Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Karbis (Canocord), 32 mg, tablets
Candesartan cilexetil
Karbis and Canocord are different trade names for the same medicine.
Please read this leaflet carefully before taking this 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Karbis is and what it is used for
Important information before taking Karbis
How to take Karbis
Possible side effects
How to store Karbis
Contents of the packaging and other information

1. What Karbis is and what it is used for

This medicine is called Karbis. The active substance in this medicine 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 and in children and adolescents aged 6 to <18 years,
in adult patients for the treatment of heart failure with reduced left ventricular function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitor therapy when symptoms of heart failure 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. Important 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 beyond 3 months (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 in doubt whether any of the above situations apply, 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 any disorders affecting the heart, liver, or kidneys, or if the patient is undergoing dialysis,
if the patient has recently undergone kidney transplantation,
if the patient has or has had severe vomiting or diarrhoea,
if the patient has an adrenal gland disorder 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 beyond 3 months 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 used to treat 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 together with a medicine belonging to a group known as mineralocorticoid receptor antagonists (MRAs). These medicines are used in the treatment of heart failure (see section "Karbis with other medicines").

The treating doctor may monitor kidney function, blood pressure, and blood levels of electrolytes (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 points apply to the patient.
If the patient is undergoing surgery, he or she should inform the doctor or dentist about taking Karbis. This is because Karbis, in combination with certain anaesthetics, may cause a drop in blood pressure.
Children and adolescents
The use of Karbis has been studied in children. For further information, speak to your doctor. Karbis must not be given to children under 1 year of age due to the potential risk to kidney development.
Karbis with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or might take in the future.
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 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 or potassium-containing salt substitutes (medicines that increase blood potassium levels),
heparin (a blood-thinning medicine),
diuretics,
lithium (a medicine used to treat psychiatric disorders).

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

if the patient is taking an ACE inhibitor or aliskiren (see also information under the heading "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 child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. The doctor will usually recommend discontinuing Karbis before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Karbis is not recommended during early pregnancy and must be avoided beyond 3 months of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Karbis is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm 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, use tools, or operate machinery.
Karbis contains monohydrate lactose, which is a type of sugar
If the patient has been informed by a doctor that they have 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 exactly as your doctor or pharmacist has advised. If in doubt,
you should consult your 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 may be taken with or without food. Swallow the tablet with water. The tablets should be taken
daily at approximately the same time. This will help the patient remember to take the dose. Tablets may be divided into equal doses.

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 diuretics.
In some patients of African origin, 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 inadequate 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 inadequate 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 increase the dose by doubling it, 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 you should
If you take more Karbis than you should, 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 your doctor tells you to do so.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It is important that the patient is aware of the possibility of such reactions occurring.
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 reduction in the number of white blood cells. This may lead to decreased resistance to infections, resulting in fatigue, infection and fever in the patient. 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 reactions include:
Common adverse reactions (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 blood potassium levels, particularly in patients with kidney disorders or heart failure. If potassium levels increase significantly, symptoms such as fatigue, weakness, irregular heartbeat or tingling sensations 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 reactions (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 cause fatigue, infection or fever.
Skin rash, urticaria
Itching
Back pain, joint pain 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 blood sodium levels. If sodium levels decrease significantly, symptoms such as weakness, lack of energy or muscle cramps may occur.

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

Diarrhoea.

Adverse reactions 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 common in children, and runny nose, fever and increased heart rate are common, although these effects have not been observed in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions helps to provide more information on the safety of this 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 instructions apply.
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 32 mg of candesartan cilexetil.
The other ingredients are: monohydrate lactose, maize starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate and red iron oxide (E 172).

What Karbis looks like and contents of the pack
The 32 mg tablets are light pink, round, slightly biconvex with bevelled edges and a division groove on one side, 9 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes: 14, 28, 30, 56 or 60 tablets in blister packs, packed in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, country of export: 58/567/11-C
Parallel import authorisation number: 63/19