Perindopril tert-butylamine 5 mg/ Indapamide 1.25 mg Tablets What is Perindopril tert-butylamine/ Indapamide and what is used for: This product consists of two active ingredients; perindopril tert-butylamine and indapamide. Perindopril tert-butylamine is a medicine that belongs to a class of medications known as “angiotensin converting enzyme (ACE) inhibitor”. it acts by widening the blood vessels making it easier for your heart to pump blood through them. Indapamide belongs to a class of medicines known as “diuretics”. Diuretics act by increasing the urinary output that your kidneys produce. Indapamide is different compared to other diuretics because it does not cause excessive urination. This combination of active ingredients is used to help reduce and control your blood pressure if you have hypertension (high blood pressure). Do not take Perindopril tert-butylamine/ Indapamide: If you have an allergy to perindopril, or any other ACE inhibitor, or indapamide or any other sulfonamides or any of the other ingredients of this medicine. If you have previously experienced angioedema to perindopril or another ACE inhibitor. Angioedema is a condition that is manifested by signs and symptoms like swelling of the face, throat or tongue, wheezing, intense itching or severe skin rashes. If a family member has previously experienced angioedema to perindopril or another ACE inhibitor. If you are more than 3 months pregnant. If you have diabetes mellitus or kidney problems and you are taking aliskiren (medicine used to treat high blood pressure). If you have liver disease or have previously experienced hepatic encephalopathy (brain disorder caused by severe liver damage). If you are taking sacubitril/valsartan (used to treat heart failure). If you are breastfeeding. If you have renal artery stenosis (artery supplying blood to the kidney becomes narrow). If you are using dialysis or another type of blood filtration. This medicine may not be used depending on the type of filtration used. If you are suspected to have untreated heart failure (heart muscle is not able to pump blood properly to the body). Warnings & Precautions: Stop the medication right away and talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness. Talk to your doctor if you have hypertrophic cardiomyopathy (heart muscle problem), aortic stenosis (main blood vessel that leads to the heart becomes narrowed) or renal artery stenosis (artery supplying blood to the kidney becomes narrow). Talk to your doctor if you are suspected to have heart failure or other heart problems. Talk to your doctor before starting this medicine if you have liver or kidney problems or if you are undergoing dialysis. Talk to your doctor before starting this medicine if you have diabetes. Talk to your doctor before starting this medicine if you have collagen vascular disease (disorder of the connective tissue) like scleroderma or systemic lupus erythematosus. Talk to your doctor before starting this medicine if you are following a salt restricted diet or are using salt substitutes that have potassium. Talk to your doctor before starting this medicine if you are to have LDL apheresis (cholesterol removal from your blood using a machine) Talk to your doctor before starting this medicine if you are due to have a surgery and/or anesthesia. Talk to your doctor before starting this medicine if you are going to undergo a desensitization therapy to decrease the effects of wasp stings or a bee allergy. Talk to your doctor before starting this medicine if you are intolerant to some sugars. Talk to your doctor before starting this medicine if you have recently suffered from vomiting, diarrhea or are dehydrated. Talk to your doctor before starting this medicine if you are pregnant or plan on getting pregnant. Talk to your doctor before starting this medicine if you have atherosclerosis (hardening of the arteries). Talk to your doctor before starting this medicine if you have photosensitive reactions (skin reactions upon exposure to UV light). Talk to your doctor before starting this medicine if you are elderly. Talk to your doctor before starting this medicine if you have hyperparathyroidism (overactive parathyroid gland). Talk to your doctor before starting this medicine if you have gout. The use of this medicine for high blood pressure in patients of black origin is not recommended. This medicine was shown to cause a higher risk of angioedema and may be less effective in patients with black origin. Make sure to tell your healthcare provider that you are taking this medicine if you are to undergo a medical test requiring injection of an iodinated contrast agent (a substance that is used to make your organs like stomach or kidney visible on an X-ray). Make sure to tell your healthcare provider if you experience any signs of glaucoma (elevated pressure in your eyes) like changes in your vision or pain in one or both of your eyes while taking this medicine. If this happens, stop taking the medication and seek immediate medical attention. If you are an athlete, taking this medicine may give a positive reaction in drug tests as it contains indapamide. Possible Side Effects: Possible rare but serious side effects include signs of an allergic reaction like; rash and itching, angioedema (swelling with a red colored rash below the surface of the skin in a localized part of the body on or near the hands, feet, lips, or eyes), low blood pressure, bronchospasm (tightening of the chest, difficulty breathing and wheezing), irregular heartbeat, pain in the jaw, chest and back upon physical exertion, signs of pancreas inflammation (fatigue and severe abdominal and back pain), signs of liver problems (yellowing of the skin or eyes, white stools and dark urine) . Stevens-Johnson syndrome signs (a rare, serious disease of the skin that usually begins with signs of a flu and followed by a severe and painful skin rash with blisters). Common side effects include dizziness, headache, vertigo, vision problems, pins and needles sensation, tinnitus (noises in your ears), cough, shortness of breath, nausea, diarrhea, constipation, indigestion, taste changes, vomiting, abdominal pain, lightheadedness, tiredness and muscles cramps. Other medicines and Perindopril tert-butylamine/ Indapamide: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including over the counter non-prescription medicines, prescription medicines, herbal supplements, vitamins and supplements. If you are taking blood pressure medications (e.g. aliskiren and angiotensin II receptor blockers also known as ARBs or sartans like irbesartan, valsartan and telmisartan). If you are taking diuretics (used to increase urination). If you are taking NSAIDs (used to reduce inflammation, pain and fever like ibuprofen) or high dose aspirin. If you are taking medicines used to treat diabetes (e.g. metformin or insulin). If you are taking lithium (used for depression or mania). If you are taking eplerenone (used to treat heart failure). If you are taking potassium-sparing medicines (like spironolactone, amiloride, triamterene), potassium-containing salt substitutes or potassium supplements. If you are taking baclofen (used to treat muscle stiffness in diseases like multiple sclerosis). If you are taking corticosteroids or immunosuppressants (medicines used to reduce your body’s defense mechanism following a transplant or for the treatment of autoimmune disorders like, ciclosporin and tacrolimus). If you are taking medicines used to treat mental disorders such as anxiety, depression and schizophrenia (e.g. antipsychotics and tricyclic antidepressants). If you are taking heparin (blood thinner). If you are taking procainamide (used to treat irregular heart beat). If you are taking estramustine (used to treat cancer). If you are taking allopurinol (used to treat gout). If you are taking gold salts, especially when given into the vein (used to treat signs and symptoms of rheumatoid arthritis). If you are taking trimethoprim (used to treat infections). If you are taking vasodilators including nitrates (medicines that widen the blood vessels). If you are taking medicines used to treat asthma, shock and low blood pressure (e.g. ephedrine, adrenaline or noradrenaline). If you are taking racecadotril (used to treat diarrhea). If you are taking pentamidine (used to treat pneumonia). If you are taking halofantrine (used to treat some types of malaria). If you are taking sacubitril/valsartan (used to treat heart failure). If you are taking methadone (used to treat addiction). If you are taking sparfloxacin or moxifloxacin (antibiotics). If you are taking terfenadine, mizolastine or astemizole (antihistamines used for allergies or hay fever). If you are taking vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss). If you are taking bepridil (used to treat angina). If you are taking medicines used to treat abnormal heart rhythms (e.g. amiodarone, quinidine, sotalol, hydroquinidine, disopyramide). If you are taking cisapride or diphemanil (used to treat digestive problems). If you are taking digoxin or other heart glycosides (used for the treatment of heart problems). If you are taking calcium including calcium supplements. If you are taking stimulant laxatives (e.g. senna). If you are taking amphotericin B by injection (used to treat severe fungal infections). If you are taking tetracosactide (used to treat Crohn’s disease). How to take Perindopril tert-butylamine/ Indapamide: Adults The recommended dose is one tablet orally once daily. Your doctor may increase the dose to 2 tablets every day or change the dosage regimen if you have kidney dysfunction. Children and adolescents Use of this medicine is not recommended in children and adolescents. How To Use: Take tablet before food in the morning. Take tablet with a full glass of water. Take exactly as prescribed by your doctor or your pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How to store Perindopril tert-butylamine/ Indapamide: Keep out of the reach of children and pets Do not store above 30°C Discard medication blister 2 months after first opening of the outer sachet Do not use beyond the expiry date mentioned on the box Keep medication in its original pack to protect it from moisture and light Do not use damaged pills Do not dispose medication in the wastewater or household waste A valid prescription should be available upon delivery