Karbis

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Karbis (Canocord)
16 mg, tablets
Candesartan cilexetil
Karbis and Canocord are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Karbis is and what it is 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 Karbis is and what it is used for

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

Karbis is used:

• for the treatment of high blood pressure (hypertension) in adults, as well as in children and adolescents aged 6 to <18 years,
• in adult patients for the treatment of heart failure with reduced left ventricular systolic function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitor therapy when heart failure symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used in the treatment of heart failure.)

2. Information before using Karbis

When not to use Karbis:

• if the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• during pregnancy after the 3rd month (Karbis should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding"),
• in case of severe liver disease or biliary obstruction (impaired 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.

If there is any doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Karbis.

Warnings and precautions

Before starting treatment with Karbis, discuss the following with your doctor or pharmacist:

• if there are or have been problems with the heart, liver, or kidneys, or if the patient is undergoing dialysis,
• if a kidney transplant has recently been performed,
• if there have been severe vomiting or diarrhoea,
• if the patient has a condition 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 the doctor about pregnancy, suspected pregnancy, or plans for pregnancy. Use of Karbis is not recommended during early pregnancy. Karbis must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (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 due to diabetes,
• aliskiren.
• if the patient is taking an ACE inhibitor together with a medicine belonging to a group known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Karbis with other medicines").

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

See also information under the heading "When not to use Karbis".

The doctor may recommend more frequent check-ups and tests if any of the above apply to the patient.

If the patient is to undergo surgery, they should inform the doctor or dentist about taking Karbis. This is because Karbis, in combination with certain anaesthetics, may cause low blood pressure.

Children and adolescents

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

Karbis with other medicines

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

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, inform the doctor if the patient is taking any of the following medicines:

• other medicines that lower blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines that relieve pain and inflammation),
• acetylsalicylic acid (at doses higher than 3 g per day) (a medicine that relieves pain and inflammation),
• potassium supplements, potassium-containing salt substitutes (medicines that increase blood potassium levels),
• heparin (a blood-thinning medicine),
• diuretics (water tablets),
• lithium (a medicine used to treat psychiatric disorders).

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

• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Karbis" and "Warnings and precautions"),
• if the patient is taking an ACE inhibitor together with certain medicines used to treat heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Karbis with food, drink, and alcohol

Karbis may be taken with or without food.

Consult your doctor if alcohol consumption is planned while taking Karbis. Karbis may cause dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Inform the doctor if pregnancy is suspected or planned. The doctor will usually recommend stopping Karbis before planning pregnancy or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Karbis is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor if breastfeeding or planning to breastfeed. Karbis is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend an alternative medicine.

Driving and using machines

While taking Karbis, some patients may experience fatigue or dizziness. If these symptoms occur, do not drive, operate tools, or use machinery.

Karbis contains monohydrate lactose, which is a type of sugar

If the patient has been diagnosed by a doctor with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Karbis

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. It is important to take Karbis every day.
Karbis may be taken during meals or independently of meals. The tablet should be
swallowed with water. Tablets should be taken at approximately the same time each day.
This will help the patient remember to take the dose. The tablet may be divided into equal doses.
Karbis is available in the following strengths: 8 mg, 16 mg, 32 mg.
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 the response to treatment.
Your doctor may recommend a lower starting dose for certain patients, e.g. patients with liver or kidney disorders, or patients who have lost a large amount of fluid, for example due to vomiting, diarrhoea, or use of diuretic medicines.
In some patients of African descent, the response to treatment may be weaker when Karbis is used as monotherapy. In such cases, higher doses may be required.
Use in children and adolescents with high blood pressure
Children aged 6 to <18 years:
The recommended starting dose is 4 mg once daily.
Patients with body weight <50 kg: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose of the medicine up to a maximum of 8 mg once daily.
Patients with body weight ≥50 kg: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose of the medicine 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 double the dose at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Karbis may be taken together with other medicines used in the treatment of heart failure, and your doctor will decide which therapy is most appropriate for the patient.
Taking more Karbis than recommended
If you take more Karbis than recommended, contact your doctor or pharmacist immediately.
If you forget to take Karbis
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
Stopping Karbis
Stopping treatment may lead to a recurrence of high blood pressure. Do not stop taking this medicine unless advised by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important that the patient is aware of the possibility of their occurrence.
Treatment with Karbis must be stopped immediately and medical help should be sought if the patient
experiences 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 raised rashes).

Karbis may cause a decrease in the number of white blood cells. This may lead to reduced resistance to infections, so the patient may experience fatigue, infection and fever. If such symptoms occur, medical advice should be sought. The doctor may periodically recommend blood tests to check whether Karbis is causing any blood disorders (agranulocytosis).
Other possible adverse effects include:
Common adverse effects (may occur in up to 1 in 10 patients):

• 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, particularly in patients with kidney disorders or heart failure. In case of a significant increase, symptoms such as fatigue, weakness, irregular heartbeat or tingling sensation may occur.
• Effects on kidney function, particularly in patients with pre-existing kidney disorders or heart failure. In very rare cases, kidney failure may occur.

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• Swelling of the face, lips, tongue and (or) throat
• Decrease in the number of red or white blood cells. This may lead to fatigue, infection or fever.
• Skin rash, urticaria
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. Symptoms may include fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Cough
• Nausea
• Changes in blood test results:
• decreased sodium levels in the blood. In case of a significant decrease, symptoms such as weakness, lack of energy or muscle cramps may occur.

Frequency unknown (frequency cannot be estimated from available data):

• Diarrhoea.

Adverse effects in children treated for high blood pressure appear to be similar to those observed in adult patients, but occur more frequently. Sore throat is very commonly observed in children, and cold, fever and increased heart rate are common, although these effects have not been observed in adults.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of further information on the safety of the medicine.

5. How to store Karbis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Karbis contains

• The active substance is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.
• Other ingredients are: monohydrate lactose, maize starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, iron oxide red (E 172).

What Karbis looks like and contents of the pack
The 16 mg tablets are light pink, round, slightly biconvex with bevelled edges and a division groove on one side, 7 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes: 28, 30, 56 or 60 tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 58/566/11-C
Parallel Import Licence number: 244/20