Perindopril krka

Package leaflet: Information for the patient

Perindopril Krka, 4 mg, tablets
tert-Butylamini perindoprilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Perindopril Krka is and what it is 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 pack and other information

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

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

• treating high blood pressure (hypertension);
• treating symptomatic heart failure (a condition in which the heart is unable to pump sufficient blood to meet the body's needs);
• reducing the risk of cardiac events such as myocardial infarction in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked), as well as in patients after myocardial infarction and/or revascularization procedures, by dilating the blood vessels supplying the heart.

2. Important information before using Perindopril Krka

When not to use 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 previously experienced an allergic reaction with sudden swelling of the lips and face, neck, and possibly hands and feet, or breathing difficulties 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 advisable to avoid using Perindopril Krka during 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 causing reduced blood flow to the kidneys (renal artery stenosis);
• if the patient is taking or has recently taken sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

Use of Perindopril Krka is not recommended in children and adolescents.
Warnings and precautions
Before starting Perindopril Krka, discuss this with your doctor or pharmacist.
Perindopril Krka may not be suitable for the patient. Therefore, before starting treatment with Perindopril Krka, inform your doctor if:

• the patient has been diagnosed with reduced or blocked blood flow to the heart (unstable angina pectoris);
• the patient has been diagnosed with thickening of the heart muscle or has heart valve disorders;
• the patient has narrowing of the artery supplying blood to the kidney (renal artery stenosis);
• the patient has abnormally increased levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has diabetes;
• the patient has other kidney, liver, or heart diseases;
• the patient is undergoing dialysis or has recently received a kidney transplant;
• the patient is on a low-salt diet, or has severe vomiting or diarrhoea, or is taking medicines that increase urine output (diuretics);
• the patient is taking lithium, a medicine used to treat mania or depression;
• the patient is taking potassium supplements or potassium-containing salt substitutes, or other medicines that may increase potassium levels in plasma, e.g. heparin;
• the patient is undergoing a procedure to remove cholesterol from the body using a special device (LDL apheresis);
• the patient is undergoing or is about to undergo allergen immunotherapy (desensitisation) for bee or wasp venom;
• the patient has a collagen disease such as systemic lupus erythematosus or scleroderma;
• the patient is receiving immunosuppressive medicines;
• blood pressure is not adequately controlled due to the patient's race (particularly patients of Black African origin);
• the patient is undergoing surgery or general anaesthesia;
• the patient has cerebrovascular disease;
• the patient is 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 (e.g. potassium) in the blood. See also subsection "When not to use Perindopril Krka"
• the patient is 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 diarrhoea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment),
• vildagliptin (a medicine used to treat diabetes).

Angioedema
Angioedema (a serious allergic reaction with symptoms such as swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindopril Krka. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Perindopril Krka immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Perindopril Krka is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
Children and adolescents
The use of perindopril in children and adolescents under 18 years of age is not recommended.
Perindopril Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take over-the-counter medicines without consulting your doctor. This is especially important for:

• cold remedies containing pseudoephedrine or phenylephrine as active ingredients;
• 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;
• potassium-containing salt substitutes.

Inform your doctor if you are taking any of the following medicines to ensure that taking Perindopril Krka concurrently is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics (medicines that increase urine output);
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium preparations, or potassium-containing salt substitutes, and other medicines that may increase potassium levels in the body (such as heparin (a medicine used to thin the blood to prevent clots); trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole (used for bacterial infections); and cyclosporine or tacrolimus (immunosuppressive medicines used to prevent rejection of transplanted organs);
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
• medicines used to treat heart rhythm disorders (procainamide);
• medicines used to treat diabetes (insulin or oral antidiabetic medicines such as vildagliptin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used in gout (allopurinol);
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, including acetylsalicylic acid used for pain relief;
• vasodilators, including nitrates;
• estramustine (used in cancer treatment);
• 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 for psychiatric disorders such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics);
• gold injections used in the treatment of arthritis (sodium aurothiomalate);
• medicines most commonly used to treat diarrhoea (racecadotril);
• medicines often used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, or other medicines belonging to the so-called mTOR inhibitors). See section "Warnings and precautions".

Your doctor may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to use 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually advise stopping Perindopril Krka before planned pregnancy or immediately after confirming pregnancy and will recommend taking another medicine instead of Perindopril Krka. Use of Perindopril Krka is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Perindopril Krka is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend using another medicine.
Driving and operating machinery
Do not drive or operate machinery until you know how Perindopril Krka affects you individually. Perindopril Krka generally 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 used with other antihypertensive medicines. Therefore, the ability to drive or operate machinery may be impaired.
Perindopril Krka contains lactose (as monohydrate lactose)
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Perindopril Krka

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

• in elderly patients,
• in patients with impaired kidney function,
• in patients with high blood pressure caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension),
• in patients being treated simultaneously with medicines that increase urine production (diuretics),
• in patients with hypertension in whom diuretic treatment cannot be discontinued,
• in patients with severe heart failure,
• in patients being treated with medicines that dilate blood vessels.

Your doctor will determine the duration of treatment based on your condition.
Use in children
The use of perindopril in children has not been evaluated. Therefore, perindopril is not recommended
for use in children.
If you feel the medicine is too strong or too weak, you should consult your doctor or pharmacist.
Taking more Perindopril Krka than recommended
If you take more than the recommended dose of this medicine, seek medical advice immediately from
your doctor or pharmacist.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other
symptoms of overdose may include: increased or decreased heart rate, sensation of irregular and (or)
forceful heartbeat, rapid and deep breathing, dizziness, restlessness and (or) cough.
If blood pressure drops significantly, the patient should be laid down with legs elevated and a small
pillow under the head.
Missing a dose of Perindopril Krka
It is important to take the medicine every day.
However, if you miss a dose, take the next dose at your usual time. Do not take a double dose to
make up for a missed dose. If you miss more than one dose, take the next dose as soon as possible
and continue taking the medicine as directed.
Stopping Perindopril Krka treatment
Stopping treatment may cause blood pressure to rise again, increasing the risk of complications
related to high blood pressure, particularly affecting the heart, brain and kidneys. The condition of
patients with heart failure may worsen, potentially requiring hospitalization. Therefore, you should
consult your doctor before stopping Perindopril Krka.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking this medicine and contact your doctor immediately if
any of the following adverse effects occur, as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (not common – may occur in less than 1 in 100 patients);
• severe dizziness or fainting caused by low blood pressure (hypotension) (common – may occur in less than 1 in 10 patients);
• extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – may occur in less than 1 in 10,000 patients);
• sudden weakness in the arms or legs, or difficulty speaking, which may be signs of stroke (very rare – may occur in less than 1 in 10,000 patients);
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; not common – may occur in less than 1 in 100 patients);
• inflammation of the pancreas, which may cause severe upper abdominal pain radiating to the back and severe malaise (very rare – may occur in less than 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in less than 1 in 10,000 patients);
• skin rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme; very rare – may occur in less than 1 in 10,000 patients).

Adverse effects that may occur:
Common adverse effects (may occur in less than 1 in 10 patients):

• headache, dizziness, sensation of spinning (vertigo), tingling or numbness in hands or feet (paraesthesia),
• visual disturbances,
• ringing, buzzing, crackling, or pulsating sounds in the ears (tinnitus),
• low blood pressure (hypotension) and symptoms related to hypotension,
• cough, shortness of breath (dyspnoea),
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhoea and constipation,
• rash, itching,
• muscle cramps,
• fatigue.

Uncommon adverse effects (may occur in less than 1 in 100 patients):

• hypoglycaemia (very low blood sugar levels),
• high blood potassium levels, which resolve after stopping treatment,
• low blood sodium levels,
• mood disturbances, sleep disturbances,
• depression,
• drowsiness, fainting,
• palpitations, tachycardia,
• vasculitis (inflammation of blood vessels),
• wheezing (bronchospasm),
• dryness of the oral mucosa,
• hypersensitivity reaction with sudden swelling of the face, neck, lips, mucous membranes, tongue or throat (with hoarseness or shortness of breath), possibly also swelling of hands and feet (angioedema), urticaria,
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain, muscle pain,
• kidney function disorders,
• inability to achieve or maintain erection (impotence),
• chest pain, malaise, peripheral oedema, fever,
• increased blood urea levels, increased blood creatinine levels,
• falls.

Rare (may occur in less than 1 in 1,000 patients):

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

Very rare adverse effects (may occur in less than 1 in 10,000 patients):

• confusion,
• heart rhythm disorders (arrhythmia), chest pain (angina), heart attack and stroke, probably due to excessive lowering of blood pressure in patients at high risk,
• lung inflammation with accumulation of a certain type of white blood cells (eosinophils) in lung tissue (eosinophilic pneumonia), inflammation of the nasal mucosa (rhinitis),
• pancreatitis,
• hepatitis,
• allergic rash in the form of pink-red flat spots (erythema multiforme).

Unknown (frequency cannot be estimated from available data):

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Perindopril Krka

Keep the medicine 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 stated month.
Store in the original container to protect from moisture and light.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril Krka contains

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

What Perindopril Krka looks like and contents of the pack
White to almost white, oval tablets (length: 8.5 mm, thickness: 2.5–3.9 mm), slightly biconvex with bevelled edges and a division groove on one side.
The tablet can be divided into halves.
Pack sizes: 30, 60 or 90 tablets in blisters, packed in a cardboard box.
Marketing authorisation holder and manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised for sale in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500