Cazhap Hct

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Carzap HCT, 16 mg + 12.5 mg, tablets

Candesartan cilexetil + Hydrochlorothiazide

The patient should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Carzap HCT and what is it used for
• 2. Important information before taking Carzap HCT
• 3. How to take Carzap HCT
• 4. Possible side effects
• 5. How to store Carzap HCT
• 6. Contents of the packaging and other information

1. What is Carzap HCT and what is it used for

The medicine is called Carzap HCT. It is used to treat high blood pressure (hypertension) in adult patients. The medicine contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both substances lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. Its action is to relax and dilate blood vessels, which helps to lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It facilitates the excretion of water and salts, such as sodium, in the urine. This helps to reduce blood pressure.

The doctor may prescribe Carzap HCT if blood pressure is not properly controlled when taking only candesartan cilexetil or only hydrochlorothiazide.

2. Important information before taking Carzap HCT

When not to take Carzap HCT

• if the patient has been diagnosed with an allergy to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with an allergy to sulfonamide derivatives - in case of doubt, the patient should consult a doctor,
• after the 3rd month of pregnancy (the patient should also avoid taking Carzap HCT in early pregnancy - see the section on pregnancy),
• if the patient has severe kidney problems,
• if the patient has severe liver disease or bile duct obstruction (disorders of bile flow from the gallbladder),

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• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has low potassium levels in the blood,
• if the patient has high calcium levels in the blood,
• if the patient has ever had gout.

In case of any doubts as to whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Carzap HCT.

Warnings and precautions

Before taking Carzap HCT, the patient should discuss it with their doctor or pharmacist:

• if the patient has diabetes,
• if the patient has heart, liver, or kidney problems,
• if the patient has recently had a kidney transplant,
• if the patient has had severe vomiting or diarrhea,
• if the patient has a adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has had skin cancer or if an unexpected skin change occurs 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 Carzap HCT, the patient should protect their skin from sunlight and UV radiation,
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - these can occur within a few hours to weeks after taking Carzap HCT. This can lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this disease,
• if the patient has ever had systemic lupus erythematosus (SLE),
• if the patient has low blood pressure,
• if the patient has ever had a stroke,
• if the patient has ever had allergies or asthma,
• if the patient has had breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Carzap HCT, they should seek medical help immediately.
• if the patient is pregnant or planning to become pregnant. Carzap HCT should not be taken during pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see the section on pregnancy),
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, or ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the section "When not to take Carzap HCT". If any of the above conditions apply to the patient, the doctor may recommend more frequent checks and tests. If surgery is planned, the patient should inform their doctor or dentist about taking Carzap HCT, as the simultaneous administration of certain anesthetics may cause excessive lowering of blood pressure. Page 2 7Carzap HCT may increase the sensitivity of the skin to sunlight.

Children and adolescents

There is no experience with the use of Carzap HCT in children and adolescents (under 18 years of age). Therefore, Carzap HCT should not be given to children and adolescents.

Carzap HCT and other medicines

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

• Other medicines used to 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 (pain-relieving and anti-inflammatory medicines).
• Acetylsalicylic acid (used in a dose greater than 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 or vitamin D supplements.
• Medicines used to lower cholesterol, such as colestyramine or colestipol.
• Medicines used to treat diabetes (tablets or insulin).
• Medicines that affect heart rhythm (anti-arrhythmic medicines), such as digoxin and beta-blockers.
• Medicines that may affect potassium levels in the blood, such as certain antipsychotic medicines.
• Heparin (a blood-thinning medicine).
• Diuretics (diuretic medicines).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (an antibiotic).
• Amphotericin (used to treat fungal infections).
• Lithium (used to treat mental disorders).
• Corticosteroids, such as prednisolone.
• Pituitary hormones (ACTH).
• Medicines used to treat cancer.
• Amantadine (used to treat Parkinson's disease or severe viral infections).
• Barbiturates (sedatives, also used to treat epilepsy).
• Carbenoxolone (used to treat esophageal or mouth ulcers).
• Anticholinergic medicines, such as atropine and bipiperiden.
• Cyclosporine, a medicine used after organ transplantation to prevent rejection.
• Other medicines that may enhance the blood pressure-lowering effect, such as baclofen (a muscle relaxant), amifostine (used to treat cancer), and certain antipsychotic medicines.

The doctor may recommend a dose change and/or take other precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also the sections "When not to take Carzap HCT" and "Warnings and precautions").

Carzap HCT with food, drink, and alcohol

When taking Carzap HCT, the patient should consult their doctor before consuming alcohol. Alcohol may cause a feeling of weakness or dizziness.

Pregnancy, breastfeeding, and fertility

Page 3 7Pregnancy The patient should inform their doctor about suspected or planned pregnancy. The doctor will usually recommend stopping Carzap HCT before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Carzap HCT. Carzap HCT should not be taken during pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby. Breastfeeding The patient should inform their doctor about breastfeeding or intending to breastfeed. Carzap HCT should not be taken during breastfeeding. The doctor may recommend taking another medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

When taking Carzap HCT, some patients may feel tired or dizzy. If such symptoms occur, the patient should not drive vehicles, use tools, or operate machines.

Carzap HCT contains lactose monohydrate and sodium

Carzap HCT contains lactose monohydrate, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine. The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Carzap HCT

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. It is important to take Carzap HCT every day. The recommended dose of Carzap HCT is one tablet once a day. The tablet should be swallowed with water. Carzap HCT can be taken with or without food. The patient should try to take the tablet at the same time every day. This will help them remember to take the tablet. The tablet can be divided into equal doses.

Taking a higher dose of Carzap HCT than recommended

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

Missing a dose of Carzap HCT

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

Stopping treatment with Carzap HCT

Stopping treatment with Carzap HCT may cause blood pressure to rise again. Therefore, the patient should not stop taking Carzap HCT without first consulting their doctor. In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Carzap HCT can cause side effects, although not everybody gets them. It is important for the patient to know about the possibility of side effects. Some of the side effects of Carzap HCT are caused by candesartan cilexetil, and others by hydrochlorothiazide. Page 4 7

The patient should stop taking Carzap HCT 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 raised bumps).

Carzap HCT may cause a decrease in the number of white blood cells. The patient's resistance to infections may be weakened, and they may experience fatigue, infection, or fever. If such symptoms occur, the patient should contact their doctor. The doctor may recommend periodic blood tests to check if Carzap HCT 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:
• Decreased sodium levels in the blood. In case of significant decrease, weakness, lack of energy, or muscle cramps may occur.
• Increased or decreased potassium levels in the blood, especially in patients with kidney problems or heart failure. In case of significant decrease or increase, fatigue, weakness, heart rhythm disturbances, or a feeling of tingling may occur.
• Increased cholesterol, sugar, or uric acid levels in the blood.
• Presence of sugar in the urine.
• Dizziness/balance disorders or weakness.
• Headache.
• Respiratory tract infections.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause fainting or dizziness.
• 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 whites of the eyes). In this case, the patient should contact their doctor immediately.
• Affecting kidney function, especially in patients with kidney problems or heart failure.
• Sleep disturbances, depression, anxiety.
• Tingling or prickling sensation in the arms or legs.
• Temporary blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and fluid accumulation in the lungs).
• High fever.
• Pancreatitis, causing moderate or severe abdominal pain.
• Muscle cramps.
• Vascular damage, causing red or purple spots on the skin.
• Decreased number of red or white blood cells, or platelets. The patient may feel tired, may experience infection, fever, or easy bruising.
• Severe, rapidly developing rash, with blisters or peeling skin and possible blisters 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.

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• Liver function disorders, including hepatitis. The patient may feel tired, may experience yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Cough.
• Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
• Nausea.

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

• Sudden short-sightedness.
• Malignant skin tumors and lip tumors (non-melanoma skin cancer).
• Vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye, acute short-sightedness, or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an autoimmune disorder causing fever, joint pain, skin rash with redness, blistering, peeling, and lump formation).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181 C, 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 Carzap HCT

There are no special recommendations for the storage conditions of the medicinal product. The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Carzap HCT contains

• The active substances of the medicine are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients of the medicine: lactose monohydrate, cornstarch, hydroxypropyl cellulose (E 463), sodium croscarmellose (E 468), magnesium stearate (E 572), and triethyl citrate (E 1505).

What Carzap HCT looks like and contents of the pack

Round, biconvex tablets, white or almost white, with the inscription CH/16 and a dividing line on one side, with a diameter of about 8 mm. The tablet can be divided into equal doses. Pack sizes: 14, 28, 56, 98 tablets. Page 6 7For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Zentiva, k. s., U Kabelovny 130, 102 37, Prague 10, Czech Republic

Manufacturer:

Zentiva, k. s., U Kabelovny 130, 102 37, Prague 10, Czech Republic

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Authorization number in the Czech Republic, the country of export: 58/772/11-C

Parallel import authorization number: 361/19

This medicine is authorized in the Member States of the European Economic Area under the following names: Bulgaria КАРЗАП H Czech Republic, Slovakia, Poland CARZAP HCT Estonia, Latvia, Lithuania Carzan HCT Portugal Candesartan + Hidroclorotiazida Zentiva Romania CANZENO HCT

Date of leaflet approval: 16.09.2024

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