Karbis

Leaflet attached to the packaging: information for the user

Karbis, 8 mg, tablets

Karbis, 16 mg, tablets

Karbis, 32 mg, tablets

Candesartan cilexetil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging and other information

1. What is Karbis and what is it used for

The medicine is called Karbis. The active substance of the medicine is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and dilation 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 cardiac function, 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 the patient is hypersensitive to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• in pregnancy over 3 months (Karbis should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding"),
• in case of severe liver disease or biliary obstruction (obstruction of bile flow from the gallbladder),
• in children under 1 year of age,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

In case of doubt whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Karbis.

Warnings and precautions

Before starting to take Karbis, the patient should discuss it with their doctor or pharmacist:

• if they have heart, liver, or kidney problems, or if they are undergoing dialysis,
• if they have recently undergone a kidney transplant,
• if they have had severe vomiting or diarrhea,
• if they have a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism),
• if they have low blood pressure,
• if they have ever had a stroke,
• they must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Karbis is not recommended during early pregnancy. Karbis should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• if the patient is taking an ACE inhibitor and a medicine belonging to a group of medicines known as mineralocorticoid receptor antagonists (MRAs) (see "Karbis and other medicines").

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

Children and adolescents

The use of Karbis has been studied in children. For further information, the patient should talk to their 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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Karbis may affect the action of other medicines, and other medicines may affect Karbis. If the patient is taking certain medicines, the doctor may periodically recommend blood tests.

In particular, the patient should inform their doctor if they 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 (medicines that relieve pain and inflammation),
• acetylsalicylic acid (in doses greater than 3 g per day) (a medicine that relieves pain and inflammation),
• potassium supplements, salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• heparin (a blood thinner),
• diuretics,
• lithium (a medicine used to treat mental disorders).

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

• if the patient is taking an ACE inhibitor or aliskiren (see also the information under "When not to take Karbis" and "Warnings and precautions"),
• if the patient is 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, the patient should consult their doctor if they plan to consume alcohol. Karbis may cause dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about suspected or planned pregnancy. The doctor will usually recommend stopping Karbis before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Karbis. Karbis should not be taken during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby.

Breastfeeding

The patient should inform their doctor about breastfeeding or intending to breastfeed. Karbis is not recommended during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend a different medicine.

Driving and using machines

During treatment with Karbis, some patients may feel tired or dizzy. If such symptoms occur, the patient should not drive, use tools, or operate machines.

Karbis contains lactose, a type of sugar

If the patient has been told by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Karbis

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. It is important to take Karbis every day.

Karbis can be taken with or without food. The tablet should be swallowed with water. The tablets should be taken every day at about the same time. This will help the patient remember to take their dose. The tablet can be divided into equal doses.

High blood pressure

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

The doctor may recommend a lower initial dose in certain patients, e.g., patients with liver or kidney problems, or patients who have lost a lot of fluid, e.g., due to vomiting, diarrhea, or diuretic use.

In some black patients, the response to treatment may be weaker if Karbis is used as monotherapy. Higher doses may be necessary in these cases.

Use in children and adolescents with high blood pressure

Children from 6 to 18 years of age:

The recommended initial dose is 4 mg once daily.

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

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

Taking a higher dose of Karbis than recommended

In case of taking a higher dose of Karbis than recommended, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Karbis

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Karbis

Stopping treatment may lead to a rise in blood pressure again. The patient should not stop taking Karbis unless their doctor tells them to.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

It is important for the patient to know that they can occur.

The patient should stop taking Karbis and seek medical help immediately if they 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 the number of white blood cells. This may lead to a decrease in resistance to infections, and the patient may experience fatigue, infection, or fever. If such symptoms occur, the patient should contact their doctor. The doctor may periodically recommend blood tests to check if Karbis is causing any blood disorders (agranulocytosis).

Other possible side effects include:

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

• Dizziness/spinning sensation
• Headache
• Respiratory tract infection
• Low blood pressure. This may cause fainting or dizziness.
• Changes in blood test results:
• increased potassium levels in the blood, especially if the patient has kidney problems or heart failure. If the increase is significant, the patient may experience fatigue, weakness, irregular heartbeat, or tingling.
• effects on kidney function, especially in patients with 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 the number of red or white blood cells. The patient may experience fatigue, infection, or fever.
• Skin rash, hives
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. The patient may experience fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Changes in blood test results:
• decrease in sodium levels in the blood. If the decrease is significant, the patient may experience weakness, lack of energy, or muscle cramps.

Frequency not known (frequency 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 occur more frequently. Very common side effects in children include pharyngitis, rhinitis, fever, and increased heart rate, but these side effects have not been seen in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

e-mail: ndl@urpl.gov.pl.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Karbis

The medicine should be stored 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 stated.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Karbis contains

• The active substance of the medicine 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 biconvex with beveled edges and a score line on one side, 7 mm in diameter.

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

The 32 mg tablets are light pink, round, slightly biconvex 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 doses) tablets in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

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

To obtain more detailed information on the names of medicinal products in other EU member states, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet: