Olmesartan Krka 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán Krka 10 mg film-coated tablets EFG

olmesartan medoxomil

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

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

Olmesartán Krka belongs to a group of medicines called angiotensin II receptor antagonists. It lowers 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 aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually has no symptoms. It is important to control your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as Olmesartán Krka tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing 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 Olmesartán Krka

Do not take Olmesartán Krka

• If you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (olmesartan should also be avoided at the beginning of pregnancy – see section Pregnancy, breastfeeding and fertility).
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartán Krka.

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

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

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (for example, potassium) at regular intervals.

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

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

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine output (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 experience severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.

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

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

You must inform your doctor if you think you are (or could be) pregnant. The use of olmesartan is not recommended at the beginning of 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 during this stage (see section Pregnancy, breastfeeding and fertility).

Children and adolescents

Olmesartán Krka has been studied in children and adolescents. For further information, consult your doctor. Olmesartán Krka is not recommended for children aged 1 to less than 6 years, and should not be used in children under 1 year of age, as there is no experience with its use in this age group.

Other medicines and Olmesartán Krka

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

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

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 Olmesartán Krka” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (a blood thinner). Using these medicines together with olmesartan may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when taken together with olmesartan. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used 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 olmesartan when used together.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan medoxomil. Your doctor may advise you to take olmesartan medoxomil at least 4 hours before colesevelam hydrochloride.
• Some antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Elderly patients

If you are over 65 years old and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, you will need regular blood pressure monitoring by your doctor to ensure your blood pressure does not become too low.

Patients of black race

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

Taking Olmesartán Krka with food and drink

Olmesartán Krka can be taken with or without food.

Pregnancy, breastfeeding and fertility

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.

Pregnancy

You must inform your doctor if you are (or could be) pregnant. Your doctor will usually advise you to stop taking olmesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Olmesartán Krka. Olmesartan is not recommended during pregnancy, and must not be given from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from that point.

Breastfeeding

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

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.

Olmesartán Krka contains lactose

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

3. How to take Olmesartán Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If you are in 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 to 20 mg or 40 mg per day or prescribe additional treatment.

Children and adolescents aged 6 to less than 18 years

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

In patients with mild to moderate renal impairment, 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, with breakfast.

If you take more Olmesartán Krka than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Olmesartán 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 forgotten doses.

If you stop taking Olmesartán Krka

It is important to continue taking olmesartan 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. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a few people:

Rare cases (may affect up to 1 in 1,000 people) of the following allergic reactions affecting the whole body have been reported:

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

Rarely (but slightly more frequently in elderly individuals), olmesartan may cause a marked drop in blood pressure in susceptible individuals or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking olmesartan, 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 itching of the skin, even if you started treatment with Olmesartán Krka some time ago, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

The following are other adverse effects known so far with olmesartan:

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

Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, bronchitis, flu-like symptoms, cough, pain, chest pain, back, 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: increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increased blood urea, elevations in liver and muscle function test values.

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

Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina (chest pain or discomfort).

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

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

Lack of energy, muscle cramps, reduced kidney function, renal failure, intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

Children and adolescents

In children, adverse effects are similar to those reported in adults. However, dizziness and headache occur more frequently in children, and nosebleeds are a frequent adverse effect seen only in children.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 outer 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 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. Pack contents and other information

Composition of Olmesartán Krka

• The active substance 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(vinyl alcohol) in the coating.

See section 2 “Olmesartán Krka contains lactose”.

Appearance of the product and pack contents

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

Olmesartán Krka 10 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, 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 the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: April 2025

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