Triplixam 10/2.5/10mg Tablets 30’s

Full Prescribing Info Triplixam 10/2.5/10mg Tablets 30’s
Contents
Perindopril arginine, indapamide, amlodipine.
Description
Triplixam 5/1.25/5 mg: One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine.
Triplixam 5/1.25/10 mg: One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10 mg of amlodipine.
Triplixam 10/2.5/5 mg: One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine.
Triplixam 10/2.5/10 mg: One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10 mg of amlodipine.
Excipients/Inactive Ingredients: Core: Calcium carbonate starch compound: Calcium carbonate 90%, Pregelatinised maize starch 10%, Cellulose microcrystalline (E460), Croscarmellose sodium (E468), Magnesium stearate (E572), Colloidal anhydrous silica, Pregelatinised starch.
Film-coating: Glycerol (E422), Hypromellose 6mPa.s (E464), Macrogol 6000, Magnesium stearate (E572), Titanium dioxide (E 171).

KSh2,380.00

Triplixam 10/2.5/10mg Tablets 30’s

Description

Triplixam 10/2.5/10mg Tablets 30’s
Description
Triplixam Tablet is a medicine that consists of Perindopril, Indapamide, and Amlodipine. It is used in the treatment of hypertension (high blood pressure). It works by relaxing the blood vessels and making it easier for the heart to pump blood. It also removes extra fluid and electrolytes in your body. This helps in reducing your blood pressure and preventing heart attack and stroke. Triplixam Tablet has some side effects like headache, diarrhoea, vertigo, sleepiness, etc. These side effects are mild and may subside by themselves. Consult your doctor if they bother you. Avoid driving vehicles or operating machines after taking this medicine as it may cause dizziness. Avoid using this medicine if you are allergic to it. Triplixam Tablet should be taken before meals or as prescribed by your doctor. Take this medicine every day at the same time for better results. Do not take more than the prescribed dose. Do not discontinue the medicine without consulting your doctor as it may worsen your health condition. Triplixam Tablet is not recommended for use in children below 18 years of age. Inform your doctor if you have any kidney, liver or heart problems before taking this medicine. This medicine is not recommended if you are pregnant as it might harm your foetus, especially if taken during the second and third trimesters. If you are breastfeeding, consult your doctor before taking this medicine.
What Triplixam is and what it is used for Triplixam is a combination of three active ingredients: perindopril, indapamide and amlodipine. It is an antihypertensive medicine used in the treatment of high blood pressure (hypertension). Patients already taking perindopril/indapamide as fixed dose combination and amlodipine from separate tablets may instead receive one tablet of Triplixam which contains the three active ingredients in the same strength. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure: – Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them. – Indapamide is a diuretic (which belongs to a class of medicines called sulfonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. – Amlodipine is a calcium channel blockers (which belongs to a class of medicines called dihydropyridines). It works by relaxing blood vessels, so blood passes through easily. 2. What you need to know before you take Triplixam Do not take Triplixam – if you are allergic to perindopril or other ACE-inhibitors, indapamide or other sulfonamides, amlodipine or other dihydropyridines, or any of the other ingredients of this medicine (listed in Section 6), – if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema), – if you have severe liver disease or suffer from a condition called hepatic encephalopathy (disease of the brain caused by liver illness), – if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing), – if you take non antiarrhythmic medicines causing life-threatening irregular beat (torsades de pointes) 2 – if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body), – if you suffer from heart failure after a heart attack. – if you have severe low blood pressure (hypotension), – if you have low blood potassium, – if you have severe kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis), – if you are receiving dialysis or any other type of blood filtration. Depending on the machine that is used, Triplixam may not be suitable for you, – if you have moderate kidney problems (for Triplixam doses containing 10mg/2.5mg/5mg and 10mg/2.5mg/10mg). – if you are more than 3 months pregnant (it is also better to avoid Triplixam in early pregnancy – see pregnancy section.), – if you are breastfeeding. – if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren, – if you are being treated with sacubitril/valsartan, a medicine for heart failure (see “Warning and Precaution” and “Other medicines and Triplixam”). Warnings and precautions Talk to your doctor or pharmacist or nurse before taking Triplixam: – if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood), – if you have heart failure or any other heart problems, – if you have severe increase in blood pressure (hypertensive crisis), – if you have liver problems, – if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma, – if you have atherosclerosis (hardening of the arteries), – if you need to have a test to check how well your parathyroid gland is working, – if you suffer from gout, – if you have diabetes, – if you are on a salt restricted diet or use salt substitutes which contain potassium (a well-balanced potassium blood level is essential), – if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Triplixam should be avoided (see “Taking other medicines”), – if you are elderly and your dose needs to be increased, – if you have photosensitivity reactions, – if you are black origin you may have higher incidence of angiodema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing) and less effective in lowering blood pressure, – if you are Haemodialysis patients dialysed with high-flux membranes, – if you have kidney problems or if you are receiving dialysis, – if you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism), – if you have too much acid in blood, which may cause an increased rate of breathing, – if you have cerebral circulatory insufficiency (low blood presure in the brain), – if you have swelling of the face, lips, mouth , tongue or throat which may cause difficulty in swallowing or breathing (angioedema), which can occur at any time during treatment, stop your treatment immediately and directly contact your doctor. – if you are taking any of the following medicines, the risk of angioedema is increased: – racecadotril (used to treat diarrhea), – sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs), – sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure. – if you are taking any of the following medicines used to treat high blood pressure: 3 – an “angiotensin II receptor blocker” (ARBs) (also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. – aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Triplixam”. Your doctor may prescribe you blood tests to check for low sodium or potassium levels or high calcium levels. You must tell your doctor if you think that you are (or might become) pregnant. Triplixam is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see “Pregnancy and breastfeeding”). When you are taking Triplixam, you should also inform your doctor or the medical staff: – if you are to undergo anaesthesia and/or surgery, – if you have recently suffered from diarrhoea or vomiting, or are dehydrated, – if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine), – if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings, – if you are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray). Children and adolescents Triplixam should not be given to children and adolescents. Other medicines and Triplixam Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Do not take aliskiren (used to treat high blood pressure) if you have diabetes or kidney problems. You should avoid Triplixam with: ✓ lithium (used to treat some mental health disorders such as mania, manic depressive illness and recurrent depression), ✓ potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,other drugs which can increase potassium in your body (such as heparin and cotrimoxazole also known as trimethoprim/sulfamethoxazole), ✓ dantrolene (infusion) is also used to treat malignant hyperthermia during anaesthesia (symptoms including very high fever and muscle stiffness), ✓ estramustine (used in cancer therapy), ✓ medicines, which are most often used to treat diarrhea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section “Warnings and precautions”, ✓ sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take Triplixam” and “Warnings and precautions”, ✓ other medicines used to treat high blood pressure: angiotensin-converting-enzyme inhibitor and angiotensin receptor blockers. Treatment with Triplixam can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required: ✓ other medicines for treating high blood pressure, including angiotensin II receptor blocker (ARB), aliskiren (see also information under the headings “Do not take Triplixam” and “Warning and precaution”), or diuretics (medicines which increase the amount of urine produced by the kidneys), ✓ potassium-sparing drugs used in the treatment of heart failure : eplerenone and spironolactone at doses between 12,5mg to 50mg per day, 4 ✓ anaesthetics medicines ✓ iodinated contrast agent ✓ bepridil (used to treat angina pectoris), ✓ moxifloxacine, sparfloxacine (antibiotic: medicine used to treat infection), ✓ methadone (used to treat addiction) ✓ dofetilide, ibutilide, bretylium, cisapride, diphemamil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol (for the treatment of an irregular heart beat), ✓ verapamil, diltiazem (heart medicines) ✓ digoxin or other cardiac glycosides (for the treatment of heart problems), ✓ rifampicin, erythromycin, clarithromycin (antibiotics for infection caused by bacteria), ✓ itraconazole, ketoconazole, amphotericin B by injection (to treat fungal disease), ✓ allopurinol (for the treatment of gout), ✓ mizolastine, terfenadine or astemizole (antihistamines for hay fever or allergies), ✓ corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. acetylsalicylic acid), ✓ immunosuppressants (medicines used to control your body’s immune response) for the treatment of autoimmune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin, tacrolimus), ✓ tetracosactide (to treat Crohn’s disease) ✓ gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis), ✓ halofantrine (used to treat certain types of malaria), ✓ baclofen used to treat muscle stiffness in diseases such as multiple sclerosis, ✓ medicines to treat diabetes such as insulin or metformin, ✓ calcium including calcium supplements, ✓ stimulant laxatives (e.g. senna), ✓ medicines for the treatment of cancer, ✓ vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss), ✓ medicines to treat mental health disorders such as depression, anxiety, schizophrenia…(e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics), ✓ pentamidine (used to treat pneumonia), ✓ ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV). ✓ hypericum perforatum (St. John’s Wort), ✓ trimethoprime (for the treatment of infections), ✓ medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline), ✓ nitroglycerin and other nitrates, or other vasodilators that may further reduce blood pressure. Triplixam with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Triplixam. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Triplixam. Pregnancy and breast-feeding If you are pregnant or 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 You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Triplixam before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Triplixam. Triplixam is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Triplixam is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is new-born, or was born prematurely. 5 Driving and using machines Triplixam may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, tired, or give you a headache, do not drive or use machines and contact your doctor immediately. Triplixam contains sodium Triplixam contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 3. How to take Triplixam Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablet with a glass of water preferably in the morning and before a meal. Your doctor will decide on the correct dose for you. This will normally be one tablet once a day. If you take more Triplixam than you should Taking too many tablets may cause you blood pressure to become low or even dangerously low sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria (passing less urine than is normal), anuria (no production or passing of urine). You may fell lightheaded, faint, or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and claimmy and you could loose consciousness. Seek immediate medical attention if you take too many Triplixam tablets. If you forget to take Triplixam It is important to take your medicine every day as regular treatment is more effective. However, If you forget to take a dose of Triplixam, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Triplixam As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, Triplixam 10/2.5/10mg Tablets 30’s medicine can cause side effects, although not everybody gets them. Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects: – sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing, (Uncommon) (may affect up to 1 in 100 people) – swelling of eyelids, face or lips, (Uncommon) (may affect up to 1 in 100 people) – swelling of the mouth, tongue and throat, which causes great difficulty breathing, (Uncommon) (may affect up to 1 in 100 people) – severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, Toxic Epidermal Necrolysis) or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people) – severe dizziness or fainting, (Common) (may affect up to 1 in 10 people) – heart attack, (Very rare) (may affect up to 1 in 10,000 people), life-threatening irregular beat.(Not known) – inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare) (may affect up to 1 in 10,000 people) In decreasing order of frequency, side effects can include: – Very common (may affect more than 1 in people) : Oedema (fluid retention)