25 mg & 50 mg film-coated tablets 
eperenone

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 can harm them, even if they show signs of illness 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 Stada is and what it is used for 
2. What you need to know before you use Eplerenone Stada 
3. How to use Eplerenone Stada 
4. Possible side effects 
5. How to store Eplerenone Stada 6. Contents of the pack 
and other information 

What Eplerenone Stada is and what it is used for

Eplerenone Stada 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 Stada is used to treat your heart failure to prevent deterioration and reduce the number of hospital stays if you have:

  • have had a recent heart attack, in combination with other medicines used to treat your heart failure, or
  • had persistent, mild symptoms despite the treatment you have received so far.

Eplerenone contained in Eplerenone Stada 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 use Eplerenone Stada

Do not use Eplerenone Stada

  • 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 ) or “salt tablets” (potassium supplements)
  • 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 Stada

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

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

You must not take Eplerenone Stada with the following medicines (see section “Do not take Eplerenone Stada”):

  • 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 nefazodone (depression) when these drugs may reduce degradation of Eplerenone STADA thereby extend 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 increased 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.

Tell your doctor if you are taking any of the following medicines:

  • 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.
  • 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 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 disorders of the adrenal cortex ) may reduce the antihypertensive effect of Eplerenone Stada.
  • Digoxin (for heart disease). The levels of digoxin in the blood can increase when taken together with Eplerenone Stada.
  • 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 Stada 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 STADA thereby lengthening Eplerenone cleaned 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 Stada and thus reduce its effect.

Eplerenone Stada with food, drink, and alcohol

Eplerenone Stada can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 Stada 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 Stada. 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 Stada contains lactose

Eplerenone Stada 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 use Eplerenone Stada

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

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

Eplerenone Stada is normally given 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 Stada, 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.

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 Stada is not recommended for patients with severe renal impairment.

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

Elderly: No adjustment of the starting dose is required.

Use for children and adolescents

Children and adolescents: Eplerenone Stada is not recommended.

If you use more Eplerenone 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 use Eplerenone Stada

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 Stada

It is important to continue taking Eplerenone Stada 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 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
  • increased level of cholesterol in the blood
  • insomnia (difficulty sleeping)
  • headache
  • heart problems such as 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 (may affect up to 1 in 100 people):

  • infection
  • eosinophilia (increase in certain white blood cells )
  • dehydration
  • increased levels of triglycerides (fats) in the blood
  • decreased sodium levels 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 Stada

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

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.

No special storage instructions.

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 film-coated tablet contains 25 mg or 50 mg of eplerenone.

Other ingredients are:

Tablet core:

Lactose monohydrate

Microcrystalline cellulose (type 101)

Croscarmellose sodium

Hypromellose (type 2910)

Microcrystalline cellulose (type 102)

Sodium lauryl sulfate

Talc

Magnesium stearate

Tablet coating:

Lactose monohydrate

Hypromellose (type 2910)

Titanium dioxide (E171)

Macrogol 400

What the medicine looks like and the contents of the pack

Eplerenone Stada 25 mg film-coated tablet: White or almost white, round, biconvex film-coated tablet with a diameter of about 6 mm. Marked with “CG3” on one side and no marking on the other side.

Eplerenone Stada 50 mg film-coated tablet: White or almost white, round, biconvex film-coated tablet with a diameter of about 8 mm. Marked with “CG4” on one side and no marking on the other side.

10, 20, 30, 50, 90, 100 film-coated tablets are packaged in PVC / aluminum blisters and cartons.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Laboratories LICONSA SA

Avda. Miralcampo no.7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Centrafarm Services BV

New Donk 9

4879 AC Etten-Leur

The Dutch

PharmaCoDane ApS

Marielundvej 46A

2730 Herlev

Denmark

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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