How does it work?
Aprovel tablets contain the active ingredient irbesartan, which is a type of medicine called an angiotensin II receptor antagonist. (Irbesartan tablets are also available without a brand name, ie as the generic medicine.) Irbesartan lowers blood pressure by preventing the action of a hormone in the body called angiotensin II.
Angiotensin II is involved in regulating blood pressure and fluid balance. It has two main actions. It causes the blood vessels to narrow and the kidneys to retain salt and water, 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 is the main mechanism by which the pressure in the blood vessels is lowered.
Blocking the actions of angiotensin II also increases 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, hence irbesartan is used to treat high blood pressure.
Irbesartan can also be used to protect the kidneys and slow down the decrease in kidney function in people with type 2 diabetes and high 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.
How do I take it?
- Irbesartan is taken once a day. It's best to try and take your tablet at the same time each day.
- The tablets should be swallowed with a drink of water. They can be taken either with or without food.
- If you accidentally miss a dose don't worry, just take your next dose as normal. Don't take a double dose to make up for a missed dose.
- Dizziness and weariness may occasionally occur during treatment with blood pressure lowering medicines. If you are affected, you should take extra care when driving or operating machinery.
- If you have any problems with your kidney function your doctor will want you to have regular blood tests to monitor the levels of potassium and creatinine in your blood while you are taking this medicine.
- People with heart failure or kidney problems will need to 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.
Use with caution in
- People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea, vomiting or dehydration.
- People over 75 years of age.
- People with decreased kidney function.
- People having haemodialysis for kidney failure.
- People with narrowing of the arteries that supply 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).
- People with narrowing of the main artery that leaves the heart to supply blood to the body (aortic stenosis).
Not to be used in
- Second and third trimesters of pregnancy.
- Aprovel tablets contain lactose and are not suitable for people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- This medicine is not recommended for children under 18 years of age.
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 during the second and third trimesters of pregnancy because it may be harmful to a developing baby. It is not recommended for use during the first trimester, as its safety in early pregnancy has not been established. If you get pregnant while taking this medicine or want to plan a pregnancy you should get medical advice from your doctor straight away. There are other medicines available for treating high blood pressure that are known to be safe when used in pregnancy.
- It is not known if irbesartan passes into breast milk. For this reason, the manufacturer states that it is not recommended for mothers who are breastfeeding. There are other medicines available that have better established safety information when used during breastfeeding and your doctor may suggest you switch to one of these while you are breastfeeding. Seek medical advice from your doctor.
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. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- High blood potassium level (hyperkalaemia) in people with diabetes.
Common (affect between 1 in 10 and 1 in 100 people)
- A drop in blood pressure that occurs when moving from a lying or sitting position to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
- Nausea and vomiting.
- Pain in muscles or bones (musculoskeletal pain).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Increased heart rate (tachycardia).
- Indigestion or heartburn.
- Chest pain.
- Sexual problems.
Frequency not known
- Allergic reactions such as itchy, blistering skin rash (urticaria) or swelling of the lips, tongue and throat (angioedema).
- High blood potassium level (hyperkalaemia).
- Decreased kidney function.
- Spinning sensation (vertigo).
- Sensation of ringing or other noise in the ears (tinnitus).
- Change in taste.
- Muscle cramps
- Abnormal liver function.
- Inflammation of the liver (hepatitis).
The side effects listed above may not include all of the side effects reported by the medicine'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 make sure that the combination is safe.
If irbesartan is used in combination with other medicines that lower blood pressure, either to treat high blood pressure (antihypertensives), or as a side effect, the combination might lower your blood pressure too much. This could make you feel dizzy or faint, particularly when moving from a lying or sitting position to sitting or standing. If this happens to you, you should sit or lie down until the symptoms pass. This is more likely to happen when you first start taking irbesartan with one of these medicines, particularly if you have been taking a high dose of a diuretic usch as furosemide. Tell your doctor if any dizziness persists, as your medicine doses may need adjusting. Other medicines that decrease blood pressure include the following:
- ACE inhibitors, eg enalapril
- alpha-blockers such as prazosin
- other angiotensin II receptor antagonists such as losartan
- antipsychotics such as chlorpromazine
- benzodiazepines, eg temazepam, diazepam
- beta-blockers such as propranolol
- calcium-channel blockers such as verapamil, nifedipine
- diuretics, eg furosemide, bendroflumethiazide
- dopamine agonists, eg bromocriptine, apomorphine
- MAOI antidepressants, eg phenelzine
- nitrates, eg glyceryl trinitrate
Irbesartan may increase the blood level of the medicine lithium, and the combination is not recommended. If it is necessary to take both lithium and irbesartan, your doctor should carefully monitor your blood level of lithium. You should let your doctor know if you experience any signs that your lithium level is increasing, for example, loss of appetite, diarrhoea, vomiting, blurred vision, muscle weakness, lack of co-ordination, drowsiness, tremor, unsteadiness, muscle twitching, ringing in the ears or confusion.
Irbesartan may increase the level of potassium in your blood. If this medicine is taken with other medicines that can increase blood potassium levels, this effect may be enhanced. Such medicines include those listed below. These are not usually recommended for use in combination with irbesartan. If they are used in combination with irbesartan, the amount of potassium in your blood should be monitored:
- ACE inhibitors, eg captopril, enalapril
- non-steroidal anti-inflammatory drugs, eg indometacin, diclofenac, ibuprofen (see also below)
- potassium-sparing diuretics eg spironolactone, triamterene, amiloride
- potassium supplements
- potassium salts, eg potassium citrate for cystitis
- potassium-containing salt substitutes such as Lo-Salt
If non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen, diclofenac or ibuprofen are taken with this medicine, they may increase the risk of side effects on the kidneys.
The following medicines may reduce the blood pressure lowering effect of this medicine:
- corticosteroids, such as dexamethasone or prednisolone
- oestrogens, such as those in the contraceptive pill
- regular use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or indomethacin (occasional painkilling doses are unlikely to have a significant effect).
Other medicines containing the same active ingredient
Irbesartan tablets are also available without a brand name, ie as the generic medicine.
CoAprovel contains irbesartan in combination with the diuretic hydrochlorothiazide.