Coarprenessa

Leaflet accompanying the packaging: patient information

CoArprenessa, 5 mg + 1.25 mg, tablets

CoArprenessa, 10 mg + 2.5 mg, tablets

Perindopril arginine+ Indapamide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, 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 is CoArprenessa and what is it 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 packaging and other information

1. What is CoArprenessa and what is it used for

What is CoArprenessa

CoArprenessa is a combination medicine that contains two active substances: perindopril and indapamide. CoArprenessa is an antihypertensive medicine used to treat high blood pressure in adults.

What is CoArprenessa used for

Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These medicines work by widening the blood vessels, making it easier for the heart to pump blood. Indapamide is a diuretic. Diuretics increase the amount of urine excreted by the kidneys. Indapamide differs from other diuretics in that it only slightly increases urine excretion. Both active substances lower blood pressure and work together to normalize the patient's blood pressure.
CoArprenessa, 10 mg + 2.5 mg, tablets
CoArprenessa is prescribed to patients who are already taking 10 mg of perindopril and 2.5 mg of indapamide in separate tablets; these patients can receive one tablet of CoArprenessa instead, which contains both ingredients.

2. Important information before taking CoArprenessa

When not to take CoArprenessa

• if you are 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 you have had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash when taking an ACE inhibitor in the past, or if you have had such symptoms in any other circumstances (a condition called angioedema);
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you have severe liver disease or a condition called hepatic encephalopathy (a disease that damages the brain);
• if you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• severe kidney problems (creatinine clearance below 30 ml/min);
• if you are undergoing dialysis or blood filtration using a different method. Depending on the device used, CoArprenessa may not be suitable for you.
• if you have low potassium levels in your blood;
• if you have untreated or uncontrolled heart failure (severe water retention in the body, difficulty breathing);
• if you are pregnant more than 3 months (it is also recommended to avoid taking CoArprenessa in early pregnancy - see "Pregnancy");
• if you have taken or are taking a combination medicine containing sacubitril and valsartan, used to treat heart failure (see "Warnings and precautions" and "CoArprenessa with other medicines").

Only for CoArprenessa, 10 mg + 2.5 mg, tablets:

• mild kidney problems (creatinine clearance below 60 ml/min).

Warnings and precautions

Before taking CoArprenessa, discuss it with your doctor or pharmacist.

• if you have a narrowing of the aortic valve (narrowing of the main blood vessel that carries blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle), or narrowing of the renal artery (narrowing of the blood vessel that supplies blood to the kidney);
• if you have heart failure or any other heart disease;
• if you have kidney disease or are undergoing dialysis;
• if you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism);
• if you have liver disease;
• if you have a collagen disease (a skin disease), such as systemic lupus erythematosus or scleroderma;
• if you have atherosclerosis (hardening of the arteries);
• if you have hyperparathyroidism (overactive parathyroid gland);
• if you have gout;
• if you have diabetes;
• if you are on a low-salt diet or using salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (such as spironolactone, triamterene), or potassium supplements - you should avoid taking these medicines while taking CoArprenessa (see "CoArprenessa with other medicines");
• if you are elderly;
• if you have had allergic reactions to light;
• if you have had a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema) - swelling may occur at any time during treatment. If such symptoms occur, you should stop taking CoArprenessa and consult a doctor immediately;
• if you are 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 you have kidney problems related to diabetes;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood. See also the subsection "When not to take CoArprenessa".
• if you are black - in this case, there may be a higher risk of angioedema and the medicine may be less effective in lowering blood pressure than in patients of other races;
• if you are undergoing dialysis using high-flux membranes;
• if you are taking any of the following medicines, which increase the risk of angioedema:
• 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.

Angioedema
Patient's treated with ACE inhibitors, including CoArprenessa, have reported angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This reaction may occur at any time during treatment. If you experience such symptoms, you should stop taking CoArprenessa and consult a doctor immediately. See also section 4.
You should tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. CoArprenessa is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see "Pregnancy and breastfeeding").
If you are taking CoArprenessa, you should also inform your doctor or medical staff:

• if you have a dry cough,
• if you are going to have anesthesia and/or surgery;
• if you have recently had diarrhea or vomiting, or have been dehydrated;
• if you are going to have dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if you are going to have desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if you are going to have a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray);
• if you experience vision disturbances or pain in one or both eyes while taking CoArprenessa. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma, increased pressure in one or both eyes - they may occur within a few hours to a few weeks after taking CoArprenessa. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of such a reaction. You should stop taking CoArprenessa and consult a doctor.

Athletes should be aware that CoArprenessa contains an active substance (indapamide) that may cause a positive doping test result.

Children and adolescents

CoArprenessa should not be used in children and adolescents.

CoArprenessa with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take 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 problems;
• potassium-sparing diuretics (such as 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: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect treatment with CoArprenessa. Your doctor may recommend a dose change and/or take other precautions. Tell your doctor if you are taking any of the following medicines, as special precautions may be necessary:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA) or aliskiren (see also sections "When not to take CoArprenessa" and "Warnings and precautions"), or diuretics (medicines that increase urine excretion);
• 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 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";
• anesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (such as moxifloxacin, sparfloxacin, erythromycin given by injection);
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• medicines used to treat cancer (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 diseases, including severe asthma and rheumatoid arthritis;
• immunosuppressive medicines used to treat autoimmune diseases or after organ transplantation to prevent rejection (e.g., cyclosporine, tacrolimus);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold salts given by injection (used to treat rheumatoid arthritis);
• vinkamine (used to treat cognitive impairment in the elderly, 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 to treat heart disease);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (e.g., senna);
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid);
• amphotericin B given by injection (used to treat severe fungal infections);
• medicines used to treat mental 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Usually, your doctor will advise you to stop taking CoArprenessa before becoming pregnant or as soon as you find out you are pregnant, and will prescribe a different medicine instead of CoArprenessa.
CoArprenessa is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.
Breastfeeding
CoArprenessa is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you intend to breastfeed, especially if your baby is a newborn or premature. You should consult your doctor immediately.

Driving and using machines

CoArprenessa does not normally affect alertness, however, 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.

CoArprenessa contains sodium

CoArprenessa contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take CoArprenessa

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 dose of CoArprenessa, 5 mg + 1.25 mg, tablets is one tablet once a day.
The usual dose of CoArprenessa, 10 mg + 2.5 mg, tablets is one tablet once a day.
Your doctor may decide to adjust the dose in case of kidney disease.
The tablet should be taken preferably in the morning, before a meal. The tablet should be swallowed with a glass of water.
CoArprenessa, 5 mg + 1.25 mg, tablets
The tablet can be divided into equal doses.

If you take more CoArprenessa than you should

If you have taken too many tablets, contact your doctor or go to the emergency department of your nearest hospital immediately. The most common symptom of overdose is low blood pressure. If you experience severe low blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine excretion), lying down with your legs raised may help.

If you forget to take CoArprenessa

It is important to take your medicine every day, as regular treatment is most effective.
If you miss a dose of CoArprenessa, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking CoArprenessa

Treatment of high blood pressure is usually long-term, so before stopping this medicine, discuss it with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking CoArprenessa and contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath; uncommon - may affect up to 1 in 100 people);
• swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing (angioedema, see section "Warnings and precautions"); uncommon - may affect up to 1 in 100 people;
• severe skin reactions, including erythema multiforme (a skin rash often starting with red, itchy patches on the face, arms, or legs), severe skin rash, hives, redness of the skin, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may affect up to 1 in 10,000 people);
• cardiovascular disorders (heart rhythm disorders, angina pectoris, heart attack; very rare - may affect up to 1 in 10,000 people);
• weakness or paralysis of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may affect up to 1 in 10,000 people);
• pancreatitis, which may cause severe abdominal pain 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 symptom of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• life-threatening heart rhythm disorders (frequency not known);
• brain disease caused by liver disease (hepatic encephalopathy; frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects are listed below by frequency:

• Common (may affect up to 1 in 10 people):
• skin reactions in patients with a tendency to allergic and asthmatic reactions, headache, dizziness of central origin, dizziness of labyrinthine origin, feeling of tingling and numbness, vision disturbances, tinnitus (feeling of hearing sounds), cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of tiredness, low potassium levels in the blood.

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

• mood changes, sleep disturbances, depression, hives, purpura (red spots on the skin), blistering, kidney disease, 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 potassium levels in the blood that are temporary and disappear after stopping treatment, low sodium levels in the blood (which may cause dehydration and low blood pressure), drowsiness, fainting, palpitations (feeling of heartbeat), tachycardia (fast heart rate), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, hypersensitivity to light, joint pain, muscle pain, chest pain, malaise, peripheral edema, fever, increased urea levels in the blood, increased creatinine levels in the blood, falls.

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

• worsening of lupus (a type of collagen disease), changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood; fatigue, decreased or absent urine excretion, sudden flushing of the face and neck, acute kidney failure,
• dark urine or nausea and vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• low chloride levels in the blood, low magnesium levels in the blood.

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

• disorientation, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (nasal congestion or runny nose), changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, high calcium levels in the blood, liver function disorders.

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

• abnormal heart rhythm detected on an electrocardiogram, changes in laboratory test results: high uric acid levels and high blood sugar levels, myopia, blurred vision, vision disturbances, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute glaucoma), cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).
• if you have systemic lupus erythematosus (a type of collagen disease), the symptoms of the disease may worsen.

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). Your doctor may recommend blood tests to monitor your health.

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
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, you can help 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 which is stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the packaging and other information

What CoArprenessa contains

• The active substances of CoArprenessa are perindopril arginine and indapamide. CoArprenessa, 5 mg + 1.25 mg, tablets One tablet contains 5 mg of perindopril arginine (which corresponds 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 (which corresponds to 6.790 mg of perindopril) and 2.5 mg of indapamide.
• The other ingredients are: calcium chloride hexahydrate, microcrystalline cellulose, siliconized microcrystalline cellulose type 90, maize starch, sodium hydrogen carbonate, colloidal silica, hydrated, 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 dividing line on both sides of the tablet. On one side of the dividing line, there is an "A" marking, and on the other side, there is a "1" marking. The tablet dimensions are 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 an "A2" marking on one side of the tablet. The tablet dimensions are approximately 8 mm in diameter.
CoArprenessa is available in blisters containing 10, 30, 60, 90, or 100 tablets in a cardboard box.
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, please contact the 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:26.04.2023