Karbis

Package Leaflet: Information for the User

Karbis, 8 mg, tablets

Karbis, 16 mg, tablets

Karbis, 32 mg, tablets

Candesartan cilexetil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Karbis and what is it used for
• 2. Important information 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 is Karbis and what is it used for

The medicine is called Karbis. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and widening of blood vessels. This helps to lower blood pressure. Karbis also makes it easier for the heart to pump blood to all parts of the body.

Karbis is used:

• to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age,
• in adult patients to treat heart failure with reduced ejection fraction, when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used or as an addition to ACE inhibitor therapy when symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used.

2. Important information before taking Karbis

When not to 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 (you should also avoid Karbis in early pregnancy - see section "Pregnancy and breast-feeding"),
• if you have severe liver disease or biliary obstruction (obstruction of bile flow from the gallbladder),
• in children under 1 year of age,
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Karbis.

Warnings and precautions

Before taking Karbis, discuss with your doctor or pharmacist:

• if you have heart, liver, or kidney problems, or if you are on dialysis,
• if you have recently had a kidney transplant,
• if you have had severe vomiting or diarrhea,
• if you have a condition called primary hyperaldosteronism (Conn's syndrome),
• if you have low blood pressure,
• if you have ever had a stroke,
• you must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Karbis is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may seriously harm your baby (see section "Pregnancy and breast-feeding").
• if you are taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.
• if you are taking an ACE inhibitor and a medicine belonging to a group of medicines known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) for heart failure (see "Karbis and other medicines").

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

Children and adolescents

Karbis has been studied in children. For further information, talk to your doctor. Karbis should not be given to children under 1 year of age due to the potential risk to kidney development.

Karbis and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.

Karbis may affect the way other medicines work, and other medicines may affect the way Karbis works.

Particularly, inform your doctor if you are taking:

• other blood pressure-lowering medicines, including beta-blockers, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medicines),
• aspirin (in doses greater than 3 g per day) (pain-relieving and anti-inflammatory medicine),
• potassium supplements, salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• heparin (blood thinner),
• diuretics,
• lithium (medicine used to treat mental disorders).

Your doctor may need to change the dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the information under "When not to take Karbis" and "Warnings and precautions"),
• if you are taking an ACE inhibitor and a medicine used to treat heart failure, known as a mineralocorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone).

Karbis with food, drink, and alcohol

Karbis can be taken with or without food.

During treatment with Karbis, consult your doctor if you plan to consume alcohol. Karbis may cause dizziness or fainting.

Pregnancy and breast-feeding

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

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Karbis before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Karbis. You should not take Karbis during early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby.

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. You should not take Karbis while breast-feeding, especially if you are breast-feeding a newborn or premature baby. Your doctor may prescribe a different medicine.

Driving and using machines

Some patients taking Karbis may experience dizziness or fainting. If you experience these symptoms, do not drive, use tools, or operate machinery.

Karbis contains lactose, a type of sugar

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Karbis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Karbis can be taken with or without food.

Swallow the tablet with water. Take the tablets at the same time each day to help you remember to take your dose.

High blood pressure

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

Your doctor may prescribe a lower starting dose for certain patients, such as those with liver or kidney problems, or those who have lost a lot of fluid (e.g., due to vomiting, diarrhea, or diuretic therapy).

Treatment of high blood pressure in children and adolescents

Children from 6 to 18 years of age:

The recommended starting dose is 4 mg once daily.

Patients weighing less than 50 kg: in some patients with insufficient blood pressure control, your doctor may decide to increase the dose to a maximum of 8 mg once daily.

Patients weighing 50 kg or more: in some patients with insufficient blood pressure control, 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 of candesartan is 4 mg once daily. Your doctor may increase the dose by doubling it at intervals of at least 2 weeks, up to 32 mg once daily. Karbis can be taken with other medicines used to treat heart failure, and your doctor will decide which treatment is most suitable for you.

Overdose of Karbis

If you have taken more Karbis than you should, contact your doctor or pharmacist immediately.

Missed dose of Karbis

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment with Karbis

Stopping treatment may lead to a rise in blood pressure. Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Karbis can cause side effects, although not everybody gets them.

It is important that you know what these side effects are.

Stop taking Karbis and seek medical help immediately if you experience any of the following allergic reactions:

• difficulty breathing, with swelling of the face, lips, tongue, and/or throat, with or without swelling,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe itching of the skin (with raised patches).

Karbis may cause a decrease in white blood cell count. This may lead to a reduced resistance to infections, and you may experience fatigue, infection, or fever. If you experience these symptoms, contact your doctor. Your doctor may periodically recommend blood tests to check if Karbis is causing any blood disorders (agranulocytosis).

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

• Dizziness/spinning sensation
• Headache
• Respiratory tract infection
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results:
• increased potassium levels in the blood, especially if you have kidney problems or heart failure. If the levels become too high, you may experience fatigue, weakness, irregular heartbeat, or tingling.
• effects on kidney function, especially if you have existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare side effects (may affect up to 1 in 10,000 people):

• Swelling of the face, lips, tongue, and/or throat
• Decrease in red or white blood cell count. You may experience fatigue, infection, or fever.
• Skin rash, hives
• Itching
• Back pain, joint or muscle pain
• Changes in liver function, including hepatitis. You may experience fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Changes in blood test results:
• decreased sodium levels in the blood. If the levels become too low, you may experience weakness, lack of energy, or muscle cramps.

Frequency not known (cannot be estimated from the available data):

• Diarrhea.

Side effects in children treated for high blood pressure are similar to those seen in adults, but may occur more frequently. Very common side effects in children include pharyngitis, rhinitis, fever, and tachycardia, which have not been observed in adults.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details below.

5. How to store Karbis

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 that month.

No special storage precautions are required.

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

6. Contents of the pack and other information

What Karbis contains

• The active substance is candesartan cilexetil. Each tablet contains 8 mg, 16 mg, or 32 mg of candesartan cilexetil.
• The other ingredients are lactose monohydrate, cornstarch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, and red iron oxide (E172).

What Karbis looks like and contents of the pack

The 8 mg tablets are light pink, round, slightly convex with beveled edges and a score line on one side, 7 mm in diameter.

The 16 mg tablets are light pink, round, slightly convex with beveled edges and a score line on one side, 7 mm in diameter.

The 32 mg tablets are light pink, round, slightly convex with beveled edges and a score line on one side, 9 mm in diameter.

The 8 mg, 16 mg, and 32 mg tablets can be divided into equal doses.

Packaging: 14, 28, 56, or 84 (only for 8 mg and 16 mg) tablets in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

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

For further information on the names of the medicinal products in other EU member states, please contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warszawa

Tel. 22 57 37 500

Date of last revision of the leaflet: