Properties
What is it?
POLYtenza 5 mg/5 mg/25 mg, hard capsule Ramipril, Amlodipine, Hydrochlorothiazide Read the package leaflet carefully before you start taking this medicine because it contains important information for you - Keep the package leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only and should not be passed on to others, as it may harm them, even if they have the same symptoms as you. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet (see section 4). The package leaflet contains: 1. What Polytenza is and what it is used for 2. What you need to know before you take Polytenza 3. How to take Polytenza 4. Possible side effects 5. How to store Polytenza 6. Contents of the pack and other information 1. What Polytenza is and what it is used for Polytenza contains three active substances - ramipril, amlodipine and hydrochlorothiazide. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). How ramipril works: • It reduces the production of substances in your body that can increase blood pressure. • It relaxes and widens your blood vessels. • It helps your heart to pump blood more effectively around your body. Amlodipine belongs to a group of medicines called calcium channel blockers. How amlodipine works: • It relaxes and widens your blood vessels, allowing blood to flow more easily through them. Hydrochlorothiazide belongs to a group of medicines called diuretics or "thiazide diuretics". How hydrochlorothiazide works: • It increases the flow of urine, which lowers blood pressure. Polytenza may be prescribed for adult patients to treat high blood pressure (hypertension) who are already taking the same doses of ramipril, amlodipine and hydrochlorothiazide individually, and these doses are effective as a combination. See also: Polytenza - Polytenza 10/10/25mg 30 capsules 2. What you need to know before you take Polytenza Do not take Polytenza if: • you are allergic to ramipril, amlodipine or hydrochlorothiazide, calcium antagonists, ACE inhibitors or sulfonamide derivatives, or any of the other ingredients of this medicine (listed in section 6); • you have severe narrowing of the aortic valve which obstructs blood flow from the left ventricle (severe aortic stenosis) or cardiogenic shock, a condition where your heart cannot supply enough blood to the body; • you have ever had allergic reactions such as angioneurotic oedema (Quincke's oedema), which includes symptoms like itching, allergic rash (hives), redness on hands, feet and neck. Swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing; • you are taking or have recently taken the medicine sacubitril/valsartan, used to treat chronic heart failure in adults, as this increases the risk of angioedema (subcutaneous swelling in the throat area); • you are undergoing dialysis or any other type of blood filtration. Depending on the type of equipment or membrane used, taking Polytenza may not be recommended; • you have severe kidney problems; • you have liver failure; • the levels of salts (calcium, potassium, sodium) in your blood are abnormal; • you have kidney disease where the blood supply to the kidneys is reduced (renal artery stenosis); • you have low or unstable blood pressure. In this case, your doctor will decide on the treatment; • you are in the last 6 months of pregnancy (see "Pregnancy, breast-feeding and fertility"); • you have very low or unstable blood pressure. • you have heart failure after a myocardial infarction. • you have diabetes or kidney dysfunction and are taking a medicine containing aliskiren to lower blood pressure. Do not take Polytenza if any of the above conditions apply to you. If you are unsure about any of these, talk to your doctor before taking Polytenza. Warnings and precautions Talk to your doctor or pharmacist before taking Polytenza. Tell your doctor if: • you are elderly and need a dose increase; • you have heart, liver or kidney problems; • you have very high blood pressure (hypertensive crisis); • you have an imbalance of water and salts in your body (loss of fluid and salts due to vomiting, diarrhoea, excessive sweating, or prolonged use of diuretics, or being on a low-salt diet, or undergoing dialysis).; • you are breast-feeding a baby; • you are undergoing treatment to reduce an allergic reaction to bee or wasp stings (desensitisation); • you have been prescribed pain relievers. This may happen when planning surgery or dental treatment. You may need to stop taking Polytenza one day before the planned procedure and consult your doctor; • you have high potassium levels in your blood (confirmed by laboratory tests); • you are being treated with medicines or have a condition that causes low sodium levels in your blood. Your doctor may order regular blood tests to check your sodium levels, especially if you are elderly. • you have been prescribed any of the following medicines: - racecadotril, a medicine for diarrhoea; - post-transplant and anti-cancer immunosuppressants (e.g. tacrolimus, sirolimus, everolimus); - vildagliptin, a medicine for diabetes; as these medicines increase the risk of angioedema; • you have a collagen vascular disease, e.g. scleroderma, or systemic lupus erythematosus. • you have impaired vision and eye pain, this could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) - especially if you are at risk of developing glaucoma or are allergic to penicillin and sulfonamide-containing medicines. • you have a photosensitivity reaction, you should stop taking Polytenza; • you have diabetes, the dose of insulin and hypoglycaemic drugs may need to be adjusted. • you are taking any of the following medicines used to treat high blood pressure: - Angiotensin II receptor blockers, also known as sartans, e.g. valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes. - Aliskiren • if you have skin cancer or develop unusual skin lesions during treatment. Treatment with hydrochlorothiazide, especially long-term treatment and high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer). Avoid exposure to sunlight and UV radiation while taking Polytenza. Your doctor may recommend regular monitoring of your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). Also, refer to the information in the section "Do not take Polytenza in the following situations". Be sure to tell your doctor if you are pregnant or plan to become pregnant. Polytenza is not recommended during the first trimester of pregnancy, and taking the medicine after 3 months of pregnancy can cause serious harm to the fetus (see "Pregnancy, breast-feeding and fertility"). Children and adolescents Polytenza is not recommended for children and adolescents under 18 years of age, as the safety and efficacy of the medicine in this age group have not been established. Other medicines and Polytenza Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Polytenza may affect the action of other medicines. In addition, some medicines may affect the action of Polytenza itself. Your doctor may need to change your dose and/or take other precautions: if you are taking an Angiotensin II receptor blocker or aliskiren (see "Do not take Polytenza" and "Warnings and precautions"). The following medicines may reduce the effectiveness of Polytenza: - Medicines used to relieve pain and inflammation symptoms (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and also aspirin); - Medicines used to treat patients with low blood pressure, as well as in cases of shock, heart failure, asthma or allergies, e.g. ephedrine, noradrenaline and adrenaline. Your doctor should check your blood pressure; - Rifampicin (an antibiotic used to treat tuberculosis); - St. John's Wort (Hypericum perforatum) (herbal treatment for depression); Taking Polytenza with the following medicines may increase the risk of side effects: • Medicines used to relieve pain and inflammation symptoms [e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and also aspirin]; • Medicines prescribed for cancer (during chemotherapy); • Medicines that prevent the rejection of transplanted organs, such as ciclosporin; • Medicines that may lower potassium levels in your blood. These include laxatives, corticosteroids, tetracosactide, amphotericin (for fungal infections) and adrenocorticotropic hormone (ACTH) (to test adrenal gland function). • Diuretics (e.g. furosemide); • Desmopressin; • Steroidal anti-inflammatory drugs, such as prednisolone; • Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for bacterial infections) ciclosporin, immunosuppressants used to prevent rejection of transplanted organs); also heparin, a medicine that prevents blood clotting; • Cardiac and antiarrhythmic medicines; • Calcium-containing dietary supplements; • Allopurinol (used to lower uric acid levels in the blood); • Procainamide (a medicine to maintain a normal heart rhythm); • Cholestyramine (a medicine to lower fat levels in the blood); • Carbamazepine, oxcarbazepine (medicines for epilepsy); • Ketoconazole, itraconazole (medicines for fungal infections); • Erythromycin, clarithromycin (medicines for bacterial infections); • Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV-infected patients); • Verapamil, diltiazem (medicines for certain heart conditions and high blood pressure); • Dantrolene (an infusion medicine for severe disorders of body temperature); Temsirolimus (for certain types of cancer); • Sirolimus, everolimus (medicines to prevent rejection of transplanted organs); • Vildagliptin (for type 2 diabetes); • Racecadotril (anti-diarrhoea medicine); • Tacrolimus (an immune system control medicine for organ transplantation); • Other medicines that lower blood pressure, e.g. phosphodiesterase type 5 inhibitors (for erectile dysfunction), nitrates, alpha-blockers (used in urology to relax smooth muscles in the prostate and urethra), tricyclic antidepressants and neuroleptics; • Medicines that alter gastrointestinal motility, e.g. anticholinergics. Polytenza may affect the following medicines and alter their action: • Medicines for diabetes, such as insulin and oral drugs that lower blood glucose levels. Polytenza may lower blood sugar levels. You should constantly monitor your blood sugar levels while taking Polytenza. • Lithium (a medicine for mental disorders). Polytenza may increase lithium levels in the blood. Your doctor should constantly monitor your lithium levels. • Simvastatin (a medicine to lower cholesterol levels in the blood). Amlodipine increases simvastatin levels. Your doctor should reduce the dose of simvastatin if you are taking Polytenza. • Quinine (an antimalarial medicine); • Medicines containing iodine, you may need these medicines in hospital during X-ray and other types of instrumental examinations. • Penicillin (a medicine for infections); • Oral blood thinners (oral anticoagulants), e.g. warfarin; If any of the above applies to you (or if you are unsure), consult your doctor before starting Polytenza. Consult your doctor or pharmacist before taking the medicine: - if you need to have parathyroid function tests. The combination of ramipril/hydrochlorothiazide may alter the test results. - if you are an athlete and need to undergo doping tests, the combination of ramipril/hydrochlorothiazide may give a false positive result. Polytenza with food, drink and alcohol • Polytenza can be taken with or without food. • Grapefruit and grapefruit juice are not recommended for patients taking Polytenza, as they can increase the level of amlodipine, one of the active ingredients, in the blood, which in turn can lead to an unpredictable drop in blood pressure. Drinking alcohol while being treated with Polytenza can cause dizziness or mild headache. If you have questions about how much alcohol you can drink while being treated with Polytenza, discuss this with your doctor, as alcohol consumption together with blood pressure lowering medicines can enhance the sedative effect. Pregnancy, breast-feeding and fertility If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Be sure to tell your doctor if you are pregnant or think you may be pregnant. Do not take Polytenza during the first 12 weeks of pregnancy. Taking the medicine from the 13th week of pregnancy is not recommended, as its use during this period can cause serious developmental disorders in the fetus. If you become pregnant while taking Polytenza, inform your doctor immediately. You should switch to an appropriate alternative treatment before planning a pregnancy. Breast-feeding Do not take Polytenza while breast-feeding. Before taking any medicine, ask your doctor for advice. Fertility At this time, there is insufficient data on the potential effects of the medicine on fertility. Driving and using machines Polytenza can affect your ability to drive and use machines. If you feel weak, dizzy, or tired, or if the medicine causes headaches, you should refrain from driving and operating machinery and contact your doctor. Sodium content in Polytenza Each capsule of the medicine contains less than 1 mmol (23 mg) of sodium, meaning it is practically sodium-free. 3. How to take Polytenza Take this medicine exactly as prescribed by your doctor. If you have any questions, ask your doctor or pharmacist. The recommended dose is 1 capsule of the strength chosen by your doctor, once a day. Your doctor may adjust the dose depending on the effect of the medicine. The maximum dose of the medicine is 1 capsule of the 10 mg/10 mg/25 mg combination, once a day. Take the medicine orally at the same time each day, with or without food. Swallow the hard capsule whole with a sufficient amount of liquid. Do not crush or chew the hard capsule. Do not take Polytenza with grapefruit juice. Use in patients with liver and kidney disease In patients with liver and kidney disease, the dosage of the medicine may need to be adjusted. Use in elderly patients Your doctor will reduce your starting dose and adjust your treatment regimen more slowly. Polytenza is not recommended for very elderly and frail patients. Use in children and adolescents Polytenza is not recommended for children and adolescents under 18 years of age, as the safety and efficacy of the medicine in this patient group have not been established. If you take more Polytenza than you should Taking more capsules than prescribed can cause a sharp or dangerous drop in blood pressure. You may experience dizziness, fainting, or weakness. In very severe cases, a drop in blood pressure can lead to shock. In this case, the person loses consciousness, and the skin becomes cold and clammy. If you take more Polytenza than prescribed, go to the emergency department of the nearest hospital immediately. Do not drive yourself to the hospital; ask someone to take you or call an ambulance. Take the medicine with its packaging so the doctor knows exactly what you have taken. If you forget to take Polytenza If you forget to take a capsule on time, skip the missed dose entirely. Take your next dose at the usual time. Do not take a double dose to make up for a missed dose. If you stop taking Polytenza Your doctor will tell you how long to take this medicine. Stopping the medicine on your own initiative may provoke the symptoms of the disease. If you have any further questions about taking this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking Polytenza and seek immediate medical attention – you may need urgent medical attention: • Swelling of the face, lips, or throat, with difficulty swallowing or breathing, as well as itching and rash. This may be a sign of a severe allergic reaction to Polytenza. • Severe skin reactions, including rash, mouth sores, worsening of existing skin disease, redness, blistering or peeling of the skin (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme). Seek immediate medical attention if you have: • Fast, irregular, or pounding heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders including heart attack and stroke; • Shortness of breath or cough. This may be a sign of impaired respiratory function; • Frequent bruising of the skin, unusually prolonged bleeding, and any other signs of bleeding (e.g. bleeding gums), purple spots on the skin, or getting infections more often than usual, sore throat and fever, feeling tired, fainting, dizziness, or pale skin. This may be a sign of a disorder of the circulatory system or bone marrow function; • Severe abdominal pain that may spread to the back. This could be a sign of pancreatitis (inflammation of the pancreas); • Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). This may be a result of liver diseases such as hepatitis (inflammation of the liver) or damage to liver tissue. Other side effects: Talk to your doctor if any of the following side effects become severe or last for more than a few days: Very common side effects (occur in ³1 in 10 patients) - Oedema - Hypokalaemia - Hyperlipidaemia Common side effects (occur in £1 in 10 patients) - Headache, dizziness, drowsiness (especially at the beginning of treatment), feeling tired; - Pounding heartbeat (palpitations), - Swelling of the ankles; - Hypotension (low blood pressure), especially when you stand up or sit up quickly from a lying position (orthostatic hypotension); facial flushing. - Difficult, non-productive cough, inflammation of the nasal sinuses (sinusitis), bronchitis, shortness of breath; - Abdominal pain, diarrhoea, gastrointestinal inflammation, indigestion (including dyspepsia), nausea or vomiting; altered bowel function (including diarrhoea and constipation), loss of appetite (anorexia), cramps. - Skin rash with or without blistering, hives. - Chest pain; - Cramps or muscle pain (myalgia); - Reduced levels of magnesium and sodium in the blood; - Weakness and feeling unwell (asthenia); - Reduced number of platelets in the blood (thrombocytopenia); - Increased levels of uric acid and potassium in the blood - Impotence - Visual disturbances (including double vision) Less common side effects: (occur in £1 in 100 patients) - Swelling of the skin, mucous membranes and surrounding tissues (angioneurotic oedema/Quincke's oedema; in very rare, exceptional cases, airway obstruction due to angioneurotic oedema can be fatal) - Swollen hands and feet (peripheral oedema; this may be a sign that your body is retaining more fluid than usual); - Intestinal oedema (angioneurotic oedema of the small intestine) - Mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia) - Ringing in the ears (tinnitus) - Sneezing/runny nose (rhinitis), nasal congestion - Difficulty breathing (bronchospasm) including worsening of asthma - Dry mouth, abdominal pain, including gastritis - Inflammation of the pancreas (pancreatitis; very rare, exceptional cases with fatal outcome have been reported with ACE inhibitors) - Kidney damage, including kidney failure, urinary disorders, increased urine output during the day, increased need to urinate at night (nocturia) - Worsening of existing proteinuria (increased protein in urine) - Feeling unwell (malaise) - Weight gain or loss - Dizziness, trembling (tremor) - Hair loss (alopecia) - Itching, small bleeding spots or bleeding areas on the skin (purpura), changes in skin colour, exanthema; - Unusual skin sensations such as numbness, tingling, burning, pricking or crawling on the skin (paresthesia), reduced skin sensitivity (hypoesthesia) - Loss of taste (ageusia) or altered taste of objects (dysgeusia); - Increased sweating (hyperhidrosis); - Heart attack (myocardial infarction), coronary artery disease (myocardial ischaemia), chest tightness and pain (angina), rapid (tachycardia) or irregular heartbeat (arrhythmia); - Joint pain (arthralgia), back pain, general pain; - Increased body temperature/fever (pyrexia); - Reduced sexual desire in men or women, enlargement of the male breast (gynaecomastia); - Increase in the number of certain white blood cells in the blood (eosinophilia); - Blood tests may show changes in liver (increased liver enzymes and/or bilirubin conjugate), pancreas (increased pancreatic enzymes) or kidney (increased creatinine) function; - Cough; - Necrotizing angiitis (vasculitis, cutaneous vasculitis) Rare: occur in £1 in 1000 patients - Confusion or feeling confused, balance disorders; - Red and swollen tongue (glossitis) - Inflammation and peeling of the skin (exfoliative dermatitis) - Nail damage e.g. loosening or detachment of the nail from the fingertips (onycholysis); - Red, swollen or watery eyes with itching sensation (conjunctivitis) - Hearing impairment - Yellowing of the skin (cholestatic jaundice), hepatocelluar damage; - Narrowing of blood vessels (vasospasm); - Circulatory disorders (hypoperfusion) - Inflammation of blood vessels (vasculitis) - Reduction in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia) and haemoglobin in the blood; - Increased blood sugar levels compared to normal. If you have diabetes, this may worsen your condition; - Sensitivity to light or sun (photosensitivity) - Hypercalcaemia; - Increased sensitivity; Very rare: occur in £1 in 10000 patients - Blistering rash and peeling of the skin over large areas, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome); - Inflammation of the liver (hepatitis, often with cholestasis); - Skin rash that may form blisters and look like a small target (dark spot in the centre, surrounded by a paler area, with a dark ring at the edge) (erythema multiforme); - Red lupus-like reactions, activation of lupus erythematosus, necrotizing vasculitis and toxic epidermal necrolysis; - Enlargement of gum tissue (gingival hyperplasia); - Increased muscle tone (hypertonia); - Peripheral nervous system disease (peripheral neuropathy); - Bone marrow failure; - Large number of damaged red blood cells in the blood (haemolytic anaemia); - Allergic reactions; - Hypochloraemic alkalosis - Respiratory distress (including pneumonitis and pulmonary oedema) Frequency unknown, based on available data: Be sure to tell your doctor if any of the following side effects become serious or persist for more than a few days: - Sharp decrease in the number of red blood cells, white blood cells and platelets (pancytopenia) - Anaphylactic or anaphylactoid reactions; - Blistering skin (pemphigus); - Increase in antinuclear antibodies; - Inattention; - Inflammation of the oral mucosa with small ulcers (aphthous stomatitis); - Aplastic anaemia; - Fingers and toes change colour when cold and then tingle or hurt, and then warm up (Raynaud's phenomenon); - Cerebral ischaemia including ischaemic stroke and transient ischaemic attack; - Reduced psychomotor skills; - Burning sensation; - A condition where objects change smell (parosmia) - Acute liver failure, cholestatic and cytolytic hepatitis (fatal cases have been reported in very rare cases); - Skin inflammation (psoriaform dermatitis), acute skin rash (pemphigoid or lichenoid exanthema), dry or peeling skin (exacerbated psoriasis), mucous membrane rash (enanthema); - Concentrated urine (dark coloured), feeling unwell, muscle cramps, confusion and spasms, which may be caused by inappropriate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible. - Tremor, rigid posture, mask-like face, slow movements and unsteady, unbalanced gait; - Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the eye's blood vessels (choroidal effusion) or acute angle-closure glaucoma); - Skin and lip cancer (non-melanoma skin cancer). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Polytenza Store at a temperature not exceeding 30°C. Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Expiry date 5 mg/5 mg/25 mg, 5 mg/10 mg/25 mg, 2.5 mg/5 mg/12.5 mg: 30 months 10 mg/10 mg/25 mg, 10 mg/5 mg/25 mg, 5 mg/5 mg/12.5 mg: 36 months 6. Contents of the pack and other information What Polytenza contains Polytenza 10 mg/10 mg/25 mg hard capsule: Each capsule contains 10 mg ramipril, 10 mg amlodipine (as 13.868 mg amlodipine besilate), 25 mg hydrochlorothiazide. The excipients are: Capsule composition: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinised maize starch, sodium starch glycolate (Type A), sodium stearyl fumarate. Capsule shell (10 mg/10 mg/25 mg): Red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), gelatin What Polytenza looks like and contents of the pack Polytenza 10 mg/10 mg/25 mg hard capsule: Caramel opaque body with a brown opaque cap. The pack may contain 10, 28, 30, 60 or 100 hard capsules in a blister pack, which is then placed in a cardboard box. Not all pack sizes may be marketed.