How does it work? Aprovel tablets contain the active ingredient irbesartan, which is a type of medicine called an angiotensin II receptor antagonist. It works by preventing the action of a hormone in the body called angiotensin II. Angiotensin II normally acts on special receptors in the body, with two main results. Firstly, it causes the peripheral blood vessels to narrow, and secondly, it stimulates the production of another hormone called aldosterone. Aldosterone causes salt and water to be retained by the kidneys, which increases the volume of fluid in the blood vessels. Irbesartan blocks the receptors that angiotensin II acts on, and so prevents its actions. The main result of this is that the peripheral blood vessels are allowed to widen, which means that there is more space and less resistance in these blood vessels. This lowers the pressure inside the blood vessels. Blocking the actions of angiotensin II also reduces the action of aldosterone on the kidneys. The result of this is an increase in the amount of fluid removed from the blood by the kidneys. This decreases the amount of fluid in the blood vessels, which also lessens the resistance and pressure in the blood vessels. The combined overall effect of these changes is to lower the blood pressure. What is it used for? High blood pressure with no known cause (essential hypertension) Kidney disease in people with type 2 diabetes and high blood pressure Warning! Dizziness and weariness may occasionally occur during treatment with blood pressure lowering medicines. If you are affected, caution is required when driving or operating machinery. People with decreased kidney function should have regular blood tests to monitor the levels of potassium and creatinine in their blood while taking this medicine. People with heart failure or diabetic kidney disease should have regular blood tests to monitor the level of potassium in their blood while taking this medicine. People with high blood pressure caused by high levels of the hormone aldosterone (primary hyperaldosteronism) do not generally respond to this type of blood pressure lowering medicine, and it is not recommended for these people. The safety and efficacy of this medicine in children has not been studied by the manufacturer. Use with caution in Elderly people over 75 years of age Decreased kidney function People having haemodialysis for kidney failure Narrowing of the artery which supplies blood to the kidneys (renal artery stenosis) Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease) Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy) Severe heart failure Heart valve disease (mitral valve stenosis) Narrowing of the main artery of the body (aortic stenosis) People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea or vomiting Not to be used in Second and third trimesters of pregnancy Breastfeeding Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Aprovel tablets contain lactose) This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and Breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. This medicine should not be used in pregnancy, particularly in the second and third trimesters, as it may affect the growth and development of the foetus or have adverse effects on foetal tissues. Seek medical advice from your doctor. It is not known if irbesartan passes into breast milk. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor. Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Dizziness Nausea and vomiting Fatigue A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension) Pain in muscles or bones (musculoskeletal pain) Diarrhoea Indigestion (dyspepsia) Increased heart rate (tachycardia) Flushing Cough High blood potassium level (hyperkalaemia) Chest pain Sexual problems Allergic reactions such as itchy, blistering skin rash (urticaria) or swelling of the lips, tongue and throat (angioedema) Decreased kidney function Headache Sensation of ringing or other noise in the ears (tinnitus) Muscle cramps Abnormal liver function The side effects listed above may not include all of the side effects reported by the drug s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines? It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe. Irbesartan may enhance the effect of other medicines that decrease blood pressure. In particular, people taking diuretic medicines, eg furosemide, may have a large drop in blood pressure with the first dose. Since this may cause dizziness or fainting, if you are taking a diuretic medicine your doctor may reduce its dose or ask you to stop taking it two to three days before starting irbesartan. This is to prevent your blood pressure from dropping too low. This medicine may increase the blood level of the medicine lithium, and it is therefore not recommended for people taking lithium. If your doctor feels the combination is necessary, your lithium level should be closely monitored. There may be a risk of raised blood potassium levels (hyperkalaemia) if this medicine is taken with any of the following, hence these are not recommended for use in combination with this medicine: potassium-sparing diuretics (eg spironolactone, triamterene, amiloride) potassium supplements potassium-containing salt substitutes other medicines that can increase blood potassium levels, eg heparin. Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin) may reduce the blood pressure lowering effect of irbesartan. They may also increase the risk of raised blood potassium and kidney problems when used in combination with irbesartan. NSAIDs should be used with caution in people taking irbesartan, particularly elderly people, and your doctor may want to monitor your kidney function. Other medicines containing the same active ingredient There are currently no other medicines available in the UK that contain irbesartan as the sole active ingredient. Medication for High Blood Pressure This leaflet is about drugs that are used to treat high blood pressure. A separate leaflet called High Blood Pressure gives more general information about high blood pressure, lifestyle changes that you can do to lower blood pressure, and the reasons why medication is advised to lower blood pressure in some cases. What is the aim of treatment? The usual target is to reduce blood pressure to below 140/85. In some cases, the target is to get it below 130/80 mmHg. For example, if you have diabetes, a cardiovascular disease such as a stroke or heart disease, or if you have certain kidney diseases. Which drugs are used to lower blood pressure? There are five main classes of drugs that are used to lower blood pressure. There are various types and brands of drug in each class. The following gives a brief overview of each of the classes. However, for detailed information about your own medication you should read the leaflet that comes inside the drug packet. Angiotensin-converting enzyme (ACE) inhibitors These drugs work by reducing the amount of a chemical that you make in your bloodstream called angiotensin II. This chemical tends to constrict (narrow) blood vessels. Therefore, less of this chemical causes the blood vessels to relax and widen, and so the pressure of blood within the blood vessels is reduced. There are various types and brands of ACE inhibitors. For example, captopril, cilazapril, enalapril, fisinopril, lisinopril, perindopril, quinapril, ramipril, and trandolapril. An ACE inhibitor is particularly useful if you also have heart failure or diabetes. ACE inhibitors should not be taken by people with certain types of kidney problems, people with some types of artery problems, and if you are pregnant. You will need a blood test before starting an ACE inhibitor, and within a week after starting it, and one week after any increase in dose. Then, a yearly blood test is usual. Angiotensin Receptor Blockers These drugs are sometimes called angiotension II receptor antagonists. There are various types and brands. For example, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and valsartan. They work by blocking the effect of angiotensin II on the blood vessel walls. So, they have a similar effect to ACE inhibitors (described above). Calcium-channel blockers These drugs affect the way calcium is used in the blood vessels and heart muscle. This has a relaxing effect on the blood vessels. Again, there are various types and brands. For example, amlodipine, diltiazem, felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, nisoldipine, and verapamil. Calcium-channel blockers can also be used to treat angina. Diuretics ( water tablets ) The most commonly used diuretic to treat high blood pressure in the UK is called bendroflumethiazide (bendrofluazide) - but there are others. For example, chlorothiazide, chlorthalidone, cyclopenthiazide, hydrochlorothiazide, and indapamide. Diuretics work by increasing the amount of salt and fluid that you pass out in your urine. This has some effect on reducing the fluid in the circulation which reduces blood pressure. They may also have a relaxing effect on the blood vessels which reduces the pressure within the blood vessels. Only a low dose of a diuretic is needed to treat high blood pressure. Therefore, you will not notice much diuretic effect (you will not pass much extra urine). Beta-blockers Again, there are various types and brands. For example, acebutolol, atenolol, bisoprolol, metoprolol, oxprenolol, pindolol, propanaolol, sotalol, and timolol. They work by slowing the heart rate, and reducing the force of the heart. These actions lower the blood pressure. Beta-blockers are also commonly used to treat angina, and some other conditions. You should not take a beta-blocker if you have asthma, chronic obstructive pulmonary disease (COPD), or certain types of heart or blood vessel problems.
Angiotensin receptor blockers (ARB s) Equivalent to Aprovel 1. Candesartan 2. Eprosartan 3. Losartan 4. Olmesartan 5. Telmisartan 6. Valsartan
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