How does it work?

Rasilez tablets contain the active ingredient aliskiren, which is a type of medicine called a renin inhibitor. It is used to help lower high blood pressure.

Aliskiren works by preventing the action of an enzyme in the body called renin. Normally renin is involved in the production of another compound called angiotensin I, which in turn is converted to angiotensin II as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels.

By blocking the action of renin, aliskiren reduces the production of angiotensin I and II. This means that the blood vessels are allowed to relax and widen.

The overall effect of this is a drop in blood pressure, hence aliskiren can be used to lower high blood pressure.

What is it used for?

• High blood pressure with no known cause (essential hypertension).

How do I take it?

• Rasilez tablets are taken once a day. The dose prescribed depends on how well your blood pressure is controlled.
• It is recommended that Rasilez tablets are taken at the same time each day with a light meal. Meals with a high fat content can lower the absorption of this medicine from the gut.
• You should avoid drinking grapefruit juice while taking this medicine because it may affect the level of the medicine in the blood.

Warning!

• Blood pressure lowering medicines such as this one can sometimes make you feel dizzy or weary. If affected you should avoid performing potentially hazardous tasks such as driving or operating machinery. If you feel dizzy this can usually be relieved by lying down until the symptoms pass. Any dizziness may be made worse by drinking alcohol. If you frequently feel dizzy you should let your doctor know, as your dose of this medicine may need adjusting.
• The most common side effect associated with this medicine is diarrhoea. If you experience diarrhoea that becomes severe or doesn’t go away you should consult your doctor.
• Your blood pressure, kidney function and the amount of potassium in your blood should be regularly monitored while you are taking this medicine.
• This medicine may rarely cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine.

Use with caution in

• Heart disease, such as heart failure.
• Kidney disease or decreased kidney function.
• People with narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
• Liver disease.
• Diabetes.
• People with low salt or fluid volume in the body, eg due to high-dose diuretic therapy, low-salt diet, or severe blood loss, diarrhoea, vomiting or dehydration.
• People with a history of swelling of the lips, face or tongue (angioedema).

Not to be used in

• People with a history of swelling of the lips, face or tongue (angioedema) with no known cause, or caused by previous use of aliskiren.
• Hereditary angioedema (angioneurotic oedema).
• People with diabetes who are also taking an ACE inhibitor or angiotensin receptor blocker medicine.
• Pregnancy.
• Breastfeeding.
• This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

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.

• The safety of this medicine for use during pregnancy has not been established, however there is potential that it could be harmful to a developing baby. It should not be used during pregnancy, in particular during the second and third trimesters. If you get pregnant while taking this medicine you should stop taking it and seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. The manufacturer states that it is not recommended for women who are 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. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Diarrhoea (see warning section above).
• Pain in the joints.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Rash.
• Increase in the amount of potassium in the blood.
• Severe allergic skin reactions.
• Decreased kidney function or acute kidney failure.
• Swollen ankles due to fluid retention (peripheral oedema).

Rare (affect between 1 in 1000 people and 1 in 10,000 people)

• Severe swelling of lips, face, tongue, throat, hands, feet or ankles (an allergic reaction called angioedema) - see warning section above.

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.

The following medicines may increase the amount of aliskiren in the blood, which may increase the risk of its side effects. As a result, aliskiren should not be taken in combination with these medicines:

• ciclosporin
• itraconazole
• quinidine.

The following medicines may also increase the amount of aliskiren in the blood, which may increase the risk of its side effects. Your doctor may decide to lower your dose of aliskiren if you are prescribed any of these medicines:

• amiodarone
• clarithromycin
• erythromycin
• ketoconazole
• telithromycin
• verapamil.

This medicine may enhance the effect of other medicines that decrease blood pressure, especially other medicines used to treat high blood pressure (antihypertensives). In particular, people taking high doses of diuretic medicines, eg furosemide or bendroflumethiazide, may have a large drop in blood pressure with the first dose of this medicine that could cause dizziness or fainting. For this reason, if you are taking a diuretic medicine your doctor may reduce its dose or ask you to stop taking it a few days before starting aliskiren, to prevent your blood pressure from dropping too low.

If you frequently feel dizzy while taking this medicine in combination with other blood pressure lowering medicines you should let your doctor know, as your doses may need adjusting.

Other medicines that decrease blood pressure include thefollowing:

• alpha-blockers such as prazosin (these are also used to treat an enlarged prostate gland)
• alprostadil
• certain antidepressants
• certain antipsychotics
• baclofen
• benzodiazepines, eg temazepam
• beta-blockers such as propranolol
• calcium-channel blockers such as verapamil, nifedipine
• clonidine
• diuretics, eg furosemide, bendroflumethiazide
• nitrates, eg glyceryl trinitrate.

Aliskiren may decrease the effects of furosemide. If you are prescribed furosemide while taking this medicine your doctor may need to do extra monitoring to check that the furosemide is still effective.

There may be a risk of raised potassium levels in the blood(hyperkalaemia) if any of the following medicines are taken with aliskiren,hence these are not normally recommended for use in combination with thismedicine. If you are taking any of the following with this medicine you shouldhave regular blood tests to monitor the amount of potassium in your blood:

• ACE inhibitors (eg captopril)
• angiotensin-II receptor antagonists (eg losartan)
• drospirenone
• heparin
• potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)
• potassium salts, eg potassium citrate for cystitis
• potassium supplements
• potassium-containing salt substitutes (eg Lo-Salt).

Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin, aspirin, ibuprofen, diclofenac) may reduce the blood pressure lowering effect of this medicine. If you have any existing kidney problems, for example due to dehydration or old age, it may also increase the risk of a decline in kidney function. You should avoid taking this type of painkiller while taking aliskiren unless recommended by your doctor.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain aliskiren as the active ingredient.