Candesartan Krka 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Krka 16 mg tablets EFG

candesartan cilexetil

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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The name of the medicine is Candesartán Krka. The active substance is candesartán cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels, which helps lower blood pressure. It also helps your heart pump blood to all parts of your body more easily.

This medicine is used for:

• The treatment of high blood pressure (hypertension) in adult patients and children and adolescents aged 6 to 18 years.
• Candesartán can be used to treat heart failure in adult patients with reduced heart muscle function when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used (ACE inhibitors and MRAs are groups of medicines used to treat heart failure).

2. What you need to know before taking Candesartán Krka

Do not take Candesartán Krka

• if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Candesartán Krka also during early pregnancy – see Pregnancy section),
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder),
• if the patient is a child under 1 year of age,
• if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartán Krka.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán Krka:

• if you have heart, liver, or kidney problems, or are undergoing dialysis,
• if you have recently received a kidney transplant,
• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhoea,
• if you have a disease of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you are pregnant (or planning to become pregnant), you must inform your doctor. Use of Candesartán Krka is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
  • if you are taking an ACE inhibitor together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartán Krka”).

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

See also the information under the heading "Do not take Candesartán Krka".

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

If any of these situations apply to you, your doctor may wish to see you more frequently and carry out certain tests.

If you are due to undergo surgery, inform your doctor or dentist that you are taking Candesartán Krka. This is because candesartan, in combination with certain anaesthetics, may cause an excessive drop in blood pressure.

Children and adolescents

Candesartán Krka has been studied in children. For further information, consult your doctor or pharmacist. Candesartán Krka must not be given to children under 1 year of age due to the potential risk to kidney development.

Other medicines and Candesartán Krka

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

Candesartán Krka may affect how some medicines work, and some medicines may influence the effect of candesartan. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines:

• • Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).
  • Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in your blood).
• Heparin (a medicine to increase blood fluidity).
• Cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic).
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).

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

• If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Candesartán Krka” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartán Krka with food, drinks, and alcohol

Candesartán Krka can be taken with or without food.

When Candesartán Krka is prescribed for you, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or think you might be). Your doctor will generally advise you to stop taking candesartan before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Candesartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding. Candesartan is not recommended for women who are breastfeeding. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartan. If this happens to you, do not drive or operate tools or machinery.

Candesartán Krka contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Candesartán Krka

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. It is important that you continue taking candesartan every day.

You may take candesartan with or without food.

Swallow the tablet with some water.

Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure

The recommended dose of candesartan is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily, and then up to 32 mg once daily, depending on your blood pressure response.

In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhoea, or diuretic use), your doctor may prescribe a lower starting dose.

Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Use in children and adolescents with high blood pressure

Children aged 6 to < 18 years:

The recommended starting dose is 4 mg once daily.

For patients with body weight < 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg daily.

For patients with body weight ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults

The recommended starting dose is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to 32 mg once daily. Candesartan may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate for you.

If you take more Candesartán Krka than you should

If you take more candesartan than prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán Krka

Do not take a double dose to make up for forgotten doses.

Simply take the next dose as scheduled.

If you stop taking Candesartán Krka

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking candesartan without first consulting your doctor.

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. It is important that you are aware of what these adverse effects might be.

Stop taking Candesartán Krka and see a doctor immediately if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat,
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing,
• Severe itching of the skin (with skin rash).

Candesartán Krka may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection or fever. If this occurs, inform your doctor. Your doctor may carry out blood tests from time to time to check that Candesartán Krka is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 in every 100 patients)

• Dizziness/vertigo.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results. An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may notice fatigue, weakness, irregular heartbeat, or tingling.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 in every 10,000 patients)

• Swelling of the face, lips, tongue and/or throat.
• A decrease in red blood cells or white blood cells. You may feel tired, or have an infection or fever.
• Skin rash, hives (urticaria).
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
• Cough.
• Nausea.
• Changes in blood test results: a reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

Frequency not known (cannot be estimated from available data)

• Diarrhoea.

In children treated for hypertension, adverse effects appear to be similar to those seen in adults, but occur more frequently. Sore throat is a very common adverse effect in children but has not been reported in adults, and rhinorrhoea, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system: 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 Candesartan 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should 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. Contents of the pack and other information

Composition of Candesartán Krka

• The active substance is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.

• The other components are lactose monohydrate, corn starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmellose, magnesium stearate (E572), and red iron oxide (E172).

See section 2 “Candesartán Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

Candesartán Krka 16 mg tablets are round, almost pink in colour, biconvex, and scored on one side. On one side of the score mark appears the number “1” and on the other side the number “6”.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide the tablet into equal doses.

Blister packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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 and in the United Kingdom under the following names:

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

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