Properties
- Form
- kafsula
- Dosage mg
- 100მგ+20მგ+2.5
- Pack
- 28
What is it?
What TRINOMIA® is and what it is used for TRINOMIA® capsules contain three active substances: acetylsalicylic acid, atorvastatin, and ramipril. - Acetylsalicylic acid belongs to a group of medicines called antiplatelet agents, which prevent blood cells from sticking together and forming blood clots. - Atorvastatin belongs to a group of medicines called statins, which regulate lipid (fat) levels and are used to lower lipid levels known as cholesterol and blood triglycerides when these cannot be controlled by a low-fat diet and lifestyle changes. If you have an increased risk of heart disease, atorvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet. - Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), which work by reducing the production of substances in the body that can raise blood pressure; they relax blood vessels and widen them, allowing the heart to pump blood through the vessels to the body more easily. TRINOMIA® is used for the secondary prevention of cardiovascular complications in adult patients for whom therapy with monocomponent drugs at equivalent therapeutic doses is indicated. What you need to know before taking TRINOMIA® Do not take TRINOMIA®: - if you are allergic to acetylsalicylic acid, other salicylates or tartrazine (a dye). Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue. - if you are allergic to ramipril or other ACE inhibitor medicines. - if you are allergic to atorvastatin, any similar lipid-lowering medicine, or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to soya or peanuts. - if you have had asthma attacks or other hypersensitivity reactions to certain pain relievers, fever or anti-inflammatory medicines (salicylates or other non-steroidal anti-inflammatory drugs) in the past. - if you have active peptic ulcers, or a history of recurrent peptic ulcers and/or gastrointestinal bleeding, or other types of bleeding such as cerebrovascular haemorrhage, or if you have a high risk of bleeding (haemophilia). - if you have heart disease that is not adequately controlled (severe heart failure). - if you are taking 15 mg or more of methotrexate per week. - if you have diabetes or kidney failure and are taking an aliskiren-containing blood pressure lowering medicine. - if you have nasal polyps associated with asthma (inflammatory growths in the nose). - if you have severe liver or kidney disease. - if your blood tests show unexplained abnormalities in liver function. - if you are a woman capable of becoming pregnant and are not using reliable contraception. - if you are pregnant or trying to become pregnant. - if you are breastfeeding. - if you are taking: o HIV protease inhibitors, such as tipranavir or ritonavir (medicines used to treat HIV infection). o Ciclosporin (a medicine often used in patients with transplanted organs). - if you have ever had a serious allergic reaction called "angioneurotic oedema". Symptoms include itching, rash (hives), red patches on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing. - if you are scheduled for dialysis or any other type of blood filtration. Depending on the dialysis system used, TRINOMIA® may be unsuitable for you. - if you have kidney problems related to reduced blood supply to your kidneys (renal artery stenosis). - if your blood pressure is abnormally low or unstable. This should be determined by your doctor. - if you are not yet 18 years old. In children and adolescents under 16 years of age with fever, flu or chickenpox, there is a risk of developing Reye's syndrome. - if you are using the combination glecaprevir and pibrentasvir to treat Hepatitis C. Special warnings and precautions before taking TRINOMIA® Tell your doctor or pharmacist if: - you are allergic to other analgesics or anti-inflammatory drugs, other fever, rheumatism medicines, apart from acetylsalicylic acid, or other allergens. - you have any other type of allergy (e.g. skin reactions, itching, hives). - you have bronchial asthma, hay fever, swelling of the nasal mucous membranes, or chronic lung disease. - you are scheduled for surgery or minor procedures, such as tooth extraction, as there is a high risk of bleeding. You may need to stop taking TRINOMIA® for a short period. - you have had stomach ulcers or bleeding in the past. - you are taking blood thinners, pain relievers, fever or anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen), corticosteroids (for allergies and inflammation), antidepressants, such as selective serotonin reuptake inhibitors, at the same time. - you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TRINOMIA® can cause serious muscle problems (rhabdomyolysis). - you are taking any of the following medicines to treat high blood pressure: o Angiotensin II receptor blockers (ARBs) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), particularly if you have diabetic kidney problems. o Aliskiren. - Your doctor may regularly check your kidney function, blood pressure and blood electrolyte levels. See also information under "Do not take TRINOMIA®". - if you have or have ever had heart, liver or kidney problems, TRINOMIA® may not be suitable for you. - if you have glucose-6-phosphate dehydrogenase deficiency. - if you are at risk of developing gout, as acetylsalicylic acid can reduce the excretion of uric acid. In certain circumstances, this can lead to a gout attack. - Your doctor should order blood tests before starting TRINOMIA® and repeat them regularly during treatment. This is necessary to check how well your liver is working. - if you consume a lot of alcohol. - if you have severe respiratory failure. - if your body has lost a lot of salt or fluid (due to illness (e.g. accompanied by vomiting), diarrhoea, excessive sweating, a diet low in salt, prolonged use of diuretics or after dialysis). - before treatment aimed at reducing allergy to bee or wasp stings (desensitisation). - if you have high potassium levels in your blood (according to blood test results). - if you have a systemic connective tissue disease, such as scleroderma or systemic lupus erythematosus. Seek immediate medical attention if you experience unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be serious, including breakdown of muscle tissue and kidney damage; and very rarely, fatal outcomes have been reported. Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed for proper diagnosis and treatment. Some patients are at increased risk of muscle tissue breakdown. Tell your doctor if any of the following apply to you: - You have previously had a stroke with cerebral haemorrhage or a small accumulation of fluid in the brain after strokes. - You have kidney problems. - You have thyroid problems. - You have had muscle problems during treatment with other lipid-lowering medicines (e.g. other "-statins" or "-fibrates"). - You or your relatives have hereditary muscle disorders. - You regularly consume large amounts of alcohol. - You are over 70 years of age. If any of the above applies to you, your doctor should perform a blood test before starting treatment and possibly during treatment to predict the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, is known to increase with the simultaneous use of certain medications (see Other medicines and TRINOMIA®). Before taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing it. You are at risk of developing diabetes if your blood glucose and lipid levels are high, you are overweight and have high blood pressure. In general, it is recommended to correct dehydration and reduce body fluid and salt levels before treatment (however, in patients with heart failure, such corrective action should be carefully assessed against the risk of volume overload). Other medicines and TRINOMIA® Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because TRINOMIA® may affect the action of other medicines. In addition, some medicines may affect the action of TRINOMIA®. TRINOMIA® contains acetylsalicylic acid, and this substance can interfere with the action of some other medicines. Also, some medicines can interfere with the action of acetylsalicylic acid. Tell your doctor if you are taking any of the following medicines, which may increase the likelihood of side effects: - Anticoagulants (such as warfarin and heparin) and medicines that dissolve blood clots may increase the risk of bleeding. Monitor for signs of internal and external bleeding (such as bruising) before treatment with these medicines. - Other platelet aggregation inhibitors (medicines that inhibit blood platelet aggregation or adhesion), such as ticlopidine and clopidogrel, may increase the risk of bleeding. - Medicines containing cortisone or cortisone-equivalent substances, such as prednisone (except for medicines used on the skin or cortisone used to treat Addison's disease), increase the risk of adverse effects on the gastrointestinal tract. - Other pain relievers or anti-inflammatory drugs; medicines (non-steroidal analgesics such as ibuprofen or indomethacin) and other anti-rheumatic drugs usually increase the risk of bleeding and gastrointestinal ulcers. - Medicines to lower blood glucose levels (antidiabetic agents) may cause low blood glucose levels. - Digoxin (a medicine to improve heart function). - Methotrexate (for cancer and some rheumatic diseases). - Valproic acid for seizures (epilepsy). - Selective serotonin reuptake inhibitors (for depression) may increase the risk of gastrointestinal bleeding. - Ciclosporin (a medicine often used in patients after organ transplantation). - Vancomycin (an antibiotic) may cause hearing problems. Tell your doctor if you are taking any of the following medicines, which may worsen the effect of acetylsalicylic acid: - Special medicines that increase urine output (diuretics, aldosterone antagonists such as spironolactone and canrenone, loop diuretics such as furosemide). - Medicines that help excrete uric acid (such as probenecid and benzbromarone). - Ibuprofen: the antiplatelet effect of acetylsalicylic acid may be weakened. Tell your doctor if you are taking any of the following medicines, which may be affected by acetylsalicylic acid: - Interferon-alpha: acetylsalicylic acid reduces its activity. - Medicines for manic-depressive psychosis (lithium). - Antacids (used to treat digestive disorders). - Barbiturates (used to treat convulsive disorders). - Zidovudine (used to treat HIV infection). - Phenytoin (a medicine used to treat epilepsy). - Acetylsalicylic acid may affect the results of blood and urine tests. TRINOMIA® contains atorvastatin, and this substance can also interfere with the action of some other medicines. Also, some medicines can interfere with the action of atorvastatin. It is possible that these interactions may increase the risk or severity of side effects, including significant muscle disorders described in the section "Special instructions and precautions". Tell your doctor if you are taking any of the following medicines: - Ciclosporin (a medicine used in patients after organ transplantation). - Certain antibiotics or antifungals, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin. - If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop using TRINOMIA®. Your doctor will tell you when it is safe to start taking TRINOMIA® again. The use of TRINOMIA® with fusidic acid has rarely caused muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. - Medicines used to treat HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, saquinavir, efavirenz, the combination of tipranavir/ritonavir, and others. - Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol. - Certain medicines for treating Hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir. - Certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem. - Heart rhythm regulating medicines, such as digoxin, verapamil, amiodarone. - Other medicines that interact with atorvastatin, including ezetimibe (lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (anti-epileptic), phenazone (pain reliever), cimetidine (H2-histamine receptor antagonist), colchicine (used to treat gout), and antacids (medicines that relieve heartburn containing aluminium or magnesium). - Over-the-counter herbal preparations containing St. John's Wort. TRINOMIA® contains ramipril, and this substance may interfere with the action of some other medicines. Also, some medicines may affect the action of ramipril. Tell your doctor if you are taking any of the following medicines, which may increase the likelihood of side effects: - Cancer medicines (chemotherapy). - Medicines to prevent organ rejection after transplantation, such as ciclosporin. - Diuretics, such as furosemide. - Medicines that increase potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood). - Steroid medicines for inflammation, such as prednisolone. - Allopurinol (used to reduce uric acid concentration in the blood). - Procainamide (used for heart rhythm disorders). Tell your doctor if you are taking any of the following medicines, which may reduce the effectiveness of ramipril: - Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine or epinephrine. Your doctor will need to check your blood pressure. If you are taking any of the following medicines, tell your doctor. Ramipril may affect their action: - Medicines for diabetes, such as oral glucose-lowering drugs and insulin. Ramipril may lower blood glucose levels. Check your blood sugar carefully when taking TRINOMIA®. - Lithium (for mental illness). Ramipril may increase lithium levels in the blood. Your doctor will need to monitor lithium levels carefully. Your doctor may need to adjust the dose of the medicine and/or take other precautions: - if you are taking an Angiotensin II receptor blocker or aliskiren (see also information under "Do not take TRINOMIA®" and "Special instructions and precautions"). If any of the above applies to you (or if you are unsure), consult your doctor before taking TRINOMIA®. TRINOMIA® with food, drink and alcohol Alcohol increases the risk of gastrointestinal ulcers and bleeding. In addition, alcohol may have additional effects on medicines used to lower blood pressure. Therefore, it is not recommended to consume alcohol while taking TRINOMIA®. Grapefruit juice contains one or more components that affect how the body uses certain medicines, including TRINOMIA®. You should avoid consuming grapefruit juice at the same time. It is recommended to take TRINOMIA® after a meal (see section 3). Pregnancy, breast-feeding and fertility Do not take TRINOMIA® if you are pregnant, suspect you are pregnant or plan to become pregnant. If you become pregnant while taking TRINOMIA®, stop taking the medicine immediately and consult your doctor. A suitable alternative treatment should be switched to before a planned pregnancy. Do not take TRINOMIA® if you are breastfeeding. Women of childbearing potential should use effective contraception during treatment. Consult your doctor or pharmacist for advice before taking any medicine. Driving and using machines When taking TRINOMIA®, you may feel dizzy. This is likely to happen when switching from other medicines to TRINOMIA® or when taking a higher dose. If this happens, do not drive or operate any tools or machinery. TRINOMIA® contains lactose and soya lecithin TRINOMIA® contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. TRINOMIA® contains soybean oil. If you are allergic to peanuts or soya, do not use this medicine. How to take TRINOMIA® Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. How to take the medicine - Take this medicine orally, preferably after a meal. - Swallow the capsule whole with water. - Do not open, crush or chew the capsules. Recommended dose: The usual dose is one capsule once a day. Your doctor will determine the appropriate dosage for you based on your condition, current treatment, and your individual risk status. If you take more TRINOMIA® than you should Dizziness and ringing in the ears, especially in elderly patients, may be symptoms of serious intoxication. Inform your doctor about this or go to the nearest hospital emergency department immediately. Do not drive yourself; have someone else drive you, or call an ambulance. Take the medicine packaging with you so the doctor knows what you are taking. If you forget to take TRINOMIA® - If you miss a dose, take your usual dose at the next scheduled time. - Do not take a double dose to make up for a missed capsule. If you stop taking TRINOMIA® Do not stop or discontinue treatment with TRINOMIA® until you have spoken to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. The assessment of side effects is based on the following frequency classification: Very common: affects more than 1 in 10 people Common: affects less than 1 in 10 people Uncommon: affects less than 1 in 100 people Rare: affects less than 1 in 1000 people Very rare: affects less than 1 in 10,000 people Unknown: frequency cannot be estimated from the available data Stop taking TRINOMIA® and seek immediate medical attention if you notice any of the following serious side effects - you may need urgent medical attention: - In very rare cases, tarry stools or vomiting blood (signs of severe gastrointestinal bleeding) have been reported. - In rare cases, hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system have been reported, especially in patients with bronchial asthma. Possible symptoms of the condition include: low blood pressure, respiratory distress attacks, rhinitis, nasal congestion, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's oedema). - Rare or very rare reports of severe bleeding, such as cerebral haemorrhage, have been reported, especially in patients with uncontrolled high blood pressure and/or treated simultaneously with anticoagulants (which prevent blood clotting); this can be life-threatening. - Muscle pain, tenderness, weakness or cramps. In rare cases, these muscle problems can be serious, including muscle disorders leading to kidney damage, and very rarely, deaths have been reported. - In rare cases, hypersensitivity reactions (allergies) have been reported, including swelling of the face, tongue and throat that makes swallowing or breathing difficult, and also itching and rash. - A serious illness with severe peeling and swelling of the skin, swelling of the skin, mouth, eyes, genitals and fever. A rash on the skin with pink-red patches, especially on the palms of the hands or soles of the feet, which may turn into blisters. - Rarely - inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale stools, liver failure (very rare). - Rarely - inflammation of the pancreas with severe abdominal pain. Immediately inform your doctor if you experience: - Rapid heartbeat, irregular or strong heartbeat, chest pain, chest tightness or more serious problems, including heart attack and stroke. - Shortness of breath or cough. This may be a sign of problems in the lungs. - Bruising; bleeding that takes longer than usual; any signs of bleeding (e.g. bleeding gums); purple spots; spots on the skin or infection without obvious cause; sore throat and fever; feeling tired; weakness; dizziness or pale skin. These could all be signs of blood or bone marrow problems. - Severe abdominal pain that may radiate to the back. This could be a sign of pancreatitis (inflammation of the pancreas). - Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). This could be a sign of liver problems, such as hepatitis (inflammation of the liver) or liver damage. Side effects related to taking acetylsalicylic acid, atorvastatin or ramipril: Tell your doctor if any of the following symptoms are severe or last for more than a few days. Acetylsalicylic acid Very common (may affect more than 1 in 10 people): - Gastrointestinal complaints, such as heartburn, nausea, vomiting, abdominal pain and diarrhoea. - Minor loss of blood from the gastrointestinal tract (microbleeding). Uncommon (may affect up to 1 in 100 people): - Bleeding and ulcers in the gastrointestinal tract. - After prolonged use of TRINOMIA®, iron deficiency anaemia may develop due to latent blood loss from the gastrointestinal tract. - Gastrointestinal ulcers may occur, but they very rarely perforate the endothelial layers. - Inflammation of the gastrointestinal tract. - Skin reactions. Rare - very rare (may affect up to 1 in 1000 people): - Nosebleeds, bleeding gums, bleeding from the skin or bleeding from the urinary tract and reproductive organs, which may also be associated with an increase in bleeding time. This effect may persist for 4 to 8 days after treatment. Very rare (may affect up to 1 in 10,000 people): - Increased values of liver function test indicators. - Kidney dysfunction. - Decrease in blood glucose concentration (hypoglycaemia). - Acetylsalicylic acid in low doses reduces uric acid excretion. In certain circumstances, this can lead to a gout attack in patients at risk. - Skin rash with fever and mucous membrane involvement (erythema multiforme). Unknown (frequency cannot be determined from available data): - Headache, dizziness, mental illness, hearing impairment or ringing in the ears (tinnitus), especially in elderly patients, may be symptoms of overdose (see section "If you take more TRINOMIA® than you should"). Atorvastatin The following side effects have been observed with certain statins (drugs of the same type): - Sexual dysfunction. - Depression. - Breathing problems, including persistent cough or shortness of breath, or fever. - Diabetes mellitus. This is more likely if you have high blood glucose and lipid levels, are overweight and have high blood pressure. All these parameters will be monitored during treatment. Common (affects up to 1 in 10 people): - Inflammation of the nasal passages, sore throat, nosebleeds. - Allergic reactions. - Increased blood glucose levels (if you have diabetes, continue to monitor glucose levels carefully), increased blood creatine kinase levels. - Headache. - Nausea, constipation, flatulence, indigestion, diarrhoea. - Joint pain, muscle and back pain. - Blood test results indicating impaired liver function. Uncommon (affects up to 1 in 100 people): - Anorexia (loss of appetite), weight gain, decrease in blood glucose concentration (if you have diabetes, you should continue to monitor glucose concentration thoroughly). - Nightmares, insomnia. - Numbness or tingling in the hands and feet and fingers, reduced sensation of pain or touch, altered taste sensitivity, memory loss. - Blurred vision. - Ringing in the ears and/or head. - Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas, causing abdominal pain). - Hepatitis (inflammation of the liver). - Rash, skin rash and itching, hives, hair loss. - Neck pain, muscle fatigue. - Fatigue, feeling unwell, weakness, chest pain, swelling of the ankle joints (oedema), increased temperature. - Presence of leukocytes in urine test. Rare (affects up to 1 in 1000 people): - Visual disturbances. - Numbness or redness of the fingers and toes. - Unexpected bleeding or bruising. - Cholestasis (yellowing of the skin and whites of the eyes). - Tendon damage. Very rare (affects up to 1 in 10,000 people): - Allergic reaction - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse. - Hair loss. - Gynaecomastia (breast enlargement in men and women). - Severe liver problems. Unknown (frequency cannot be determined from available data): - Persistent muscle weakness. Ramipril Common (may affect up to 1 in 10 people): - Headache or feeling tired. - Dizziness. The probability is high if you have started taking TRINOMIA® or started taking a higher dose. - Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down sharply. - Dry cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath. - Pain in the stomach or intestines, diarrhoea, indigestion, feeling unwell. - Skin rash, with or without swollen areas. - Chest pain. - Cramps or muscle pain. - Your blood test results confirming high potassium levels. Uncommon (may affect up to 1 in 100 people): - Balance disorders (vertigo). - Itching and unusual sensations on the skin, such as numbness, tingling or reduced skin sensation (paraesthesia). - Loss or alteration of taste. - Sleep disturbances. - Depression, feeling of anxiety, nervousness (more than usual) or restlessness. - Nasal congestion, difficulty breathing or worsening of asthma. - Intestinal swelling, called "intestinal angioneurotic oedema", with symptoms such as abdominal pain, vomiting and diarrhoea. - Heartburn, constipation or dry mouth. - More frequent urination during the day. - Increased sweating. - Reduced or loss of appetite (anorexia). - Increased pulse rate or arrhythmia. - Swollen hands and feet. This may be a sign that your body is retaining more water than usual. - Hyperaemia (redness). - Blurred vision. - Joint pain. - Fever. - Male impotence, decreased libido in men and women. - Increase in the number of certain leukocytes (eosinophilia, found in blood tests). - Blood tests reflecting changes in liver, pancreas or kidney function. Rare (may affect up to 1 in 1000 people): - Feeling of tingling or confusion. - Red swollen tongue. - Severe skin exfoliation or peeling, itching, actinomycotic rash. - Nail problems (e.g. nail splitting, or peeling from the nail bed). - Skin rash or bruising. - Patches on the skin and cold extremities. - Red, itchy, swollen or watery eyes. - Hearing impairment and ringing in the ears. - Feeling of weakness. - Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets, or haemoglobin. Very rare (may affect up to 1 in 10,000 people): - Unusually increased sensitivity to sunlight. Unknown (frequency cannot be estimated from available data): - Attention disorders. - Swollen mouth. - Blood tests confirm the presence of very few cells. - Blood tests show lower than normal sodium levels in the blood. - When you are cold, your fingers and toes change colour, and then when warmed, you feel tingling or pain (Raynaud's phenomenon). - Breast enlargement in men. - Slow or impaired reactions. - Burning sensation. - Change in sense of smell. - Hair loss. Side effects related to TRINOMIA® (acetylsalicylic acid, atorvastatin or ramipril): Very common (may affect up to 1 in 10 people): - Gastrointestinal complaints, such as heartburn, nausea, vomiting, abdominal pain and diarrhoea. - Minor loss of blood from the gastrointestinal tract (microbleeding). Common (may affect up to 1 in 10 people): - Inflammation of the nasal cavity, sore throat, nosebleeds. - Dry cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath. - Chest pain. - Constipation, flatulence, indigestion. - Pain in the stomach or intestines, pain. - Headache or feeling tired. - Dizziness. This is more likely if you have started taking TRINOMIA® or started taking higher doses. - Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down sharply. - Allergic reactions. - Skin rash with or without swollen areas. - Cramps or muscle pain. - Joint and back pain. - Blood tests showing changes in liver, pancreas or kidney function. - Increased blood glucose levels (if you have diabetes, continue to monitor glucose levels carefully), increased blood creatine kinase levels. - Your blood test results indicating high potassium levels. Uncommon (may affect up to 1 in 100 people): - Gastrointestinal bleeding and ulcers, but very rarely perforation of the endothelium. - Inflammation of the gastrointestinal tract. - Anorexia (loss of appetite), decreased appetite, weight gain, decrease in blood glucose concentration (if you have diabetes, you should continue to monitor blood glucose concentration closely). - Constipation, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing abdominal pain). - Intestinal swelling, called "intestinal angioneurotic oedema", with symptoms such as abdominal pain, vomiting and diarrhoea. - After prolonged use of TRINOMIA®, iron deficiency anaemia may develop due to latent blood loss from the gastrointestinal tract. - Skin reactions. - Rash, itching, hives, hair loss. - Nightmares, insomnia. - Sleep disturbances. - Dizziness, numbness or tingling in the fingers and toes, reduced sensation of pain or touch, altered taste sensitivity, memory loss. - Loss of balance (vertigo). - Blurred vision. - Ringing in the ears or/and head. - Loss or alteration of taste. - Itching and unusual sensations on the skin, such as numbness, tingling, burning sensation or feeling of "ants crawling" on the skin (paraesthesia). - Depression and feeling of anxiety, nervousness (more than usual) or restlessness. - Hepatitis (inflammation of the liver). - Neck pain, muscle fatigue. - Fatigue, feeling unwell, weakness, swelling, especially in the ankle joints (oedema), fever. - Nasal congestion, shortness of breath or worsening of asthma. - Dry mouth. - Increased sweating. - More frequent urination during the day. - Swollen hands and feet. This may be a sign that your body is retaining more water than usual. - Hyperaemia (redness). - Fever. - Fast or irregular heartbeat. - Male impotence, decreased libido in men or women. - Presence of leukocytes in urine test. - Increased number of certain leukocytes (eosinophilia), found in blood tests. - Blood tests showing demonstrative changes in liver, pancreas and kidney function. Rare - very rare (may affect up to 1 in 1000 people): - Nosebleeds, bleeding gums, bleeding from the skin or bleeding from the urinary tract and reproductive organs, which may also be associated with an increase in bleeding time. This effect may persist for 4 to 8 days after treatment. Rare (may affect up to 1 in 1000 people): - Numbness or tingling in the fingers and toes. - Unexpected bleeding or bruising. - Cholestasis (yellowing of the skin and whites of the eyes). - Tendon damage. - Feeling of tingling or confusion. - Red, swollen tongue. - Severe skin exfoliation or dryness, itching, actinomycotic rash. - Nail-related problems (e.g. nail splitting, or peeling from the nail bed). - Patches on the skin and cold extremities. - Red, itchy, swollen or watery eyes. - Hearing impairment. - Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets, or haemoglobin. Very rare (may affect up to 1 in 10,000 people): - Increased values of liver function tests. - Severe liver dysfunction. - Acetylsalicylic acid in low doses reduces uric acid excretion. In certain circumstances, this can lead to a gout attack in patients at risk. - Allergic reaction - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse. - Unusually increased sensitivity to sunlight. - Hair loss. - Gynaecomastia (breast enlargement in men and women). Unknown (frequency cannot be determined from available data): - Attention disorders. - Swollen mouth. - Fingers and toes change colour in the cold, and then when warmed, you feel tingling or pain (Raynaud's phenomenon). - Delayed or impaired reactions. - Burning sensation. - Change in sense of smell. - Your blood test shows that you have very few cells in your blood. - Blood test shows lower than normal sodium levels in the blood. The following side effects have been reported with the use of certain statins: - Sexual dysfunction. - Depression. - Breathing problems, including cough, shortness of breath, or fever. Reporting of suspected side effects Reporting suspected side effects after the medicinal product has been authorised is important. It allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected side effects to the Republican Unitary Enterprise "Center for Expertise and Testing in Healthcare" (see section "Sending information about adverse reactions to"). How to store TRINOMIA® Store the medicine at a temperature not exceeding 25°C. Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month indicated. Do not dispose of medicines down the drain. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. What TRINOMIA® contains and other information What TRINOMIA® contains TRINOMIA® capsules 100 mg / 20 mg / 2.5 mg Each capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (equivalent to 21.69 mg of atorvastatin calcium trihydrate) and 2.5 mg of ramipril. Excipients with known effect: contains 73.61 mg of lactose monohydrate and 0.48 mg of soya lecithin. Tablet core: microcrystalline cellulose 101; sodium starch glycolate type A; talc; lactose monohydrate; pregelatinised starch 1500; calcium carbonate; hypromellose; polysorbate 80; crospovidone type A; colloidal anhydrous silica; magnesium stearate; hypromellose 2910; microcrystalline cellulose 200; sodium stearyl fumarate. Tablet film coating: Opadry ABM White OY-B-28920, containing polyvinyl alcohol, titanium dioxide (E171), talc, soya lecithin, xanthan gum; Opadry Green 06O21881, containing titanium dioxide (E171), talc, iron yellow oxide (E172), hypromellose 6 cP, hypromellose 15 cP, triethyl citrate, povidone, iron black oxide (E172); Opadry ABM Yellow 80W32039 (for 100/20/2.5 mg dosage)/ 80W32656 (for 100/20/5 mg dosage) / 80W32880 (for 100/20/10 mg dosage), containing polyvinyl alcohol, titanium dioxide (E171), talc, iron yellow oxide (E172), soya lecithin, xanthan gum. Capsule shell (for fixed combination 100/20/2.5): gelatin; titanium dioxide (E171); iron oxide black (E172); black ink containing shellac-enamel in 45% ethanol, iron black oxide (E172), propylene glycol, ammonium hydroxide 28%. Description of the medicinal product TRINOMIA® Capsules. Description Hard gelatin capsules of size 0, consisting of a light pink body and cap, with the marking "AAR 100/20/10" on the cap. The contents of the capsules are two 50 mg acetylsalicylic acid tablets, two 10 mg atorvastatin tablets, and one 10 mg ramipril tablet (for the fixed combination 100 mg /20 mg /10mg). Hard gelatin capsules of size 0, consisting of a light grey body and a light pink cap, with the marking "AAR 100/20/5" on the cap. The contents of the capsules are two 50 mg acetylsalicylic acid tablets, two 10 mg atorvastatin tablets, and one 5 mg ramipril tablet (for the fixed combination 100 mg / 20 mg / 5 mg). Hard gelatin capsules of size 0, consisting of a light grey body and cap, with the marking "AAR 100/20 /2.5" on the cap. The contents of the capsules are two 50 mg acetylsalicylic acid tablets, two 10 mg atorvastatin tablets, and one 2.5 mg ramipril tablet (for the fixed combination 100mg/ 20mg/2.5 mg). Description of capsule contents: Tablets coated with a white or almost white film, round, biconvex, with the marking "AS" on one side (acetylsalicylic acid tablet). Tablets coated with a greenish-brown film, round, biconvex, with the marking "AT" on one side (atorvastatin tablet). Tablets coated with a light yellow film, round, biconvex, with the marking "R2" on one side (ramipril tablet 2.5 mg dose). Tablets coated with a light yellow film, round, biconvex, with the marking "R5" on one side (ramipril tablet 5mg dose). Tablets coated with a light yellow film, round, biconvex, with the marking "Rl" on one side (ramipril tablet 10 mg dose). Packaging 7 capsules are placed in an OPA/Al/PVC/Al blister. 4 blisters are placed in a cardboard box together with the instructions for medical use. Shelf life: 3 years Dispensing regime: Pharmaceutical product group - II, dispensed by prescription №3