Eplerenone Tecnigen 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Eplerenona TecniGen 50 mg film-coated tablets EFG

Eplerenone

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

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

Leaflet contents:

1. What Eplerenona TecniGen is and what it is used for
2. What you need to know before taking Eplerenona TecniGen
3. How to take Eplerenona TecniGen
4. Possible adverse effects
5. How to store Eplerenona TecniGen
6. Contents of the pack and other information

1. What Eplerenona TecniGen is and what it is used for

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

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

2. What you need to know before starting to take Eplerenone TecniGen

Do not take Eplerenone TecniGen

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Eplerenone TecniGen.

• if you have kidney or liver disease (see section “Do not take Eplerenone TecniGen”)
• if you are taking lithium (used for manic-depressive disorder, also called bipolar disorder)
• if you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs).

Taking Eplerenone TecniGen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

You must not take Eplerenone TecniGen if you are taking any of the following medicines (see section “Do not take Eplerenone TecniGen”):

• Itraconazole or ketoconazole (used to treat fungal infections); ritonavir, nelfinavir (used to treat HIV infection).
• Clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone TecniGen, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements, as these medicines increase the risk of high potassium levels in the blood.

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

• Lithium (used for manic-depressive disorder, also called 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 may lead to adverse effects such as loss of appetite, vision disturbances, tiredness, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs). These medicines may cause kidney problems and therefore increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs – certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney problems and therefore 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 conditions), may lead to a drop in blood pressure and dizziness upon standing.
• Tricyclic antidepressants, such as amitriptiline or amoxapine (for the treatment of depression); antipsychotics (known as neuroleptics), such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders); amifostine (used during cancer chemotherapy); and baclofen (used to treat muscle spasms). These medicines may lead to a drop in blood pressure and dizziness upon standing.
• 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 TecniGen.
• Digoxin (used to treat heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone TecniGen.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high levels of warfarin in the blood may affect how Eplerenone TecniGen works in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, verapamil (used to treat heart problems and high blood pressure) as these medicines reduce the metabolism of Eplerenone TecniGen and thereby prolong its effect in the body.
• St. John’s wort (a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, in combination with other medicines, to treat epilepsy) may increase the metabolism of Eplerenone TecniGen and thereby reduce its effect.

Taking Eplerenone TecniGen with food, drinks, and alcohol

Eplerenone TecniGen may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. The effect of Eplerenone TecniGen during pregnancy has not been evaluated in humans.

It is unknown whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to discontinue breastfeeding or stop treatment with eplerenone.

Driving and use of machines

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

Eplerenone TecniGen contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Eplerenone TecniGen contains sodium

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

3. How to take Eplerenona TecniGen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 together with other medications for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once daily, increasing after approximately 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets).

Blood potassium measurements should be performed before starting treatment with Eplerenona TecniGen, during the first week, and one month after initiating treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

No initial dose adjustment is required in patients with mild renal impairment or in patients with mild to moderate hepatic impairment. If you have any liver or kidney disease, more frequent blood potassium monitoring may be necessary (see section “Do not take Eplerenona TecniGen”).

Elderly patients

No initial dose adjustment is required.

Use in children and adolescents

There are no available data to support the use of eplerenone in children and adolescents under 18 years of age; therefore, 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 medicine, the most likely symptoms are 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona TecniGen

If you forget to take your dose of Eplerenona TecniGen and it is almost time for your 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 remain before the time of the next dose. Resume taking Eplerenona TecniGen according to your doctor's instructions.

Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenona TecniGen

It is important to continue taking Eplerenona TecniGen as directed by your doctor, unless your doctor specifically instructs you to discontinue treatment.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

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

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

These are symptoms of angioedema.

Other reported adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people):

• elevated blood potassium levels (these symptoms include muscle cramps, nausea, dizziness or headache)
• dizziness
• low blood pressure
• diarrhea
• nausea
• abnormal kidney function
• rash

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

• eosinophilia (increase in certain white blood cells)
• dehydration
• elevated levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood
• insomnia (difficulty sleeping)
• headache
• heart-related discomfort, such as irregular heartbeat, heart attack, and heart failure
• drop in blood pressure that may cause dizziness upon standing
• arterial thrombosis (blood clot) in the legs
• sore throat
• flatulence
• vomiting
• itching
• increased sweating
• back pain
• leg cramps
• weakness and general malaise
• increased levels of urea and creatinine in the blood, which may indicate kidney problems
• kidney inflammation
• breast enlargement 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 leaflet.

5. Storage of Eplerenone TecniGen

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton or blister pack following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone TecniGen

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.
• The yellow opadry 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 pack

Eplerenone TecniGen 50 mg are yellow, film-coated, round, and convex tablets. Eplerenone TecniGen 50 mg tablets are available in boxes with blisters containing 30, 50, or 200 tablets. It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid), Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Date of the most recent review of this leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/