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

• You should keep this leaflet, so 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 the 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. Package contents 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

Before starting treatment with Cilan, you should discuss it with your doctor or pharmacist. 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 higher in patients with electrolyte disturbances associated with diuretic use, salt-restricted diet, dialysis, diarrhea, or vomiting, and in patients with severe renin-dependent hypertension. Hypotension has been observed in patients with symptomatic heart failure, with or without renal insufficiency. The risk of hypotension is higher in patients with more severe heart failure, treated with high doses of loop diuretics, patients with hyponatremia (low sodium levels in the blood) or renal impairment. 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 continuation of treatment.
• after kidney transplantation, due to the lack of information on the use of Cilan in patients with recent 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 occur, Cilan should be discontinued immediately and a doctor should be consulted.

The frequency of angioedema during ACE inhibitor therapy is higher in black patients compared to patients of other races. In patients who have had angioedema not associated with ACE inhibitors in the past, there may be a higher 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 ACE inhibitors have rarely caused a syndrome starting with cholestatic jaundice, leading to fulminant hepatic necrosis and (sometimes) death;
• because a dry, persistent cough may occur, which disappears without treatment after discontinuation of the medicine;
• because during treatment with ACE inhibitors, including cilazapril, some patients have been observed to have increased potassium levels in the blood, especially in cases of co-existing renal insufficiency, uncontrolled diabetes, concomitant use of potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes, or concomitant use of drugs that increase potassium levels in the blood (e.g. heparin);
• because patients treated with ACE inhibitors may experience 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). In patients with normal renal function and without additional risk factors, neutropenia is rare. Particular caution is recommended when using Cilan in patients with connective tissue diseases (vasculitis), taking immunosuppressive drugs, allopurinol, or procainamide, as well as when these factors coexist, especially if renal impairment has occurred previously. In some cases, these patients have developed severe infections resistant to intensive antibiotic treatment.
• in black patients, because 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 scheduled surgical procedure.
• in diabetic patients treated with oral antidiabetic agents or insulin;
• in patients taking lithium;
• in patients taking potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes;
• -if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if the patient has diabetic nephropathy.
• aliskiren.

You should talk to your doctor, even if the above warnings refer 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 agent used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent blood clots). 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 Cilan". Children Cilan is not recommended for use due to the lack of appropriately conducted and controlled studies on the efficacy and safety of the medicine in children. Patients with renal impairment 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 currently taking, or have recently taken, and about medicines you plan to take. Your doctor may need to change the dose and/or take other precautions: If you are taking an angiotensin II 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 individuals may experience hyperkalemia (elevated potassium levels in the blood). Potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride, and potassium supplements or salt substitutes may lead to significant increases in potassium levels in the blood. Diuretics In patients treated with diuretics, especially those with electrolyte disturbances, excessive blood pressure lowering may occur at the start of ACE inhibitor therapy. Lithium During concomitant administration of ACE inhibitors and lithium, reversible increases in lithium levels in the blood and symptoms of lithium toxicity have been observed. Concomitant use of thiazide diuretics may increase the already increased risk of lithium toxicity during ACE inhibitor therapy. Oral antidiabetic agents Concomitant use of ACE inhibitors and oral antidiabetic agents (insulin, oral hypoglycemic agents) may increase the blood glucose-lowering effect, with a risk of hypoglycemia (low blood sugar levels). This applies especially to the first few weeks of combined therapy and to patients with renal impairment. 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 increase potassium levels in the blood, which may lead to worsening of renal function. This effect is usually reversible. Rarely, acute renal failure may occur, especially in patients at risk of renal failure (e.g. elderly or dehydrated). Antihypertensive agents and vasodilators Concomitant use of other antihypertensive agents may enhance the antihypertensive effect of cilazapril. Concomitant use of nitroglycerin, other nitrates, or vasodilators may cause further lowering of blood pressure. Sympathomimetic agents Sympathomimetic agents may weaken the antihypertensive effect of ACE inhibitors. Antipsychotic/tricyclic antidepressant/anesthetic agents Concomitant use of these agents with cilazapril may increase the risk of further lowering blood pressure. Aspirin, thrombolytic agents, beta-blockers, nitrates Cilazapril may be used concomitantly with aspirin (used as an antiplatelet agent), thrombolytic agents, beta-blockers, and/or nitrates.

  Pregnancy and breastfeeding

  If you are pregnant, think you may be pregnant, or are planning to become pregnant, you should consult your 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 lactose (0.05866 g glucose and 0.05866 g galactose), Cilan 1 mg: 0.063876 g lactose (0.031938 g glucose and 0.031938 g galactose), Cilan 2.5 mg: 0.12721 g lactose (0.063605 g glucose and 0.063605 g galactose), Cilan 5 mg: 0.12468 g lactose (0.06234 g glucose and 0.06234 g 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) sodium per coated tablet, which means the medicine is considered "sodium-free".

  3. How to take Cilan

  This medicine should always be taken exactly as prescribed 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 daily. The dose will be determined by your doctor, depending on your blood pressure. For most patients, the maintenance dose is between 2.5 mg and 5 mg once daily. If blood pressure does not normalize after taking a dose of 5 mg, your 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, your 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 daily. Diuretic therapy can be resumed later if necessary. Chronic heart failure In patients with chronic heart failure, Cilan may be used concomitantly with digitalis glycosides and/or diuretics. Your doctor will start treatment with an initial dose of 0.5 mg once daily, 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 once daily. The decision to further increase the dose to 2.5 mg once daily will be made by your doctor, depending on the patient's response. The maximum dose is 5 mg once daily. Elderly patients Hypertension Treatment should be started with a dose of 0.5 mg - 1 mg once daily. The maintenance dose will be determined by your 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 your doctor according to the patient's clinical condition. In elderly patients with chronic heart failure who are taking high doses of diuretics, treatment should be started with a dose of 0.5 mg once daily. Dosage in patients with renal impairment - 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.

  Overdose of Cilan

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

  Missed 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 presented 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 - a chronic condition of the body, in which there is a general decrease in activity, and subjective symptoms are most often associated with feelings of chronic fatigue, apathy, lack of motivation to act.

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

  • mood disorders or sleep disorders;
  • 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);
  • renal 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 patients (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);
  • erythema multiforme;
  • acute renal failure;
  • decreased hemoglobin levels and decreased hematocrit (ratio of red blood cell volume to total blood volume), thrombocytopenia, leukopenia (decreased 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 levels of urea and creatinine in the blood may occur, which usually disappear after discontinuation of the medicine, especially in cases of renal insufficiency, severe heart failure, and renovascular hypertension.

  Reporting side effects

  If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 the month. Store in the original packaging. 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. Package contents 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 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