Karbicombi

Package leaflet: Information for the user

Karbicombi, 8 mg + 12.5 mg, tablets
Karbicombi, 16 mg + 12.5 mg, tablets
Karbicombi, 32 mg + 12.5 mg, tablets
Karbicombi, 32 mg + 25 mg, tablets
candesartan cilexetil + hydrochlorothiazide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Karbicombi is and what it is used for
2. What you need to know before taking Karbicombi
3. How to take Karbicombi
4. Possible side effects
5. How to store Karbicombi
6. Contents of the pack and other information

1. What Karbicombi is and what it is 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 work together to lower blood pressure.
Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes blood vessels to relax and widen, thus helping to lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps the body get rid of excess water and salts, such as sodium salts, through the urine. This also helps to lower blood pressure.
Your doctor may prescribe Karbicombi if your blood pressure is not sufficiently controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. Important information before using Karbicombi

When not to use Karbicombi:

• if the patient is allergic to candesartan cilexetil or hydrochlorothiazide, or to 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;
• during the second and third trimesters of pregnancy (it is also better to avoid using Karbicombi in early pregnancy – see section "Pregnancy and breastfeeding");
• if the patient has severe kidney disease;
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder);
• if the patient has persistently low blood potassium levels;
• if the patient has persistently high blood calcium levels;
• 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.

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before taking Karbicombi.

Warnings and precautions

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

• if the patient has diabetes;
• if the patient has heart, liver or kidney disease;
• if the patient has recently received a kidney transplant;
• if the patient has had severe vomiting or has diarrhoea;
• if the patient has a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism);
• if the patient has ever had 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;
• inform the doctor if pregnancy is suspected (or planned). Use of Karbicombi is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding");
• if the patient has previously had skin cancer or develops an unexpected skin lesion. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Karbicombi, protect the skin from sunlight and UV radiation;
• if the patient has previously experienced breathing problems or lung disorders (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Karbicombi, seek immediate medical help;
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (the blood vessel layer surrounding the eye) or increased intraocular pressure – these may occur from several hours to weeks after taking Karbicombi. If left untreated, they may lead to permanent vision loss. Patients who previously had an allergic reaction to penicillin or sulphonamides may be at higher risk of developing this condition;
• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril, etc.), especially if the patient has kidney problems related to diabetes,
• aliskiren.

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 Karbicombi:".

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Karbicombi, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not make decisions about stopping Karbicombi on your own.

If the patient has any of the conditions listed above, the doctor may recommend more frequent check-ups and diagnostic tests.

If the patient is scheduled for surgery, inform the doctor or dentist about taking Karbicombi. Karbicombi may cause excessive lowering of blood pressure when used together with certain anaesthetics.

Karbicombi may cause skin sensitivity to sunlight.

Children and adolescents

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

Karbicombi and 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.

Karbicombi may affect the action of other medicines and other medicines may affect the action of Karbicombi. In some cases, the doctor may recommend periodic blood tests.

In particular, inform the doctor if the patient is taking any of the following medicines, as the doctor may need to adjust the dose and/or take additional precautions:

• other blood pressure-lowering medicines, including beta-blockers, medicines containing aliskiren, diazoxide and angiotensin-converting enzyme inhibitors (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 reduce inflammation);
• acetylsalicylic acid (in doses exceeding 3 g per day) (a medicine that relieves pain and reduces inflammation);
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels);
• calcium supplements or vitamin D;
• cholesterol-lowering medicines, such as colestipol or cholestyramine;
• antidiabetic medicines (tablets or insulin);
• medicines controlling heart rhythm (antiarrhythmics), such as digoxin and beta-blockers;
• medicines whose effects may be influenced by blood potassium levels, such as certain antipsychotics;
• heparin (a blood-thinning medicine);
• diuretics (water tablets);
• laxatives;
• penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics);
• amphotericin (a medicine used to treat fungal infections);
• lithium (a medicine used to treat psychiatric disorders);
• steroids, such as prednisolone;
• pituitary 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 oesophageal disease or oral ulcers);
• anticholinergic medicines, such as atropine and biperiden;
• cyclosporine, a medicine used to prevent rejection of transplanted organs;
• other medicines that may enhance the antihypertensive effect, such as baclofen (a muscle relaxant), amifostine (an anticancer medicine) and certain antipsychotics;
• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Karbicombi:" and "Warnings and precautions").

Karbicombi with food, drink and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Inform the doctor if pregnancy is suspected (or planned). The doctor will usually recommend stopping Karbicombi before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend taking another medicine instead of Karbicombi. Use of Karbicombi is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor if you are breastfeeding or plan to breastfeed. Use of Karbicombi is not recommended during breastfeeding. The doctor may recommend using another medicine during breastfeeding.

Driving and using machines

In some patients, Karbicombi may cause fatigue or dizziness. If these occur, do not drive, use tools or operate machinery.

Karbicombi contains lactose, a type of sugar.

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

3. How to use Karbicombi

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
It is important to take Karbicombi every day.
The usual recommended dose of Karbicombi is one tablet once daily.
The tablet should be swallowed with water.
Try to take the tablet at the same time each day, as this will help you remember to take it.
Taking more Karbicombi than prescribed
If you take more Karbicombi than prescribed, contact your doctor or pharmacist immediately.
If you miss a dose of Karbicombi
Do not take a double dose to make up for a missed dose.
Take the next dose at your usual time.
Stopping Karbicombi
Stopping treatment with Karbicombi may cause blood pressure to rise again. Therefore, do not discontinue treatment with Karbicombi without consulting 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 for the patient to be aware of which adverse effects may occur. Some adverse effects
of Karbicombi are caused by candesartan cilexetil, and some by hydrochlorothiazide.
You should stop taking Karbicombi and seek immediate medical help if any of the following
allergic reactions occur:

• 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 rash (with hives).

Karbicombi may cause a decrease in white blood cells, which may lead to reduced immunity to infections and the occurrence of fatigue, infection or fever. If such symptoms occur, you should inform your doctor. Your doctor may recommend periodic blood tests to check whether Karbicombi affects your blood composition (agranulocytosis).
Other possible adverse effects include:
Common (may affect up to 1 in 10 patients):

• Changes in blood test results:
• Decreased sodium levels in the blood. If significantly reduced, weakness, fatigue or muscle cramps may occur.
• Increased or decreased potassium levels in the blood, especially in patients with pre-existing kidney disease or heart failure. If significant changes in potassium levels occur, fatigue, weakness, heart rhythm disturbances or tingling sensations may occur.
• Increased levels of cholesterol, glucose or uric acid in the blood.
• Presence of glucose in the urine.
• Dizziness/spinning sensation or weakness.
• Headache.
• Respiratory tract infection.

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

• Low blood pressure. This may cause fainting or dizziness.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, urticaria, photosensitivity rash.

Rare (may affect up to 1 in 1000 patients):

• Jaundice (yellowing of the skin or eyes). If such symptoms occur, contact your doctor immediately.
• Effects on kidney function, especially in patients with pre-existing kidney disease or heart failure.
• Sleep disorders, depression, anxiety.
• Tingling or pricking sensations in the upper or lower limbs.
• Transient blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and fluid accumulation in the lungs).
• High temperature (fever).
• Pancreatitis, causing moderate or severe pain in the upper abdomen.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Decreased number of red blood cells, white blood cells or platelets. Fatigue, infection, fever or easy bruising may occur.
• Severe rash, rapidly progressing with blistering or peeling of the skin, and possible blistering in the mouth.

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

• Swelling of the face, lips, tongue and (or) throat.
• Itching.
• Back pain, joint pain and muscle pain.
• Changes in liver function, including hepatitis. Fatigue, yellowing of the skin and eyes, and flu-like symptoms may occur.
• Cough.
• Nausea.
• Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

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

• Malignant skin and lip tumours (non-melanoma skin cancers).
• Diarrhoea.
• Sudden onset of myopia.
• Visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (allergic reaction with associated fever, joint pain, skin rashes including darkening, blisters, peeling and skin nodules).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Karbicombi

Keep this medicine out of the 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.
PVC/PVDC/Aluminium blister:
Do not store above 30°C.
OPA/Aluminium/PVC/Aluminium blister:
No special storage instructions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Karbicombi contains

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• Other ingredients: monohydrate lactose, corn starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, red iron oxide (E 172) – only in tablets of 16 mg + 12.5 mg and 32 mg + 25 mg, yellow iron oxide (E 172) – only in tablets of 32 mg + 12.5 mg. See section 2: "Karbicombi contains lactose".

What Karbicombi looks like and contents of the packaging
Karbicombi, 8 mg + 12.5 mg, tablets: white, biconvex, oval tablets with a score line on one side. The score line on the tablet is intended only to facilitate breaking for ease of swallowing and does not guarantee an equal dose division.
Karbicombi, 16 mg + 12.5 mg, tablets: light pink, biconvex, oval tablets with a score line on one side. The score line on the tablet is intended only to facilitate breaking for ease of swallowing and does not guarantee an equal dose division.
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 intended only to facilitate breaking for ease of swallowing and does not guarantee an equal dose division.
Karbicombi, 32 mg + 25 mg, tablets: light pink, biconvex, oval tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging: 28, 56 or 84 tablets (only for doses 8 mg + 12.5 mg and 16 mg + 12.5 mg) in blister packs, in a cardboard box.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorized for marketing in the Member States of the European Economic Area under the following names:

10/17/2025