• 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.

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

• 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 (hyperkalaemia)
• if you are taking groups of drugs which help you to excrete excessive body fluid (potassium sparing diuretics)
• if you have severe kidney disease
• if you have severe 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 (so called angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.

Talk to your doctor or pharmacist or nurse before taking Eplerenone.

• if you have kidney or liver disease (see also “Do not take Eplerenone Film-coated Tablets”)
• 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)

The safety and efficacy of eplerenone in children and adolescents have not been established.

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 may be taken with or without food.

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.

You may feel dizzy after taking Eplerenone. If this should happen, do not drive or operate machinery.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 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.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active substance of Eplerenone Film-coated Tablets is eplerenone.

• Each tablet contains 25 mg or 50 mg of eplerenone.

The other ingredients are:

Tablet core:

Lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc (E553b) and magnesium stearate.

Tablet coating:

Opadry white 13B58802 (hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521) and polysorbate 80 (E433)).

• Eplerenone 25 mg Film-coated Tablets:
  White colour diamond shaped biconvex film-coated tablets (7.22 mm long, 6.55 mm wide, 2.92 mm thick), debossed with “E” on one side and “25” on other side.
• Eplerenone 50 mg Film-coated Tablets:
  White colour diamond shaped biconvex film-coated tablets (9.28 mm long, 8.26 mm wide, 3.74 mm thick), debossed with “E” on one side and “50” on other side.

Eplerenone 25 mg and 50 mg Film-coated Tablet are available in PVC/PVdC Al blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer