Arprenessa

Package leaflet: Information for the patient

Arprenessa, 5 mg, tablets
Arprenessa, 10 mg, tablets
Perindoprilum argininum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Arprenessa is and what it is used for
2. What you need to know before taking Arprenessa
3. How to take Arprenessa
4. Possible side effects
5. How to store Arprenessa
6. Contents of the pack and other information

1. What Arprenessa is and what it is used for

Arprenessa is an angiotensin-converting enzyme (ACE) inhibitor. It works by widening blood vessels, which helps the heart pump blood more easily.
Arprenessa 5 mg and 10 mg tablets are used:

• to treat high blood pressure (hypertension);
• to reduce the risk of cardiac 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 supply to the heart by widening the blood vessels (stable coronary artery disease is a condition in which blood supply to the heart is reduced or blocked).

Arprenessa 5 mg tablets are also used:

• to treat heart failure (a condition in which the heart is unable 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 to any other angiotensin-converting enzyme (ACE) inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
• if during previous treatment with an ACE inhibitor symptoms such as wheezing, facial swelling, swelling of the tongue or throat, severe itching or severe skin rash occurred, or if the patient or a family member has experienced such symptoms under other circumstances (a condition known as angioedema);
• if the patient is more than 3 months pregnant (it is also better to avoid using Arprenessa in early pregnancy - see section on pregnancy);
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or other blood filtration methods. Depending on the device used, Arprenessa may not be suitable for the patient;
• if the patient has kidney disorders causing reduced blood supply to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used in the treatment of heart failure, because this increases the risk of angioedema (rapid swelling of tissues under the skin around the throat) (see "Warnings and precautions" and "Arprenessa with other medicines").

Warnings and precautions
Before starting Arprenessa, discuss this with your doctor or pharmacist.

• the patient has been diagnosed with aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of arteries supplying blood to the kidneys);
• the patient has any other heart diseases;
• the patient has liver diseases;
• the patient has kidney diseases or is undergoing dialysis;
• the patient has abnormally increased levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-sodium diet or uses potassium-containing salt substitutes;
• the patient is undergoing anaesthesia and/or surgery;
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is undergoing allergen immunotherapy to reduce allergic reactions to bee or wasp stings;
• the patient has recently experienced diarrhoea 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 antagonists (ARBs) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disorders 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 take Arprenessa".
• patients of Black race have a higher risk of developing angioedema, and this medicine may be less effective in lowering blood pressure compared to patients of other races.
• if the patient is taking any of the following medicines, the risk of angioedema increases:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as mTOR inhibitors (used to prevent rejection of transplanted organs);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used in the treatment of chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group known as gliptins (used in the treatment of diabetes).

Angioedema
In patients treated with ACE inhibitors, including Arprenessa, cases of angioedema (a severe allergic reaction; symptoms include: swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, the patient should stop taking Arprenessa immediately and contact a doctor without delay. See also section 4.
The patient must inform the doctor if she thinks she is (or might be) pregnant. Arprenessa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used 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 with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Other medicines may affect treatment with Arprenessa. The treating doctor may need to adjust the dose and/or take additional precautions regarding medicines such as:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also information under "When not to take Arprenessa" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys);
• 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 clotting; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
• lithium used in the treatment of mania or depression;
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used for pain relief, or high doses of acetylsalicylic acid, a substance found in many medicines used for pain relief, fever reduction, and prevention of blood clots;
• medicines used in the treatment of diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotic medicines);
• immunosuppressive medicines (reducing the body's immune responses) used in the treatment of autoimmune disorders or after organ transplantation (e.g. cyclosporine, tacrolimus);
• trimethoprim (used to treat infections);
• estramustine (used in the treatment of cancer);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as mTOR inhibitors). See section "Warnings and precautions";
• combination medicine containing sacubitril and valsartan (used in the treatment of chronic heart failure). See sections "When not to take Arprenessa" and "Warnings and precautions";
• allopurinol (used in the treatment of gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
• gold salts, particularly when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Arprenessa with food and drink
It is recommended to take Arprenessa before meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient must inform her doctor if she thinks she is (or might be) pregnant. Usually, the doctor will recommend discontinuing Arprenessa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend using an alternative medicine instead of Arprenessa. Arprenessa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.

Breastfeeding
Inform the doctor if the patient is breastfeeding or starts breastfeeding. Arprenessa is not recommended for mothers who are breastfeeding. The doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

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

3. How to take Arprenessa

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

Hypertension
The usual starting and maintenance dose is 5 mg once daily. After one month of treatment, if necessary, the dose may be increased to 10 mg once daily.
The dose of 10 mg per day is the highest recommended dose for hypertension.
In patients aged 65 years or older, the usual starting dose is 2.5 mg once daily. After one month of treatment, the dose may be increased to 5 mg once daily, and subsequently, if necessary, to 10 mg once daily.

Heart failure
The usual starting dose is 2.5 mg once daily. After two weeks of treatment, the dose may be increased to 5 mg once daily. This is the highest recommended dose for heart failure.

Stable angina pectoris
The usual starting dose is 5 mg once daily. After two weeks of treatment, the dose may be increased to 10 mg once daily. This is the highest recommended dose for this indication.
In patients aged 65 years or older, the usual starting dose is 2.5 mg once daily. After one week of treatment, the dose may be increased to 5 mg once daily, and after another week, to 10 mg once daily.

Use in children and adolescents
Use in children and adolescents is not recommended.

Taking more Arprenessa than recommended
If you take too many tablets, contact your doctor or go to the nearest hospital emergency department immediately.
The most likely symptom of overdose is low blood pressure, which may cause dizziness and fainting. In such a case, it may help to lay the patient down with their legs raised.

If you miss a dose of Arprenessa
It is important to take the medicine regularly for optimal effectiveness. However, if you miss a dose, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.

Stopping Arprenessa
Since treatment with Arprenessa is long-term, you should consult your doctor before stopping the medication.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking this medicine and contact your doctor immediately if any of the following
side effects 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 caused by low blood pressure (common - may occur in up to 1 in 10 patients);
• extremely fast or irregular heartbeat, chest pain (angina) or heart attack (very rare - may occur in up to 1 in 10,000 patients);
• sudden weakness in the 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);
• inflammation of the pancreas, 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).

You should inform your doctor if any of the following side effects occur in the patient:
Common (may occur in up to 1 in 10 patients):

• headache,
• dizziness,
• vertigo (dizziness of labyrinthine origin),
• tingling and numbness,
• visual disturbances,
• tinnitus (sensation of hearing sounds),
• cough,
• shortness of breath,
• 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 (may occur in up to 1 in 100 patients):

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• severe itching or severe rash,
• formation of clusters of blisters on the skin,
• kidney function disorders,
• impotence,
• sweating,
• increase in eosinophils (a type of white blood cells),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• malaise,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high blood potassium levels, which resolve after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in patients with diabetes, increased blood urea levels, increased blood creatinine levels.

Rare (may occur in up to 1 in 1,000 patients):

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

Very rare (may occur in up to 1 in 10,000 patients):

• disorientation,
• eosinophilic pneumonia (a rare type of lung inflammation),
• rhinitis (nasal mucosa inflammation; swelling or nasal discharge),
• blood count abnormalities such as decreased number of white and red blood cells, decreased haemoglobin concentration, decreased platelet count.

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

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

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Arprenessa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Arprenessa contains

• The active substance is perindopril with arginine.
  Arprenessa 5 mg tablets: Each tablet contains 5 mg of perindopril arginine, equivalent to 3.395 mg of perindopril.
  Arprenessa 10 mg tablets: Each tablet contains 10 mg of perindopril arginine, equivalent to 6.790 mg of perindopril.
• Other ingredients are: calcium chloride dihydrate, microcrystalline cellulose, colloidal anhydrous 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 division line on both sides of the tablet. On one side of the tablet there is the imprint V1 (V is located on one side of the division line and 1 on the other side of the division line). Tablet dimensions: 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 imprint V2 on one side of the tablet. Tablet diameter: approximately 8 mm.
Arprenessa is available in cardboard boxes containing:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Krka - Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: + 48 22 573 75 00