Perindopril Krka

Leaflet accompanying the packaging: patient information

Perindopril Krka, 4 mg, tablets

Tert-butylamine perindopril

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

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Perindopril Krka and what is it used for

The active substance of Perindopril Krka belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Medicines in this group widen the blood vessels, making it easier for the heart to pump blood through them.
Perindopril Krka is used in:

• treatment of high blood pressure (hypertension);
• treatment of symptomatic heart failure (a condition in which the heart is not able to pump enough blood to meet the body's needs);
• reducing the risk of heart events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) and in patients who have had a heart attack and/or a procedure to improve blood flow to the heart, by widening the blood vessels that supply the heart with blood.

2. Important information before taking Perindopril Krka

When not to take Perindopril Krka

• if the patient is allergic to perindopril, any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a hypersensitivity reaction with sudden swelling of the lips and face, neck, and possibly also swelling of the hands and feet or difficulty breathing or wheezing (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in the patient's family or in the patient under other circumstances;
• after the third month of pregnancy (it is also recommended to avoid taking Perindopril Krka in early pregnancy - see section "Pregnancy");
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren.
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Perindopril Krka may not be suitable for the patient;
• if the patient has severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently 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 the throat) increases.

Perindopril Krka is not recommended for use in children and adolescents.

Warnings and precautions

Before starting treatment with Perindopril Krka, discuss it with your doctor or pharmacist.
There is a possibility that Perindopril Krka may not be suitable for the patient. For this reason, before starting to take Perindopril Krka, the patient should inform their doctor if:

• they have reduced or blocked blood flow to the heart (unstable angina pectoris);
• they have been diagnosed with enlarged heart muscle or have heart valve problems;
• they have narrowing of the artery that supplies the kidney with blood (renal artery stenosis);
• they have abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• they have diabetes;
• they have other kidney, liver, or heart diseases;
• they are undergoing dialysis or have recently had a kidney transplant;
• they are on a low-salt diet or have severe vomiting or diarrhea, or are taking diuretics;
• they are taking lithium, a medicine used to treat mania or depression;
• they are taking potassium supplements or salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin;
• they will undergo a procedure to remove cholesterol from the body using a special device (LDL apheresis);
• they will be or are undergoing desensitization to bee or wasp venom;
• they have collagenosis, such as systemic lupus erythematosus or scleroderma,
• they are taking immunosuppressive medicines;
• their blood pressure is not well controlled due to their race (this applies especially to black patients);
• they will undergo surgery or general anesthesia;
• they have cerebrovascular disease;
• they are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the subsection "When not to take Perindopril Krka:"
• they are taking any of the following medicines, which may increase the risk of angioedema (rapid swelling of the skin in areas such as the throat):
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent rejection of a transplanted organ and to treat cancer)
• wildagliptin (a medicine used to treat diabetes).

Angioedema
Patients treated with ACE inhibitors, including Perindopril Krka, have reported angioedema (a severe allergic reaction with symptoms such as swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Perindopril Krka and contact their doctor immediately. See also section 4.
The patient should inform their doctor about suspected or planned pregnancy. Perindopril Krka is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").
Children and adolescents
Perindopril Krka is not recommended for use in children and adolescents under 18 years of age.

Perindopril Krka and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take medicines available without a prescription without consulting their doctor. This is especially true for:

• medicines used to treat colds, containing pseudoephedrine or phenylephrine as active substances;
• painkillers, including acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting);
• potassium supplements;
• salt substitutes containing potassium.

The patient should inform their doctor about taking any of the following medicines to ensure that concurrent use of Perindopril Krka is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics;
• diuretics that spare potassium (e.g., triamterene, amiloride), potassium preparations, or salt substitutes containing potassium, and other medicines that may increase potassium levels in the body (such as heparin; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole; and cyclosporine or tacrolimus, immunosuppressive medicines used to prevent rejection of a transplanted organ);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• medicines used to treat irregular heart rhythms (procainamide);
• medicines used to treat diabetes (insulin or oral antidiabetic medicines such as wildagliptin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat gout (allopurinol);
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, diclofenac, including acetylsalicylic acid used as a pain reliever;
• vasodilators, including nitrates;
• estramustine (used to treat cancer);
• medicines that stimulate certain parts of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics);
• medicines used to treat mania or depression (lithium);
• medicines used to treat mental illnesses, such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotic medicines);
• gold injections used to treat arthritis (sodium aurothiomalate);
• medicines commonly used to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, or other medicines belonging to the so-called mTOR inhibitors). See the "Warnings and precautions" section.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the subsections "When not to take Perindopril Krka:" and "Warnings and precautions").

Perindopril Krka with food and drink

It is recommended to take Perindopril Krka before a meal to reduce the effect of food on the medicine's action.

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 about suspected or planned pregnancy. The doctor will usually recommend stopping Perindopril Krka before planned pregnancy or as soon as pregnancy is confirmed, and will recommend taking a different medicine instead of Perindopril Krka. Perindopril Krka is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. Perindopril Krka is not recommended during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend a different medicine.

Driving and using machines

The patient should not drive or operate machinery until they know how Perindopril Krka affects them. Perindopril Krka usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure, especially at the beginning of treatment or when taking other blood pressure-lowering medicines. Therefore, the ability to drive or operate machinery may be impaired.

Perindopril Krka contains lactose (in the form of lactose monohydrate)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Perindopril Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril once a day (1 tablet of Perindopril Krka 4 mg). If necessary, the doctor may increase the dose to 8 mg of perindopril once a day (2 tablets of Perindopril Krka 4 mg).
The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril once a day. If necessary, the doctor may increase the dose to 4 mg of perindopril once a day (1 tablet of Perindopril Krka 4 mg).
The recommended initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril once a day (1 tablet of Perindopril Krka 4 mg); if the medicine is well tolerated, the doctor may increase the dose to 8 mg of perindopril once a day (2 tablets of Perindopril Krka 4 mg).
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal.
During treatment, the doctor will adjust the dose according to the patient's response and condition.
The dose may be lower than usual and will be determined by the doctor:

• in elderly patients,
• in patients with kidney problems,
• in patients with high blood pressure caused by narrowing of the arteries that supply blood to the kidneys (renovascular hypertension),
• in patients taking diuretics at the same time,
• in patients with high blood pressure who cannot stop taking diuretics,
• in patients with severe heart failure,
• in patients taking vasodilators.

The doctor will determine the duration of treatment based on the patient's condition.

Use in children

The use of perindopril in children has not been evaluated. Therefore, perindopril is not recommended for use in children.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Perindopril Krka

In case of overdose, the patient should immediately consult their doctor or pharmacist.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other symptoms of overdose may include: rapid or slow heart rate, unpleasant feeling of irregular and/or strong heartbeat, rapid and deep breathing, dizziness, anxiety, and/or cough.
In case of significant hypotension, the patient should be placed in a supine position with their legs elevated and a small pillow under their head.

Missed dose of Perindopril Krka

It is important to take the medicine every day.
However, if a dose is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose. If more than one dose is missed, the next dose should be taken as soon as possible, and the medicine should be continued as prescribed.

Stopping Perindopril Krka

Stopping treatment may cause blood pressure to rise again, increasing the risk of complications related to high blood pressure, especially affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen, requiring hospitalization. Therefore, before stopping Perindopril Krka, the patient should consult their doctor.
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, Perindopril Krka can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following serious side effects:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people);
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• very rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people);
• weakness of the arms or legs, or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people);
• pancreatitis, which may cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy spots on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

Side effects that may occur:

• Common side effects (may affect up to 1 in 10 people):
• headache, dizziness, feeling of spinning (vertigo), feeling of tingling or numbness in the hands or feet (paresthesia),
• vision disturbances,
• ringing, buzzing, hissing, clicking in the ears (tinnitus),
• low blood pressure (hypotension) and symptoms related to hypotension,
• cough, shortness of breath (dyspnea),
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea, and constipation,
• rash, itching,
• muscle cramps,
• weakness.

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

• hypoglycemia (very low blood sugar),
• high potassium levels in the blood, which may be temporary and resolve after stopping treatment,
• low sodium levels,
• mood disturbances, sleep disturbances,
• depression,
• drowsiness, fainting,
• palpitations, tachycardia,
• vasculitis,
• wheezing (bronchospasm),
• dryness of the mucous membranes of the mouth,
• hypersensitivity reaction with sudden swelling of the face, neck, lips, mucous membranes, tongue, or throat (with hoarseness or difficulty breathing), possibly also swelling of the hands and feet (angioedema), hives,
• hypersensitivity to light (increased skin sensitivity to sunlight),
• joint pain, muscle pain,
• kidney problems,
• impotence,
• chest pain, poor general condition, peripheral edema, fever,
• increased levels of urea and creatinine in the blood,
• falls.

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

• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood,
• worsening of psoriasis,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• reduced or absent urine production,
• sudden flushing of the face and neck,
• acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people):

• disorientation,
• heart rhythm disturbances (arrhythmia), chest pain (angina pectoris), heart attack, and stroke, possibly due to excessive blood pressure lowering in patients at high risk,
• inflammation of the lungs with accumulation of a type of white blood cell (eosinophilic pneumonia), inflammation of the nasal mucous membranes (rhinitis),
• pancreatitis,
• liver inflammation,
• rash in the form of reddish-purple flat spots (erythema multiforme).

Unknown frequency (cannot be estimated from the available data):

• blue discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

Reporting side effects
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Perindopril Krka

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 stated.
Store in the original packaging to protect from moisture and light.
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 Perindopril Krka contains

• The active substance of Perindopril Krka is perindopril tert-butylamine. Each tablet contains 4 mg of perindopril tert-butylamine, which corresponds to 3.338 mg of perindopril.
• The other ingredients are calcium chloride hexahydrate, lactose monohydrate, crospovidone type A, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. See section 2 "Perindopril Krka contains lactose (in the form of lactose monohydrate)".

What Perindopril Krka looks like and contents of the pack

White to almost white, oval (length: 8.5 mm, thickness: 2.5-3.9 mm), slightly biconvex tablets with beveled edges and a score line on one side.
The tablet can be divided into two halves.
Packaging: 30, 60, or 90 tablets in blisters, in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:10.11.2021