Product Details

Do not take eplerenone if you: − are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6). − have high levels of potassium in your blood (hyperkalemia). − are taking groups of drugs which help you to excrete excessive body fluid, (potassium sparing diuretics) or ‘‘salt tablets‘‘ (potassium supplements). − have severe kidney disease. − have severe liver disease. − are taking medicines that are used to treat fungal infection (ketoconazole or itraconazole). − are taking antiviral medication for treating HIV (nelfinavir or ritonavir). − are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin). − are taking nefazodone used to treat depression. − are taking medicines used to treat certain heart conditions or hypertension (a so called angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together. Warnings and precautions Talk to your doctor or pharmacist before taking eplerenone if you: − have kidney or liver disease (see also “Do not take eplerenone”). − are taking lithium (usually given for manic depressive disorder, also called bipolar disorder). − are taking tacrolimus or cyclosporin (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation). Children and adolescents The safety and efficacy in children and adolescents have not been established. Other medicines and eplerenone Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. − Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medication for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) as these drugs reduce the break-down of eplerenone, thereby prolonging its effect on the body. − Potassium sparing diuretics (drugs which help you to excrete excess body fluid) and potassium supplements (salt tablets) as these drugs increase the risk of high potassium levels in your blood. − Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) together (which are used to treat high blood pressure, heart disease or particular kidney conditions) as these drugs may increase the risk of high potassium levels in your blood. − Lithium (usually given for manic depressive disorder, also called bipolar disorder). Use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause levels of lithium in the blood to become too high, which may cause side effects of: loss of appetite; visual impairment; tiredness; muscle weakness; muscle twitches. − Cyclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation). These drugs can cause kidney problems and therefore increase the risk of high potassium levels in your blood. − Non-steroidal anti-inflammatory drugs (NSAIDs – certain pain killers such as ibuprofen, used to relieve pain, stiffness and inflammation). These drugs may lead to kidney problems and therefore increase the risk of high potassium levels in your blood. − Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in your blood. − Alpha I blockers, such as prazosin or alfuzosin (used to treat high blood pressure and particular prostate conditions) may lead to a fall in blood pressure and dizziness upon standing. − Tricyclic antidepressants such as amitryptyline or amoxapine (for treatment of depressions), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used during cancer chemotherapy) and baclofen (used to treat muscle spasm). These drugs may lead to a fall in blood pressure and dizziness upon standing. − Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used for diagnosing and treating disorders of the adrenal cortex) may reduce the blood- pressure lowering effect of eplerenone. − Digoxin (used in the treatment of heart conditions). Digoxin blood levels may be increased when taken together with eplerenone. − Warfarin (an anti-clotting drug): Caution is warranted when taking warfarin because high levels of warfarin in the blood may cause changes in the effect of eplerenone on the body. − Erythromycin (used to treat bacterial infections), saquinavir (antiviral medication for treating HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart problems and high blood pressure) reduce the break-down of eplerenone thereby prolonging the effect of eplerenone on the body. − St. John‘s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the break-down of eplerenone and thus decrease its effect. Eplerenone with food Eplerenone may be taken with or without food.

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. The effect of eplerenone has not been evaluated during pregnancy in humans. It is not known if eplerenone is excreted in human breast milk. A decision should be made with your doctor, whether to discontinue breast-feeding or to discontinue the drug. Driving and using machines You may feel dizzy after taking eplerenone. If this should happen, do not drive or operate machinery. Eplerenone contains lactose monohydrate (a type of sugar) and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Eplerenone contains sodium This medicine contains less than 1 mmol sodium(23 mg) per tablet, that is to say essentially ‘sodium-free’.