydrochlorothiazide is not recommended during pregnancy and must not be used from the third month of pregnancy onward, 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. 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 may 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 in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Krka 40 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 40 mg/25 mg daily.

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

If you take more Olmesartán/Hidroclorotiazida Krka than you should

If you take more tablets than prescribed 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 number: 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 missed 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:

• Rarely, allergic reactions affecting the whole body may occur, including 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 skin itching, even if you started treatment with olmesartan/hydrochlorothiazide some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide Krka is a combination of two active substances. The information below first 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 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 you do not need to stop treatment.

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

Infrequent changes in blood test results have also been observed, including:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose levels, increase in liver function test values. Your doctor will monitor you with 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 renal failure.

Rare changes in blood test results have also been observed, including:

Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values.

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

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:

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

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

Frequent changes in blood test results have also been observed, including:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test values.

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).

Uncommon changes in blood test results have also been observed, including:

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

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

Worsening of kidney function, lack of energy.

Rare changes in blood test results have also been observed, including:

Increase in blood potassium levels.

Hydrochlorothiazide:

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

Changes in blood tests including:

Increase in blood fat levels and blood uric acid levels.

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

Feeling confused, abdominal pain, stomach discomfort, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.

Changes in blood test results have also been observed, including:

Increase in creatinine, urea, calcium and blood glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasemia).

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

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

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

Inflammation and pain of the salivary glands, decrease in white blood cell count, decrease in platelet count, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, 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, 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 blood chloride levels (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Adverse effects with 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 type of 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. Olmesartán/Hidroclorotiazida Krka Storage

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

Do not use this medicine after the expiry date stated on the packaging 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 unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil 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 40 mg/12.5 mg film-coated tablets are white to almost white, round, bevel-edged tablets marked with "C3" on one side; diameter 12 mm.

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

You can request further information about this medicinal product 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2026

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/