Perindopril krka

Package leaflet: Information for the patient

Perindopril Krka, 8 mg, tablets
tert-Butylamini perindoprilum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell 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 widen blood vessels, making it easier for the heart to pump blood through them.
Perindopril Krka is used:

• for the treatment of high blood pressure (hypertension);
• to reduce the risk of cardiovascular 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 previous heart attack and/or undergone a procedure to improve blood flow to the heart, by dilating the blood vessels supplying it.

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 a hypersensitivity reaction with sudden swelling of the lips and face, neck, and possibly also hands and feet, or with 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 3rd 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 function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or hemofiltration by another method. Depending on the equipment used, Perindopril Krka may not be suitable for the patient;
• if the patient has severe kidney disease causing reduced blood supply to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking 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 beneath the skin, such as in the throat) increases.

Use of Perindopril Krka is not recommended in children and adolescents.
Warnings and precautions
Before starting treatment with Perindopril Krka, discuss this with your doctor or pharmacist.
Perindopril Krka may not be suitable for the patient. Therefore, before starting 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 thickened 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 scheduled for cholesterol removal from the body using a special device (LDL apheresis);
• the patient is undergoing or scheduled for allergen immunotherapy (desensitisation) for bee or wasp venom;
• the patient has a collagenosis 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 in black patients);
• the patient is scheduled for 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 disorders related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use Perindopril Krka"
• the patient is taking any of the following medicines, as this 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 organ transplant rejection and in cancer treatment)
• vildagliptin (a medicine used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Krka, cases of angioedema (a severe allergic reaction with symptoms such as swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, discontinue Perindopril Krka immediately and contact a 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 3rd 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 a doctor. This is particularly 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, and also 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 volume);
• 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 in bacterial infections); and cyclosporine or tacrolimus (immunosuppressive medicines used to prevent organ transplant rejection);
• 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 heart rhythm disorders (procainamide);
• medicines used to treat diabetes (insulin or oral antidiabetic medicines such as vildagliptin);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medicines used to treat gout (allopurinol);
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, including acetylsalicylic acid used for pain relief;
• vasodilators, including nitrates;
• estramustine (used to treat cancer);
• medicines stimulating 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);
• potassium tablets;
• gold injections used to treat arthritis (sodium aurothiomalate);
• medicines most commonly used to treat diarrhoea (racecadotril);
• medicines often used to prevent organ transplant rejection (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 sections "When not to use Perindopril Krka" and "Warnings and precautions").

Perindopril Krka with food and drink
Perindopril Krka should be taken before meals 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. The doctor will usually recommend discontinuing Perindopril Krka before planned pregnancy or immediately after pregnancy is confirmed, and will advise taking another medicine instead of Perindopril Krka. Use of Perindopril Krka is not recommended during early pregnancy and must not be used after the 3rd 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. The doctor may recommend using another medicine.
Driving and using machines
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 due 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 a doctor before taking this medicine.

3. How to use Perindopril Krka

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril once daily.
If necessary, your doctor may increase the dose to 8 mg of perindopril once daily
(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 daily; if the medicine is well tolerated, your doctor may
increase the dose to 8 mg of perindopril once daily (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 each day, in the morning
before a meal.
During treatment, your doctor will adjust the dose according to the treatment response and your condition.
The dose may be lower than the usual dose 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 effect of 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, you should contact your doctor or pharmacist
immediately.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other symptoms of
overdose may include: rapid or slow heartbeat, unpleasant 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 the usual time. Do not take a double dose to make up for
the 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
Stopping treatment may cause blood pressure to rise again, increasing the risk of complications related to
hypertension, particularly affecting the heart, brain and kidneys. The condition of patients with heart failure
may worsen, up to the point requiring hospitalization. Therefore, you should consult your doctor before
stopping treatment with Perindopril Krka.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking this medicine and contact your doctor immediately if any of the following adverse reactions 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);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general 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 (hepatitis) (very rare – may occur in less than 1 in 10,000 patients);
• 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 reactions that may occur:
Common adverse reactions (may occur in less than 1 in 10 patients):

• headache, dizziness, sensation of spinning (vertigo), tingling or numbness in hands or feet (paresthesia),
• 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 (dyspnea),
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea and constipation,
• rash, itching,
• muscle cramps,
• fatigue.

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

• hypoglycemia (very low blood sugar levels),
• high potassium levels in blood, transient after discontinuation of treatment,
• low sodium levels,
• mood disturbances, sleep disorders,
• depression,
• drowsiness, fainting,
• palpitations, tachycardia,
• vasculitis,
• 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 breathing difficulty), 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 edema, 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, elevated serum bilirubin levels,
• exacerbation 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 reactions (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), nasal mucosa inflammation (rhinitis),
• pancreatitis,
• hepatitis,
• allergic rash in the form of pink-red flat spots (erythema multiforme).

Not known (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 packaging 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 8 mg of perindopril with tert-butylamine, equivalent to 6.676 mg of perindopril.
• The other ingredients are: calcium chloride hexahydrate, lactose monohydrate, crospovidone type A, microcrystalline cellulose, colloidal silicon dioxide anhydrous, and magnesium stearate. See section 2 "Perindopril Krka contains lactose (in the form of monohydrate)".

What Perindopril Krka looks like and contents of the pack
White to almost white, round (diameter: 12 mm), slightly biconvex tablets with bevelled edges and a score line on one side.
The score line on the tablet is intended only to facilitate breaking for ease of swallowing, and does not ensure equal dose division.
Pack sizes: 30, 60 or 90 tablets in blister packs, contained 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 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
02-235 Warszawa
Poland
Tel. 22 57 37 500