Coarprenessa

Package leaflet: Information for the patient

CoArprenessa, 5 mg + 1.25 mg, tablets
CoArprenessa, 10 mg + 2.5 mg, tablets
Perindoprilum argininum + Indapamidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What CoArprenessa is and what it is used for

What CoArprenessa is
CoArprenessa is a combination medicine containing two active substances: perindopril and indapamide. CoArprenessa is an antihypertensive medicine used to treat high blood pressure (hypertension) in adults.

What CoArprenessa is used for
Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These medicines work by widening blood vessels, which helps the heart pump blood more easily. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. Indapamide differs from other diuretics in that it increases urine output only slightly. Both active substances lower blood pressure and work together to help normalize the patient's blood pressure.

CoArprenessa, 10 mg + 2.5 mg, tablets
CoArprenessa medicine is prescribed for patients already receiving 10 mg of perindopril and 2.5 mg of indapamide as separate tablets. These patients may instead receive one tablet of CoArprenessa containing both components.

2. Important information before taking CoArprenessa

When not to take CoArprenessa

• if the patient is allergic to perindopril or other ACE inhibitors, to indapamide or other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes during prior treatment with an ACE inhibitor, or if such symptoms occurred in the patient or a blood relative under any circumstances (a condition known as angioedema);
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver damage);
• if the patient has severe kidney disease causing reduced blood flow to the kidneys (renal artery stenosis);
• severe kidney impairment (creatinine clearance below 30 ml/min);
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, CoArprenessa may not be suitable for the patient;
• if the patient has low potassium levels in the blood;
• if the patient is suspected of having untreated, decompensated heart failure (marked fluid retention, breathing difficulties);
• if the patient is more than 3 months pregnant (it is also better to avoid using CoArprenessa in early pregnancy – see "Pregnancy");
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure (see "Warnings and precautions" and "CoArprenessa with other medicines").

Applies only to CoArprenessa 10 mg + 2.5 mg tablets:

• moderate kidney impairment (creatinine clearance below 60 ml/min).

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

• if the patient has aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• if the patient has heart failure or any other heart conditions;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• if the patient has liver disease;
• if the patient has a collagen vascular disease such as systemic lupus erythematosus or scleroderma;
• if the patient has atherosclerosis (hardening of the arteries);
• if the patient has hyperparathyroidism (overactive parathyroid glands);
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or using potassium-containing salt substitutes;
• if the patient is taking lithium or potassium-sparing medicines (spironolactone, triamterene), or potassium supplements – these should be avoided while taking CoArprenessa (see "CoArprenessa with other medicines");
• if the patient is elderly;
• if the patient has previously experienced photosensitivity reactions;
• if the patient develops a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema) – swelling may occur at any time during treatment. If such symptoms occur, treatment must be stopped immediately and medical advice sought without delay;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to take CoArprenessa".
• if the patient is of Black race – in such cases, there may be a higher risk of angioedema and the medicine may be less effective in lowering blood pressure compared to patients of other races;
• if the patient is undergoing dialysis using high-flux membranes;
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs known as 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.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including CoArprenessa. This reaction may occur at any time during treatment. If such symptoms occur, stop taking CoArprenessa immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. CoArprenessa is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the unborn child (see "Pregnancy and breastfeeding").
While taking CoArprenessa, you should also inform your doctor or medical staff:

• if you develop a dry cough;
• if you are to undergo anaesthesia and/or surgery;
• if you have recently had diarrhoea or vomiting, or have been dehydrated;
• if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is planned;
• if desensitisation treatment is planned to reduce allergic reactions to bee or wasp stings;
• if a diagnostic test requiring an iodine-containing contrast agent (a substance used to visualise organs such as the kidney or stomach in X-ray imaging) is to be performed;
• if you experience vision disturbances or pain in one or both eyes during treatment with CoArprenessa. These may be signs of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or glaucoma, increased pressure in one or both eyes – which may occur from several hours to several weeks after taking CoArprenessa. If untreated, these may lead to permanent vision loss. Patients with a history of allergy to penicillin or sulfonamides may be at higher risk of such reactions. Stop taking CoArprenessa and consult your doctor immediately.

Athletes should be aware that CoArprenessa contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
CoArprenessa must not be used in children and adolescents.
CoArprenessa with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Avoid using CoArprenessa with:

• lithium (used to treat mania or depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney impairment;
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole);
• estramustine (used to treat cancer);
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take CoArprenessa" and "Warnings and precautions";
• other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with CoArprenessa. Your doctor may recommend dose adjustments and/or additional precautions. Inform your doctor if you are taking any of the following medicines, as special caution may be required:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections "When not to take CoArprenessa" and "Warnings and precautions"), or diuretics (medicines that increase urine output by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
• 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 of mTOR inhibitors). See section "Warnings and precautions".
• anaesthetic agents;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, intravenous erythromycin);
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• anticancer medicines (cytostatics);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine, astemizole);
• corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• immunosuppressive medicines used to treat autoimmune diseases or to prevent organ rejection after transplantation (e.g. cyclosporine, tacrolimus);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• injectable gold salts (used to treat rheumatoid arthritis);
• vinpocetine (used to treat cognitive disorders in elderly patients, including memory loss);
• bepridil (used to treat angina pectoris);
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used in heart diseases);
• baclofen (used to treat muscle stiffness occurring in conditions such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. senna);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid);
• intravenous amphotericin B (used to treat severe fungal infections);
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• tetracosactide (used to treat Crohn's disease);
• trimethoprim (used to treat infections);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

CoArprenessa with food and drink
It is recommended to take CoArprenessa before a meal.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will usually advise stopping CoArprenessa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
CoArprenessa is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the unborn child.
Breastfeeding
CoArprenessa is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you intend to breastfeed, especially if the baby is a newborn or was born prematurely. Contact your doctor immediately.
Driving and operating machinery
CoArprenessa usually does not affect alertness; however, some patients may experience side effects such as dizziness or weakness due to lowered blood pressure. In such cases, the ability to drive or operate machinery may be impaired.
CoArprenessa contains sodium
CoArprenessa contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take CoArprenessa

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose of CoArprenessa 5 mg + 1.25 mg tablets is one tablet once daily.
The usual dose of CoArprenessa 10 mg + 2.5 mg tablets is one tablet once daily.
Your doctor may decide to adjust the dosage if you have kidney disease.
The tablet should preferably be taken in the morning, before a meal. Swallow the tablet whole with
a glass of water.
CoArprenessa 5 mg + 1.25 mg tablets
The tablet may be divided into equal doses.
Taking more CoArprenessa than prescribed
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
The most common symptom of overdose is low blood pressure. If significantly low blood pressure occurs (accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, or changes in urine output), lying down with your legs raised may help.
Missing a dose of CoArprenessa
It is important to take the medicine every day, as regular use is most effective.
However, if you miss a dose of CoArprenessa, take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.
Stopping CoArprenessa
Treatment for high blood pressure is usually long-term, so you should discuss with your doctor before stopping this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following adverse reactions, which may be
serious, treatment with this medicine must be discontinued and immediate contact with a physician is required:

• Severe dizziness or fainting due to low blood pressure (common – may occur in up to 1 in 10 patients);
• Bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath; uncommon – may occur in up to 1 in 100 patients);
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema, see section “Warnings and precautions” in section 2); uncommon – may occur in up to 1 in 100 patients;
• Severe skin reactions, including erythema multiforme (skin rash often starting with red, itchy spots on the face, arms or legs), or severe skin rash, urticaria, redness of the entire body, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in up to 1 in 10,000 patients);
• Cardiovascular disorders (heart rhythm disturbances, angina pectoris (chest pain radiating to the jaw and back, caused by physical exertion), myocardial infarction; very rare – may occur in up to 1 in 10,000 patients);
• Weakness of arms or legs, or speech disturbances, which may be signs of stroke (very rare – may occur in up to 1 in 10,000 patients);
• Pancreatitis, 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 hepatitis (very rare – may occur in up to 1 in 10,000 patients);
• Life-threatening heart rhythm disturbances (frequency unknown);
• Brain disease caused by liver disease (hepatic encephalopathy; frequency unknown);
• Muscle weakness, cramps, tenderness or muscle pain, particularly when the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Adverse reactions, grouped by decreasing frequency of occurrence, may include:
Common (may occur in up to 1 in 10 patients):

• Skin reactions in patients predisposed to allergic or asthmatic reactions, headache, central dizziness, labyrinthine dizziness, prickling and tingling sensations, visual disturbances, tinnitus (perception of ringing sounds), cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue, low blood potassium levels.

Uncommon (may occur in up to 1 in 100 patients):

• Mood swings, sleep disturbances, depression, urticaria, purpura (small red spots on the skin), clusters of blisters, kidney disorders, impotence (inability to achieve or maintain an erection), excessive sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high blood potassium levels (which may resolve after discontinuation of treatment), low blood sodium levels (which may cause dehydration and low blood pressure), drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heart rate), hypoglycaemia (very low blood sugar levels) in diabetic patients, vasculitis, dryness of the oral mucosa, photosensitivity reactions (increased skin sensitivity to sunlight), joint pain, muscle pain, chest pain, malaise, peripheral oedema, fever, increased blood urea levels, increased blood creatinine levels, falls.

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

• Worsening of psoriasis, changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels; fatigue, reduced or absent urine output, sudden redness of the face and neck, acute kidney failure,
• 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),
• Low blood chloride levels, low blood magnesium levels.

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

• Disorientation, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (nasal congestion or runny nose), blood test abnormalities such as reduced white blood cell count and red blood cell count, reduced haemoglobin levels, reduced platelet count, high blood calcium levels, liver function disturbances.

Frequency unknown (cannot be estimated from available data):

• Abnormal heart function detected on ECG, changes in laboratory test results: high blood uric acid levels and high blood glucose levels, myopia, blurred vision, visual disturbances, worsening vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma), cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon).
• If the patient has systemic lupus erythematosus (a type of collagenosis), symptoms of the disease may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory test results (blood tests) may occur.
Your doctor may recommend blood tests to monitor your health status.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store CoArprenessa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation:
"EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What CoArprenessa contains

• The active substances are perindopril with arginine and indapamide.
  CoArprenessa 5 mg + 1.25 mg tablets: One tablet contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril) and 1.25 mg of indapamide.
  CoArprenessa 10 mg + 2.5 mg tablets: One tablet contains 10 mg of perindopril arginine (equivalent to 6.790 mg of perindopril) and 2.5 mg of indapamide.
• Other ingredients are: calcium chloride dihydrate, microcrystalline cellulose, microcrystalline cellulose siliconised type 90, pregelatinised maize starch, sodium hydrogen carbonate, colloidal anhydrous silica, and magnesium stearate. See section 2 "CoArprenessa contains sodium".

What CoArprenessa looks like and contents of the pack
CoArprenessa 5 mg + 1.25 mg tablets
White or almost white capsule-shaped tablets, with a division line on both sides of the tablet. On one side of the division line is the marking "A", and on the other side of the division line is the marking "1". Tablet dimensions: approximately 8 mm x 5 mm.
The tablet can be divided into equal doses.
CoArprenessa 10 mg + 2.5 mg tablets
White or almost white, round, biconvex tablets with the imprint "A2" on one side. Tablet dimensions: diameter approximately 8 mm.
CoArprenessa is available in blister packs containing 10, 30, 60, 90, or 100 tablets per cardboard box.
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 information on this medicinal product, please contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: +48 22 573 75 00