Prenessa

Leaflet attached to the packaging: patient information

Prenessa, 4 mg, tablets

tert-Butylamine perindopril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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. Package contents 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 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 heart attack and/or a procedure to improve blood flow to the heart, by dilating the blood vessels that supply it.

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 another ACE inhibitor;
• if the patient has experienced a hypersensitivity reaction with sudden swelling of the lips and face, neck, and possibly also swelling of the hands and feet or difficulty breathing or wheezing (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in the patient's family or in the patient under 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/valsartan, a medicine used to treat a certain type of long-term (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, discuss it with your doctor or pharmacist.
There is a possibility that Prenessa is not suitable for the patient or that its use requires regular medical supervision. For this reason, before starting to take Prenessa, the patient should inform their doctor if:

• they have aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy or heart valve problems;
• they have renal artery stenosis (narrowing of the blood vessel supplying the kidney);
• they have primary aldosteronism (a condition characterized by excessive production of a hormone called aldosterone);
• they have diabetes;
• they have other kidney, liver, or heart diseases;
• they are undergoing hemodialysis or have recently had a kidney transplant;
• they have collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• they are on a low-salt diet or have severe vomiting or diarrhea or are taking diuretics (medicines that increase urine production);
• they are taking lithium (a medicine used to treat mania or depression);
• they are taking potassium supplements or potassium-sparing salt substitutes;
• they are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonists (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic nephropathy,
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Prenessa:".
• they 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 transplant rejection and treat cancer)
• wildagliptin (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
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 the patient experiences such symptoms, they should stop taking Prenessa and contact their doctor immediately. See also section 4.
The patient should inform their doctor about suspected or planned 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 fetus (see section "Pregnancy").
The patient should immediately inform their doctor if they experience any of the following symptoms:

• dizziness after taking the first dose. Some patients may 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 white blood cell count);
• 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 ACE inhibitor treatment, but it may also be a sign of upper respiratory tract disease.

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

To avoid possible complications during treatment with Prenessa, the patient should inform their doctor about taking Prenessa:

• if the patient is to undergo anesthesia and/or surgery (even dental surgery);
• if the patient is to undergo allergy treatment for bee or wasp venom (desensitization);
• 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take over-the-counter medicines without consulting their 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 preparations and potassium-sparing salt substitutes.

The patient should inform their doctor about taking any of the following medicines to ensure that concurrent use of Prenessa is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics;
• vasodilators, including nitrates (medicines that cause blood vessels to dilate);
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium preparations, or potassium-sparing salt substitutes, 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 transplant rejection);
• 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 wildagliptin);
• 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 prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other medicines belonging to the so-called mTOR inhibitors). See section "Warnings and precautions".

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

• if the patient is 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. The patient should discuss with their doctor the possibility of consuming alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about suspected or planned pregnancy. The doctor will usually advise stopping Prenessa before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Prenessa.
Prenessa should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

The patient should inform their doctor about breastfeeding or intending to breastfeed. Prenessa should not be taken during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.

Driving and using machines

The patient should not drive or operate machinery until they know how they 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 machinery may be impaired.

Prenessa contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their 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 the doctor or pharmacist. If the patient has any doubts, they should consult their 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) 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) 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) 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 initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril (one 4 mg Prenessa tablet) once daily; if the medicine is well tolerated, the doctor may increase the dose to 8 mg of perindopril (two 4 mg Prenessa tablets) 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, the doctor will adjust the dose according to the treatment results and the patient's needs.
Kidney problems
The doctor may recommend taking the medicine in a lower dose.
Liver problems
Dose adjustment is not necessary.
Elderly patients
In elderly patients, the dosage recommendations depend on kidney function.
The doctor will determine the duration of treatment, depending on the patient's health condition.

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 the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Prenessa

In case of overdose, the patient should immediately consult their 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 and/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 a dose is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for a missed dose. If more than one dose is missed, the next dose should be taken as soon as possible, and the patient should 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, particularly affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen, to the point of requiring hospitalization. Therefore, before stopping Prenessa, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Prenessa can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and contact their doctor immediately if they 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 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 disease (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy patches 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 of occurrence:
Common side effects (may affect up to 1 in 10 people):

• headache,
• dizziness,
• feeling of spinning (vertigo),
• tingling or numbness of 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 rash, itching),
• muscle cramps,
• feeling of weakness.

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

• mood disturbances,
• sleep disturbances,
• depression,
• dry mouth,
• increased itching or severe rash,
• formation of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• reactions to sunlight (increased skin sensitivity to the sun),
• 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) in diabetic patients, 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,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• 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),
• inflammation of the nasal mucosa (swelling or discharge from the nose),
• blood test changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count.

If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.
Frequency not known (frequency cannot be estimated from the available data):

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the 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 after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
Store in the original packaging. Store at a temperature not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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, colloidal anhydrous silica, magnesium stearate (E 572). See section 2 "Prenessa contains lactose and sodium".

What Prenessa looks like and contents of the pack

White, oblong, 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

Marketing authorization holder

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

Manufacturer

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of medicines in other European Economic Area member states, the patient should contact the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:01.11.2021