Cilan

Leaflet attached to the packaging: information for the user

CILAN, 0.5 mg, coated tablets

CILAN, 1 mg, coated tablets

CILAN, 2.5 mg, coated tablets

CILAN, 5 mg, coated tablets

Cilazapril

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

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

1. What Cilan is and what it is used for

Cilan contains cilazapril, which inhibits the action of the enzyme that converts angiotensin I to angiotensin II (angiotensin-converting enzyme inhibitor - ACE inhibitor). Angiotensin II narrows blood vessels, causing an increase in blood pressure. Cilan is indicated for the treatment of:

• hypertension;
• chronic heart failure.

2. Important information before taking Cilan

When not to take Cilan:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting treatment with Cilan. You should be particularly careful when taking Cilan:

• because ACE inhibitors, including Cilan, may cause excessive lowering of blood pressure. Symptomatic hypotension is rare in patients with uncomplicated hypertension. The likelihood of hypotension is greater in patients with electrolyte and water balance disorders, associated with the use of diuretics, a low-salt diet, dialysis, diarrhea, or vomiting, and in patients with severe renin-dependent hypertension (dependent on renin - an enzyme produced by the kidneys). Symptomatic hypotension has been observed in patients with symptomatic heart failure, with or without renal failure. The risk of hypotension is greater in patients with more severe heart failure, treated with high doses of loop diuretics, patients with hyponatremia (low sodium levels in the blood) or kidney problems. Patients at risk will be closely monitored at the start of treatment and during dose increases. It is possible that the doctor will temporarily discontinue the diuretic. The above comments also apply to patients with coronary heart disease or cerebrovascular disorders, in whom excessive blood pressure lowering may cause myocardial infarction or cerebrovascular incident. In some patients with congestive heart failure, with normal or low blood pressure, there is a risk of further lowering blood pressure after taking Cilan. This effect is expected and usually does not preclude continuing treatment.
• after kidney transplantation, due to the lack of information on the use of Cilan in patients who have recently undergone kidney transplantation;
• in patients undergoing dialysis using high-flux membranes and taking Cilan, as pseudo-anaphylactic reactions may occur;
• because angioedema of the face, limbs, lips, mucous membranes of the tongue, glottis, and/or larynx may occur at any time during treatment, which can cause airway obstruction, leading to death in extreme cases. If the above symptoms appear, Cilan should be discontinued immediately and a doctor should be consulted.

The frequency of angioedema during ACE inhibitor treatment is higher in black patients compared to patients of other races. In patients who have had angioedema not associated with ACE inhibitor treatment in the past, there may be a greater risk of its occurrence during treatment with Cilan.

• in patients undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate, as life-threatening pseudo-anaphylactic reactions have been observed;
• during desensitization (e.g. with insect venom - bees, wasps), as pseudo-anaphylactic reactions may occur;
• because during ACE inhibitor treatment, cholestatic jaundice leading to fulminant hepatic necrosis and (sometimes) death has rarely occurred;
• because a dry, persistent cough may occur, which disappears without treatment after discontinuation of the medicine;
• because during treatment with ACE inhibitors, including cilazapril, an increase in potassium levels in the blood has been observed in some patients, especially in cases of coexisting kidney failure, uncontrolled diabetes, concurrent use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes, or concurrent use of drugs that increase potassium levels in the blood (e.g. heparin);
• because in patients treated with ACE inhibitors, neutropenia/agranulocytosis (deficiency of white blood cells - neutrophils or lack of neutrophils), thrombocytopenia (low platelet count), and anemia (decrease in red blood cells and hemoglobin levels) may occur. In patients with normal kidney function and without additional risk factors, neutropenia is rare. Particular caution is advised when using Cilan in patients with connective tissue diseases (vasculitis), taking immunosuppressive drugs, allopurinol, or procainamide, and when these factors coexist, especially if kidney problems have occurred before. In some cases, these patients have developed severe infections resistant to intensive antibiotic treatment.
• in black patients, as ACE inhibitors are much more likely to cause angioedema, and may also be less effective in lowering blood pressure;
• in patients undergoing surgical procedures or anesthesia with agents that cause hypotension, as Cilan may enhance hypotension. The administration of the medicine should be stopped one day before the planned surgical procedure.
• in patients with diabetes, treated with oral antidiabetic drugs or insulin;
• in patients taking lithium;
• in patients taking potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes;
• - if you are 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 you have kidney problems associated with diabetes.
• aliskiren.

You should talk to your doctor, even if the above warnings apply to situations that have occurred in the past. In particular, you should talk to your doctor or pharmacist if you are taking, have recently taken, or may take any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole, used in bacterial infections; cyclosporine, an immunosuppressive drug used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots).

Your 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 Cilan". Children Cilan should not be used in children due to the lack of appropriately conducted and controlled studies on the efficacy and safety of the medicine in children. Patients with kidney problems The doctor will determine the dose based on creatinine clearance. Elderly patients See section 3.

Cilan and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Your doctor may need to change the dose and/or take other precautions: If you are taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the headings "When not to take Cilan" and "Warnings and precautions"). Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes Although patients treated with cilazapril usually have normal potassium levels in the blood, some people may develop hyperkalemia (high potassium levels in the blood). Potassium-sparing diuretics, such as spironolactone, triamterene, and amiloride, as well as potassium supplements and potassium-containing salt substitutes, may lead to a significant increase in potassium levels in the blood. Diuretics In patients treated with diuretics, especially those with electrolyte and water balance disorders, excessive lowering of blood pressure may occur at the start of ACE inhibitor therapy. Lithium During concurrent administration of ACE inhibitors and lithium, reversible increases in lithium levels in the blood and symptoms of lithium toxicity have been observed. Concurrent use of thiazide diuretics may increase the already increased risk of lithium toxicity during ACE inhibitor treatment. Antidiabetic drugs Concurrent use of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetic drugs) may enhance the blood glucose-lowering effect, with a risk of hypoglycemia (low blood sugar levels). This applies especially to the first few weeks of combined treatment and to patients with kidney problems. Non-steroidal anti-inflammatory drugs, including aspirin ≥ 3 g/day Non-steroidal anti-inflammatory drugs may weaken the antihypertensive effect of ACE inhibitors and, acting additively, may cause an increase in potassium levels in the blood, which may lead to worsening of kidney function. This effect is usually reversible. Rarely, acute renal failure may occur, especially in patients at risk of developing kidney failure (e.g. elderly or dehydrated patients). Antihypertensive drugs and vasodilators The use of other antihypertensive drugs may enhance the antihypertensive effect of cilazapril. Concurrent use of nitroglycerin, other nitrates, or vasodilators may cause further lowering of blood pressure. Sympathomimetic drugs Sympathomimetic drugs may weaken the antihypertensive effect of ACE inhibitors. Antipsychotic/tricyclic antidepressant drugs/general anesthetics The use of these drugs concurrently with cilazapril may increase the risk of further lowering of blood pressure. Aspirin, thrombolytic drugs, beta-blockers, nitrates Cilazapril may be used concurrently with aspirin (used as an antiplatelet agent), thrombolytic drugs, beta-blockers, and/or nitrates.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine. You should not take Cilan during pregnancy. If you become pregnant or plan to become pregnant, you should change your treatment as soon as possible. You should not take Cilan during breastfeeding.

Driving and using machines

In some cases, the ability to drive and use machines may be impaired due to the possibility of dizziness or fatigue.

Cilan contains lactose and sodium

Cilan contains lactose. One coated tablet contains: Cilan 0.5 mg: 0.11732 g of lactose (0.05866 g of glucose and 0.05866 g of galactose), Cilan 1 mg: 0.063876 g of lactose (0.031938 g of glucose and 0.031938 g of galactose), Cilan 2.5 mg: 0.12721 g of lactose (0.063605 g of glucose and 0.063605 g of galactose), Cilan 5 mg: 0.12468 g of lactose (0.06234 g of glucose and 0.06234 g of galactose). This should be taken into account in patients with diabetes. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. Cilan contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Cilan

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. Cilan should be taken orally, once a day. The medicine can be taken with or without food, as food does not affect its absorption significantly. The medicine should be taken at the same time every day. Hypertension The recommended initial dose is 1 mg once a day. The dose is determined by the doctor, depending on blood pressure. For most patients, the maintenance dose is between 2.5 mg and 5 mg per day. If blood pressure does not normalize after taking a dose of 5 mg, the doctor may also prescribe a diuretic in a low dose (from a different group than potassium-sparing diuretics) to enhance the antihypertensive effect. Patients with hypertension treated with diuretics On the second to third day before starting treatment with Cilan, the doctor will discontinue the diuretic to reduce the risk of hypotension. The recommended initial dose of cilazapril for these patients is 0.5 mg once a day. If necessary, the use of the diuretic can be resumed later. Chronic heart failure In patients with chronic heart failure, Cilan may be used concurrently with digitalis glycosides and/or diuretics. The doctor will start treatment with an initial dose of 0.5 mg once a day, under close medical supervision. Depending on the patient's clinical condition and tolerance to the medicine, the dose will be increased to the smallest maintenance dose, which is 1 mg per day. The decision to further increase the dose to 2.5 mg per day will be made by the doctor, depending on the patient's response. The maximum dose is 5 mg once a day. Elderly patients Hypertension Treatment should be started with a dose of 0.5 mg - 1 mg once a day. The maintenance dose is determined by the doctor, depending on the patient's tolerance and clinical condition. Chronic heart failure Treatment should be started with a dose of 0.5 mg. The maintenance dose, which is 1 mg to 2.5 mg, will be adjusted by the doctor according to the patient's clinical condition. In elderly patients with chronic heart failure who are taking high doses of diuretics, treatment should always be started with a dose of 0.5 mg per day. Dosage in patients with kidney problems - see section 2. Use in children - see section 2. If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Taking a higher dose of Cilan than recommended

There is limited data on overdose in humans. The most likely symptoms of overdose are: severe hypotension, shock (feeling of weakness, anxiety, paleness, cold sweats, rapid and shallow breathing, rapid and weak pulse, loss of consciousness), stupor, bradycardia (slow heart rate), electrolyte disturbances, kidney failure. In case of overdose, you should immediately go to the hospital.

Missing a dose of Cilan

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Cilan can cause side effects, although not everybody gets them. During treatment with cilazapril, the following side effects have been observed, with the frequency shown below:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Side effects that occur commonly(in 1 to 10 people in 100):

• headache, dizziness, paresthesia (tingling sensation);
• visual disturbances;
• tinnitus;
• hypotension, including symptomatic hypotension;
• cough, dyspnea;
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea, constipation;
• muscle cramps;
• rash, itching;
• asthenia - this is a chronic condition of the body, in which there is a general decrease in activity, and subjective symptoms are most often associated with feeling chronic fatigue, apathy, lack of motivation to act.

Side effects that occur uncommonly(in 1 to 10 people in 1,000):

• mood or sleep disturbances;
• bronchospasm;
• dryness of the mucous membranes of the mouth;
• angioedema of the face, limbs, lips, mucous membranes, tongue, glottis, and/or larynx, urticaria (see section 2);
• kidney failure;
• impotence;
• excessive sweating.

Side effects that occur rarely(in 1 to 10 people in 10,000):

• increased activity of liver enzymes and increased bilirubin levels in the blood.

Side effects that occur very rarely(in less than 1 in 10,000 people):

• confusion;
• arrhythmias, angina pectoris, myocardial infarction, and stroke, probably secondary to enhanced hypotension in high-risk groups (see section 2);
• eosinophilic pneumonia (pneumonia associated with the accumulation of one type of white blood cell - eosinophils in the lungs), rhinitis;
• pancreatitis;
• hepatitis (see section 2);
• Stevens-Johnson syndrome;
• acute kidney failure;
• decrease in hemoglobin and hematocrit (ratio of red blood cell volume to total blood volume), thrombocytopenia, leukopenia (decrease in white blood cell count)/neutropenia, and cases of agranulocytosis or pancytopenia;
• hemolytic anemia (red blood cell deficiency due to their accelerated breakdown) in patients with a congenital deficiency of glucose-6-phosphate dehydrogenase (an enzyme).

Hyperkalemia and/or increased urea and creatinine levels in the blood may occur, which usually disappear after discontinuation of the medicine, especially in cases of kidney failure, severe heart failure, and renovascular hypertension.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Cilan

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Store in the original package. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cilan contains

• The active substance of the medicine is cilazapril. One coated tablet of Cilan contains 0.5 mg, 1 mg, 2.5 mg, or 5 mg of cilazapril in the form of cilazapril monohydrate, respectively: 0.522 mg, 1.044 mg, 2.61 mg, or 5.22 mg.
• The other ingredients are: lactose monohydrate, cornstarch, hypromellose, talc, sodium stearyl fumarate. Coating: Cilan, 0.5 mg and 5 mg: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171) Cilan, 1 mg: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172) Cilan, 2.5 mg: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171), red iron oxide (E 172)

What Cilan looks like and contents of the pack

Cilan 0.5 mg - the pack contains 30 tablets Cilan 1 mg - the pack contains 30 tablets Cilan 2.5 mg and 5 mg - the pack contains 28 or 30 tablets

Marketing authorization holder and manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Tel.: (24) 357 44 44 Fax: (24) 357 45 45

Date of last revision of the leaflet:

December 2022