Label: Information for the User

Eplerenone TecniGen 50 mg Film-Coated Tablets

Eplerenone

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

Eplerenona TecniGen belongs to a group of medications known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body that controls blood pressure and cardiac function. Elevated levels of aldosterone may cause changes in the body that lead to heart failure.

Eplerenona TecniGen may help prevent the worsening of heart failure after a myocardial infarction, in combination with other medications used in the treatment of heart failure.

Do not take Eplerenona TecniGen

• if you are allergic to eplerenone or any of the other components of this medication (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medications that help eliminate excess fluids in the body, such as potassium-sparing diuretics or potassium supplements
• if you have moderate to severe kidney failure
• if you have severe liver failure
• if you are taking medications used to treat fungal infections (ketoconazole and itraconazole)
• if you are taking antiviral medications used to treat HIV infections (nelfinavir or ritonavir)
• if you are taking antibiotics to treat bacterial infections (clarithromycin, telithromycin)
• if you are taking nefazodone to treat depression.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Eplerenona TecniGen.

• if you have kidney or liver disease (see section “Do not take Eplerenona TecniGen”)
• if you are taking lithium (used to treat manic-depressive disorders, also known as bipolar disorder)
• if you are taking tacrolimus or cyclosporine (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection).

Taking Eplerenona TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You should not take Eplerenona TecniGen if you are taking any of the following medications (see section “Do not take Eplerenona TecniGen”):

• Itraconazole or ketoconazole (used to treat fungal infections); ritonavir, nelfinavir (for HIV infection treatment).
• Clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medications reduce the metabolism of Eplerenona TecniGen, and thus prolong its effect in the body.
• Potassium-sparing diuretics (medications that help eliminate excess fluids from the body) or potassium supplements, as these medications increase the risk of high potassium levels in the blood.

Inform your doctor if you are taking any of the following medications:

• Lithium (used to treat manic-depressive disorders, also known as bipolar disorder). The use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause excessively high levels of lithium in the blood, which can cause adverse effects such as loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection). These medications can cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs – certain analgesics such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications can cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the blood.
• ACE inhibitors (such as enalapril) and angiotensin II receptor antagonists (such as candesartan) (used to treat high blood pressure, heart disease, or certain kidney diseases) may increase the risk of high potassium levels in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases) may lead to a decrease in blood pressure and the appearance of dizziness when standing up.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression); antipsychotics (known as neuroleptics), such as chlorpromazine or haloperidol (used to treat psychiatric disorders); amifostine (used during cancer chemotherapy) and baclofen (used to treat muscle spasms). These medications may lead to a decrease in blood pressure and the appearance of dizziness when standing up.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases) and tetracosactide (used primarily to diagnose and treat adrenal cortex diseases) may reduce the blood pressure-lowering effect of Eplerenona TecniGen.
• Digoxin (used to treat heart diseases). The blood levels of digoxin may increase when taken with Eplerenona TecniGen.
• Warfarin (an anticoagulant medication): caution is required when administering warfarin doses due to the risk of high warfarin levels in the blood, which may cause changes in the effect of Eplerenona TecniGen on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication for HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, verapamil (used to treat heart problems and high blood pressure) as these medications reduce the metabolism of Eplerenona TecniGen and thus prolong its effect in the body.
• St. John's Wort (a medicinal plant product), rifampicin (used to treat bacterial infections); carbamazepine, phenytoin, and phenobarbital (used, associated with other medications, to treat epilepsy) may increase the metabolism of Eplerenona TecniGen and thus reduce its effect.

Taking Eplerenona TecniGen with food, drinks, and alcohol

Eplerenona TecniGen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Eplerenona TecniGen has not been evaluated for its effect on human pregnancy.

The elimination of eplerenone in breast milk is unknown. Your doctor will decide with you whether to stop breastfeeding or the eplerenone treatment.

Driving and operating machinery

After taking Eplerenona TecniGen, you may feel dizzy. If this happens, do not drive or operate machinery.

Eplerenona TecniGen contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Eplerenona TecniGen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Eplerenona TecniGen tablets can be taken with or without food. Swallow the tablets whole with a glass of water.

Eplerenona TecniGen is usually administered along with other medications for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing after 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets).

Blood potassium levels should be determined before starting treatment with Eplerenona TecniGen, during the first week, and one month after starting treatment or after a change in dose. Your doctor may adjust the dose based on your blood potassium levels.

No dose adjustment is necessary for patients with mild renal insufficiency, or for patients with mild to moderate liver disease. If you have any liver or kidney disease, you may need to have your blood potassium levels checked more frequently (see section “Do not take Eplerenona TecniGen”).

Patients in advanced age

No dose adjustment is required.

Use in children and adolescents

No data are available to recommend the use of eplerenone in children and adolescents under 18 years of age, so its use is not recommended in this age group.

If you take more Eplerenona TecniGen than you should

If you take more Eplerenona TecniGen than you should, inform your doctor or pharmacist immediately. If you have taken too much of this medication, the possible symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona TecniGen

If you have forgotten to take your dose of Eplerenona TecniGen and it is almost time for the next dose, skip the missed dose and take the next tablet at the scheduled time. Otherwise, take the tablet as soon as you remember, provided that at least 12 hours have elapsed since the scheduled time for the next tablet. Resume taking Eplerenona TecniGen according to your doctor's instructions.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona TecniGen

It is essential to continue taking Eplerenona TecniGen as instructed by your doctor, unless your doctor tells you to stop treatment.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Seek immediate medical attentionif you experience any of the following adverse effects:

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Blisters and difficulty breathing.

These are the symptoms of angioneurotic edema.

Other adverse effects reported include:

Frequent Adverse Effects(may affect up to 1 in 10 patients):

• Elevated potassium levels in the blood (these symptoms include muscle cramps, nausea, dizziness, or headache)
• Dizziness
• Low blood pressure
• Diarrhea
• Nausea
• Abnormal kidney function
• Rash

Rare Adverse Effects(may affect up to 1 in 100 patients):

• Eosinophilia (increase in certain white blood cells)
• Dehydration
• High levels of cholesterol or triglycerides (fats) in the blood
• Low sodium levels in the blood
• Insomnia (difficulty sleeping)
• Headache
• Cardiac discomfort, such as irregular heartbeats, myocardial infarction, and heart failure
• Drop in blood pressure that may cause dizziness when standing up
• Arterial thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Vomiting
• Itching
• Increased sweating
• Back pain
• Leg cramps
• Weakness and general discomfort
• Elevation of urea and creatinine levels in the blood that may indicate kidney problems
• Renal inflammation
• Enlargement of the breasts in men.

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box or blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Eplerenona TecniGen

• The active ingredient is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.
• The opadry yellow coating contains hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the packaging

Eplerenona TecniGen 50 mg are yellow-coated tablets with a film coating, round, and convex. Eplerenona TecniGen 50 mg tablets are available in boxes with blisters containing 30, 50, or 200 tablets. Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid), Spain

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Last review date of this leaflet: August 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/