Perindopril Krka

Leaflet attached to the packaging: patient information

Perindopril Krka, 8 mg, tablets

tert-Butylamine perindopril

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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 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);
• reducing the risk of heart attacks, 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 after a heart attack and (or) surgery to improve blood flow to the heart, by widening the blood vessels that supply them 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 experienced 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 hoarseness (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in the patient's family or in the patient under any 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 being treated with 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.

It is not recommended to use Perindopril Krka in children and adolescents.

Warnings and precautions

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

• you have reduced or blocked blood flow to the heart (unstable angina pectoris);
• you have been diagnosed with enlarged heart muscle or have valve problems;
• you have narrowing of the artery that supplies the kidney with blood (renal artery stenosis);
• you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism);
• you have diabetes;
• you have other kidney, liver, or heart diseases;
• you are undergoing dialysis or have recently had a kidney transplant;
• you are on a low-salt diet or have severe vomiting or diarrhea, or you are taking medicines that increase urine production (diuretics);
• you are taking lithium, a medicine used to treat mania or depression;
• you are taking potassium supplements or salt substitutes containing potassium, or other medicines that may increase potassium levels in your blood, such as heparin;
• you will undergo a procedure to remove cholesterol from your body using a special device (LDL apheresis);
• you will be or are being treated to reduce your allergy to bee or wasp venom (desensitization);
• you have collagenosis, such as systemic lupus erythematosus or scleroderma,
• you are taking immunosuppressive medicines;
• your blood pressure is not well controlled due to your race (this applies especially to black patients);
• you will undergo surgery or general anesthesia;
• you have cerebrovascular disease;
• you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood. See also the subsection "When not to take Perindopril Krka:"
• you 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 you experience such symptoms, you should stop taking Perindopril Krka and contact your doctor immediately. See also section 4.
You should inform your doctor about suspected (or planned) pregnancy. It is not recommended to take Perindopril Krka in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").
Children and adolescents
Use of perindopril in children and adolescents under 18 years of age is not recommended.

Perindopril Krka and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
You should not take medicines available without a prescription without consulting your 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.

You should inform your 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 medicines that increase urine production (diuretics);
• potassium-sparing diuretics (e.g., triamterene, amiloride), potassium preparations, or salt substitutes containing potassium, and other medicines that may increase potassium levels in your blood (such as heparin (a medicine used to thin the blood to prevent clots); trimethoprim and cotrimoxazole (also known as trimethoprim/sulfamethoxazole; used to treat bacterial infections); 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 at 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 anti-diabetic 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);
• potassium tablets;
• gold injections for the treatment of arthritis (sodium aurothiomalate);
• medicines commonly used to treat diarrhea (racecadotril);
• medicines often 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.

Your doctor may recommend a dose change and (or) take other precautions:

• if you are 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should inform your doctor about suspected (or planned) pregnancy. Your doctor will usually recommend stopping Perindopril Krka before planned pregnancy or as soon as possible after confirmation of pregnancy and recommend taking another medicine instead of Perindopril Krka. It is not recommended to take Perindopril Krka in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
You should inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Perindopril Krka during breastfeeding, especially when breastfeeding a newborn or premature baby. Your doctor may recommend taking another medicine.

Driving and using machines

You should not drive or operate machines until you know how Perindopril Krka affects you. Perindopril Krka usually does not affect alertness, but some patients may experience dizziness or weakness related to low blood pressure, especially at the beginning of treatment or when taking it with other blood pressure-lowering medicines. Therefore, the ability to drive or operate machines may be impaired.

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

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Perindopril Krka

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril once a day. If necessary, your doctor may increase the dose to 8 mg of perindopril once a day (two tablets of Perindopril Krka 4 mg or one tablet of Perindopril Krka 8 mg).
The recommended initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril (one tablet of Perindopril Krka 4 mg) once a day; if the medicine is well tolerated, your doctor may increase the dose to 8 mg of perindopril once a day (two tablets of Perindopril Krka 4 mg or one tablet of Perindopril Krka 8 mg).
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before breakfast.
During treatment, your doctor will adjust the dose according to the treatment effects and your condition.
The dose may be lower than usual and will be determined by your 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 (renal hypertension),
• in patients being treated with medicines that increase urine production (diuretics),
• in patients with high blood pressure who cannot stop taking diuretics,
• in patients with severe heart failure,
• in patients being treated with medicines that widen blood vessels.

Your doctor will determine the duration of treatment based on your condition.

Use in children

Use of perindopril in children has not been evaluated. For this reason, use of perindopril in children is not recommended.
If you feel that the effect of Perindopril Krka is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Perindopril Krka

In case of overdose, you should immediately consult your 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 with their legs elevated and a small pillow under their head.

Missing a dose of Perindopril Krka

It is important to take the medicine every day.
However, if you miss a dose, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you miss more than one dose, you should take the next dose as soon as possible and continue taking the medicine as recommended.

Stopping treatment with Perindopril Krka

Stopping treatment may cause blood pressure to rise again, increasing the risk of complications related to high blood pressure, especially those affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen, to the point of requiring hospitalization. Therefore, before stopping Perindopril Krka, you should consult your doctor.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should stop taking this medicine and contact your doctor immediately if you 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 arm or leg muscles, 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 can 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 patches 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, crackling, knocking 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 disappear 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 reddening 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, probably due to excessive blood pressure lowering in high-risk patients,
• pulmonary inflammation with accumulation of a type of white blood cell (eosinophils) in lung tissue (eosinophilic pneumonia), nasal mucous membrane inflammation (rhinitis),
• pancreatitis,
• liver inflammation,
• rash in the form of reddish-purple flat patches (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 you experience any side effects, including any side effects not listed in this 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:
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindopril Krka

The medicine should be stored out of the 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. 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 packaging and other information

What Perindopril Krka contains

• The active substance of Perindopril Krka is perindopril tert-butylamine. Each tablet contains 8 mg of perindopril tert-butylamine, which corresponds to 6.676 mg of perindopril.
• The other ingredients are: calcium chloride hexahydrate, lactose monohydrate, crospovidone type A, microcrystalline cellulose, colloidal silica anhydrous, 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, round (diameter: 12 mm), slightly convex tablets with beveled edges and a score line on one side.
The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.
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:
In order to obtain more detailed information on this medicine, you should contact your 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