Properties
What is it?
1. What is Prestiqlo and what is it used for Each tablet of Prestiqlo contains two active substances - bisoprolol fumarate and perindopril arginine: • Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers reduce the heart rate and make the heart's pumping of blood into the vessels more efficient. • Perindopril arginine is an angiotensin-converting enzyme (ACE) inhibitor. It has a dilating effect on blood vessels, making it easier for the heart to pump blood into them. Prestiqlo is used to treat high blood pressure (hypertension) and/or chronic stable heart failure (a heart condition where the heart no longer supplies the body with enough blood, leading to shortness of breath and swelling) and/or to reduce the risk of heart complications (such as myocardial infarction) in patients with ischemic heart disease (a condition where the blood supply to the heart is reduced or blocked), in individuals who have already had a myocardial infarction and/or have undergone surgery to improve blood supply to the heart by widening its supplying blood vessels. Instead of taking bisoprolol fumarate and perindopril arginine separately, you will need to take only one Prestiqlo tablet, which contains both active substances, in the same dosages. 2. What you need to know before taking Prestiqlo Situations when Prestiqlo should not be taken: • You are allergic to bisoprolol or any other beta-blocker, perindopril or any ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6); • You have heart failure that has suddenly worsened and/or may require hospitalization; • You have developed cardiogenic shock (a serious disorder of heart function caused by very low blood pressure); • You have a heart condition characterized by very slow or irregular heartbeats (second or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome); • Your heart rate is slow; • You have very low blood pressure; • You have severe asthma or severe chronic lung disease; • You have a severe disorder of blood circulation in the extremities (such as Raynaud's syndrome), which can cause tingling, or paleness or blueness of the fingers or toes; • You have a pheochromocytoma (a rare tumor of the adrenal gland's medulla) for which you are not receiving treatment; • You have metabolic acidosis (a condition in which the blood contains too much acid); • Previously, when taking other ACE inhibitors or in other circumstances, you or a member of your family have experienced symptoms such as wheezing, swelling of the face, tongue, or throat, intense itching, or widespread skin rash (a condition called angioedema); • You are pregnant and your pregnancy is more than 3 months advanced (Prestiqlo should also be avoided in early pregnancy - see section <<Pregnancy>>); • You have diabetes or kidney impairment and are taking a blood pressure-lowering medicine containing aliskiren. • If you are undergoing dialysis or other hemofiltration procedures. Depending on the apparatus used, Prestiqlo may not be suitable for you. • You have kidney disease with reduced blood flow to the kidneys (renal artery stenosis). • If you were taking or are currently taking sacubitril and valsartan – medicines for heart failure, as the risk of Quincke's edema (rapid swelling of subcutaneous tissue, e.g. in the throat area) increases (see sections <<Be especially careful>> and <<Taking Prestiqlo with other medicines>>). Be especially careful in the following cases Before starting Prestiqlo, tell your doctor or pharmacist if: • You have diabetes • You have kidney disease (including kidney transplant) or if you are undergoing hemodialysis; • You have liver disease; • You have aortic stenosis (narrowing of the main blood vessel leaving the heart) and mitral stenosis, hypertrophic cardiomyopathy (heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidney) • You have abnormally high levels of the hormone aldosterone in your blood (primary hyperaldosteronism); • You have heart failure or any other heart disease, for example, minor heart rhythm disturbances or chest pain at rest (Prinzmetal's angina); • You have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma; • You are on a diet with restricted salt intake or are using salt substitutes containing potassium (very high potassium levels in the blood can cause changes in heart rate); • You have recently had diarrhea, vomiting, or dehydration (under these conditions, Prestiqlo may cause a drop in blood pressure); • You are undergoing low-density lipoprotein apheresis (mechanical removal of cholesterol from the blood); • You are currently undergoing or are scheduled for allergy treatment or therapy to reduce your sensitivity to wasp and bee stings; • You are fasting strictly or are on a diet; • You are to undergo anesthesia and/or major surgery; • You have problems with blood circulation in your extremities; • You have asthma or chronic lung disease; • You have psoriasis (currently or in the past); • You have an adrenal gland tumor called pheochromocytoma; • You have a thyroid disease (Prestiqlo may mask signs of an overactive thyroid); • You have angioedema (a severe allergic reaction characterized by swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing); These reactions can occur at any time during treatment. If you experience these symptoms, you should stop taking Prestiqlo immediately and consult your doctor. • You are of African descent, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to patients of non-African descent; • You are taking any of the following medicines used to lower high blood pressure: - Angiotensin II receptor blockers (ARBs) (a group of medicines called sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney impairment due to diabetes; - Aliskiren Your doctor may perform regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See information in the section <<Situations when Prestiqlo should not be taken>>. • You are taking any of the following medicines, as the risk of angioedema may increase: - Racecadotril (used to treat diarrhea); - Sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer); - Sacubitril (available in a fixed combination with valsartan), used to treat chronic heart failure. - Linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class of gliptins (used to treat diabetes). Sudden discontinuation of Prestiqlo is not recommended, as it can lead to a significant worsening of heart function. Treatment should not be stopped abruptly, especially in patients with ischemic heart disease. You should inform your doctor if you suspect you are pregnant (or planning a pregnancy). The use of Prestiqlo in early pregnancy is not recommended. The medicine should not be used after 3 months of pregnancy, as it can seriously harm the baby's health (see section <<Pregnancy>>). Children and adolescents The administration of Prestiqlo to children and adolescents under 18 years of age is not recommended. Taking Prestiqlo with other medicines If you are taking, have recently taken, or might take any other medicines, tell your doctor or pharmacist. There are certain medicines that can alter the effect of Prestiqlo or, conversely, their effect can be altered by taking them with Prestiqlo. Such interactions can lead to a decrease in the effectiveness of one or both medicines. In addition, this can increase the risk or severity of side effects. Be sure to tell your doctor if you are taking any of the following medicines: • Medicines used to control high blood pressure or treat heart conditions (e.g., amiodarone, amlodipine, clonidine, cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil) • Other medicines used to lower high blood pressure, including angiotensin II receptor blockers (ARBs), aliskiren (also see information in the sections <<Situations when Prestiqlo should not be used>> and <<Be especially careful in the following cases>>), or diuretics (medicines that increase the volume of urine excreted by the kidneys); • Potassium-sparing drugs (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that increase potassium levels in the body (e.g., heparin, a medicine used to thin the blood to prevent clot formation; trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections); • Potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone in doses of 12.5-50 mg/day. • Sympathomimetic agents for the treatment of clinical shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine); • Estramustine, used to treat cancer; • Medicines more commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors) see section <<Be especially careful>>; • Sacubitril and valsartan (used to treat chronic heart failure) see sections <<Situations when Prestiqlo should not be taken>> and <<Be especially careful>>; • Lithium preparations, used to treat mania or depression; • Certain antidepressants such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs, except type B MAOIs); • Some medicines used to treat schizophrenia (antipsychotics); • Some medicines for epilepsy (phenytoin, barbiturates, e.g., phenobarbital); • Anesthetics used during surgery; • Vasodilators, including nitrates (medicines that cause blood vessel dilation); • Trimethoprim, used to treat infections; • Immunosuppressants (medicines that suppress the body's immune defenses) used in autoimmune disorders and after transplantation (e.g., cyclosporine, tacrolimus); • Allopurinol, used to treat gout; • Parasympathomimetic agents used to treat conditions such as Alzheimer's disease and glaucoma; • Topical beta-blockers used to treat glaucoma (increased intraocular pressure); • Mefloquine, used to prevent or treat malaria; • Baclofen, used to treat muscle rigidity in conditions such as multiple sclerosis; • Gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis); • Medicines for diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin; • Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac, or high-dose acetylsalicylic acid, used to treat arthritis, headache, pain in other locations, or inflammation. Use of Prestiqlo with food, drink, and alcohol Prestiqlo is best taken before meals. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You must inform your doctor if you suspect you are pregnant (or planning a pregnancy). In most cases, your doctor will advise you to stop taking Prestiqlo before pregnancy, or as soon as pregnancy is confirmed, and prescribe another medicine instead. The use of Prestiqlo in early pregnancy is not recommended. The medicine should not be used after 3 months of pregnancy, as it can cause serious harm to the baby's health. Breastfeeding If you are breastfeeding or planning to breastfeed, inform your doctor. Prestiqlo is not recommended for breastfeeding mothers. If you wish to breastfeed, your doctor may prescribe another medicine for you, especially if the baby is a newborn or premature. Driving and operating machinery Prestiqlo usually does not affect alertness, but some patients may experience dizziness and weakness due to a drop in blood pressure, especially at the beginning of treatment or when changing medications or consuming alcohol simultaneously. In such cases, the ability to drive or operate machinery may be impaired. Prestiqlo contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially sodium-free. 3. How to take Prestiqlo Always take Prestiqlo exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. The recommended dose is one tablet once a day. It is recommended to take the tablets in the morning, before breakfast, with a glass of water. In some cases, doctors prescribe half a tablet of Prestiqlo once a day, in the morning before breakfast. Patients with kidney disease The use of Prestiqlo is not recommended in patients with moderate to severe kidney disease. Administration in children and adolescents The administration of the medicine to children and adolescents is not recommended. If you take more Prestiqlo than you should If you have taken more tablets than prescribed, contact your doctor or pharmacist immediately. In case of overdose, the most likely effect is a drop in blood pressure, which may cause you to feel dizzy or go into shock (if this happens, lie down and raise your legs, this may alleviate your condition). You may experience severe difficulty breathing, tremors (due to low blood sugar), and a slow heart rate. If you forget to take Prestiqlo It is important to take the medicine every day, as regular use makes the treatment more effective. However, if you forget to take Prestiqlo, take the next dose at the usual time. Do not double the next dose. If you stop taking Prestiqlo Sudden discontinuation of Prestiqlo is not recommended, nor is changing the dose without consulting your doctor, as this can lead to a significant worsening of heart function. Treatment should not be stopped abruptly, especially in patients with ischemic heart disease. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse. 4. Possible side effects Like all medicines, this medicine may cause side effects, but not everybody gets them. Stop taking this medicine and seek immediate medical attention if you experience any of the following: • Severe dizziness or shock caused by low blood pressure (common side effects - occur in less than 1 in 10 patients) • Worsening of heart failure, manifested by increased shortness of breath and/or fluid retention in the body (common side effects - occur in less than 1 in 10 patients) • Swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema) (uncommon side effects - occur in less than 1 in 100 patients) • Sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon side effects - occur in less than 1 in 100 patients) • Unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare side effects - occur in less than 1 in 10,000 patients) • Weakness in arms or legs, speech problems, which may be signs of a stroke (very rare side effects - occur in less than 1 in 10,000 patients) • Inflammation of the pancreas, which can cause severe pain in the abdomen and back and be accompanied by feeling unwell (very rare side effects - occur in less than 1 in 10,000 patients) • Yellowing of the skin or whites of the eyes (jaundice), which may be a sign of hepatitis (very rare side effects - occur in less than 1 in 10,000 patients) • Skin rash, often starting with red itchy patches on the skin of the face, hands, or feet (erythema multiforme) (very rare side effects - occur in less than 1 in 10,000 patients) Prestiqlo is generally well tolerated, but as with any medication, people may experience side effects, especially at the beginning of treatment. If you notice any of the following side effects (or any others), tell your doctor or pharmacist immediately: Very common (occurs in more than 1 in 10 patients) • Slow heart rate Common (occurs in less than 1 in 10 patients) • Headache; • Dizziness; • Vertigo; • Taste disturbances; • Tingling sensation; • Tingling or numbness in the feet or hands; • Visual disturbances; • Tinnitus (ringing in the ears); • Feeling of coldness in the hands and feet; • Cough; • Shortness of breath; • Gastrointestinal disorders, such as nausea, vomiting, abdominal pain, indigestion or dyspepsia, diarrhea, constipation; • Allergic reactions, such as skin rash, itching; • Muscle cramps • Feeling of fatigue; • Rapid fatigue. Uncommon (occurs in less than 1 in 100 patients) • Mood changes; • Sleep disturbances; • Depression; • Dry mouth; • Intense itching or widespread skin rash; • Formation of groups of blisters on the skin; • Increased sensitivity of the skin to the sun (photosensitivity reaction); • Sweating; • Kidney function impairment; • Sexual dysfunction; • Increased number of eosinophils (a type of white blood cell) • Drowsiness; • Shock; • Palpitations; • Tachycardia • Irregular heart rhythm (atrioventricular conduction disorder), inflammation of blood vessels (vasculitis); • Dizziness upon standing • Muscle weakness; • Arthralgia (joint pain) • Myalgia (muscle pain); • Chest pain; • Weakness; • Localized swelling (peripheral edema); • Increased body temperature; • Falls; • Changes in laboratory test results: high potassium levels in the blood, which decrease after discontinuation of therapy, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased blood urea and creatinine. Rare (occurs in less than 1 in 1,000 patients): • Nightmares, hallucinations; • Reduced tear production (dry eyes); • Hearing disturbances; • Erectile dysfunction; • Inflammation of the liver, which can cause yellowing of the skin or whites of the eyes; • Allergic rhinitis, sneezing; • Allergy-like reactions, such as itching, hyperemia, rash; • Worsening of psoriasis; • Changes in laboratory test results: increased liver enzyme levels, high bilirubin levels in blood serum, abnormal blood lipid levels. • Discoloration, numbness, and pain in fingers or toes (Raynaud's syndrome) Very rare (occurs in less than 1 in 10,000 patients) • Confusion; • Eye irritation or redness (conjunctivitis); • Eosinophilic pneumonia (a rare type of pneumonia); • Pancreatitis (manifested by severe pain in the abdomen or back); • Hair loss; • Development of psoriasis (scaly skin rash), psoriasis-like rash; • Acute kidney failure; • Blood disorders, such as a decrease in the number of red blood cells and white blood cells, decreased hemoglobin, decreased platelet count; Increased urine concentration (darkening), nausea or vomiting, muscle cramps, confusion, and seizures, which may be caused by inadequate secretion of ADH (antidiuretic hormone) when taking ACE inhibitors. If such symptoms develop, consult your doctor immediately. Reporting of side effects If you experience any side effects, tell your doctor, pharmacist, or nurse. This includes any side effects not listed in the package leaflet. By reporting side effects, you are helping to gather more information about the safety profile of the medicine. 5. Storage of Prestiqlo Store in a place inaccessible and invisible to children. Do not use the medicine after the expiry date indicated on the cardboard box. The expiry date refers to the last day of that month. Store at a temperature not exceeding 30°C. Do not dispose of medicines in drains and sewers. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures are aimed at protecting the environment. 6. Composition and other information What Prestiqlo contains • Active substances - bisoprolol fumarate and perindopril arginine. Each tablet of Prestiqlo contains 5 mg of bisoprolol fumarate (equivalent to 4.24 mg of bisoprolol) and 10 mg of perindopril arginine (equivalent to 6.790 mg of perindopril). • Other tablet components: microcrystalline cellulose PH 102, (E460), calcium carbonate (E170), pregelatinized corn starch, sodium starch glycolate - type A (E468). Colloidal anhydrous silica (E551), magnesium stearate (E572), croscarmellose sodium (E468), glycerol (E422), hypromellose (E464), macrogol 6000, titanium dioxide (E171), iron yellow oxide (E172), iron red oxide (E172), and purified water.