EPLERENONE TECNIGEN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone TecniGen 25 mg film-coated tablets EFG

Eplerenone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

Eplerenone 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 controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenone TecniGen may help prevent the worsening of heart failure after a heart attack, in combination with other medicines used to treat heart failure.

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

Do not take Eplerenone TecniGen

• if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medicines that help your body get rid of excess fluid, such as potassium-sparing diuretics or potassium supplements
• if you have moderate to severe kidney problems
• if you have severe liver problems
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking antiviral medicines used to treat HIV infections (nelfinavir or ritonavir)
• if you are taking antibiotics used 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 Eplerenone TecniGen.

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

Taking Eplerenone TecniGen with other medicines

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

Do 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 (for the treatment of HIV infection).
• clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone TecniGen, and thus prolong 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 levels of potassium in the blood.

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

• lithium (used to treat manic-depressive disorders, also called bipolar disorder). The use of lithium 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 such as loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• cyclosporin or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• non-steroidal anti-inflammatory medicines (NSAIDs - certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium 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 levels of potassium in the blood.
• alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases) may cause a decrease in blood pressure and dizziness when standing up.
• tricyclic antidepressants, such as amitriptyline or amoxapine (for the treatment of depression); antipsychotics (also 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 cause a decrease in blood pressure and 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 Eplerenone TecniGen.
• digoxin (used to treat heart diseases). Blood levels of digoxin may increase when taken with Eplerenone TecniGen.
• warfarin (an anticoagulant medicine): caution is required when administering warfarin doses because high levels of warfarin in the blood may cause changes in the effect of Eplerenone TecniGen in the body.
• erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, verapamil (for the treatment of heart problems and high blood pressure) as these medicines reduce the metabolism of Eplerenone 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, in combination with other medicines, to treat epilepsy) may increase the metabolism of Eplerenone TecniGen and thus reduce its effect.

Taking Eplerenone TecniGen with food, drinks, and alcohol

Eplerenone TecniGen can be taken with or without food.

Pregnancy, breast-feeding, 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 effect of Eplerenone TecniGen during pregnancy in humans has not been evaluated.

It is not known whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to stop breast-feeding or treatment with eplerenone.

Driving and using machines

After taking Eplerenone TecniGen, you may feel dizzy. If this happens, do not drive or use machines.

Eplerenone TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Eplerenone TecniGen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Eplerenone TecniGen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

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

Eplerenone TecniGen is usually given together with other medicines for heart failure, such as beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing later after about 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets).

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

No initial dose adjustment is necessary in patients with mild kidney problems or in patients with mild to moderate liver problems. If you have liver or kidney disease, it may be necessary to perform potassium level tests in the blood more frequently (see section "Do not take Eplerenone TecniGen").

Elderly patients

No initial dose adjustment is required.

Use in children and adolescents

There are no data 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 Eplerenone TecniGen than you should

If you take more Eplerenone TecniGen than you should, contact your doctor or pharmacist immediately. If you have taken too much of this medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenone TecniGen

If you have forgotten to take your dose of Eplerenone 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 have passed since the last dose. Continue taking Eplerenone TecniGen according to your doctor's instructions.

Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone TecniGen

It is important to continue taking Eplerenone TecniGen as your doctor has told you, unless your doctor tells you to stop.

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

4. Possible side effects

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

Seek medical attention immediatelyif you experience any of the following side effects:

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

These are symptoms of angioedema.

Other reported side effects include:

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

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

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

• eosinophilia (an increase in certain white blood cells)
• dehydration
• high levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeats, heart attack, and heart failure
• low blood pressure that can 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 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 side effects, talk to your doctor, pharmacist, or nurse, even if it is 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 which is stated on the carton or blister after EXP. The expiry date is the last day of the month stated.

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 protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone TecniGen

• The active substance is eplerenone. Each tablet contains 25 mg of eplerenone.
• The other ingredients are: lactose monohydrate, 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 and packaging

Eplerenone TecniGen 25 mg are yellow film-coated tablets, round and convex.

Eplerenone TecniGen 25 mg tablets are available in packs with blisters containing 30, 50, or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid), España

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Date of last revision of this leaflet:August 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/