Prenessa

Package Leaflet: Information for the User

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

Prenessa

8 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 necessary.
• In case of any doubts, you should 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 the symptoms of their illness 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. 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 reduce the risk of heart attacks, such as myocardial infarction, 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 heart surgery to improve blood flow to the heart.

2. Important information before taking Prenessa

When not to take Prenessa

• after the third month of pregnancy (it is also recommended to avoid taking Prenessa during early pregnancy - see "Pregnancy");

Warnings and precautions

Before starting to take Prenessa, you should discuss it with your doctor or pharmacist.
There is a possibility that Prenessa may not be suitable for you, or that you may need to be kept under regular medical supervision. For this reason, before starting to take Prenessa, you should tell your doctor if:

• you have narrowing of the aorta (the main blood vessel leading from the heart), enlargement of the heart muscle, or problems with the heart valves;
• you have narrowing of the artery that supplies blood to the kidney (renal artery stenosis);
• you have an increased level of a hormone called aldosterone in your blood (primary aldosteronism);
• you have diabetes;
• you have other kidney, liver, or heart problems;
• you are undergoing haemodialysis or have recently had a kidney transplant;
• you have 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 diarrhoea, or are taking diuretics (water tablets);
• you are taking lithium (a medicine used to treat mania or depression);
• you are taking potassium supplements or salt substitutes that contain potassium;
• you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information under "When not to take Prenessa" and "Warnings and precautions".
• you are taking any of the following medicines, which may increase the risk of angioedema (rapid swelling of tissues under the skin, such as the throat):
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus, and other medicines known as mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• wildagliptin (a medicine used to treat diabetes).
• if you are black, there is a higher risk of angioedema, and Prenessa may be less effective in lowering blood pressure than in patients of other races.

Angioedema
Angioedema has been reported in patients taking ACE inhibitors, including Prenessa. This reaction may occur at any time during treatment. If you experience any of these 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 to become pregnant. It is not recommended to take Prenessa during early pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
You should immediately inform your doctor if you experience any of the following symptoms:

• dizziness after taking the first dose. Some patients may react to the first dose or to an increase in the dose of Prenessa with dizziness, weakness, fainting, and nausea;
• fever, sore throat, or mouth ulcers (which may be signs of an infection caused by a low 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. Cough is a side effect reported with ACE inhibitors, but it may also be a sign of a respiratory infection.

At the start of treatment and/or when adjusting the dose, 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 that you are taking Prenessa:

Children and adolescents

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

Prenessa and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
You should not take medicines available without a prescription without consulting your doctor. This is especially important for:

• medicines used to treat colds, which contain pseudoephedrine or phenylephrine as active substances;
• painkillers, including aspirin;
• potassium supplements and salt substitutes that contain potassium.

You should inform your doctor if you are taking any of the following medicines, to ensure that it is safe to take Prenessa:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics;
• vasodilators, including nitrates;
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium, and other medicines that may increase potassium levels in the body (such as heparin, trimethoprim/sulfamethoxazole, cyclosporin, or tacrolimus);
• 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 irregular heart rhythms (procainamide);
• medicines used to treat diabetes (insulin or oral antidiabetic medicines such as wildagliptin);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medicines used to treat gout (allopurinol);
• non-steroidal anti-inflammatory medicines (NSAIDs, such as ibuprofen, diclofenac), including aspirin used as a painkiller;
• 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 disorders, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotic medicines);
• gold injections used to treat arthritis (sodium aurothiomalate);
• medicines used to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See "Warnings and precautions".

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

Prenessa with food, drink, and alcohol

Prenessa should be taken before a meal, to reduce the effect of food on the medicine.
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 are planning 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 to become pregnant. Your doctor will usually recommend stopping Prenessa before a planned pregnancy or as soon as possible after confirmation of pregnancy, and will recommend an alternative medicine.
Prenessa should not be taken during early pregnancy and must 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. Prenessa should not be taken during breastfeeding, especially during breastfeeding of a newborn or premature baby. Your doctor may recommend an alternative medicine.

Driving and using machines

You should not drive or operate machinery until you know how Prenessa affects you.
Prenessa usually does not affect alertness, but some patients may experience dizziness or weakness related to low blood pressure, especially at the start of treatment or when taking other blood pressure-lowering medicines. Therefore, your ability to drive or operate machinery may be impaired.

Prenessa contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking Prenessa.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Prenessa

This medicine should always be taken exactly as directed 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) once daily. If necessary, after one month of treatment, your doctor may increase the dose to 8 mg of perindopril (one 8 mg Prenessa tablet or two 4 mg Prenessa tablets) 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 4 mg Prenessa tablet) once daily; if the medicine is well tolerated, your doctor may increase the dose to 8 mg of perindopril (one 8 mg Prenessa tablet or two 4 mg Prenessa tablets) once daily.
The tablet should be swallowed with a glass of water, preferably at the same time each day, in the morning, before breakfast.
During treatment, your doctor will adjust the dose according to the results of the treatment and your needs.
Kidney problems
Your doctor may recommend taking a lower dose.
Liver problems
No dose adjustment is necessary.
Elderly patients
The dosage recommendations for elderly patients depend on kidney function. Your doctor will determine the duration of treatment, depending on your 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, perindopril is not recommended for use in children and adolescents.
If you feel that the effect of Prenessa is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Prenessa

If you have taken more than the prescribed dose of Prenessa, 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 forceful heartbeat (palpitations), rapid or 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 have missed more than one dose, you should take the next dose as soon as possible and continue taking the medicine as directed by your doctor.

Stopping treatment with Prenessa

Stopping treatment may cause blood pressure to rise again, which increases the risk of complications related to high blood pressure, particularly affecting the heart, brain, and kidneys. Therefore, before stopping Prenessa, you should consult your doctor.
If you have any further questions 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 Prenessa 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 fast 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 and very bad 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 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:

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 (paraesthesia),
• vision disturbances,
• ringing in the ears (tinnitus),
• cough,
• shortness of breath (dyspnoea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhoea, 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,
• dryness of the 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,
• photosensitivity reactions (increased sensitivity of the skin to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• bad general condition,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycaemia (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 the blood,
• worsening of psoriasis,
• SIADH (inappropriate antidiuretic hormone secretion), which may cause symptoms such as dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures,
• reduced 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 congestion or discharge (rhinitis),
• blood test abnormalities, such as decreased white blood cell count, decreased red blood cell count, decreased haemoglobin level, 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 the 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. You can also report side effects directly to the national reporting system:
Department for Monitoring of Adverse Reactions to 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
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 kept 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 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 (perindopril erbumine). Each tablet contains 8 mg of perindopril tert-butylamine (perindopril erbumine), which corresponds to 6.68 mg of perindopril.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E 460), sodium hydrogen carbonate, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2 "Prenessa contains lactose and sodium".

What Prenessa looks like and contents of the pack

Round, white, slightly convex tablets with a score line on one side. The tablet can be divided into two equal doses.
Packaging: 30 tablets in PVC/PE/PVDC/Al blisters in a cardboard box.
For more detailed information, you should consult the marketing authorisation holder or the parallel importer.

Marketing authorisation 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.
Równoległa 5
02-235 Warsaw
Poland

Parallel importer:

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

Repackaged by:

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

Marketing authorisation number in the Czech Republic, the country of export: 58/405/08-C

Parallel import authorisation number: 285/23

Date of approval of the leaflet: 13.12.2023

[Information about the trademark]