Co-prenessa 2 mg/0,625 mg tabletki

Leaflet accompanying the packaging: patient information

Co-Prenessa 2 mg /0.625 mg tablets

tert-butylamineperindopril+ indapamide

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.
• 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 packaging and other information

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

Co-Prenessa is used to treat high blood pressure (hypertension), in cases where treatment with perindopril alone is not effective. Co-Prenessa contains a combination of two active substances: perindopril and indapamide. Perindopril belongs to a group of angiotensin-converting enzyme inhibitors (ACE inhibitors). Indapamide belongs to diuretics, which means it increases urine production.

2. Important information before taking Co-Prenessa

When not to take Co-Prenessa:

• if the patient is allergic to perindopril or another ACE inhibitor;
• if the patient is allergic to indapamide or other sulfonamides;
• 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, severe itching, or severe skin rash during previous treatment with ACE inhibitors, or if these symptoms have occurred in the patient or their family in other circumstances (a condition called angioedema);
• in patients with severe liver dysfunction or with symptoms of hepatic encephalopathy (a degenerative brain disease);
• in patients with severe kidney dysfunction or in patients undergoing dialysis;
• in patients with abnormally low or high potassium levels in the blood;
• in patients with suspected untreated, uncontrolled heart failure (symptoms may include severe water retention and breathing difficulties);
• above 3 months 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 (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat).

The risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases when taking certain medications, including:

Warnings and precautions

Before starting Co-Prenessa, you should discuss the following with your doctor or pharmacist:

• if the patient has aortic stenosis (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• 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 dysfunction;
• if the patient has collagenosis, such as systemic lupus erythematosus (a type of chronic inflammation) or scleroderma (a disease of the connective tissue);
• if the patient has been diagnosed with atherosclerosis (hardening of the arteries);
• if the patient has hyperparathyroidism (a disorder of parathyroid function);
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or uses salt substitutes containing potassium;
• if the patient is taking lithium;
• if the patient is taking potassium-sparing diuretics (spironolactone, triamterene) as these medications should be avoided when taking 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 medications for high blood pressure:
• angiotensin 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 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 medications, which 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 mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other gliptins (used to treat diabetes).

Angioedema In patients treated with ACE inhibitors, including Co-Prenessa, angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing) has been reported. 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 use of Co-Prenessa is not recommended in early pregnancy and should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the fetus after 3 months of pregnancy (see "Pregnancy and breastfeeding"). When taking Co-Prenessa, the patient should inform their doctor or medical staff:

• if they are to be given anesthesia and/or undergo surgery;
• if they have recently had diarrhea or vomiting, or are dehydrated;
• if they are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if they are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if they are to undergo a test that requires the administration 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 they experience vision disturbances or pain in one or both eyes 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 - these 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.

Athletes should be informed that Co-Prenessa contains an active substance (indapamide) that may give a positive result in a doping test.

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

The patient should tell their doctor if they are taking any of the following medicines, as they may interact with Co-Prenessa:

• other medicines used to treat high blood pressure, including angiotensin receptor antagonists (AIIRA) or aliskiren (see also "When not to take Co-Prenessa" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• 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 "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 transplant surgery to prevent rejection (e.g. cyclosporine, tacrolimus);
• cancer medicines;
• erythromycin given intravenously (an antibiotic);
• halofantrine (used to treat certain types of malaria);
• cisapride or difemanil (used to treat gastrointestinal disorders);
• sparfloxacin or moxifloxacin (antibiotics used to treat infections);
• methadone;
• pentamidine (used to treat pneumonia);
• vincamine (used to treat cognitive impairment in elderly patients);
• 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);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulating effect on intestinal peristalsis (e.g. senna);
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid);
• amphotericin B given intravenously (used to treat severe fungal diseases);
• medicines used to treat mental disorders, such as depression, anxiety, 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 salts given intravenously (used to treat rheumatoid arthritis);
• medicines used for anesthesia before or during surgery;
• contrast agents given intravenously before a "special" type of X-ray;
• medicines used to treat diarrhea (racecadotril) or prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See "Warnings and precautions";
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also "When not to take Co-Prenessa" and "Warnings and precautions"). In case of doubt, the patient should consult their doctor.

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. PregnancyThe patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor usually recommends stopping Co-Prenessa before planned pregnancy or as soon as possible after pregnancy is confirmed, and recommends taking a different medicine instead of Co-Prenessa. Co-Prenessa is not recommended in early pregnancy and should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the fetus after 3 months of pregnancy. BreastfeedingThe patient should inform their doctor about breastfeeding or intending to breastfeed. Co-Prenessa is not recommended during breastfeeding. The doctor may prescribe a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Co-Prenessa does not affect the ability to drive and use machines, however, some patients may experience dizziness or fatigue related to low blood pressure. In such cases, the ability to drive or operate machines may be impaired.

Co-Prenessa contains lactose monohydrate 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, which means it is essentially "sodium-free".

3. How to take Co-Prenessa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose is one tablet per day. The doctor may adjust the dose in case of kidney problems. The tablet should be taken in the morning, before a meal. The tablet should be swallowed with a glass of water.

Overdose of Co-Prenessa

In case of overdose, the patient should immediately contact their doctor or go to the nearest hospital. The most common symptom of overdose is low blood pressure. If the patient experiences significantly low blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, or changes in urine production), they should lie down with their legs raised.

Missed dose of Co-Prenessa

It is important to take the medicine regularly for it to work best. If the patient misses a dose of Co-Prenessa, they should take the next dose at the usual time. The patient should not take a double dose to make up for a missed tablet.

Stopping Co-Prenessa treatment

Treatment of high blood pressure is long-term, so before stopping Co-Prenessa, the patient should consult their doctor. 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 serious side effects, they should stop taking Co-Prenessa and contact their doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath; uncommon - may occur in less than 1 in 100 patients);
• angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing; uncommon - may occur in less than 1 in 100 patients);
• severe skin reactions, including erythema multiforme (skin rash often starting with the appearance of red, itchy patches on the face, arms, or legs) or severe skin rash, urticaria, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (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 may 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);
• hepatic encephalopathy (a brain disease caused by liver disease; frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high fever, 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 disturbances,
• 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 disturbances,
• depression,
• hives, 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 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 (fast heart rate),
• hypoglycemia (very low blood sugar) in patients with diabetes,
• vasculitis (inflammation of blood vessels),
• dryness of the mucous membranes of the mouth,
• photosensitivity reactions (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 mucous membranes),
• eosinophilic pneumonia (a rare form of pneumonia),
• changes in blood parameters, such as decreased white blood cell count and red blood cell count,
• decreased platelet count,
• high calcium levels in the blood,
• liver function disorders.

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

• abnormal heart function detected by ECG,
• 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 or acute glaucoma),
• if the patient has systemic lupus erythematosus (a type of collagenosis), the symptoms of the disease may worsen,
• cyanosis, numbness, and pain in the fingers of the hands or feet (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 the patient experiences any side effects, including any side effects not listed in the 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 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 authorization holder. By reporting side effects, more information can be collected 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 "EXP". The expiry date refers to the last day of the month stated. The batch number is stated on the packaging after "Lot". Store in the original packaging to protect from moisture. Store at a temperature below 30°C. 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 Co-Prenessa contains

• The active substances of Co-Prenessa are: perindopril tert-butylamine and indapamide. Each tablet contains 2 mg of perindopril tert-butylamine (which corresponds to 1.67 mg of perindopril) and 0.625 mg of indapamide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium bicarbonate, colloidal anhydrous silica, 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, biconvex tablet with a score line on one side. Packaging: 30 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., ul. Równoległa 5, 02-235 Warsaw Date of last revision of the leaflet:13.01.2022