Patient Leaflet Updated 04-Aug-2020 | Zentiva
Eplerenone 25-50 mg film-coated tablets
Package leaflet: Information for the patient
Eplerenone 25 mg film-coated tablets
Eplerenone 50 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. WHAT EPLERENONE IS AND WHAT IT IS USED FOR
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 worsening and reduce hospitalisations if you have:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPLERENONE
Do not take eplerenone
Warnings and precautions
Talk to your doctor or pharmacist before taking eplerenone
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.
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.
3. HOW TO TAKE EPLERENONE
Always take this medicine exactly as your doctor 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.
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”).
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.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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):
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.
5. HOW TO STORE EPLERENONE
Keep this medicine out of the sight and reach of children.
This medicinal product 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
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
This leaflet was last revised in April 2019