Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What eplerenone is and what it is used for
2. What you need to know before you take eplerenone
3. How to take eplerenone
4. Possible side effects
5. How to store eplerenone
6. Contents of the pack and other information

Do not take eplerenone

• if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of potassium in your blood (hyperkalemia),
• if you are taking groups of drugs which help you to excrete excessive body fluid, (potassium sparing diuretics) or “salt tablets” (potassium supplements),
• if you have severe kidney or liver disease,
• if you are taking medicines that are used to treat fungal infection (ketoconazole or itraconazole),
• if you are taking antiviral medication for treating HIV (nelfinavir or ritonavir),
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin),
• if you are taking nefazodone used to treat depression,
• if you 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”),
• if you are taking lithium (usually given for manic depressive disorder, also called bipolar disorder),
• if you 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.

You must not take eplerenone with the following medications (see section “Do not take eplerenone”):

• 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.

Please inform your doctor if you are taking any of the following medicines:

• 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 1 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)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Patients with kidney or liver disease

If you have mild kidney disease, you should start on one 25 mg tablet every day. And if you have moderate kidney disease, you should start on one 25 mg tablet every other day. These doses may be adjusted if your doctor recommends and according to your blood potassium levels.

In patients with severe kidney disease, eplerenone is not recommended.

In patients with mild-to-moderate liver disease no adjustment of the starting dose is required. If you have liver or kidney problems, you may need more frequent testing of your blood potassium levels (see also “Do not take eplerenone”).

Elderly

No adjustment of the starting dose is required.

Children and adolescents

Eplerenone is not recommended for children and adolescents.

If you take more eplerenone than you should

If you take more eplerenone than you should, tell your doctor or pharmacist immediately. If you have taken too much of your medicine, the most likely symptoms will be low blood pressure (expressed as a light feeling in your head, dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (expressed by muscle cramps, diarrhoea, nausea, dizziness or headache).

If you forget to take eplerenone

If it is almost time for your next tablet, skip the tablet you missed and take your next tablet when it is due.

Otherwise take the tablet as soon as you remember, providing there is more than 12 hours to when you are due to take your next tablet. Then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the forgotten tablet.

If you stop taking eplerenone

It is important to keep taking eplerenone as prescribed unless your doctor tells you to stop your treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

What eplerenone contains

The active substance is eplerenone.

Each tablet contains 25 mg or 50 mg of eplerenone.

The other ingredients are lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate and magnesium stearate.

The coating contains hypromellose, titanium dioxide, macrogol, polysorbate 80 and iron oxide yellow.

What eplerenone looks like and contents of the pack

The eplerenone 25 mg tablet is a yellow, round, biconvex film-coated tablet with a diameter approximately 6 mm and thickness approximately 3.0 mm.

The eplerenone 50 mg tablet is a yellow, round, biconvex film-coated tablet with a diameter approximately 7.5 mm and thickness approximately 3.7 mm.

Eplerenone 25 mg and 50 mg film-coated tablets are available in blister packs containing 10, 20, 28, 30, 50, 90,100 or 200 tablets, in perforated unit dose blisters containing 10x1, 20x1, 28x1, 30x1, 50x1, 90x1, 100x1 or 200x1 tablets and bottles containing 10, 20, 28, 30, 50, 90,100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer