Package leaflet: Information for the user

Warning! Keep this 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.
Please read the entire leaflet carefully before using 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. The medicine may harm another person, even if their symptoms are similar.
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

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 pack and other information

1. What Karbis is and what it is used for

The 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 cardiac 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 (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 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, the patient should
consult a doctor or pharmacist before using Karbis.
Warnings and precautions
Before starting treatment with Karbis, discuss with your doctor or pharmacist:

if there are any disorders of the heart, liver, or kidneys, or if the patient is undergoing dialysis,
if the patient has recently undergone a kidney transplant,
if there have been or are severe vomiting or diarrhoea,
if the patient has a disorder 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 in 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 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 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 "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 the 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 scheduled for 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, please consult your doctor. Karbis must not be given to children under 1 year of age due to potential risks to kidney development.
Karbis with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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, 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 (in doses exceeding 3 g per day) (a medicine that relieves pain and inflammation),
potassium supplements, salt substitutes containing potassium (medicines that increase blood potassium levels),
heparin (a blood-thinning medicine),
diuretics (water pills),
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 "When not to use Karbis:" and "Warnings and precautions"),
if the patient is taking an ACE inhibitor together with certain medicines used in heart failure treatment known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Karbis with food, drink, and alcohol
Karbis may be taken with or without food.
While taking Karbis, consult your doctor if alcohol consumption is planned. 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor about suspected (or planned) pregnancy. The doctor will usually advise discontinuing Karbis before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Karbis is not recommended during early pregnancy and must not be used beyond 3 months of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor about breastfeeding or plans to breastfeed. Karbis is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. The doctor may recommend an alternative medicine.
Driving and operating machinery
While taking Karbis, some patients may experience fatigue or dizziness. If these symptoms occur, the patient should not drive, use tools, or operate 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, he or she should consult the doctor before taking this medicine.

3. How to take Karbis

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a 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.
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.

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 response to treatment.
The 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 black patients, 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. The doctor may increase the dose by doubling it at intervals of at least 2 weeks, up to 32 mg once daily. Karbis may be taken together with other medicines used in the treatment of heart failure, and the 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 miss a dose of Karbis
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Karbis
Stopping treatment may lead to a renewed increase in 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
It is important that the patient is aware of the possibility of their occurrence.
The treatment with Karbis must be stopped immediately and medical help should be sought if the
patient experiences any of the following allergic reactions:

difficulty in 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 in swallowing,
severe skin itching (with raised rashes).

Karbis may cause a decrease in the number of white blood cells. This may lead to reduced immunity to infections, therefore 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 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 potassium levels in the blood, especially if the patient has 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 cases of 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 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 not known (frequency cannot be estimated from the available data):

Diarrhea.

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, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 of candesartan cilexetil.
The other ingredients are: monohydrate lactose, corn starch, 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 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.
Packaging: 14, 28, 30, 56, 60 or 84 tablets in blister packs, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, 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, the country of export: 58/565/11-C
Parallel import authorisation number: 374/18