Olmesartan/amlodipine/hydrochlorothiazide Krka 40 mg/10 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide Krka 20 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Krka 40 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Krka 40 mg/5 mg/25 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Krka 40 mg/10 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Krka 40 mg/10 mg/25 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine/hydrochlorothiazide

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

Leaflet contents

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

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

This medicine contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. These three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists,” which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers.” Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (“medicines that increase urine elimination”). It lowers blood pressure by helping remove excess fluid through increased urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure. Olmesartan/hydrochlorothiazide/amlodipine is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine taken as a fixed-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide together with tablets containing amlodipine only, or a fixed-dose combination of olmesartan medoxomil and amlodipine together with tablets containing hydrochlorothiazide only.

2. What you need to know before taking Olmesartán/Amlodipino/Hidroclorotiazida Krka

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if:

• you are allergic to olmesartán medoxomilo, amlodipino, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking this medicine.
• you have severe kidney problems.
• you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• you are more than 3 months pregnant. (It is also advisable to avoid this medicine in early pregnancy – see section “Pregnancy and breastfeeding”).
• you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or you have jaundice (yellowing of the skin and eyes).
• you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• you have very low blood pressure.
• blood flow from your heart is slow or blocked. This may occur if blood vessels or heart valves collecting blood from the heart are narrowed (aortic stenosis).
• you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may cause shortness of breath or swelling in your feet and ankles.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if any of the above apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting Olmesartán/Amlodipino/Hidroclorotiazida Krka.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

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

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if:”.

Tell your doctor if you have any of the following health conditions:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of "water pills" (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after sun exposure or use of sunbeds.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 this medicine.
• 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 this medicine, contact your doctor immediately.

Contact your doctor if you experience any of the following symptoms:

• Abdominal pain, nausea, vomiting, or diarrhea after taking olmesartán/amlodipino/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán/amlodipino/hidroclorotiazida on your own.
• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• Vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours or weeks of taking this medicine. This may lead to permanent visual impairment if untreated. If you previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this.

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 carefully monitor your blood pressure.

This medicine may increase blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor may want to perform blood tests periodically to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform 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, slow, tired, drowsy, or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you must stop taking this medicine before the tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant (or think you might be). Use of this medicine is not recommended during early pregnancy, and it must 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 section “Pregn游戏副本

3. How to take/use Olmesartan / Amlodipine / Hydrochlorothiazide Krka

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

• The recommended dose of this medicine is one tablet daily.
• The tablets can be taken with or without food. Take the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example, with breakfast.

If you take more Olmesartan/Amlodipine/Hydrochlorothiazide Krka than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop within 24–48 hours after ingestion.

If you take more tablets than prescribed, or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine pack or this leaflet 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.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Krka

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

If you stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Krka

It is important to continue taking this medicine unless your doctor tells you to stop.

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 experiences them. If they occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small number of people:

During treatment with Olmesartan/Amlodipine/Hydrochlorothiazide, allergic reactions may occur with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking this medicine and consult your doctor immediately.

Olmesartan/Amlodipine/Hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. If this happens to you, stop taking this medicine, consult your doctor immediately, and lie down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itching of the skin, even if you started treatment with Olmesartan/Amlodipine/Hydrochlorothiazide some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

This medicine is a combination of three active substances. The following information first describes the adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the individual active substances, or when two of the substances are taken together.

To give you an idea of how many patients may experience adverse effects, they have been classified as very common, common, uncommon, rare, and very rare.

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

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

Common

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nasal symptoms, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon

(may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, flushing and sensation of warmth in the face, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

These are the known adverse effects for each of the active substances individually or when two of the substances are taken together:

These may be adverse effects due to Olmesartan/Amlodipine/Hydrochlorothiazide Krka, even if they have not been observed so far with this medicine.

Very common

(may affect more than 1 in 10 people)

Edema (fluid retention).

Common

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), difficulty sleeping, irritability, mood changes including anxiety, feeling depressed, chills, sleep disorders, altered sense of taste, loss of consciousness, reduced sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, redness of the skin, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin eruption, muscle pain, difficulty urinating, sensation of needing to urinate at night, breast enlargement in men, decreased sexual desire, facial swelling, feeling unwell, weight gain or loss, exhaustion.

Rare

(may affect up to 1 in 1,000 people)

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures, yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very serious, impaired movement, acute kidney failure, non-infectious inflammation of the kidney, decreased kidney function, fever.

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare

(may affect up to 1 in 10,000 people)

High muscle tension, numbness of hands or feet, heart attack, inflammation of the stomach, gum enlargement, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects of unknown frequency

(frequency cannot be estimated from the available data)

Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unbalanced gait with shuffling steps.

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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/Amlodipine/Hydrochlorothiazide Krka

Keep this medicine out of 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Krka

• The active substances are olmesartan medoxomil, amlodipine, and hydrochlorothiazide.

20 mg/5 mg/12.5 mg:

Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate), and 12.5 mg of hydrochlorothiazide.

40 mg/5 mg/12.5 mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate), and 12.5 mg of hydrochlorothiazide.

40 mg/5 mg/25 mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate), and 25 mg of hydrochlorothiazide.

40 mg/10 mg/12.5 mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate), and 12.5 mg of hydrochlorothiazide.

40 mg/10 mg/25 mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate), and 25 mg of hydrochlorothiazide.

• The other components (excipients) are: pregelatinized maize starch, silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), lactose monohydrate, sodium croscarmellose, copovidone, and magnesium stearate in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172) – only for 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg, iron oxide yellow (E172) – only for 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg, and iron oxide black (E172) – only for 40 mg/10 mg/25 mg in the coating. See section 2 “Olmesartan/Amlodipine/Hydrochlorothiazide Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

20 mg/5 mg/12.5 mg:

The film-coated tablets (tablets) are white or almost white, round, biconvex, with bevelled edges.

Dimensions: diameter 8.5 mm ± 0.5 mm.

40 mg/5 mg/12.5 mg:

The film-coated tablets (tablets) are pale brownish-yellow to pale brown-yellow, biconvex, capsule-shaped, marked with the code “C1” on one side of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/5 mg/25 mg:

The film-coated tablets (tablets) are pale pinkish-orange, biconvex, capsule-shaped, marked with the code “C2” on one side of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/10 mg/12.5 mg:

The film-coated tablets (tablets) are pale pink, biconvex, capsule-shaped, marked with the code “C3” on one side of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/10 mg/25 mg:

The film-coated tablets (tablets) are pale greyish-violet to pale grey-violet, biconvex, capsule-shaped, scored on both sides of the tablet. The tablet can be divided into equal doses.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

Olmesartan/Amlodipine/Hydrochlorothiazide Krka is available in packs containing:

• 14, 28, 30, 56, 60, 84, 90 and 98 film-coated tablets in blister packs.
• 14, 28, 56 and 98 film-coated tablets in calendar blister packs.

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, Smarjeska Cesta 6, 8501 Novo Mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Groden Cuxhaven 27472, Germany

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

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 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: March 2025

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