CAZAPROL 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Cazaprol, 1 mg, coated tablets
3. Cazaprol, 2.5 mg, coated tablets
4. Cazaprol, 5 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the pack
5. What Cazaprol is and what it is used for
6. Before you take Cazaprol
   1. Do not take Cazaprol:
   2. Warnings and precautions
   3. Children and adolescents
   4. Cazaprol with other medicines
   5. Cazaprol with food and drink
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Cazaprol contains lactose and sodium
7. How to take Cazaprol
   1. How to take Cazaprol
   2. High blood pressure (hypertension)
   3. Chronic heart failure
   4. Use in children
   5. What to do if you take more Cazaprol than you should
   6. What to do if you forget to take Cazaprol
8. Possible side effects
   1. Severe side effects:
   2. Other possible side effects:
   3. Blood disorders reported with ACE inhibitors:
9. How to store Cazaprol
10. Contents of the pack and other information
    1. What Cazaprol contains
    2. What Cazaprol looks like and contents of the pack
    3. Marketing Authorisation Holder and Manufacturer

Package Leaflet: Information for the Patient

Cazaprol, 1 mg, coated tablets

Cazaprol, 2.5 mg, coated tablets

Cazaprol, 5 mg, coated tablets

Cilazapril

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

• You should 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 symptoms 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

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

1. What Cazaprol is and what it is used for

Cazaprol contains the active substance cilazapril, which 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.
Your doctor may prescribe other medicines to take with Cazaprol.

2. Before you take Cazaprol

Do not take Cazaprol:

• if you are allergic to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to other ACE inhibitors, such as captopril, enalapril, lisinopril, and ramipril;
• if you have had a severe allergic reaction to other ACE inhibitors, known as angioedema, or if you have hereditary or idiopathic angioedema. Symptoms include swelling of the face, lips, tongue, or throat.
• after the third month of pregnancy (and also avoid taking Cazaprol during early pregnancy - see section "Pregnancy and breast-feeding");
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are taking sacubitril/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 in the throat) is increased;

If any of the above applies to you, do not take Cazaprol. If you are in any doubt, consult your doctor or pharmacist before taking Cazaprol.

Warnings and precautions

Before taking Cazaprol, talk to your doctor or pharmacist if:

• you have heart disease. Cazaprol may not be suitable for patients with certain heart diseases;
• you have had a stroke or problems with blood flow to the brain;
• you have severe liver disease or jaundice;
• you have kidney disease or problems with blood flow to the kidneys, known as renal artery stenosis;
• you are on dialysis;
• you have recently had vomiting or diarrhea;
• you are on a low-salt diet;
• you are going to have an allergy test (desensitization) to bee or wasp stings;
• you are going to have surgery (including dental surgery). Some anesthetics can lower your blood pressure, which may become too low.
• you have fluid in your abdomen (ascites);
• you have diabetes;
• you have collagen vascular disease;
• you are having low-density lipoprotein (LDL) apheresis using dextran sulfate;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, such as in 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 you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans, such as valsartan, telmisartan, and irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor will monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.
See also the information under the heading "Do not take Cazaprol".
If any of the above applies to you, or if you are in any doubt, consult your doctor or pharmacist before taking Cazaprol.
You must tell your doctor if you think you might be pregnant or are planning to have a baby. Cazaprol is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breast-feeding").

Children and adolescents

Cazaprol is not recommended for children.

Cazaprol with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines. This is because Cazaprol may affect the way other medicines work, and some medicines may affect the way Cazaprol works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines to lower blood pressure and (or) to treat heart failure, including diuretics (water tablets),
• medicines for diabetes (insulin or tablets),
• medicines to relieve pain in the joints (non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, indometacin, and ibuprofen),
• medicines to treat inflammation (corticosteroids for systemic use, such as hydrocortisone, prednisolone, and dexamethasone) or medicines to 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), and other medicines that may increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole; cyclosporin, an immunosuppressant used to prevent rejection of transplanted organs, and heparin, a medicine used to thin the blood to prevent clots),
• aldosterone antagonists,
• sympathomimetics,
• anesthetics, opioids,
• medicines used to treat mental disorders, such as depression, anxiety disorders, and 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 section "Warnings and precautions".

Your doctor may need to change the dose and (or) take other precautions:

• if you are taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the headings "Do not take Cazaprol" and "Warnings and precautions").

Cazaprol with food and drink

Take the medicine before or after meals. Swallow the tablets whole with water or another non-alcoholic drink.
Tell your doctor or pharmacist if you are taking potassium supplements.

Pregnancy and breast-feeding

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.
Pregnancy
Tell your doctor if you think you might be pregnant or are planning to have a baby. Your doctor will normally advise you to stop taking Cazaprol before you become pregnant or as soon as you find out that you are pregnant, and will advise you to take a different medicine instead of Cazaprol. Do not take Cazaprol during early pregnancy and do not take it after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breast-feeding").
Breast-feeding
Tell your doctor if you are breast-feeding or thinking of breast-feeding. Cazaprol is not recommended during breast-feeding, especially if you are breast-feeding a newborn baby or a premature baby. Your doctor may advise you to take a different medicine.

Driving and using machines

Cazaprol does not affect the ability to drive or use machines. However, you may feel dizzy, especially when you first start taking the medicine, when your dose is increased, or when you take Cazaprol with other medicines for high blood pressure.
If you feel dizzy, do not drive, operate machinery, or perform other activities that require you to be alert.

Cazaprol contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Cazaprol

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How to take Cazaprol

• Take one tablet of Cazaprol every day.
• Swallow the tablet with water.
• The time of day you take the tablet does not matter. However, you 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 starting dose for adults is 1 mg per day.
• Your doctor will increase the dose until your blood pressure is controlled - the usual maintenance dose is between 2.5 mg and 5 mg per day.
• Your doctor may prescribe a lower dose if you have kidney problems or are elderly.
• If you are taking diuretics, your doctor may ask you to stop taking them for about 3 days before starting Cazaprol. The usual starting dose of Cazaprol is then 0.5 mg per day. Your doctor will then increase the dose until your blood pressure is controlled.

Chronic heart failure

• The usual starting dose is 0.5 mg per day.
• Your doctor will then increase the dose - the usual maintenance dose is between 1 mg and 2.5 mg per day.
• Your doctor may prescribe a lower dose if you have kidney problems or are elderly.
• If you have liver cirrhosis without ascites, your doctor will not prescribe a dose higher than 0.5 mg per day and will closely monitor your blood pressure.

Use in children

Do not give Cazaprol to children.
Do not intentionally change the prescribed dose. If you feel that the effect of Cazaprol is too strong or too weak, talk to your doctor or pharmacist.

What to do if you take more Cazaprol than you should

If you take more Cazaprol than you should, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you.
You may experience the following symptoms: dizziness or feeling of "emptiness" in the head, shallow breathing, cold and clammy skin, inability to move or speak, and slow heart rate.

What to do if you forget to take Cazaprol

If you forget to take a dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects:

If you experience a severe allergic reaction called angioedema, stop taking Cazaprol and contact your doctor immediately. Symptoms include:

• sudden swelling of the face, throat, lips, or tongue. 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 stuffy nose 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 pain, 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 damage due to low blood flow, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low)
• heart attack (may occur if blood pressure is too low)
• heart rhythm disorders
• interstitial lung disease
• systemic lupus erythematosus-like reactions
• tingling or numbness of the 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 disorders, such as hepatitis or liver damage
• severe skin reactions, including blistering or peeling of the skin
• increased sensitivity to sunlight
• 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, fast or irregular heartbeat, and shortness of breath.
• low white blood cell count. Symptoms include increased risk of infection, such as mouth, gum, throat, or lung infections.
• low platelet count. Symptoms include easy bruising and bleeding from the nose.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details below:
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cazaprol

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. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture. Do not store above 30°C.
Medicines should 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 pack and other information

What Cazaprol contains

• The active substance is cilazapril. Each coated tablet contains 1 mg, 2.5 mg, or 5 mg of cilazapril.
• The other ingredients are: sodium stearyl fumarate, talc, lactose monohydrate, hypromellose, and maize starch 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, oval, slightly biconvex coated tablets
Cazaprol 2.5 mg: light reddish-brown, oval, slightly biconvex coated tablets
Cazaprol 5 mg: reddish-brown, oval, slightly biconvex coated tablets
Packaging: 28 or 30 coated tablets in blisters, in a cardboard box

Marketing Authorisation 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