Prenessa

Package Leaflet: Information for the Patient

Prenessa, 8 mg, Tablets

tert-Butylamine perindopril

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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

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 heart attacks, in patients with stable coronary artery disease (a condition where blood flow to the heart is reduced or blocked) and in patients who have had a heart attack and/or undergone surgery to improve blood flow to the heart, by widening the blood vessels that supply the heart.

2. Important information before taking Prenessa

When not to take Prenessa

• if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors;
• if you have ever had a reaction called angioedema (a severe allergic reaction with symptoms such as swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing) after taking an ACE inhibitor;
• if you have had angioedema in the past, or if it has occurred in your family;
• after the third month of pregnancy (it is also recommended to avoid taking Prenessa during early pregnancy - see section "Pregnancy");
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are undergoing dialysis or having your blood filtered using a machine. Depending on the machine used, Prenessa may not be suitable for you;
• if you have severe kidney disease, which reduces blood flow to the kidneys (renal artery stenosis);
• if you have taken or are 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, such as in the throat) is increased.

Warnings and precautions

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

• you have a narrowing of the aorta (the main blood vessel that carries blood from the heart), an enlarged heart muscle, or heart valve problems;
• you have a narrowing of the artery that supplies the kidney with blood (renal artery stenosis);
• you have an excessive amount of a hormone called aldosterone in your blood (primary aldosteronism);
• you have diabetes;
• you have other kidney, liver, or heart problems;
• you are undergoing hemodialysis or have recently had a kidney transplant;
• you have a disease called 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 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 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 tissues under the skin, such as in the throat):
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines that belong to the so-called mTOR inhibitors (used to prevent the rejection of a transplanted organ and to treat cancer)
• wildagliptin (a medicine used to treat diabetes).
• if you are black, 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 you experience such symptoms, 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 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 may react to the first dose or an increase in the dose of the medicine with dizziness, weakness, fainting, and nausea;
• fever, sore throat, or mouth ulcers (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 during treatment with ACE inhibitors, but it may also be a sign of a respiratory disease.

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

To avoid possible complications during treatment with Prenessa, inform your doctor about taking Prenessa:

• if you are to be anesthetized and/or undergo surgery (even dental surgery);
• if you are to undergo allergy treatment (desensitization) for bee or wasp stings;
• 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 18 years of age is not recommended.

Prenessa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take medicines available without a prescription without consulting your doctor. This is especially important 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 salt substitutes containing potassium.

Inform your doctor about taking any of the following medicines to ensure that concurrent use with 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 supplements, or salt substitutes containing potassium, 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 sulfamethoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine or tacrolimus, an immunosuppressive medicine used to prevent organ 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 irregular heart rhythms (procainamide);
• medicines used to treat diabetes (insulin or oral antidiabetic 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 disorders, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotic medicines);
• gold injections for the treatment of arthritis (sodium aurothiomalate);
• medicines used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus, or other 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 blocker (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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Inform your doctor if you suspect or plan to become pregnant. Your doctor will usually advise you to stop taking Prenessa before planned pregnancy or as soon as possible after confirmation of pregnancy and 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

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

Do 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 beginning of treatment or when taking other blood pressure-lowering medicines. Therefore, the 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, 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

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask 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 a day. 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) taken once a day, 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) taken once a day; 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) taken once a day.
Swallow the tablet 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 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 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 you feel that the effect of Prenessa is too strong or too weak, consult your doctor or pharmacist.

Overdose of Prenessa

If you have taken more than the prescribed dose of Prenessa, 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: 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, take the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you forget to take more than one dose, take the next dose as soon as possible and continue taking the medicine as prescribed by your doctor.

Stopping treatment with Prenessa

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. Therefore, before stopping Prenessa, consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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 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);
• a 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:

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 disturbances (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,
• dryness of the mucous membranes 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,
• reactions to sunlight (increased sensitivity of the skin 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 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 (nasal mucositis),
• blood test abnormalities, 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, 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 those not listed in this leaflet, please inform your 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, you can help 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 after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Store in the original packaging to protect from moisture. Store below 30°C.
Medicines should 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 pack and other information

What Prenessa contains

• The active substance is perindopril tert-butylamine. Each tablet contains 8 mg of perindopril tert-butylamine, 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 572). See section 2 "Prenessa contains lactose and sodium".

What Prenessa looks like and contents of the pack

Round, white, slightly convex tablets with beveled edges, with a score line on one side. The tablet can be divided into two equal halves.
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 Warszawa
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of the medicines in other European Economic Area countries, contact the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Phone: 22 57 37 500
Date of last revision of the leaflet:01.01.2023