Co-prenessa

Leaflet attached to the packaging: patient information

Co-Prenessa, 8 mg + 2.5 mg, tablets

tert-butylamineperindopril+ indapamide

You should carefully read the contents of the leaflet before using 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.
• 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 Co-Prenessa and what is it used for
• 2. Important information before taking Co-Prenessa
• 3. How to take Co-Prenessa
• 4. Possible side effects
• 5. How to store Co-Prenessa
• 6. Contents of the pack and other information

1. What is Co-Prenessa and what is it used for

What is Co-Prenessa

Co-Prenessa is a combination of two active substances, perindopril and indapamide. Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). The mechanism of action of these medicines is based on dilating blood vessels, which makes it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine excreted by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine production. Each of the active substances lowers blood pressure, and their combination improves blood pressure control.

What is Co-Prenessa used for

Co-Prenessa is an antihypertensive medicine used to treat high blood pressure (hypertension). Co-Prenessa is intended for patients who have already been treated with perindopril at a dose of 8 mg and indapamide at a dose of 2.5 mg in the form of separate medicines. These patients can take one Co-Prenessa tablet with a strength of 8 mg + 2.5 mg, which contains both active substances, instead of taking separate tablets.

2. Important information before taking Co-Prenessa

When not to take Co-Prenessa:

• if the patient is allergic to perindopril or any other ACE inhibitor;
• if the patient is allergic to indapamide or any other sulfonamide;
• if the patient is allergic to any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash while taking ACE inhibitors in the past;

or if these symptoms have occurred in the patient or someone in their family in any other circumstances (a condition called angioedema);

• in patients with severe liver disease or liver encephalopathy (a degenerative brain disease);
• in patients with severe kidney disease or those undergoing dialysis;
• in case of increased or decreased potassium levels in the blood;
• in patients with suspected untreated, uncontrolled heart failure (symptoms may include water retention in the body and breathing difficulties);
• after the third month of pregnancy (it is also recommended to avoid taking Co-Prenessa in early pregnancy - see "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (persistent) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and precautions

Before starting to take Co-Prenessa, you should discuss it with your doctor or pharmacist:

• if the patient has a narrowing of the aortic valve (narrowing of the main artery valve coming out of the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle), or narrowing of the renal artery (narrowing of the artery supplying the kidney with blood);
• if the patient has heart failure or any other heart disease;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has liver disease;
• if the patient has connective tissue diseases, such as systemic lupus erythematosus or systemic scleroderma;
• if the patient has atherosclerosis (hardening of the artery walls);
• if the patient has hyperparathyroidism (overactivity of the parathyroid glands);
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or using salt substitutes containing potassium;
• if the patient is taking lithium;
• if the patient is taking potassium-sparing diuretics (spironolactone, triamterene); it is recommended to avoid taking them with Co-Prenessa (see "Co-Prenessa and other medicines");
• if the patient is elderly;
• if the patient has had allergic reactions to light;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• 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. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Co-Prenessa:".
• if the patient is black - in this case, there may be a greater risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• if the patient is undergoing dialysis using high-flux membranes;
• if the patient is taking any of the following medicines, as they may increase the risk of angioedema (rapid swelling of the skin in areas such as the throat:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty breathing or swallowing) has been reported in patients treated with ACE inhibitors, including Co-Prenessa. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Co-Prenessa and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Co-Prenessa before planned pregnancy or as soon as possible after pregnancy is confirmed, and recommend taking a different medicine instead of Co-Prenessa. It is not recommended to take Co-Prenessa in early pregnancy, and it should not be taken after the third month of pregnancy, as it may have a very harmful effect on the development of the child if taken during this period of pregnancy.
About taking Co-Prenessa, the patient should also inform their doctor or medical staff in the event of:

• planned anesthesia and/or surgery,
• recently experienced diarrhea, vomiting, or dehydration,
• planned hemodialysis or LDL cholesterol apheresis (a procedure to remove cholesterol from the body using a special device),
• planned desensitization treatment for bee or wasp venom,
• planned diagnostic tests involving intravenous administration of contrast agents containing iodine (a substance that allows organs such as the kidneys or stomach to be visualized on X-ray images),
• if the patient experiences vision disturbances or eye pain while taking Co-Prenessa. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or glaucoma, increased pressure in one or both eyes - they can occur within a few hours to a few weeks after taking Co-Prenessa. If left untreated, they can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at greater risk of such a reaction. The patient should stop taking Co-Prenessa and consult their doctor.

The medicine contains the active substance (indapamide) that may give a positive result in doping tests.

Children

Co-Prenessa should not be used in children.

Co-Prenessa 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.
The patient should avoid taking Co-Prenessa with:

• lithium (used to treat depression),
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• 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 of trimethoprim and sulfamethoxazole);
• estramustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

The patient should inform their doctor if they are taking any of the following medicines, as they may affect the action of Co-Prenessa:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA) or aliskiren (see also the subsections "When not to take Co-Prenessa:" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• a combination of sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Co-Prenessa" and "Warnings and precautions".
• procainamide (used to treat heart rhythm disorders),
• allopurinol (used to treat gout),
• terfenadine, astemizole, or mizolastine (antihistamines used to treat hay fever or allergies),
• 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),
• anticancer medicines,
• intravenous erythromycin (an antibiotic),
• halofantrine (used to treat certain types of malaria),
• cisapride or difemanil (used to treat gastrointestinal diseases),
• sparfloxacin or moxifloxacin (antibiotics used to treat infections),
• methadone,
• pentamidine (used to treat pneumonia),
• vincamine (used to treat memory disorders in the elderly),
• bepridil (used to treat angina pectoris),
• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium),
• digoxin or other cardiac glycosides (used to treat heart diseases),
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• antidiabetic medicines, such as insulin, metformin, or gliptins,
• calcium, including calcium supplements,
• laxatives that stimulate peristalsis (e.g., senna),
• nonsteroidal anti-inflammatory medicines (e.g., ibuprofen) or salicylates in high doses (e.g., aspirin),
• intravenous amphotericin B (used to treat severe fungal infections),
• medicines used to treat neurological disorders, such as depression, anxiety, and schizophrenia, including tricyclic antidepressants and neuroleptics (e.g., amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
• tetracosactide (used to treat Crohn's disease),
• vasodilators, including nitrates,
• gold given intravenously (used to treat arthritis), e.g., aurothioglucose sodium,
• anesthetics given before and during surgery,
• contrast agents given intravenously before certain radiological examinations,
• medicines used to treat diarrhea (racecadotril) or prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other medicines belonging to the so-called mTOR inhibitors). See the "Warnings and precautions" section,
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, norepinephrine, or epinephrine).

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the subsections "When not to take Co-Prenessa:" and "Warnings and precautions").

Co-Prenessa with food and drink

It is recommended to take Co-Prenessa 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 should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Co-Prenessa before planned pregnancy or as soon as possible after pregnancy is confirmed, and recommend taking a different medicine instead of Co-Prenessa. It is not recommended to take Co-Prenessa in early pregnancy, and it should not be taken after the third month of pregnancy, as it may have a very harmful effect on the development of the child if taken during this period of pregnancy.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. Co-Prenessa is not recommended for use during breastfeeding, and the doctor may prescribe a different medicine if the patient wants to breastfeed.

Driving and using machines

Co-Prenessa does not affect the ability to drive and use machines, but some patients may experience individual reactions, such as dizziness or weakness, resulting from lowered blood pressure. Before driving or using machines, the patient should make sure that such reactions do not occur in their case.

Co-Prenessa contains lactose and sodium

If the patient has an intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "sodium-free".

3 How to take Co-Prenessa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one tablet once a day.
The doctor may decide to change the dosage in case of kidney disease.
It is recommended to take the tablet in the morning, before a meal.
The tablet should be swallowed with a glass of water.

Taking a higher dose of Co-Prenessa than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. The most likely symptom of overdose is low blood pressure.
In case of significant lowering of blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, or changes in urine production), the patient should lie down with their legs raised above the level of the torso.

Missing a dose of Co-Prenessa

It is important to take the medicine every day, as the effectiveness of hypertension treatment depends on regular medication. However, if a dose of Co-Prenessa 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 treatment with Co-Prenessa

Since hypertension treatment usually lasts a lifetime, 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, Co-Prenessa can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, which may be serious, they should stop taking this medicine and contact their doctor immediately:

• severe dizziness or fainting due to low blood pressure (often - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of compression in the chest, wheezing, and shortness of breath; uncommon - may occur in less than 1 in 100 patients);
• facial, lip, oral, tongue, or throat swelling, difficulty breathing - sudden allergic reaction with shortness of breath, rash (angioedema, see the "Warnings and precautions" section in section 2); uncommon - may occur in less than 1 in 100 patients;
• severe skin reactions, including erythema multiforme (a skin rash often starting with the appearance of red, itchy spots on the face, arms, or legs) or severe skin rash, urticaria, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• cardiovascular disorders (heart rhythm disorders, angina pectoris, myocardial infarction; very rare - may occur in less than 1 in 10,000 patients);
• weakness or paralysis of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• jaundice (yellowing of the skin or eyes), which may be a symptom of liver inflammation (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• liver disease caused by liver disease (hepatic encephalopathy; frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

The following side effects have been reported:

Common (may occur in less than 1 in 10 patients):

• skin reactions in patients with a tendency to allergic and asthmatic reactions,
• headache,
• vision disturbances,
• dizziness,
• weakness (asthenia),
• ringing in the ears,
• vertigo (feeling of spinning),
• tingling or numbness,
• shortness of breath,
• cough,
• gastrointestinal disorders (nausea and vomiting),
• abdominal pain,
• taste disorders,
• indigestion, diarrhea, constipation,
• muscle cramps,
• allergic reactions (such as skin rashes, itching),
• fatigue,
• low potassium levels in the blood.

Uncommon (may occur in less than 1 in 100 patients):

• mood changes,
• sleep disorders,
• depression,
• urticaria, purpura (red spots on the skin), blistering,
• kidney function disorders,
• excessive sweating,
• impotence (inability to achieve or maintain an erection),
• 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 treatment is stopped, low sodium levels in the blood, which may cause dehydration and low blood pressure,
• drowsiness, fainting,
• palpitations (feeling of heartbeat), tachycardia (rapid heart rate),
• hypoglycemia (very low blood sugar levels) in patients with diabetes,
• vasculitis (inflammation of blood vessels),
• dry mouth,
• reactions of hypersensitivity to light (increased skin sensitivity to sunlight), 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 occur in less than 1 in 1,000 patients):

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

Very rare (may occur in less than 1 in 10,000 patients):

• confusion,
• nasal congestion or rhinitis (inflammation of the nasal mucosa),
• eosinophilic pneumonia (a rare form of pneumonia),
• 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.

Unknown (frequency cannot be estimated from the available data):

• abnormal heart function as shown in an EKG,
• changes in laboratory test results: high uric acid levels and high blood sugar levels, myopia, blurred vision, vision disturbances, decreased vision, or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera - or acute glaucoma),
• if the patient has systemic lupus erythematosus (a type of collagen disease), the symptoms of the disease may worsen),
• cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects can help gather more information on the safety of the medicine.

5 How to store Co-Prenessa

The medicine should be stored out of sight and reach of children
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
Do not store above 30°C.
Store in the original packaging to protect from moisture.
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 pack and other information

What Co-Prenessa contains

• The active substances of Co-Prenessa are perindopril tert-butylamine and indapamide. Each tablet contains 8 mg of perindopril tert-butylamine, which corresponds to 6.68 mg of perindopril, and 2.5 mg of indapamide.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, and magnesium stearate. See section 2 "Co-Prenessa contains lactose monohydrate and sodium".

What Co-Prenessa looks like and contents of the pack

Co-Prenessa is a white, oval, slightly convex tablet with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking, and not to divide into equal doses.
Packaging: 28, 30, 56, 60, or 100 tablets in blisters in a cardboard box

Marketing authorization holder

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

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., Równoległa Street 5, 02-235 Warsaw
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of medicinal products in other European Economic Area member states, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:13.01.2022