Arprenessa

Leaflet accompanying the packaging: patient information

Arprenessa, 5 mg, tablets

Arprenessa, 10 mg, tablets

Perindopril arginine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have 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 their symptoms are the same as yours.
• 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 Arprenessa and what is it used for
• 2. Important information before taking Arprenessa
• 3. How to take Arprenessa
• 4. Possible side effects
• 5. How to store Arprenessa
• 6. Contents of the packaging and other information

1. What is Arprenessa and what is it used for

Arprenessa is an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by widening the blood vessels, making it easier for the heart to pump blood. Arprenessa, 5 mg and 10 mg, tablets are used:

• to treat high blood pressure (hypertension);
• to reduce the risk of heart events, such as heart attack in patients with stable coronary artery disease who have had a heart attack and/or a procedure to improve blood flow to the heart by widening the blood vessels supplying the heart (stable coronary artery disease is a condition where the blood flow to the heart is reduced or blocked).

Arprenessa, 5 mg, tablets are also used:

• to treat heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs).

2. Important information before taking Arprenessa

When not to take Arprenessa

• if the patient is allergic to perindopril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, swelling of the face, lips, tongue, or throat, intense itching, or severe skin rash during previous treatment with an ACE inhibitor, or if the patient or a family member has experienced such symptoms in other circumstances (a condition called angioedema);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Arprenessa in early pregnancy - see section on 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 using a different method. Depending on the device used, Arprenessa may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of the tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Arprenessa and other medicines").

Warnings and precautions

Before starting to take Arprenessa, the patient should discuss it with their doctor or pharmacist.

• the patient has aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the blood vessels supplying the kidneys);
• the patient has other heart diseases;
• the patient has liver diseases;
• the patient has kidney diseases or is undergoing dialysis;
• the patient has high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• the patient has collagenosis (a connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-sodium diet or is taking potassium-sparing diuretics;
• the patient is undergoing anesthesia and/or surgery;
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• the patient has recently experienced diarrhea or vomiting or is dehydrated;
• the patient has been diagnosed with intolerance to certain sugars;
• the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
• 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 Arprenessa".
• 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.
• if the patient is taking any of the following medicines, the risk of angioedema increases:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of transplanted organs);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema
Patients treated with ACE inhibitors, including Arprenessa, have reported angioedema (a severe allergic reaction; symptoms include 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 Arprenessa and contact their doctor immediately. See also section 4.
The patient must tell their doctor if they think they are (or may be) pregnant. Arprenessa is not recommended in early pregnancy and should not be taken if the patient is pregnant over 3 months, as the medicine may cause serious harm to the baby if taken during this period (see section on pregnancy).

Children and adolescents

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

Arprenessa 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.
Other medicines may affect the treatment with Arprenessa. The doctor may need to change the dose and/or take other precautions regarding such medicines as:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonist (ARB), aliskiren (see also the information under the heading "When not to take Arprenessa" and "Warnings and precautions") or diuretics;
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium preparations, 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 blood clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• lithium used to treat mania or depression;
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to relieve pain or high doses of acetylsalicylic acid, a substance found in many medicines, which relieves pain and fever and prevents blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics);
• immunosuppressive medicines (which reduce the body's immune response) used to treat autoimmune disorders or used after transplants (e.g., cyclosporine, tacrolimus);
• trimethoprim (used to treat bacterial infections);
• estramustine (used to treat cancer);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Arprenessa" and "Warnings and precautions".
• allopurinol (used to treat gout);
• procainamide (used to treat irregular heart rhythms);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis).

Arprenessa with food and drink

It is recommended to take Arprenessa before a meal.

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 must tell their doctor if they think they are (or may be) pregnant. Usually, the doctor will advise stopping Arprenessa before becoming pregnant or as soon as the patient finds out they are pregnant and will prescribe a different medicine instead of Arprenessa. Arprenessa is not recommended in early pregnancy and should not be taken if the patient is pregnant over 3 months, as the medicine may cause serious harm to the baby if taken during this period.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or about to start breastfeeding. Arprenessa is not recommended for breastfeeding mothers, and the doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Arprenessa usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. In such cases, the ability to drive or operate machines may be impaired.

3. How to take Arprenessa

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning before breakfast. The doctor will determine the appropriate dose for the patient.
Arprenessa, 5 mg, tablets
The tablet can be divided into equal doses.
The recommended doses are as follows:

Hypertension

Usually, the initial and maintenance dose is 5 mg, taken once a day. After one month of treatment, the dose may be increased to 10 mg taken once a day if necessary.
The dose of 10 mg per day is the maximum recommended dose for hypertension.
In patients over 65 years of age, the initial dose is usually 2.5 mg, taken once a day. After one month of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day if necessary.

Heart failure

Usually, the initial dose is 2.5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 5 mg taken once a day. This is the maximum recommended dose for heart failure.

Stable coronary artery disease

Usually, the initial dose is 5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 10 mg taken once a day. This is the maximum recommended dose for this indication.
In patients over 65 years of age, the initial dose is usually 2.5 mg, taken once a day. After one week of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day after another week.

Use in children and adolescents

The use of Arprenessa in children and adolescents is not recommended.

Taking a higher dose of Arprenessa than recommended

In case of taking too many tablets, the patient should contact their doctor or go to the hospital emergency department immediately. The most likely symptom of overdose is low blood pressure, which can cause dizziness and fainting. In such cases, it is helpful to lay the patient down with their legs elevated.

Missing a dose of Arprenessa

It is important to take the medicine regularly for it to work best. However, if a dose of Arprenessa is missed, the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Arprenessa treatment

Since treatment with Arprenessa is long-term, the patient should consult their doctor before stopping treatment.
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, Arprenessa 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:

any of the following serious side effects, which may be serious:

• 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 onset of 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 health (very rare - may affect up to 1 in 10,000 people);
• jaundice (yellowing of the skin or eyes), which may be a sign of liver inflammation (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).

The patient should tell their doctor if they experience any of the following side effects:

Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling or numbness,
• vision disturbances,
• tinnitus (ringing in the ears),
• cough,
• shortness of breath,
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting food, diarrhea, constipation),
• allergic reactions (such as rash, itching),
• muscle cramps,
• feeling of weakness.

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

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• intense 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 (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• poor general health,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.

Rare (may affect up to 1 in 1,000 people):

• exacerbation of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• reduced or absent urine production,
• sudden reddening of the face and neck,
• acute kidney failure.

Very rare (may affect up to 1 in 10,000 people):

• disorientation,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal mucositis (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.

Frequency not known (frequency cannot be estimated from the available data):

• cyanosis, numbness, and pain in the fingers of the hands or feet (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
Al. Jerozolimskie 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 Arprenessa

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
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. Contents of the packaging and other information

What Arprenessa contains

• The active substance of Arprenessa is perindopril arginine. Arprenessa, 5 mg, tablets Each tablet contains 5 mg of perindopril arginine, which corresponds to 3.395 mg of perindopril. Arprenessa, 10 mg, tablets Each tablet contains 10 mg of perindopril arginine, which corresponds to 6.790 mg of perindopril.
• The other ingredients are: calcium chloride hexahydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

What Arprenessa looks like and contents of the pack

Arprenessa, 5 mg, tablets
White or almost white capsule-shaped tablets with a dividing line on both sides of the tablet. On one side of the tablet, there is a marking V1 (V on one side of the dividing line and 1 on the other side of the dividing line). The tablet dimensions are approximately 8 mm x 5 mm. The tablet can be divided into equal doses.
Arprenessa, 10 mg, tablets
White or almost white round, biconvex tablets with the marking V2 on one side of the tablet. The tablet diameter is approximately 8 mm.
Arprenessa is available in cardboard boxes containing:

• 30, 60, or 90 tablets in blisters made of OPA/Aluminum/PVC/Aluminum foil.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of last revision of the leaflet: