Prenessa

Patient Information Leaflet: Information for the User

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Prenessa
8 mg, tablets
tert-Butylamine perindopril
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of Contents

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 (ACE) inhibitors.
Prenessa is used:

• for the treatment of high blood pressure (hypertension);
• to reduce the risk of cardiac 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 after a heart attack and/or undergoing a procedure to improve blood supply to the heart, by dilating the blood vessels supplying the heart.

2. Important 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 an allergic reaction with sudden swelling of the lips and face, possibly also swelling of the hands and feet or shortness of breath or hoarseness (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in the patient's family or in the patient under any 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 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 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 heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat).

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 aortic stenosis (narrowing of the main blood vessel leading from the heart), thickening of the heart muscle, or heart valve problems;
• the patient has narrowing of the artery supplying blood to the kidney (renal artery sten0sis);
• 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 collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• 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 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, ARBs), also known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• 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 diarrhoea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the so-called mTOR inhibitors (used to prevent organ transplant rejection and to treat cancer),
• vildagliptin (a medicine used to treat diabetes).
• in patients of black race, 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
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 Prenessa. 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 taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
Inform your doctor immediately if any of the following symptoms occur:

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

More frequent medical check-ups may be necessary at the beginning of treatment and/or during dose adjustment. Do not miss scheduled appointments, even if the patient's condition improves. The frequency of check-ups will be determined by the doctor.
To avoid possible complications during treatment with Prenessa, inform your doctor that the patient is taking Prenessa:

• if the patient is to undergo anaesthesia and/or surgery (even dental procedures);
• if the patient is to undergo treatment to reduce allergy to bee or wasp venom (desensitisation);
• if the patient is to undergo haemodialysis 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 salt substitutes containing potassium.

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

• other medicines used to treat high blood pressure and/or heart failure, including diuretics (medicines that increase urine output);
• 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 cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used for bacterial infections; 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 diseases 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;
• 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 disorders, schizophrenia or other psychoses (tricyclic antidepressants and antipsychotics);
• gold injections used to treat arthritis (sodium aurothiomalate);
• medicines most commonly used to treat diarrhoea (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
Prenessa should be taken before meals to reduce the effect of food on the medicine's action. Drinking alcohol during treatment with Prenessa may cause dizziness or a "hollow" feeling 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 baby, 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 recommend stopping Prenessa before planned pregnancy or immediately after pregnancy is confirmed, and will recommend taking another medicine instead of Prenessa. 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 intend to breastfeed. Use of Prenessa is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend using another medicine.
Driving and operating machinery
Do not drive or operate machinery until you know how Prenessa affects you individually. 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 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, so it can essentially be considered "sodium-free".

3. How to use Prenessa

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
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 Prenessa 4 mg tablet) taken once daily. If necessary, after one month of treatment, your doctor may increase the dose to 8 mg of perindopril (one Prenessa 8 mg tablet or two Prenessa 4 mg tablets), taken once daily, which is the maximum recommended dose.
The recommended initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril (one Prenessa 4 mg tablet) taken once daily. If the medicine is well tolerated, your doctor may increase the dose to 8 mg of perindopril (one Prenessa 8 mg tablet or two Prenessa 4 mg 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, your doctor will adjust the dose according to treatment response and individual patient needs.

Renal impairment
Your doctor may recommend a lower dose.

Hepatic impairment
Dose adjustment is not necessary.

Elderly patients
Dosing recommendations for elderly patients depend on renal function. Your doctor will determine the duration of treatment according to 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 is not recommended in children and adolescents.

If you feel the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking more Prenessa than recommended
If you take more than the recommended dose, 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: 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.
In case of significant drop in blood pressure, the patient should be laid down with legs elevated and a small pillow under the head.

If you miss a dose of Prenessa
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 the missed dose. If you have missed more than one dose, you should take the next dose as soon as possible and then continue taking the medicine as directed by your doctor.

Stopping Prenessa
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. Therefore, you should consult your doctor before stopping Prenessa.

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 everybody 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")(uncommon - may occur in up to 1 in 100 patients);
• severe dizziness or fainting due to low blood pressure (hypotension) (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 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; uncommon - may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe 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 liver inflammation (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.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• mood disturbances,
• sleep disorders,
• depression,
• dryness of the oral mucosa,
• intensified itching or severe skin rashes,
• formation of clusters of blisters on the skin,
• kidney function disorders,
• impotence,
• sweating,
• increased number of eosinophils (a type of white blood cells),
• 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, transient after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar) 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),
• decreased 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 pneumonia),
• inflammation of the nasal mucosa (nasal swelling or discharge),
• blood test abnormalities such as decreased number of white and red blood cells, decreased haemoglobin concentration, 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 of hands or feet (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 Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Prenessa

Keep this 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 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 (perindopril with erbumine). Each tablet contains 8 mg of perindopril with tert-butylamine (perindopril with erbumine), equivalent to 6.68 mg of perindopril.
• Other components: monohydrate lactose, microcrystalline cellulose (E 460), sodium hydrogen carbonate, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2 "Prenessa contains monohydrate lactose and sodium".

What Prenessa looks like and contents of the pack
Round, white, slightly biconvex tablets with bevelled edges and a dividing line on one side. The tablet can be divided into two equal parts.
Packaging: 30 tablets in PVC/PE/PVDC/Al blisters, 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.
ul. Równoległa 5
02-235 Warszawa
Poland

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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 58/405/08-C
Parallel Import Licence Number: 285/23