25 mg, 50 mg film-coated tablets 
eplerenone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Eplerenone Accord is and what it is used for 
2. What you need to know before taking Eplerenone Accord 
3. How to take Eplerenone Accord 
4. Possible side effects 
5. How to store Eplerenone Accord 
6. Contents of the packaging and other information 

What Eplerenone Accord is and what it is used for

Eplerenone Accord belongs to a group of medicines called selective aldosterone antagonists. These antagonists inhibit the effect of aldosterone, a substance that the body produces to regulate blood pressure and heart function. High levels of aldosterone can cause changes in the body that lead to heart failure.

Eplerenone Accord is used to treat heart failure to prevent worsening and reduce the number of hospital stays if you have:

1. have had a recent heart attack, in combination with other medicines used to treat your heart failure, or

2. had persistent, mild symptoms despite the treatment you have received so far.

Eplerenone contained in the Eplerenone Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Eplerenone Accord

Do not take Eplerenone Accord

  • if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6).
  • if you have elevated levels of potassium in your blood (hyperkalemia)
  • if you take diuretics that reduce the body’s excess fluid (potassium-sparing diuretics )
  • if you have severe kidney disease
  • if you have severe liver disease
  • if you are taking medicines for fungal infections ( ketoconazole or itraconazole)
  • if you take medicines to prevent viruses to treat HIV (nelfinavir or ritonavir)
  • if you are taking antibiotics to treat bacterial infections (clarithromycin or telithromycin)
  • if you are taking nefazodone to treat depression
  • if you are taking medicines to treat certain heart conditions or high blood pressure (so-called angiotensin-converting enzyme [ACE] inhibitors and an angiotensin receptor blocker [ARB] together).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Eplerenone Accord

  • if you have kidney or liver disease (see also “Do not take Eplerenone Accord”)
  • if you are taking lithium (commonly used for depressive illness, also known as bipolar disorder )
  • if you are taking tacrolimus or cyclosporine (to treat skin conditions such as psoriasis or eczema and to prevent organ rejection after organ transplantation)

Children and young people

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

Other medicines and Eplerenone Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

  • Itraconazole or ketoconazole (for the treatment of fungal infections), ritonavir, nelfinavir (medicines to prevent infections against HIV – infection ), clarithromycin, telithromycin (drugs for bacterial infections), or nefazadone (depression), then these drugs can reduce the degradation of Eplerenone Accord and thereby prolonging its effect in the body.
  • Potassium-sparing diuretics (medicines that help reduce the body’s excess fluid) and potassium supplements (salt tablets), as these medicines increase the risk of elevated levels of potassium in the blood.
  • Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) together (which are used to treat high blood pressure, heart disease, or certain kidney conditions), as these medicines may increase the risk of high levels of potassium in the blood.
  • Lithium (commonly used for manic-depressive illness, also called bipolar disorder). The use of lithium in combination with diuretics and ACE inhibitors (for the treatment of high blood pressure and heart disease) has been shown to cause high levels of lithium in the blood, which can cause side effects: loss of appetite, visual disturbances, fatigue, muscle weakness, and muscle twitching.
  • Cyclosporine or tacrolimus (to treat skin conditions such as psoriasis or eczema and to prevent organ rejection after organ transplantation). These drugs can cause problems with the kidneys and thus increase the risk of elevated levels of potassium in the blood.
  • Non-steroidal anti-inflammatory drugs (so-called NSAIDs – painkillers such as ibuprofen, for the treatment of pain, stiffness, and inflammation ). These drugs can lead to kidney problems and thus increase the risk of elevated levels of potassium in the blood.
  • Trimethoprim (a medicine used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
  • Alpha-1 receptor blockers, such as prazosin or alfuzosin (used for high blood pressure and certain prostate conditions) can cause a drop in blood pressure and dizziness when standing up.
  • Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (also called neuroleptics ) such as chlorpromazine or haloperidol (for the treatment of mental illness), amifostine (used during cancer treatment), and baclofen (for the treatment of muscle cramps). These medicines can cause a drop in blood pressure and dizziness when standing up.
  • Glucocorticoids such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat disorders of the adrenal cortex ) may reduce the blood pressure-lowering effect of Eplerenone Accord.
  • Digoxin (for heart disease). The levels of digoxin in the blood can increase when taken together with Eplerenone Accord.
  • Warfarin (medicine for blood clots): Caution should be exercised when treating warfarin as high levels of warfarin in the blood may cause changes in the effect of Eplerenone Accord in the body.
  • Erythromycin (for bacterial infections), saquinavir (drugs that counteract viruses used in the treatment of HIV ), fluconazole (antifungal), amiodarone, diltiazem, and verapamil (for cardiac problems, high blood pressure ) decreases degradation of Eplerenone Accord, thus prolonging Eplerenone Accords effect in the body.
  • St. John’s wort (herbal medicine), rifampicin (for bacterial infections), carbamazepine, phenytoin, and phenobarbital (medicines for epilepsy, among others ) can increase the breakdown of Eplerenone Accord and thus reduce its effect.

Eplerenone Accord with food and drink

Eplerenone tablets can be taken with or without food

Pregnancy and breastfeeding

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 efficacy of Eplerenone Accord during human pregnancy has not been studied.

It is not known whether eplerenone is excreted in human breast milk. Discuss with your doctor before deciding whether to stop breast-feeding or discontinue treatment with this medicine.

Driving and using machines

You may feel dizzy after taking Eplerenone Accord. In this case, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Eplerenone Accord contains lactose monohydrate

Eplerenone Accord contains lactose monohydrate (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Eplerenone Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Eplerenone Accord can be taken with food or on an empty stomach. Swallow the tablets whole along with a copious amount of water.

Eplerenone Accord is normally given together with other medicines for heart failure, e.g. beta-blockers. The usual starting dose is 25 mg once daily, which after about 4 weeks is increased to 50 mg once daily (either as one 50 mg tablet or two 
25 mg tablets). The maximum dosage is 50 mg daily.

Potassium levels in the blood should be monitored before treatment with Eplerenone Accord, during the first week of treatment and, one month after starting a treatment or changing the dose. Dosage one may need to be adjusted by your doctor, depending on the potassium levels in your blood.

If you have mild renal impairment, you should start with a 25 mg tablet every day. And if you have moderate renal impairment, you should start with a 25 mg tablet every other day. These doses can be adjusted if your doctor recommends so and based on the levels of potassium in your blood.

Eplerenone Accord is not recommended for patients with severe renal impairment.

The starting dose does not need to be adjusted in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, your potassium levels may need to be checked more often (see also “Do not take Eplerenone Accord”).

Elderly: No adjustment of the starting dose is required.

Use for children and adolescents

Eplerenone Accord is not recommended.

If you take more Eplerenone Accord then you should

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poisons Information Center for risk assessment and advice. 
If you have taken too much of your medicine, the most likely symptoms will be low blood pressure (may manifest as a “slight” feeling in the head, dizziness, blurred vision, weakness, acute unconsciousness) or hyperkalemia, elevated levels of potassium in the blood ( may manifest as muscle cramps, diarrhea, nausea, dizziness or headache).

If you forget to take Eplerenone Accord

If it is soon time for your next dose, skip the missed tablet and take the next one as usual.

Otherwise, take it as soon as you remember, provided it takes more than 12 hours for you to take the next tablet. Then return to your regular medication.

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

If you stop using Eplerenone Accord

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

If you have any further questions on the use of this product, 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 get any of the following side effects, talk  to your healthcare provider immediately:

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

These are symptoms of angioneurotic edema, a less common side effect (may affect up to 1 in 100 people).

Other reported side effects include:

Common  side effects are (may affect up to 1 in 10):

  • high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
  • dizziness
  • fainting
  • increase in blood cholesterol
  • insomnia (difficulty sleeping)
  • headache
  • heart problems, e.g. irregular heartbeat and heart failure
  • cough
  • constipation
  • low blood pressure
  • diarrhea
  • nausea
  • vomiting
  • impaired renal function
  • rash
  • itching
  • back pain
  • impotence
  • muscle twitching
  • increased level of urea in the blood
  • increased content of creatinine in the blood, which may indicate problems with the kidneys

Uncommon side effects (may affect up to 1 in 100 people):

  • infection
  • eosinophilia (increase in certain white blood cells )
  • dehydration
  • increase in triglycerides (fats) in the blood
  • decreased sodium levels in the blood
  • fast heartbeat
  • inflammation of the gallbladder
  • lowered blood pressure which can cause dizziness when standing up
  • thrombosis (blood clot) in the legs
  • sore throat
  • gas formation
  • underactive thyroid gland
  • elevated blood sugar
  • the decreased sensation on touch
  • increased sweating
  • musculoskeletal pain
  • general malaise
  • kidney inflammation
  • breast augmentation in men
  • changes in certain blood test results

5. How to store Eplerenone Accord

Keep this medicine out of sight  and the sight of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat and blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.

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

The tablet coating (Opadry 13B52001 yellow) contains hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

What the medicine looks like and the contents of the pack

Eplerenone Accord 25 mg: yellow, diamond-shaped, biconvex film-coated tablets, marked with “E1” on one side and no label on the other. Length 7.20 ± 0.3 mm, width 6.40 ± 0.3 mm and thickness 3.15 ± 0.3 mm.

Eplerenone Accord 50 mg: yellow, diamond-shaped, biconvex film-coated tablets, marked with “E2” on one side and no label on the other side. Length 9.00 ± 0.3 mm, width 8.10 ± 0.3 mm, and thickness 4.25 ± 0.3 mm.

Eplerenone Accord 25 mg and 50 mg film-coated tablets are packaged in blisters containing 10, 20, 28, 30, 50, 90 or 100 tablets or in perforated unit dose blisters containing 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 or 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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