Karbicombi

Leaflet accompanying the packaging: information for the user

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

Karbicombi (Candecor comp.), 32 mg + 12.5 mg, tablets
Candesartan cilexetil + Hydrochlorothiazide
Karbicombi and Candecor comp. are different trade names for the same drug.

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 a specific person. It should not be given 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 Karbicombi and what is it used for
• 2. Important information before taking Karbicombi
• 3. How to take Karbicombi
• 4. Possible side effects
• 5. How to store Karbicombi
• 6. Contents of the packaging and other information

1. What is Karbicombi and what is it used for

Karbicombi is used to treat high blood pressure (hypertension) in adult patients. This medicine contains two active substances: candesartan cilexetil and hydrochlorothiazide. These substances together lower blood pressure.
Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists.
It causes relaxation and widening of blood vessels, which helps to lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts such as sodium in the urine. This helps to lower blood pressure.
The doctor may prescribe Karbicombi if blood pressure is not sufficiently controlled when taking only candesartan cilexetil or only hydrochlorothiazide.

2. Important information before taking Karbicombi

When not to take Karbicombi:

• if the patient is allergic to candesartan cilexetil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to sulphonamide medicines. In case of doubt, consult a doctor;
• after the third month of pregnancy (it is also recommended to avoid taking Karbicombi in early pregnancy - see the section "Pregnancy and breastfeeding");
• if the patient has severe kidney disease;
• if the patient has severe liver disease or biliary obstruction (disorders of bile flow from the gallbladder);
• if the patient has a persistently low potassium level in the blood;
• if the patient has a persistently high calcium level in the blood;
• if the patient has ever had gout;
• 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 Karbicombi.

Warnings and precautions

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

• if the patient has diabetes;
• if the patient has heart, liver, or kidney disease;
• if the patient has recently had a kidney transplant;
• if the patient has severe vomiting or diarrhea;
• if the patient has a disease of the adrenal glands called Conn's syndrome (or primary hyperaldosteronism);
• if the patient has ever had a disease called systemic lupus erythematosus;
• if the patient has low blood pressure;
• if the patient has ever had a stroke;
• if the patient has ever had an allergy or asthma;
• the patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Karbicombi in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see the section "Pregnancy and breastfeeding");
• if the patient has a history of skin cancer or if an unexpected skin change appears during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Karbicombi, the patient should protect their skin from sunlight and UV radiation;
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril, etc.), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Karbicombi:" and "Warnings and precautions".
If the patient has any of the above diseases, the doctor may recommend more frequent check-ups and diagnostic tests.
If the patient is scheduled to have surgery, they should tell their doctor or dentist that they are taking Karbicombi. Karbicombi may cause excessive lowering of blood pressure when used in combination with certain anesthetics.
Karbicombi may cause increased sensitivity of the skin to sunlight.

Children and adolescents

There is no experience with the use of Karbicombi in children (under 18 years of age), so it should not be used in this group of patients.

Karbicombi and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Karbicombi may affect the action of other medicines, and other medicines may affect the action of Karbicombi. In the case of taking certain medicines, the doctor may recommend periodic blood tests.
In particular, the patient should inform their doctor if they are taking any of the following medicines, as the doctor may need to change the dose and/or take other precautions:

• other blood pressure-lowering medicines, including beta-blockers, aliskiren, 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 (pain-relieving and anti-inflammatory medicines).
• aspirin (in doses over 3 g per day) (pain-relieving and anti-inflammatory medicine).
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood).
• calcium supplements or vitamin D.
• medicines that lower cholesterol, such as colestyramine or colestipol.
• antidiabetic medicines (tablets or insulin).
• medicines that control heart rhythm (anti-arrhythmic medicines), such as digoxin and beta-blockers.
• medicines whose action may be affected by potassium levels in the blood, such as certain antipsychotic medicines.
• heparin (a blood-thinning medicine).
• diuretics (medicines that increase urine production).
• laxatives.
• penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics).
• amphotericin (a medicine used to treat fungal infections).
• lithium (a medicine used to treat mental disorders).
• corticosteroids, such as prednisolone.
• adrenocorticotropic hormone (ACTH).
• anticancer medicines.
• amantadine (a medicine used to treat Parkinson's disease or severe viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (a medicine used to treat esophageal disease or mouth ulcers).
• anticholinergic medicines, such as atropine and bipiperiden.
• cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• other medicines that may enhance the blood pressure-lowering effect, such as baclofen (a muscle relaxant), amifostine (an anticancer medicine), and certain antipsychotic medicines.
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Karbicombi:" and "Warnings and precautions").

Karbicombi with food, drink, and alcohol

• Karbicombi can be taken with or without food.
• Before taking Karbicombi, the patient should discuss with their doctor the possibility of consuming alcohol, as alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend stopping Karbicombi before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Karbicombi. It is not recommended to take Karbicombi in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Karbicombi during breastfeeding. The doctor may recommend taking a different medicine during breastfeeding.

Driving and using machines

Some patients taking Karbicombi may experience dizziness or fatigue. If these occur, the patient should not drive, use tools, or operate machines.

Karbicombi contains lactose, a type of sugar

If the patient has been informed that they have an intolerance to some sugars, they should consult their doctor before taking Karbicombi.

3. How to take Karbicombi

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
It is important to take Karbicombi every day.
The recommended dose of Karbicombi is one tablet once a day.
The tablet should be swallowed with water.
The patient should try to take the tablet at the same time every day, which will help them remember to take the medicine.

Taking a higher dose of Karbicombi than recommended

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

Missing a dose of Karbicombi

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

Stopping treatment with Karbicombi

Stopping treatment with Karbicombi may cause blood pressure to rise again. Therefore, the patient should not stop taking Karbicombi without consulting their doctor.
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, Karbicombi can cause side effects, although not everybody gets them.
It is important for the patient to know what side effects may occur. Some side effects of Karbicombi are caused by candesartan cilexetil, and some by hydrochlorothiazide.

The patient should stop taking Karbicombi and seek medical help immediately if they experience 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 itching of the skin (with lumps).

Karbicombi may cause a decrease in the number of white blood cells, which may be associated with decreased immunity to infections and the occurrence of fatigue, infection, or fever. If such symptoms occur, the patient should tell their doctor. The doctor may recommend periodic blood tests to check if Karbicombi is affecting the blood count (agranulocytosis).
Other possible side effects include:

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

• Changes in blood test results:
• Decrease in sodium levels in the blood. In case of significant decrease, weakness, fatigue, or muscle cramps may occur.
• Increase or decrease in potassium levels in the blood, especially in people with existing kidney disease or heart failure. In case of significant changes, fatigue, weakness, heart rhythm disturbances, or a feeling of tingling may occur.
• Increase in cholesterol, sugar, or uric acid levels in the blood.
• Presence of sugar in the urine.
• Dizziness/spinning sensation or weakness.
• Headache.
• Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people):

• Low blood pressure. This may cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach upset.
• Skin rash, hives, sun-related skin rash.

Rare (may affect up to 1 in 1,000 people):

• Jaundice (yellowing of the skin or eyes). If such symptoms occur, the patient should immediately contact their doctor.
• Affecting kidney function, especially in people with existing kidney disease or heart failure.
• Sleep disturbances, depression, anxiety.
• Numbness or tingling in the arms or legs.
• Temporary blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and fluid in the lungs).
• High temperature (fever).
• Pancreatitis, causing moderate or severe pain in the upper abdomen.
• Muscle cramps.
• Damaged blood vessels causing red or purple spots on the skin.
• Decrease in the number of red or white blood cells or platelets. This may cause fatigue, infection, fever, or easy bruising.
• A severe rash that develops quickly, with blistering or peeling of the skin, and possible blistering in the mouth.

Very rare (may affect up to 1 in 10,000 people):

• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back pain, joint pain, and muscle pain.
• Changes in liver function, including hepatitis. This may cause fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Cough.
• Nausea.

Unknown frequency (cannot be estimated from the available data):

• Malignant skin tumors and lip cancer (non-melanoma skin cancer).
• Diarrhea.
• Sudden short-sightedness.
• Sudden eye pain (acute angle-closure glaucoma).
• Systemic lupus erythematosus and cutaneous lupus (an allergic reaction with accompanying fever, joint pain, skin rashes, including discoloration, blisters, peeling, and lumps on the skin).

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 Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Karbicombi

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. The expiry date refers to the last day of the month stated.
PVC/PVDC/Aluminum blister:
Do not store above 30°C.
OPA/Aluminum/PVC/Aluminum blister:
No special storage precautions.
Leków nie należy wyrzucać do kanalizacji ani domowych pojemników na odpadki. Należy zapytać farmaceutę, jak usunąć leki, których się już nie używa. Takie postępowanie pomoże chronić środowisko.

6. Contents of the packaging and other information

What Karbicombi contains

• The active substances of Karbicombi are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, corn starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, yellow iron oxide (E 172).

What Karbicombi looks like and contents of the pack

Karbicombi, 32 mg + 12.5 mg, tablets: yellowish-white, biconvex, oval tablets, with a score line on one side. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Packaging: 28 or 56 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 Germany, the country of export:

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

Manufacturer:

KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Germany, the country of export:79912.00.00

Parallel import authorization number: 47/23

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Approval date of the leaflet: 16.03.2023

[Information about the trademark]