Cazaprol

Leaflet accompanying the packaging: patient information

Cazaprol, 1 mg, film-coated tablets

Cazaprol, 2.5 mg, film-coated tablets

Cazaprol, 5 mg, film-coated tablets

Cilazapril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Cazaprol and what is it used for

The active substance of Cazaprol, cilazapril, belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Cazaprol is used to treat:

• high blood pressure (hypertension),
• chronic (long-term) heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs).

The medicine works by relaxing and widening the blood vessels, which helps to lower blood pressure. This also makes it easier for the heart to pump blood in patients with chronic heart failure.
The doctor may prescribe other medicines to be taken at the same time as Cazaprol.

2. Important information before taking Cazaprol

When not to take Cazaprol:

• if the patient is allergic to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to other ACE inhibitors. These include captopril, enalapril, lisinopril, and ramipril;
• if the patient has experienced a severe side effect called angioedema after taking other ACE inhibitors. If the patient has hereditary angioedema or angioedema of unknown cause. Symptoms include swelling of the face, lips, mouth, or tongue.
• after the third month of pregnancy (it is also recommended to avoid taking Cazaprol during early pregnancy - see "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) is increased:

If any of the above situations apply to the patient, they should not take Cazaprol. In case of any doubts, before taking Cazaprol, the patient should consult a doctor or pharmacist.

Warnings and precautions

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

• the patient has heart disease. Cazaprol may not be suitable for patients with certain heart diseases;
• the patient has had a stroke or cerebral blood flow disorders in the past;
• the patient has severe liver disease or jaundice;
• the patient has kidney disease or renal artery stenosis;
• the patient is undergoing dialysis;
• the patient has recently experienced vomiting or diarrhea;
• the patient is on a low-salt diet;
• the patient is scheduled to undergo desensitization to bee or wasp venom;
• the patient is scheduled to undergo surgery (including dental surgery). Some anesthetics may lower blood pressure, which can become too low.
• the patient has fluid in the abdominal cavity (ascites);
• the patient has diabetes;
• the patient has collagen vascular disease;
• the patient is undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate;
• if the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) is increased:
• racecadotril, a medicine used to treat diarrhea;
• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer);
• vildagliptin, a medicine used to treat diabetes;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease,
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Cazaprol".
If any of the above situations apply to the patient or in case of any doubts before taking Cazaprol, the patient should consult a doctor or pharmacist.
The patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Cazaprol during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").

Children and adolescents

Cazaprol is not recommended for children.

Cazaprol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription and herbal medicines. This is because Cazaprol may affect the way other medicines work. Some medicines may also affect the way Cazaprol works.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• other blood pressure-lowering medicines and/or medicines used to treat heart failure, including diuretics,
• medicines for diabetes (insulin or tablets),
• medicines for pain relief (non-steroidal anti-inflammatory medicines (NSAIDs), including aspirin, indometacin, and ibuprofen),
• medicines for inflammation (corticosteroids for systemic use, such as hydrocortisone, prednisolone, and dexamethasone) or medicines that suppress the immune system (immunosuppressants),
• medicines used to treat mania and depression (lithium),
• potassium supplements or salt substitutes containing potassium, diuretics (water tablets, especially those that spare potassium), other medicines that may increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim with sulfamethoxazole), used to treat bacterial infections; cyclosporin, an immunosuppressant used to prevent rejection of transplanted organs, and heparin, a medicine used to thin the blood to prevent blood clots),
• aldosterone antagonists,
• sympathomimetics,
• anesthetics, opioids,
• medicines used to treat mental disorders, such as depression, anxiety disorders, schizophrenia (tricyclic antidepressants, antipsychotics),
• gold compounds (used to treat rheumatoid arthritis),
• medicines most commonly taken to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See "Warnings and precautions".

The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the headings "When not to take Cazaprol" and "Warnings and precautions").

Cazaprol with food and drink

The medicine should be taken before or after meals. The tablets should be swallowed whole, with a glass of water or another non-alcoholic drink.
The patient should inform their doctor or pharmacist if they are taking potassium supplements.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend stopping Cazaprol before planned pregnancy or as soon as possible after confirmation of pregnancy and will recommend an alternative medicine to Cazaprol. It is not recommended to take Cazaprol during early pregnancy and it should not be taken after 3 months 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 Cazaprol during breastfeeding, especially in newborns or premature babies. The doctor may recommend an alternative medicine.

Driving and using machines

Cazaprol does not affect the ability to drive or use machines. However, the patient should be aware of the possibility of dizziness, especially at the beginning of treatment, when increasing the dose, or when taking Cazaprol with other blood pressure-lowering medicines.
If the patient experiences dizziness, they should not drive, use tools, or operate machinery.

Cazaprol contains lactose and sodium

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Cazaprol

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Taking Cazaprol

• The patient should take one Cazaprol tablet per day.
• The tablet should be swallowed, with a glass of water.
• The time of taking the tablet does not matter. However, the patient should take the tablet at the same time every day.
• Cazaprol can be taken before or after a meal.

High blood pressure (hypertension)

• The usual initial dose for adults is 1 mg per day.
• The doctor will increase the dose until blood pressure is controlled - the usual maintenance dose is between 2.5 mg and 5 mg per day.
• The doctor may recommend a lower dose for patients with kidney problems or in elderly patients.
• If the patient is taking diuretics, the doctor may recommend stopping them about 3 days before starting Cazaprol. The usual initial dose of Cazaprol is then 0.5 mg per day. The doctor will then increase the dose until blood pressure is controlled.

Chronic heart failure

• The usual initial dose is 0.5 mg per day.
• The doctor will then increase the dose - the usual maintenance dose is between 1 mg and 2.5 mg per day.
• The doctor may recommend a lower dose for patients with kidney problems or in elderly patients.
• For patients with liver cirrhosis without ascites, the doctor will not recommend a dose higher than 0.5 mg per day and will closely monitor blood pressure.

Taking Cazaprol in children

Cazaprol should not be taken by children.
The patient should not intentionally change the prescribed dose. If they feel that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking more Cazaprol than prescribed

In case of taking more Cazaprol than prescribed or taking it by another person, the patient should contact their doctor or go to the nearest hospital as soon as possible. They should take the packaging of the medicine with them. The following symptoms may occur: dizziness or feeling of "emptiness" in the head, shallow breathing, cold and sweaty skin, inability to move or speak, and slow heart rate.

Missing a dose of Cazaprol

In case of missing a dose, the patient should skip the missed dose. They should then take the next dose at the usual time.
The patient should not take a double dose (two doses at the same time) to make up for the missed dose.
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, Cazaprol can cause side effects, although not everybody gets them.

Severe side effects:

In case of a severe reaction called angioedema, the patient should stop taking Cazaprol and go to their doctor as soon as possible. Symptoms include:

• sudden swelling of the face, throat, lips, or mouth. This swelling can cause difficulty breathing or swallowing.

Other possible side effects:

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

• dizziness
• cough
• nausea
• fatigue
• headache

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

• low blood pressure. This can cause weakness, dizziness, or feeling of "emptiness" in the head, blurred vision, and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke.
• rapid heart rate
• weakness
• chest pain
• breathing difficulties, including shortness of breath and tightness in the chest
• runny nose or nasal congestion and sneezing (rhinitis)
• dryness or swelling of the mouth
• loss of appetite
• change in taste
• diarrhea and vomiting
• skin rash (which can be severe)
• muscle cramps or muscle or joint pain
• impotence
• increased sweating
• sudden flushing (especially of the face)
• sleep disturbances

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

• low red and white blood cell or platelet count, found in blood tests (anemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylaxis)
• brain hypoperfusion, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low)
• myocardial infarction (may occur if blood pressure is too low)
• heart rhythm disorders
• interstitial lung disease
• systemic lupus erythematosus-like reactions
• tingling or numbness of hands or feet
• wheezing
• feeling of pressure or pulsating pain behind the nose, cheeks, and eyes (sinusitis)
• tongue pain
• pancreatitis; symptoms include severe abdominal pain radiating to the back
• changes in kidney or liver function (shown in blood and urine tests)
• liver function disorders, such as hepatitis or liver damage
• severe skin reactions, including blistering or peeling of the skin
• increased sensitivity to light
• hair loss (which may be temporary)
• loosening or separation of the nail from the nail bed
• breast enlargement in men

Blood disorders reported with ACE inhibitors:

• low red blood cell count (anemia). Symptoms include feeling tired, pale skin, rapid or irregular heartbeat (palpitations), and shortness of breath.
• low white blood cell count. Symptoms include increased risk of infections, such as mouth, gum, throat, and lung infections.
• low platelet count. Symptoms include easy bruising and bleeding from the nose.

Reporting side effects
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cazaprol

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.
Store in the original packaging to protect from moisture. Do not store above 30°C.
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 Cazaprol contains

• The active substance of Cazaprol is cilazapril. Each film-coated tablet contains 1 mg, 2.5 mg, or 5 mg of cilazapril.
• The other ingredients are: sodium stearylfumarate, talc, lactose monohydrate, hypromellose, and cornstarch in the tablet core; and hypromellose, talc, and titanium dioxide (E 171), yellow iron oxide (E 172) in Cazaprol 1 mg, and red iron oxide (E 172) in Cazaprol 2.5 mg and Cazaprol 5 mg, in the tablet coating. See section 2 "Cazaprol contains lactose and sodium".

What Cazaprol looks like and contents of the pack

Cazaprol 1 mg: yellow, elongated, slightly biconvex film-coated tablets
Cazaprol 2.5 mg: light reddish-brown, elongated, slightly biconvex film-coated tablets
Cazaprol 5 mg: reddish-brown, elongated, slightly biconvex film-coated tablets
Packaging: 28 or 30 film-coated tablets in blisters, in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Date of last revision of the leaflet:21.03.2019