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 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 Sandoz is and what it is used for 
2. What you need to know before you use Eplerenone Sandoz 
3. How to use Eplerenone Sandoz 
4. Possible side effects 
5. How to store Eplerenone Sandoz 6. Contents of the pack 
and other information 

1. What Eplerenone Sandoz is and what it is used for

Eplerenone Sandoz contains the active substance eplerenone. Eplerenone 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 Sandoz is used to treating 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. persistent, mild symptoms despite the treatment you have received so far.

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

What you need to know before you use Eplerenone Sandoz

Do not use Eplerenone Sandoz

  • 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 or pharmacist before using Eplerenone Sandoz:

  • if you have kidney or liver disease (see also “Do not use Eplerenone Sandoz”)
  • 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 Sandoz

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) when these drugs may reduce degradation of eplerenone and thus prolong its effect in the body.
  • Potassium-sparing diuretics (medicines that help reduce the body’s excess fluid) and potassium supplements (saline 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.
  • 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 – some 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.
  • Alpha1-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 for cancer treatment,) and baclofen (for treatment of muscle spasm). These medicines can cause a drop in blood pressure and dizziness when standing up.
  • Glucocorticoid s (such as hydrocortisone or prednisone) (used in the treatment of inflammation s and certain skin diseases) and tetracosactide (principally used for the diagnosis and treatment of disorders of adrenal a) may reduce the eplerenone blood pressure-lowering effect.
  • Digoxin (for heart disease). Levels of digoxin in the blood may increase when taken with eplerenone.
  • Warfarin (medicine for blood clots): Caution should be exercised when treatingwarfarin as high levels of warfarin in the blood may cause changes in the effect of eplerenone in the body.
  • Erythromycin (for bacterial infections), saquinavir (medicines to prevent infections against HIV ), fluconazole (antifungal), amiodarone, diltiazem, and verapamil (against heart problems and high blood pressure ) decreases degradation of eplerenone and thus prolongs the effect of eplerenone in the body.
  • St. John’s wort  (traditional herbal medicines), rifampicin (for bacterial infections), carbamazepine, phenytoin, and phenobarbital (medicines for epilepsy, among others) can increase the breakdown of eplerenone and thus reduce its effect.

Eplerenone Sandoz with food and drink

Eplerenone Sandoz 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 effect of eplerenone during pregnancy in humans 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 Sandoz. 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 Sandoz contains lactose and sodium

This medicine contains milk sugar ( lactose ). 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 (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Eplerenone Sandoz

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

Eplerenone Sandoz can be taken with food or on an empty stomach.

Swallow the tablets whole along with a copious amount of liquid.

Eplerenone Sandoz is normally given with other medicines for heart failure, e.g. 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, during the first week of treatment, and one month after starting a treatment or after 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 Sandoz 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 use Eplerenone Sandoz”).

Elderly: no dose adjustment is required.

Children and young people

Eplerenone Sandoz is not recommended.

If you take more Eplerenone Sandoz 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 Sandoz

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 dose.

If you stop taking Eplerenone Sandoz

It is important to continue taking Eplerenone Sandoz 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 (affects up to 1 in 100 people) side effect.

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 e.g. irregular heartbeat and heart failure
  • cough
  • constipation
  • low blood pressure
  • diarrhea
  • nausea
  • vomiting
  • impaired renal function
  • rash
  • itching
  • muscle twitching
  • back pain
  • impotence
  • increased level of urea in the blood
  • increased content of creatinine in the blood which may indicate problems with the kidneys.

Less common side effects are (may affect up to 1 in 100): 

  • infection
  • increase in certain white blood cells ( eosinophilia )
  • 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 e.g. if you get up
  • 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
  • general malaise
  • kidney inflammation
  • breast augmentation in men
  • changes in certain blood test results.

5. How to store Eplerenone Sandoz

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 blister and carton 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. One film-coated tablet contains 25 mg of eplerenone. One film-coated tablet contains 50 mg of eplerenone.
  • The other ingredients of the tablet core are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), and magnesium stearate and in the film coating: hypromellose (E464, E4or4), titanium dioxide (E171) and yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

25 mg film-coated tablets:

Light yellow, round, biconvex, film-coated tablet with a diameter of approx. 6 mm. The tablets are marked with “E9RN” on one side and “25” on the other side.

50 mg film-coated tablets:

Light yellow, round, biconvex, film-coated tablet with a diameter of approx. 8 mm. The tablets are marked with “E9RN” on one side and “50” on the other side.

The film-coated tablets are packaged in PVC / Aluminum blister and inserted in a carton.

Pack sizes:

Blisters: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets

Single-dose blisters: 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 or 100 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands

or

Synthon Hispania SL, C / Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, ​​Spain

Muhammad Nadeem

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