Karbicombi

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Karbicombi (Candecor comp.), 32 mg + 12.5 mg, tablets
Candesartanum cilexetili + Hydrochlorothiazidum
Karbicombi and Candecor comp. are different brand 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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

1. What Karbicombi is and what it is 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 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 known as angiotensin II receptor antagonists. It causes blood vessels to relax and widen, thereby helping to lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as diuretics (water tablets). It helps the body eliminate water and salts, such as sodium salts, through the urine. This helps reduce blood pressure.
Your doctor may prescribe Karbicombi if your blood pressure is not adequately 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 sulfonamide drugs. If in doubt, consult a doctor;
• after the 3rd month of pregnancy (it is also advisable to avoid using Karbicombi early in 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, consult a doctor or pharmacist before using Karbicombi.

Warnings and precautions

Before starting Karbicombi, discuss the following with a 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 is experiencing or has recently experienced severe vomiting or diarrhoea;
• if the patient has or has had a condition of the adrenal glands called Conn’s syndrome (also known as 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 3rd 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 change during treatment. Treatment with hydrochlorothiazide, especially at 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 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 due to diabetes,
• aliskiren.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under the heading "When not to use Karbicombi".
If the patient has any of the conditions listed above, the doctor may recommend more frequent check-ups and diagnostic tests.
If surgery is planned, inform the doctor or dentist that Karbicombi is being taken. 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
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 taking any of the following medicines, as the doctor may need to adjust the dose and/or take other precautions:

• other medicines that lower blood pressure, 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 (at doses above 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 that control 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 pills);
• 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 used also in epilepsy treatment);
• 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 medicine that reduces muscle spasm), 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 during or independent of meals.
• 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 discontinuing Karbicombi before a planned pregnancy or immediately after confirming pregnancy, and will recommend an alternative medicine. Use of Karbicombi 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.
Breast-feeding
Inform the doctor if breast-feeding or planning to breast-feed. Use of Karbicombi is not recommended during breast-feeding. The doctor may recommend an alternative medicine during this period.

Driving and operating machinery
Some patients may experience fatigue or dizziness while taking Karbicombi. 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 the physician. In case of doubts, 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 the medicine.
Taking more Karbicombi than recommended
If you have taken more Karbicombi than recommended, contact your doctor or pharmacist immediately.
If you forget to take Karbicombi
Do not take a double dose to make up for the missed dose.
Take the next dose at the usual time.
Stopping Karbicombi treatment
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur. Some adverse
reactions of Karbicombi are caused by candesartan cilexetil, and some by
hydrochlorothiazide.
Discontinue use of 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 itching (with hives).

Karbicombi may cause a reduction in the number of white blood cells, which may be associated with
reduced resistance to infections and the occurrence of fatigue, infection or fever. If such symptoms
occur, inform your doctor. Your doctor may recommend periodic blood tests to check whether Karbicombi
affects blood composition (agranulocytosis).
Other possible adverse reactions include:
Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in 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 occur in up to 1 in 1000 patients):

• Jaundice (yellowing of the skin or eyes). If such symptoms occur, contact your doctor immediately.
• Effect on kidney function, especially in patients with existing kidney disease or heart failure.
• Sleep disorders, depression, anxiety.
• Tingling or prickling sensations in the upper or lower limbs.
• Transient blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and fluid in the lungs).
• High body temperature (fever).
• Pancreatitis, causing moderate or severe upper abdominal pain.
• 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, developing rapidly, with blistering or skin peeling, and possibly mouth sores.

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

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

Unknown (frequency cannot be estimated from available data):

• Malignant skin and lip tumours (non-melanoma skin malignancies).
• Diarrhoea.
• Sudden myopia.
• Sudden eye pain (acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (allergic reaction with associated fever, joint pain, skin rashes including darkening, blisters, skin peeling and skin nodules).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 specified month.
PVC/PVDC/Aluminium blister:
Do not store above 30°C.
OPA/Aluminium/PVC/Aluminium blister:
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 pack and other information

What Karbicombi contains

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, corn starch, polyethylene glycol 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 is intended only to facilitate tablet fragmentation for ease of swallowing and does not guarantee equal dosing.
Pack sizes: 28 or 56 tablets in blister packs, contained in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
German Marketing Authorisation Number (country of export): 79912.00.00
Parallel Import Authorisation Number: 47/23
This medicinal product is authorised for sale in the European Economic Area countries under the following names: