Co-prenessa 4 mg/1,25 mg tabletki

Leaflet accompanying the packaging: patient information

Co-Prenessa 4 mg/1.25 mg tablets

tert-butylamineperindopril+ indapamide

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 ineffective. 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 by the kidneys.

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 symptoms of hepatic encephalopathy (a degenerative brain disease);
• in patients with severe kidney dysfunction or those undergoing dialysis;
• in patients with abnormally low or high potassium levels in the blood;
• in patients with suspected untreated or 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 (long-term) 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 Co-Prenessa, the doctor or pharmacist should be consulted:

• if the patient has aortic stenosis (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel supplying 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) because these medicines should be avoided during Co-Prenessa treatment (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 receptor blockers (ARBs) (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 medicines, 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 medicines belonging to the so-called mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema In patients treated with ACE inhibitors, including Co-Prenessa, angioedema (a 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 doctor should be informed about pregnancy, suspected pregnancy, or planned pregnancy. Co-Prenessa is not recommended during 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 doctor or medical staff should be informed:

• if the patient is to undergo anesthesia and/or surgery;
• if the patient has recently had diarrhea or vomiting, or is dehydrated;
• if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is to be performed;
• if desensitization treatment is to be performed to reduce allergic reactions to bee or wasp stings;
• if a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray) is to be administered.
• 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) - these conditions can occur within a few hours to a few weeks after taking Co-Prenessa and, if left untreated, 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. Co-Prenessa should be discontinued, and the doctor should be consulted.

Athletes should be warned 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 doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Co-Prenessa should be avoided:

• 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 blockers.

The doctor should be told if the patient is taking any of the following medicines, as they may interact with Co-Prenessa:

• other medicines used to treat high blood pressure, including angiotensin receptor blockers (ARBs) or aliskiren (see also "When not to take Co-Prenessa" and "Warnings and precautions"), or diuretics (medicines that increase urine production 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 conditions, including severe asthma and rheumatoid arthritis;
• immunosuppressive medicines used to treat autoimmune diseases or after transplant surgery to prevent transplant rejection (e.g., cyclosporine, tacrolimus);
• medicines used to treat cancer;
• erythromycin administered 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 conditions);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulant 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 administered intravenously (used to treat severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, or 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 administered intravenously (used to treat rheumatoid arthritis);
• medicines used for anesthesia before or during surgery;
• contrast agents administered intravenously before a special type of X-ray examination;
• 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 blocker (ARB) or aliskiren (see also "When not to take Co-Prenessa" and "Warnings and precautions"). In case of doubt, the doctor should be consulted.

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 child, they should consult their doctor or pharmacist before taking this medicine. PregnancyThe doctor should be informed 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 another medicine instead of Co-Prenessa. Co-Prenessa is not recommended during early pregnancy and should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the fetus if taken after 3 months of pregnancy. BreastfeedingThe doctor should be informed about breastfeeding or plans to breastfeed. Co-Prenessa is not recommended during breastfeeding. The doctor may prescribe another 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 or use machines, however, some patients may experience dizziness or fatigue related to low blood pressure. In such cases, the ability to drive or use 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 as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. 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 doctor or the nearest hospital should be contacted immediately. The most common symptom of overdose is low blood pressure. If severe low blood pressure occurs (with nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine production), it may be helpful to lie down with elevated legs.

Missing a dose of Co-Prenessa

It is essential to take the medicine regularly for it to work best. If a dose of Co-Prenessa is missed, the next dose should be taken at the usual time. A double dose should not be taken 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 doctor should be consulted. In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 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);
• facial, lip, mouth, tongue, or throat swelling, difficulty swallowing (angioedema, see "Warnings and precautions" 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 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, 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 may cause severe abdominal pain radiating to the back and severe illness (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 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 disorders,
• depression,
• urticaria, purpura (red spots on the skin), blistering,
• kidney problems,
• 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 (rapid heart rate),
• hypoglycemia (very low blood sugar) in patients with diabetes,
• vasculitis (inflammation of blood vessels),
• dryness of the mucous membranes of the mouth,
• reactions 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 mucous membranes),
• eosinophilic pneumonia (a rare type 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 available data):

• abnormal heart function detected on an 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 pharmacist should be asked how to dispose of unused medicines. 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 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 1.25 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

White, slightly biconvex, oblong tablets with beveled edges 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