Leaflet: information for the user

Olmesartán/Hidroclorotiazida Krka 40 mg/25 mg film-coated tablets EFG

olmesartán medoxomilo/hidroclorotiazida

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What isOlmesartán/Hidroclorotiazida Krkaand what it is used for

2.What you need to know before you start takingOlmesartán/Hidroclorotiazida Krka

3.How to takeOlmesartán/Hidroclorotiazida Krka

4.Possible side effects

5.Storage ofOlmesartán/Hidroclorotiazida Krka

6.Contents of the pack and additional information

Olmesartán/HidroclorotiazidaKrkacontains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension) in adults:

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

-Hidroclorotiazida belongs to a group of medicines called thiazide diuretics (“medicines that increase the elimination of urine”). It reduces blood pressure by helping the body to eliminate excess fluids, causing the kidneys to increase urine production.

They will only give you Olmesartán/HidroclorotiazidaKrkaif treatment with olmesartán medoxomilo alone has not adequately controlled blood pressure. The concurrent administration of both active principles in this medicine contributes to reducing blood pressure more than each substance administered separately.

You may already be taking medicines to treat high blood pressure, but your doctor may want to administer Olmesartán/HidroclorotiazidaKrkato lower it further.

High blood pressure can be controlled with medicines like Olmesartán/HidroclorotiazidaKrkatablets. Your doctor has probably also recommended that you make some 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 essential to follow your doctor's advice.

Do not takeOlmesartán/Hidroclorotiazida Krka

• If you are allergic toolmesartán medoxomilo or to hidroclorotiazidaor to any of the other components of this medication (listed in section 6) or to substances similar to hidroclorotiazida (sulfonamides).
• If you are more than 3 months pregnant (it is also better to avoid olmesartán/hidroclorotiazida at the beginning of pregnancy - see Pregnancy section).
• If you have kidney problems.
• If you have low levels of potassium, 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, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., by gallstones).
• If you have diabetes or kidney insufficiency and receive treatment with a medication to reduce blood pressure that contains aliskireno.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeOlmesartán/HidroclorotiazidaKrka.

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

• Renal transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Intense or prolonged vomiting (feeling sick) or diarrhea.
• Treatment with high doses of medications that increase urine elimination (diuretics), or if you are following a low-sodium 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. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while takingOlmesartán/Hidroclorotiazida Krka.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after takingOlmesartán/Hidroclorotiazida Krka, go to your doctor immediately.
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours to weeks after taking Olmesartán/HidroclorotiazidaKrka. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this.
• If you are taking any of the following medications to treat high blood pressure:

• A renin-angiotensin-aldosterone system inhibitor (RAAS inhibitor) (e.g., enalapril, lisinopril, ramipril),particularly if you have kidney problems related to diabetes.
• Aliskireno.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

Also see the information in the section “Do not take Olmesartán/Hidroclorotiazida Krka”.

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

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

Olmesartán/hidroclorotiazida may cause an increase in blood levels of fats and uric acid (which causes gout – painful swelling of the joints). Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

A change in blood levels of certain chemical substances called electrolytes may occur. Your doctor will probably want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Inform your doctor if you notice any of these symptoms.

Like any other medication that reduces blood pressure, an excessive decrease in blood pressure in patients with heart or brain blood flow problems may cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are scheduled to undergo parathyroid function tests, stop taking olmesartán/hidroclorotiazida before performing them.

It is reported to athletes that this medication may establish a doping control analytical result as positive.

You must inform your doctor if you think you are (or could be) pregnant. Olmesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Children and adolescents

Olmesartán/hidroclorotiazida is not recommended for children and adolescents under 18 years old.

Other medications andOlmesartán/HidroclorotiazidaKrka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Medications that may increase blood potassium levels if used at the same time as olmesartán/hidroclorotiazida. These medications include:

• Potassium supplements (as well as salt substitutes containing potassium).
• Diuretics.
• Heparin (to thin the blood).
• Laxatives.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for treating mouth and stomach ulcers).
• Penicillin G sodium (antibiotic, also called benzylpenicillin sodium).
• Some analgesics such as aspirin or salicylates.

• Your doctor may need to change your dose and/or take other precautions:
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskireno (see also the information under the headings “Do not take Olmesartán/Hidroclorotiazida Krka” and “Warnings and precautions”).
• The toxicity of lithium (medication used to treat mood changes and some types of depression) may increase if taken at the same time as olmesartán/hidroclorotiazida. If you need to take lithium, your doctor will measure your lithium levels in the blood.

• Nonsteroidal anti-inflammatory drugs (NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartán/hidroclorotiazida may increase the risk of kidney insufficiency and reduce the effect of olmesartán/hidroclorotiazida.

• Other blood pressure-lowering medications (antihypertensives), because they may increase the effect of olmesartán/hidroclorotiazida.

• Sedatives, sleep inducers, and antidepressants, because used together with olmesartán/hidroclorotiazida may cause a sudden drop in blood pressure when standing up.

• Some medications such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.

• Colestiramine and colestipol, medications to reduce blood fat levels.

• Colesevelam hydrochloride, a medication that reduces blood cholesterol levels, as it may reduce the effect of olmesartán/hidroclorotiazida. Your doctor may advise you to take olmesartán/hidroclorotiazida at least 4 hours before colesevelam hydrochloride.

• Anticholinergic medications, such as atropine and biperiden.

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

• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used in heart disease treatment.

• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, which may change heart rhythm.

• Oral antidiabetic medications, such as metformin, or insulin, used to reduce blood sugar levels.

• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as olmesartán/hidroclorotiazida may intensify the effect of increasing blood sugar that these medications produce.

• Metildopa, a medication used to treat high blood pressure.

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

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

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

• Calcium supplements.

• Amantadine, an antiviral medication.

• Ciclosporin, a medication used to prevent organ transplant rejection.

• Some antibiotics called tetracyclines, or enoxacin.

• Amphotericin, a medication 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 olmesartán/hidroclorotiazida.

• Cisapride, used to increase stomach and intestinal movement.

• Halofantrine, used to treat malaria.

TakingOlmesartán/HidroclorotiazidaKrkawith food and drinks

Olmesartán/Hidroclorotiazida Krkacan be taken with or without food.

Be careful when drinking alcohol while takingolmesartán/hidroclorotiazida, as some people may feel dizzy or lightheaded. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients

Like with other similar medications, the blood pressure-lowering effect of olmesartán/hidroclorotiazida is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or could be) pregnant. Your doctor will usually recommend that you stop taking olmesartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead. Olmesartán/hidroclorotiazida is not recommended for use during pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Olmesartán/hidroclorotiazida is not recommended for use during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding.

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

Driving and operating machines

You may feel drowsy or dizzy while taking treatment for high blood pressure. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is1 Olmesartán/Hidroclorotiazida Krka 40 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 Olmesartán/Hidroclorotiazida Krka 40 mg/25 mg tablet per day.

Take the tablet with water. If possible, take your doseat the same time every day, for example, with breakfast. It is essential to continue taking olmesartán/hidroclorotiazida until your doctor tells you to stop.

If you take moreOlmesartán/HidroclorotiazidaKrkathan you should

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

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

If you forget to takeOlmesartán/HidroclorotiazidaKrka

If you forget to take a dose, take your usual dose the next day as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withOlmesartán/HidroclorotiazidaKrka

It is essential to continue taking olmesartán/hidroclorotiazida, unless your doctor tells you to stop.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

• In rare cases, an allergic reaction 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, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately..

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

• Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartan/Hidroclorotiazida Krka some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Olmesartan/Hidroclorotiazida Krkais a combination of two active principles and the following information, first, describes the side effects reported so far with the combinationolmesartan/hydrochlorothiazide(in addition to those already mentioned) and, secondly, the side effects known of the two active principles separately.

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

If these effects occur, they are often mild andyou do not need to interrupt treatment..

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

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

Rare side effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood tests have been observed, including:

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

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

Increased urea in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

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

Olmesartan medoxomilo:

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

Bronchitis, cough, congestion or nasal 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 levels.

Rare side effects (may affect up to 1 in 100 people):

Fast and intense allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid drop in blood pressure that can even cause fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin rash, itching, exanthema (skin eruption), skin swelling (hives).

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

Reduced number of a type of blood cell, called platelets (thrombocytopenia).

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

Renal function deterioration, lack of energy.

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

Increased potassium in the blood.

Hidroclorotiazida:

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

Changes in blood tests, including:

Increased fat in the blood and uric acid levels.

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

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

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

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

Rare side effects (may affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light sensitivity reactions, skin itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, 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, 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, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

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

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

Side effects of unknown frequency (cannot be estimated from 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 hemorrhage) or acute angle-closure glaucoma), skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box 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 through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofOlmesartán/Hidroclorotiazida Krka

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the package

Olmesartán/Hidroclorotiazida Krka 40 mg/ 25 mg film-coated tablets are white to almost white, oval, biconvex tablets with a notch on both sides; measuring 15 mm x 8 mm. The notch is only for breaking and facilitating swallowing, but not for dividing into equal doses.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

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

For further 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 member states of the European Economic Area with the following names:

Last revision date of this leaflet: June 2022

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/