The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0049.
Eplerenone 25mg and 50mg film-coated tablets
Eplerenone 25 mg film-coated tablets
Eplerenone 50 mg film-coated tablets
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
Eplerenone belongs to a group of medicines known as selective aldosterone blocking agents. These blocking agents inhibit the action of aldosterone, a substance produced within the body, which controls your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure.
Eplerenone is used to treat your heart failure; to prevent it worsening and reduce hospitalisation if you:
1. have had a recent heart attack, and in combination with other medicines that are used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment you have been receiving so far.
Talk to your doctor or pharmacist before taking Eplerenone:
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.
You must not take Eplerenone with the following medications (see section ‘Do not take Eplerenone’):
Please inform your doctor if you are taking any of the following medicines:
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 medicine.
You may feel dizzy after taking Eplerenone. If this should happen, do not drive or operate machinery.
Eplerenone contains lactose (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 medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Eplerenone tablets may be taken together with food or on an empty stomach. Swallow the tablets whole with plenty of water.
Eplerenone is usually administered together with other medication for heart failure e.g. beta blockers. The usual starting dose is one 25 mg tablet once daily, increasing after about 4 weeks to 50 mg once daily (either as one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50 mg daily.
Blood potassium levels should be measured before starting Eplerenone therapy, within the first week and at one month after the start of treatment or after a change in dose. The dose may be adjusted by your doctor, depending on the potassium levels in your blood.
If you have mild kidney disease, you should start on one 25 mg tablet every day. 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’).
No adjustment of the starting dose is required.
Eplerenone is not recommended.
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 have any further questions on the use of this medicine ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, you should seek immediate medical attention
These are the symptoms of angioneurotic oedema, an uncommon (affecting up to 1 in 100 people) side effect.
Other reported side effects include:
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
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 (website 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.
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack and blister after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The opadry yellow coating of Eplerenone 25 mg and 50 mg film-coated tablets contain macrogol/PEG 6000, HPMC 2910/Hypromellose 5cP, talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
Eplerenone 25 mg film-coated tablets are presented as yellow, round biconvex tablets, engraved with ‘E25’ on one side.
Eplerenone 50 mg film-coated tablets are presented as yellow, round biconvex tablets, engraved with ‘E50’ on one side.
Eplerenone 25 mg and 50 mg film-coated tablets are available in a cardboard box containing white opaque PVC-Aluminium foil blisters with 10, 20, 28, 30, 50, 90, 100, and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in 08/2021