Karbis 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

1. What Karbis is and what it is used for

The name of the medicine is Karbis. The active substance is candesartan cilexetil. 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.
• Karbis can be used for the treatment of heart failure in adult patients with reduced heart muscle function when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE inhibitors and MRAs are medicines used in the treatment of heart failure).

2. What you need to know before taking Karbis

Do not take Karbis

• if you are allergic to candesartan cilexetil or 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 Karbis also during early pregnancy – see Pregnancy section),
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder),
• if the patient is a child under 1 year of age,
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether you fall into any of these situations, consult your doctor or pharmacist before taking Karbis.

Warnings and precautions

Talk to your doctor or pharmacist before starting Karbis:

• 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 diarrhea,
• if you have an adrenal gland disorder 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), inform your doctor. Use of Karbis is not recommended during early pregnancy and must not be used after the third month of pregnancy because 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 diabetes related to kidney problems.
  • aliskiren.
• if you are being treated with 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 Karbis").

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 Karbis".

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

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

If you are scheduled for surgery, inform your doctor or dentist that you are taking Karbis. This is because candesartan, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

Karbis has been studied in children. For more information, consult your doctor or pharmacist.

Karbis must not be given to children under 1 year of age due to the potential risk to kidney development.

Other medicines and Karbis

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

Karbis 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 periodically.

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, or diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).

• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine 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 (an antibiotic), also known as trimethoprim/sulfamethoxazole.

• Diuretics (medicines that increase urine elimination).

• Lithium (a medicine 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 Karbis" and "Warnings and precautions").
  • if you are being treated with an ACE inhibitor together with other specific medicines for heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Karbis with food, drinks, and alcohol

Karbis may be taken with or without food.

When prescribed Karbis, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Karbis contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Karbis

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

You may take Karbis 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 Karbis 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 (for example due to vomiting, diarrhoea, or use of diuretics), 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 these patients 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 dose of Karbis 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. Karbis 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 Karbis than you should

If you take more Karbis 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 Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Karbis

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

Simply take the next dose as scheduled.

If you stop taking Karbis

If you stop taking Karbis, your blood pressure may rise again. Therefore, do not stop taking Karbis 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 could be.

Stop taking Karbis 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 skin itching (with rash).

Karbis 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 Karbis is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects between 1 and 10 out of every 100 patients)

• Dizziness/vertigo.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results: increased levels of potassium in the blood, 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 fewer than 1 in 10,000 patients)

• Swelling of the face, lips, tongue and/or throat.

• Decrease in red 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 diarrhea.

• Cough.

• Nausea.

• Changes in blood test results: reduced levels of sodium in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.

Frequency not known (cannot be estimated from available data)

• Diarrhea.

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 rhinorrhea, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any type of 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 through the national reporting system: Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Karbis

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 refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Karbis

• The active substance is candesartan cilexetilo. Each tablet contains 4 mg of candesartan cilexetilo.
• The other components are monohydrate lactose, corn starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmellose, and magnesium stearate.

See section 2 “Karbis contains lactose and sodium”.

Appearance of the product and contents of the container

Karbis 4 mg tablets are round, white, biconvex, scored on one side and marked with a “4”.

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

Packs of:

• 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets in blister packs are available.
• 250 tablets in a plastic container with a child-resistant closure.

Only some 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 (Northern Ireland) under the following names:

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

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