Prenessa

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Prenessa
4 mg, tablets
tert-Butylamini perindoprilum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Prenessa is and what it is 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 Prenessa is and what it is used for

The active substance in 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 unable to pump enough blood to meet the body's needs);
• 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 previously had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the blood vessels supplying it.

2. Information before using Prenessa

When not to use Prenessa

• if the patient is allergic to perindopril, any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor;
• if the patient has previously experienced a hypersensitivity reaction with sudden swelling of the lips and face, possibly also involving 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 3rd month of pregnancy (it is also better to avoid using Prenessa 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 another form of blood filtration. Depending on the device used, Prenessa 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 under the skin, such as in the throat) increases.

Warnings and precautions
Before starting treatment with Prenessa, discuss this with your doctor or pharmacist.
Prenessa may not be suitable for the patient, or its use may require regular medical monitoring. Therefore, before starting Prenessa, inform your doctor if:

• the patient has been diagnosed with aortic stenosis (narrowing of the main blood vessel leading from the heart), 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 high 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 hemodialysis or has recently received a kidney transplant;
• the patient has been diagnosed with a collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient is on a low-salt diet, or has severe vomiting or diarrhea, 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 salt substitutes containing potassium;
• the patient is taking any of the following medicines used to treat high blood pressure: an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes, or aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Prenessa:".
• 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 diarrhea), sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment), or vildagliptin (a medicine used to treat diabetes);
• in black patients, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.

Angioedema
In patients treated with ACE inhibitors, including Prenessa, 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, stop taking Prenessa immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Prenessa 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 (see section "Pregnancy").
Immediately inform your doctor if any of the following symptoms occur:

• dizziness after the first dose. Some patients may experience dizziness, weakness, fainting, or nausea after the first dose or after dose increase;
• fever, sore throat, or mouth mucosal ulcers (which may be signs of infection due to reduced white blood cell count);
• yellowing of the skin or whites of the eyes (jaundice), which may indicate liver disease;
• a persistent dry cough lasting for a long time. Cough is an adverse effect reported during ACE inhibitor use, but may also be a symptom of upper respiratory tract disease.

During the initial phase of treatment and/or dose adjustment, more frequent medical check-ups may be necessary.
Do not miss scheduled appointments, even if the patient's condition improves.
The frequency of follow-up examinations will be determined by the doctor.
To avoid possible complications during treatment with Prenessa, inform your doctor about taking Prenessa:

• if the patient is to undergo anesthesia and/or surgery (including dental procedures);
• if the patient is to undergo allergen immunotherapy (desensitization) for bee or wasp venom;
• if the patient is 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 18 years of age is not recommended.
Prenessa 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 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, as well as to prevent blood clotting);
• potassium supplements and potassium-containing salt substitutes.

Inform your doctor if you are taking any of the following medicines to ensure that taking Prenessa together is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics (medicines that increase urine volume);
• vasodilators, including nitrates (medicines that cause blood vessel dilation);
• 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 co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used for bacterial infections; cyclosporine or tacrolimus, immunosuppressive medicines used to prevent organ transplant rejection);
• 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 for gout (allopurinol);
• non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen, diclofenac), including acetylsalicylic acid used for pain relief;
• 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 for psychiatric disorders such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics);
• gold injections used to treat arthritis (sodium aurothiomalate);
• medicines most commonly used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "Warnings and precautions".

The treating doctor may need to adjust the dose and/or take additional precautions:

• if the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under the headings "When not to use Prenessa:" and "Warnings and precautions").

Prenessa with food, drink, and alcohol
It is recommended to take Prenessa before meals to reduce the influence of food on the medicine's effect. Drinking alcohol during treatment with Prenessa may cause dizziness or a sensation of "emptiness" in the head. Discuss with your doctor whether alcohol consumption is possible.
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. The doctor will usually advise stopping Prenessa before planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Use of Prenessa 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 plan to breastfeed. Use of Prenessa is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend an alternative medicine.
Driving and operating machinery
Do not drive or operate machinery until you know how Prenessa affects you individually.
Prenessa 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.
Prenessa contains monohydrate lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, and is therefore considered essentially "sodium-free."

3. How to use Prenessa

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended starting 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,
the doctor may increase the dose to 8 mg of perindopril (two 4 mg Prenessa tablets) taken once daily.
The recommended starting 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) once daily. If necessary, the
doctor may increase the dose to 4 mg of perindopril (one 4 mg Prenessa tablet or two 2 mg Prenessa
tablets, if available) once daily.
The recommended starting 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, the 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 each day, in the
morning before a meal.
During treatment, the doctor will adjust the dose according to treatment outcomes and the patient's
needs.
Renal impairment
The doctor may recommend a lower dose.
Hepatic impairment
Dose adjustment is not necessary.
Elderly patients
Dosage recommendations for elderly patients depend on renal function.
The doctor will determine the duration of treatment based on the patient's health status.
Use in children and adolescents
The efficacy and safety of perindopril in children and adolescents under 18 years of age have not
been established.
Therefore, 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, consult your doctor or pharmacist.
Taking more Prenessa than recommended
If you take more than the recommended dose of the medicine, seek immediate advice from a 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 slowed heart rate (tachy- or bradycardia), unpleasant
sensation of irregular and (or) forceful heartbeat (palpitations), rapid and deep breathing, dizziness,
anxiety 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 Prenessa
It is important to take the medicine every day. However, if a dose is missed, take the next dose at
the usual time. Do not take a double dose to make up for a missed dose. If more than one dose has
been missed, take the next dose as soon as possible and continue treatment as recommended.
Stopping Prenessa treatment
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, consult your doctor
before stopping Prenessa.
If you have any further doubts about using 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 you experience
any of the following adverse reactions, as these 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 up to 1 in 100 patients);
• severe dizziness or fainting due to low blood pressure (common - may occur in up to 1 in 10 patients);
• extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare - may occur in up to 1 in 10,000 patients);
• sudden onset of muscle weakness in arms or legs, or difficulty speaking, which may be signs of stroke (very rare - may occur in up to 1 in 10,000 patients);
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; not common - may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare - may occur in up to 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare - may occur in up to 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 up to 1 in 10,000 patients).

Adverse reactions are grouped according to their frequency of occurrence:
Common adverse reactions (may occur in up to 1 in 10 patients):

• headache,
• dizziness,
• sensation of spinning (vertigo),
• tingling or numbness in hands or feet (paraesthesia),
• visual disturbances,
• tinnitus (perception of ringing or other sounds),
• cough,
• shortness of breath (dyspnoea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhoea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling of weakness.

Not common adverse reactions (may occur in up to 1 in 100 patients):

• mood disturbances,
• sleep disturbances,
• depression,
• dryness of the oral mucosa,
• severe itching or severe rashes,
• formation of clusters of blisters on the skin,
• kidney function disorders,
• impotence,
• sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• malaise,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high blood potassium levels, which resolve after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• abnormal laboratory test results: increased liver enzyme activity, high 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 up to 1 in 10,000 patients):

• confusion,
• eosinophilic pneumonia (a rare type of lung inflammation),
• inflammation of the nasal mucosa (nasal swelling or discharge),
• blood count changes such as decreased white blood cells and red blood cells, decreased haemoglobin levels, decreased platelet count.

If any of these symptoms occur, you should contact your doctor as soon as possible.
Frequency not known (frequency cannot be estimated from available data):

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

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

5. How to store Prenessa

Keep this medicine 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 specified month.
Store below 30°C.
Keep in the original packaging to protect from moisture.
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 packaging and other information

What Prenessa 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.
• Other ingredients: lactose monohydrate, microcrystalline cellulose (E 460), sodium hydrogen carbonate, colloidal anhydrous 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 bevelled edges and a score line on one side dividing the tablet into equal parts. The tablet can be divided into equal doses.

Packaging: 30 tablets in blisters, packed in a cardboard box.

For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, 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.
Równoległa 5
02-235 Warsaw
Poland

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 58/561/05-C
Parallel Import Authorisation Number: 327/22