Leaflet: information for the user

Olmesartan Krka 10 mg film-coated tablets EFG

olmesartan medoxomil

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, ask 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 isOlmesartan Krkaand what it is used for

2.What you need to know before starting totakeOlmesartan Krka

3.How to takeOlmesartan Krka

4.Possible side effects

5.Storage ofOlmesartan Krka

6.Contents of the pack and additional information

OlmesartánKrkabelongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by relaxing blood vessels.

OlmesartánKrkais used to treat high blood pressure (also known as “hypertension”)in adults, and in children and adolescents from 6 years of age to less than 18 years of age. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to a heart attack, heart failure, or stroke, or blindness. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like OlmesartánKrkatablets. Your doctor may also have 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 Krka

• If you are allergic toolmesartán medoxomiloor to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also best to avoid olmesartán at the beginning of pregnancy - see sectionEmbarazo, lactancia y fertilidad).
• If you have a yellowish skin and eye color (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney insufficiency and are receiving treatment with a medication to reduce blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán Krka.

Consult your doctorif you are taking any of the following medications to treat high blood pressure:

• An angiotensin-converting enzyme (ACE) inhibitor (for example, enalapril, lisinopril, ramipril),particularly if you have kidney problems related to diabetes..
• Aliskirén.

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

See also the information under the heading “Do not take Olmesartán Krka”.

Consult your doctorif you have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

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

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you believe you are (or may be) pregnant. Olmesartán 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 during this period (see sectionEmbarazo, lactancia y fertilidad).

Children and adolescents

Olmesartán Krka has been studied in children and adolescents. For more information, consult your doctor. Olmesartán Krka is not recommended for children aged 1 year to less than 6 years, and it should not be used in children under 1 year, as there is no experience.

Other medications and Olmesartán Krka

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

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

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

Older patients

If you are over 65 years old and your doctor decides to increase your olmesartán medoxomilo dose to 40 mg daily, then your doctor will need to regularly check your blood pressure to ensure that your blood pressure does not become too low.

Black patients

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

TakingOlmesartánKrkawith food and drinks

Olmesartán Krkacan be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are (or may be) pregnant. Your doctor will usually recommend that you stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Olmesartan Krka. Olmesartán is not recommended for use during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken during this period (see sectionEmbarazo, lactancia y fertilidad).

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Olmesartán is not recommended for use during breastfeeding. Your doctor may choose another treatment if you wish to continue breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

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

Olmesartán Krkacontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Adults

The recommended initial dose is 1 tablet of 10 mg per day. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day or prescribe additional treatment.

Children and adolescents from 6 to less than 18 years of age

The recommended initial dose is 10 mg per day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose up to 20 or 40 mg once a day. In children weighing less than 35 kg, the dose will not exceed 20 mg once a day.

In patients with mild to moderate renal insufficiency, the maximum dose is 20 mg once a day.

The tablets can be taken with or without food. Take the tablets with a sufficient amount of water (for example, a glass). If possible, take your dose at the same time every day, for example, at breakfast time.

If you take moreOlmesartánKrkathan you should

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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to takeOlmesartánKrka

If you forgot 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 the treatment withOlmesartánKrka

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

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. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious, although they are not common:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the entire body:

During treatment with olmesartan, inflammation of the face, mouth, and/or larynx (voice box) may occur, along with itching and skin rash.If this happens, stop taking olmesartan and consult your doctor immediately.

Rarely (but slightly more common in older adults), olmesartan may cause a pronounced drop in blood pressure in susceptible individuals or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking olmesartan, consult your doctor immediately, and remain lying down in a horizontal position.

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

These are other side effects known so far with olmesartan:

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

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, congestion, and nasal secretion, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infection, swelling of the ankles, feet, legs, hands, or arms, blood in the urine.

Some changes in the results of certain blood tests have also been observed: increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in the blood, increased values in liver and muscle function tests.

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

Quick allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that can even cause fainting (anaphylactic reactions), dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), chest pain (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cell called platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, decreased kidney function, kidney insufficiency.

Some changes in the results of blood tests have also been observed. These include increased levels of potassium (hyperkalemia) and increased levels of compounds related to kidney function.

Children and adolescents

In children, side effects are similar to those reported in adults. However, dizziness and headache have been seen more often in children, and nosebleeds are a frequent side effect seen only in children.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofOlmesartán Krka

• The active ingredient is olmesartan medoxomil.

Each film-coated tablet contains 10 mg of olmesartan medoxomil.

• The other components are:

microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose, and magnesium stearate in the tablet core and titanium dioxide, talc, macrogol 3000, and poly(vinylalcohol) in the coating.

See section 2 “Olmesartán Krka contains lactose”.

Appearance of the product and contents of the package

The film-coated tablets are white, round, slightly biconvex film-coated tablets with the mark S1 on one face of the tablet, tablet diameter: 6.5 mm, tablet thickness: 2.4 mm – 3.4 mm.

Olmesartán Krka 10 mg film-coated tablets are available in blister packs of 10, 14, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets and in bottles of 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 theEconomic Area and in the United Kingdom (Northern Ireland)under the following names:

Last review date of this leaflet: September 2022

The detailed and updated 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/