25 mg and 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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Eplerenone Bluefish is and what it is used for

Eplerenone Bluefish 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 Bluefish is used to treat your heart failure to prevent deterioration 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 Eplerenone Bluefish 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 you take Eplerenone Bluefish

Do not take Eplerenone Bluefish

  • 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 are taking 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 Bluefish:

  • if you have impaired kidney or liver function (see also “Do not take Eplerenone Bluefish”)
  • if you are taking lithium (commonly used for manic depressive illness, also called bipolar disorder)
  • if you are taking tacrolimus or ciclosporin (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 Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken o,r 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) when these drugs may reduce degradation of Eplerenone Bluefish and thus extend its effect in the body.
  • potassium-sparing diuretics (medicines that help to 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 your blood.
  • lithium (commonly used to treat manic-depressive illness, also known as bipolar disorder). The use of lithium in combination with diuretics and ACE inhibitors(used to treat 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; muscle twitching.
  • ciclosporin 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 to treat 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 spasms). 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 adrenal cortex disorders ) may reduce the blood pressure-lowering effect of Eplerenone Bluefish.
  • digoxin (for heart disease). The levels of digoxin in the blood can increase when taken together with Eplerenone Bluefish.
  • warfarin (medicine for blood clots): Caution is warranted with warfarin treatment as high levels of warfarin in the blood may cause changes in the effect of Eplerenone Bluefish in the body.
  • erythromycin (for bacterial infections), saquinavir (medicines to prevent infection against HIV ), fluconazole (antifungal), amiodarone, diltiazem, and verapamil (for cardiac problems, high blood pressure ) decreases degradation of Eplerenone Bluefish, thus prolonging Eplerenone Bluefish 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 Bluefish and thus reduce its effect.

Eplerenone Bluefish with food and drink

Eplerenone Bluefish 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 Bluefish 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 breastfeeding or stop taking the medicine.

Driving and using machines

You may feel dizzy after taking Eplerenone Bluefish. In this case, do not drive, use any tools or 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 Bluefish contains lactose

Eplerenone Bluefish 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.

Eplerenone Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 25 mg and 50 mg tablets, ie essentially ‘sodium-free’.

How to take Eplerenone Bluefish

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

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

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

Potassium levels in the blood should be checked before treatment with Eplerenone Bluefish, during the first week of treatment, and one month after starting a treatment or changing the dose.

Dose one may need to be adjusted by your doctor, depending on the potassium levels in your blood.

Patients with renal or hepatic impairment

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 Bluefish 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 blood potassium levels may need to be checked more often (see also “Do not take Eplerenone Bluefish”).

Older

No adjustment of the starting dose is required for elderly patients.

Use for children and adolescents

Eplerenone Bluefish is not recommended for use in children and adolescents.

If you take more Eplerenone Bluefish then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison 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 your 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 Bluefish

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 taking Eplerenone Bluefish

It is important to continue taking Eplerenone Bluefish 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 experience any of the following:

Should you seek immediate medical attention:

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

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

Other reported side effects include:

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

  • high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
  • fainting
  • dizziness
  • increase in cholesterol (fats) in the blood
  • 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 )
  • decreased sodium levels in the blood
  • dehydration
  • increase in triglycerides (fats) in the blood
  • fast heartbeat
  • inflammation of the gallbladder
  • lowered blood pressure which can sometimes cause dizziness for example if you get up too fast
  • thrombosis (blood clot) in the legs
  • sore throat
  • gas formation
  • underactive thyroid gland
  • increase in blood sugar
  • the decreased sensation on touch
  • increased sweating
  • pain in muscles and bones
  • feeling sick
  • kidney inflammation
  • breast augmentation in men
  • changes in certain blood test results

5. How to store Eplerenone Bluefish

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton 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. One tablet of Eplerenone Bluefish contains 25 mg or 50 mg of eplerenone.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium (Type A), hypromellose (Benecel E3), talc, and magnesium stearate.

The tablet coating of Eplerenone Bluefish 25mg and 50mg consists of macrogol / PEG 6000, HPMC 2910 / Hypromellose 5cP, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What the medicine looks like and the contents of the pack

Eplerenone Bluefish 25 mg is a yellow, round biconvex tablet with “E25” engraved on one side.

Eplerenone Bluefish 50 mg is a yellow, round biconvex tablet but “E50” is engraved on one side.

Eplerenone Bluefish 25 mg and 50 mg film-coated tablets are available in opaque PVC / Al pressure packs of 10, 20, 28, 30, 50, 90, 100, and 200 tablets respectively.

However, not all pack sizes will be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

PO Box 49013

100 28 Stockholm

Sweden

Manufacturer

Pharmathen SA

6 Dervenakion str., 15351 Pallini Attiki

Greece

and

Pharmathen International SA

Industrial Park Sapes Rodopi prefecture, Block No. 5, Rodopi, 69300

Greece

This medicinal product is authorized under the European Economic Area under the names:

Denmark Eplerenone Bluefish
Spain Eplerenone Bluefish 25mg / 50mg compresses recovered with EFG film
Ireland Eplerenone Bluefish 25 mg / 50mg film-coated tablets
Iceland Eplerenone 25 mg / 50 mg film-coated tablets

Muhammad Nadeem

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