Prenessa

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Prenessa

4 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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Prenessa and what is it used for
• 2. Important information before taking Prenessa
• 3. How to take Prenessa
• 4. Possible side effects
• 5. How to store Prenessa
• 6. Contents of the pack and other information

1. What is Prenessa and what is it used for

The active substance of Prenessa belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Prenessa is used:

• to treat high blood pressure (hypertension);
• to treat symptomatic heart failure (a condition in which the heart is not able to pump blood in sufficient quantities for the body's needs);
• to reduce the risk of heart incidents, 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 heart blood flow, by widening the blood vessels that supply the heart.

2. Important information before taking Prenessa

When not to take Prenessa

• if the patient is allergic to perindopril, any of the other ingredients of this medicine (listed in section 6) or any other ACE inhibitor;
• if the patient has had a hypersensitivity reaction in the past 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 Prenessa 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, Prenessa 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 with valsartan, a medicine used to treat a certain type of chronic (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and precautions

Before starting to take Prenessa, you should discuss it with your doctor or pharmacist.
There is a possibility that Prenessa is not suitable for you or that its use requires regular medical supervision. For this reason, before starting to take Prenessa, you should inform your doctor if:

• you have been diagnosed with aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy or heart valve problems;
• you have renal artery stenosis (narrowing of the blood vessel supplying the kidney with blood);
• you have primary aldosteronism (abnormally high levels of a hormone called aldosterone in the blood);
• you have diabetes;
• you have other kidney, liver or heart diseases;
• you are undergoing hemodialysis or have recently had a kidney transplant;
• you have been diagnosed with collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• you are on a low-salt diet or have severe vomiting or diarrhea or are taking diuretics (medicines that increase urine production);
• you are taking lithium, a medicine used to treat mania or depression;
• you are taking potassium supplements or potassium-containing salt substitutes;
• you are taking any of the following medicines used to treat high blood pressure: an angiotensin receptor antagonist (ARB) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, or aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading "When not to take Prenessa:".
• 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), or vildagliptin (a medicine used to treat diabetes)
• if you are of black race, there is a greater risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Prenessa, 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 Prenessa and contact your doctor immediately. See also section 4.
You should inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Prenessa 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").
You should immediately inform your doctor if you experience any of the following symptoms:

• dizziness after taking the first dose. Some patients react to the first dose or dose increase with dizziness, weakness, fainting, and nausea;
• fever, sore throat, or mouth ulcers (may be signs of infection, caused by a decrease in the number of white blood cells);
• yellowing of the skin and whites of the eyes (jaundice), which may be a sign of liver disease;
• persistent dry cough. Cough is a side effect reported during treatment with ACE inhibitors, but it may also be a sign of a respiratory tract disease.

At the beginning of treatment and/or during dose adjustment, more frequent medical check-ups may be necessary.
You should not miss scheduled appointments, even if your condition improves.
The frequency of check-ups will be determined by your doctor.

In order to avoid possible complications during treatment with Prenessa, you should inform your doctor about taking Prenessa:

• if you are to undergo anesthesia and/or surgery (even dental surgery);
• if you are to undergo allergy treatment (desensitization) for bee or wasp venom;
• if you are to undergo hemodialysis or LDL cholesterol apheresis (removal of cholesterol from the body using a special device).

Children and adolescents

The use of perindopril in children and adolescents under the age of 18 is not recommended.

Prenessa and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take.
You should not take over-the-counter medicines 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 and potassium-containing salt substitutes.

You should inform your doctor about taking any of the following medicines to ensure that concomitant use of Prenessa is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics (medicines that increase urine production);
• vasodilators, including nitrates (medicines that cause blood vessels to dilate);
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, 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 cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine or tacrolimus, an immunosuppressive medicine 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 heart rhythm disorders (procainamide);
• medicines used to treat diabetes (insulin or oral anti-diabetic medicines such as vildagliptin);
• 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;
• estramustine (a medicine 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 salts);
• 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 used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, or other medicines belonging to the so-called mTOR inhibitors). See section "Warnings and precautions".

Your doctor may need to change the dose and/or take other precautions:

• if you are taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Prenessa:" and "Warnings and precautions").

Prenessa with food, drink, and alcohol

Prenessa should be taken before a meal to reduce the effect of food on the medicine's action. Drinking alcohol during treatment with Prenessa may cause dizziness or a feeling of "emptiness" in the head. You should discuss with your doctor the possibility of consuming alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should inform your doctor if you suspect (or plan) pregnancy. Your doctor will usually recommend stopping Prenessa before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Prenessa. It is not recommended to take Prenessa 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 if you are breastfeeding or plan to breastfeed. It is not recommended to take Prenessa during breastfeeding, especially during breastfeeding of 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 you react to Prenessa.
Prenessa 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.

Prenessa contains lactose monohydrate and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "sodium-free".

3. How to take Prenessa

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended initial and maintenance dose for the treatment of high blood pressure is 4 mg of perindopril (one 4 mg Prenessa tablet) taken once daily. If necessary, after one month of treatment, your doctor may increase the dose to 8 mg of perindopril (two 4 mg Prenessa tablets) taken once daily.
The recommended initial dose for the treatment of symptomatic heart failure is 2 mg of perindopril (half a 4 mg Prenessa tablet or one 2 mg Prenessa tablet, if available) taken once daily. If necessary, your doctor may increase the dose to 4 mg of perindopril (one 4 mg Prenessa tablet or two 2 mg Prenessa tablets, if available) taken once daily.
The recommended initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril (one 4 mg Prenessa tablet) taken once daily; if the medicine is well tolerated, your doctor may increase the dose to 8 mg of perindopril (two 4 mg Prenessa tablets) taken once daily.
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 results and your needs.
Kidney problems
Your doctor may recommend taking the medicine in a lower dose.
Liver problems
Dose adjustment is not necessary.
Elderly patients
The dosage recommendations for elderly patients depend on kidney function.
Your doctor will determine the duration of treatment, depending on your health condition.

Use in children and adolescents

The efficacy and safety of perindopril in children and adolescents under the age of 18 have not been established.
For this reason, the use of perindopril in children and adolescents is not recommended.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Prenessa

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 (tachy- or bradycardia), unpleasant feeling of irregular or strong heartbeat (palpitations), 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.

Missed dose of Prenessa

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 prescribed.

Stopping Prenessa treatment

Stopping treatment may cause blood pressure to rise again, increasing the risk of complications associated with 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. For this reason, before stopping Prenessa, you should consult your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prenessa 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 muscle strength in 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, radiating to the back, 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 are grouped by frequency:

• Common side effects (may affect up to 1 in 10 people):
• headache,
• dizziness,
• feeling of spinning (vertigo),
• tingling or numbness in the hands or feet (paresthesia),
• vision disturbances,
• ringing in the ears (tinnitus),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling of weakness.

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

• mood disorders,
• sleep disorders,
• depression,
• dry mouth,
• increased itching or severe rashes,
• formation of blisters on the skin,
• kidney problems,
• impotence,
• excessive sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• photosensitivity reactions (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• poor general condition,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.

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

• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in serum,
• worsening of psoriasis,
• SIADH (inappropriate secretion of antidiuretic hormone),
• decreased 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,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal mucosa inflammation (swelling or discharge from the nose),
• blood changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count.

If you experience any of these symptoms, you should contact your doctor as soon as possible.
Frequency not known (frequency cannot be estimated from 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prenessa

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 a temperature below 30°C.
Store in the original packaging to protect from moisture.
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 pack and other information

What Prenessa contains

• The active substance of Prenessa 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: lactose monohydrate, microcrystalline cellulose (E 460), sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate (E 572). See section 2 "Prenessa contains lactose monohydrate and sodium".

What Prenessa looks like and contents of the pack

White, elongated, biconvex tablets with beveled edges and a score line on one side. The tablet can be divided into equal doses.
Packaging: 30 tablets in blisters, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Polska

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 58/561/05-C

Parallel import authorization number: 327/22 Date of leaflet approval: 05.09.2022

[Information about the trademark]