Cazhap

Package Leaflet: Information for the Patient

Carzap, 8 mg, tablets

Carzap, 16 mg, tablets

Carzap, 32 mg, tablets

Candesartan cilexetil

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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What Carzap is and what it is used for

The name of your medicine is Carzap. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

Carzap is used:

• to treat high blood pressure (hypertension) in adult patients, and in children and adolescents aged 6 to 18 years,
• to treat adult patients with heart failure with reduced ejection fraction, when ACE inhibitors (Angiotensin Converting Enzyme Inhibitors) are not suitable or as an addition to ACE inhibitors when symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Carzap

Do not take Carzap

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant (it is also better to avoid Carzap in early pregnancy - see section “Pregnancy and breast-feeding”),
• if you have severe liver disease or biliary obstruction (difficulty in draining bile from the gallbladder),
• if you are a child under 1 year of age,
• if you have diabetes or kidney problems and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Carzap.

Warnings and precautions

Before taking Carzap, tell your doctor if:

• you have heart, liver or kidney problems, or are on dialysis,
• you have recently had a kidney transplant,
• you have vomiting or have recently had severe vomiting or diarrhea,
• you have a condition called primary hyperaldosteronism (Conn’s syndrome),
• you have low blood pressure,
• you have ever had a stroke,
• you are taking any of the following medicines used to treat high blood pressure: ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes; or aliskiren.

Your doctor may check your kidney function, blood pressure, and the levels of salts (such as potassium) in your blood at regular intervals.

Children and adolescents

Carzap has been studied in children and adolescents aged 6 to 18 years. For more information, please contact your doctor.

Carzap with food, drink and alcohol

When taking Carzap, consult your doctor if you plan to consume alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to take Carzap

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Carzap can be taken with or without food.

Swallow the tablet with a glass of water.

Take the tablet at the same time each day.

High blood pressure:

• The recommended dose is 8 mg once daily. Your doctor may decide to increase the dose to 16 mg once daily and then to 32 mg once daily, depending on your response to treatment.

Use in children and adolescents with high blood pressure

Children from 6 to 18 years of age:

The recommended starting dose is 4 mg once daily.

Heart failure in adults:

The recommended starting dose of Carzap is 4 mg once daily. Your doctor may decide to increase the dose to 8 mg once daily and then to 32 mg once daily, with intervals of at least 2 weeks, depending on your response to treatment.

If you take more Carzap than you should

If you take more Carzap than you should, contact your doctor or pharmacist immediately.

If you forget to take Carzap

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Carzap

Do not stop taking Carzap without talking to your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Carzap and seek medical help immediately if you have 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 in swallowing,
• severe skin itching (with raised lumps),

Carzap may cause a decrease in white blood cells. You may experience infections more easily. If you have any signs of infection such as fever or sore throat, contact your doctor.

Very common (may affect more than 1 in 10 people)

• Dizziness/spinning sensation
• Headache
• Respiratory tract infections
• Low blood pressure. This may cause dizziness or fainting

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

• Back pain, joint pain and muscle pain
• Changes in liver function, including hepatitis. You may experience tiredness, yellowing of the skin and eyes, and flu-like symptoms

5. How to store Carzap

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Carzap contains

The active substance is candesartan cilexetil.

Carzap 8 mg tablets: Each tablet contains 8 mg of candesartan cilexetil.

Carzap 16 mg tablets: Each tablet contains 16 mg of candesartan cilexetil.

Carzap 32 mg tablets: Each tablet contains 32 mg of candesartan cilexetil.

The other ingredients are: lactose monohydrate, corn starch, hydroxypropyl cellulose (E463), croscarmellose sodium (E468), magnesium stearate (E572), triethyl citrate (E1505).

What Carzap looks like and contents of the pack

Carzap 8 mg tablets are white, round, biconvex tablets with a score line on one side and marked C/8 on the same side. The diameter of the tablet is approximately 8 mm.

Carzap 16 mg tablets are white, round, biconvex tablets with a score line on one side and marked C/16 on the same side. The diameter of the tablet is approximately 8 mm.

Carzap 32 mg tablets are white, round, biconvex tablets with a score line on one side and marked C/32 on the same side. The diameter of the tablet is approximately 10.5 mm.

The tablet can be divided into equal doses.

Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

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

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

tel.: +48 22 375 92 00

Date of last revision of the leaflet: June 2025