OLMESARTAN KRKA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartán Krka 40 mg film-coated tablets EFG

olmesartán medoxomil

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

1. What is Olmesartán Krka and what is it used for

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

Olmesartán Krka is used to treat high blood pressure (also known as “hypertension”) in adults, and in children and adolescents from 6 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 or kidney failure, stroke, or blindness. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines such as Olmesartán Krka tablets. Your doctor will probably also have recommended that you make some changes to your lifestyle to help lower your blood pressure (for example, losing weight, stopping 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 important to follow your doctor's advice.

2. What you need to know before you take Olmesartán Krka

Do not takeOlmesartán Krka

• If you are allergic to olmesartán medoxomil or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also better to avoid olmesartán at the start of pregnancy - see section Pregnancy, breast-feeding and fertility).
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (bile obstruction, for example, due to gallstones).
• If you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

Warnings and precautions

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

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

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

Your doctor may need to check 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 diuretics, or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

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

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

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you think you are (or might become) pregnant. Olmesartán is not recommended at the start of pregnancy and 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 Pregnancy, breast-feeding and fertility).

Children and adolescents

Olmesartán Krka has been studied in children and adolescents. For more information, consult your doctor. Olmesartán Krka is not recommended in children under 6 years of age and must not be used in children under 1 year of age, as there is no experience with its use in these age groups.

Other medicines and Olmesartán Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of Olmesartán Krka.

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 Olmesartán Krka” and “Warnings and precautions”).

• Potassium supplements, salt substitutes that contain potassium, diuretics, or heparin (to thin the blood). Using these medicines at the same time as olmesartán may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as olmesartán. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as they may increase the risk of kidney failure and reduce the effect of olmesartán when used at the same time.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartán medoxomil. Your doctor may advise you to take olmesartán medoxomil at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartán.

Elderly patients

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

Black patients

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

Taking Olmesartán Krka with food and drinks

Olmesartán Krka can be taken with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are (or might become) pregnant. Your doctor will normally advise you to stop taking olmesartán before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartán Krka. Olmesartán 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 this time.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartán is not recommended during breast-feeding. Your doctor may choose another treatment if you want to continue breast-feeding, especially if your baby is newborn or premature.

Driving and using machines

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

Olmesartán Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Olmesartán Krka

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The recommended initial dose is 10 mg once daily. If your blood pressure is not controlled adequately, your doctor may increase the dose to 20 mg or 40 mg once daily, or prescribe additional treatment.

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

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

In patients with mild to moderate kidney problems, the maximum dose is 20 mg once daily.

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 each day, for example, at breakfast time.

If you take more Olmesartán Krka than you should

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Take the medicine pack with you.

If you forget to take Olmesartán 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 a forgotten dose.

If you stop taking Olmesartán Krka

It is important to continue taking olmesartán 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare (may affect up to 1 in 1,000 people):

In rare cases (may affect up to 1 in 1,000 people), the following allergic reactions have been reported:

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

Rarely (but slightly more frequently in elderly people), olmesartán may cause a pronounced drop in blood pressure in susceptible individuals or as a result of an allergic reaction. This can cause fainting or severe dizziness. If this happens to you, stop taking olmesartán, consult your doctor immediately, and lie down.

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

These are other known side effects of olmesartán:

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

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

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

Uncommon side 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), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), angina pectoris (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 failure, intestinal angioedema: swelling in the intestine that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes in blood test results have also been observed, including increased potassium levels (hyperkalemia) and increased levels of compounds related to kidney function.

Children and adolescents

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Information System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Krka

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition ofOlmesartán Krka

• The active ingredient is olmesartan medoxomil.

Each film-coated tablet contains 40 mg of olmesartan medoxomil.

• The other ingredients are:

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

See section 2 "Olmesartán Krka contains lactose".

Appearance and Package Contents

The film-coated tablets are white, oval, biconvex film-coated tablets, with the mark S3 on one face of the tablet, dimensions: 13 x 8 mm, thickness: 4.3 mm - 5.5 mm.

Olmesartán Krka 40 mg film-coated tablets are available in packs of 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters and in bottles of 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation 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

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

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the Member States of theEconomic European Areaand in the United Kingdom (Northern Ireland)under the following names:

Date of last revision of this leaflet: April 2025

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