Karbis

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Karbis (Canocord), 8 mg, tablets

Candesartan cilexetil
Karbis and Canocord are different trade names for the same medicine.

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 pack 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. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. Important information before taking Karbis

When not to take Karbis:

• if the patient is allergic 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 bile duct 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 doubts 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 there are problems with the heart, liveror kidneysor if the patient is undergoing dialysis,
• if the patient has recently undergone a kidney transplant,
• if the patient has had severe vomiting or diarrhea,
• if the patient has a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism),
• if the patient has low blood pressure,
• if the patient has ever had a stroke,
• the patient must inform their doctor about pregnancy, suspected pregnancy, or planning 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). These medicines are used to treat heart failure (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.
See also the information under the heading "When not to take Karbis:".
The doctor may recommend more frequent checks and tests if any of the above points apply to the patient.
If the patient is going to have surgery, they should inform their doctor or dentist that they are taking Karbis. This is because Karbis, in combination with certain anesthetics, may cause a drop in blood pressure.

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, have recently taken, or might take.
Karbis may affect the way other medicines work, and other medicines may affect the way Karbis works. If the patient is taking certain medicines, their doctor may periodically recommend blood tests.
In particular, the patient should inform their doctor if they are taking the following medicines:

• 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 a dose 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-thinning medicine),
• 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 the heading "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.
The patient should consult their doctor if they plan to consume alcohol while taking Karbis. 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 is not recommended during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").
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

While taking Karbis, some patients may feel tired and dizzy. If such symptoms occur, the patient should not drive, use tools, or operate machines.

Karbis contains lactose monohydrate, 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 the doctor or pharmacist has told the patient. If the patient is unsure, they should ask their doctor or pharmacist. It is important to take Karbis every day.
Karbis is available in the following strengths: 8 mg, 16 mg, 32 mg.
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 a day. The doctor may increase the dose to 16 mg once a day, and then to 32 mg once a day, depending on the patient's response to treatment.
The doctor may recommend a lower initial dose for certain patients, e.g., patients with liver or kidney problems, patients who have lost a lot of fluid, e.g., due to vomiting, diarrhea, or the use of diuretics.
In some black patients, the response to treatment may be weaker if Karbis is used as monotherapy. In that case, higher doses may be necessary.

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 a day.
Patients with a body weight of less than 50 kg: in some patients with inadequate blood pressure control, the doctor may decide to increase the dose of Karbis to a maximum of 8 mg once a day.
Patients with a body weight of 50 kg or more: in some patients with inadequate blood pressure control, the doctor may decide to increase the dose of Karbis to 8 mg once a day and then to 16 mg once a day.

Heart failure in adults

The recommended initial dose of candesartan is 4 mg once a day. The doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to 32 mg once a day. 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

If the patient has taken a higher dose of Karbis than recommended, they should contact their doctor or pharmacist immediately.

Missing a dose of Karbis

The patient should not take a double dose to make up for a forgotten 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.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Karbis can cause side effects, although not everybody gets them.
It is important that the patient knows about the possibility of these effects.

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 reduced ability to fight infections, and the patient may experience tiredness, 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 tiredness, 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
• Decreased number of red or white blood cells. This may cause tiredness, infection, or fever.
• Skin rash, hives
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. This may cause tiredness, 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 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 appear to be similar to those seen in adults, but they occur more frequently. Very common side effects in children include pharyngitis, common cold, fever, and rapid heart rate, but these side effects were not 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 Adverse Reaction Monitoring 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Karbis

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Karbis contains

• The active substance of Karbis is candesartan cilexetil. Each tablet contains 8 mg of candesartan cilexetil.
• The other ingredients are: lactose monohydrate, cornstarch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, and red iron oxide (E 172).

What Karbis looks like and contents of the pack

The 8 mg tablets are pink, round, slightly convex with beveled edges and a score line on one side, with a diameter of 7 mm.
The tablet can be divided into equal doses.
Pack sizes: 14, 28, 30, 56, 60, or 84 tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

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-Str. 5, 27472 Cuxhaven, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:58/565/11-C
Parallel import authorization number:374/18
Date of leaflet approval: 01.02.2022
[Information about the trademark]