Eplerenone Teva-Ratio 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Eplerenone Teva-ratio 25 mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Eplerenone Teva-ratio is and what it is used for

2. What you need to know before taking Eplerenone Teva-ratio

3. How to take Eplerenone Teva-ratio

4. Possible side effects

5. How to store Eplerenone Teva-ratio

6. Contents of the pack and other information

1. What Eplerenone Teva-ratio is and what it is used for

Eplerenone Teva-ratio belongs to a group of medicines known as selective aldosterone blockers. These blocking agents 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.

Eplerenone is used to treat heart failure to prevent worsening and reduce hospitalization if:

1. you have recently had a myocardial infarction, in combination with other medicines used to treat your heart failure, or
2. you have persistent mild symptoms despite the treatment you have been receiving up to now.

2. What you need to know before taking Eplerenona Teva-ratio

Do not take Eplerenona Teva-ratio

• 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 from groups that help your body eliminate excess fluid (potassium-sparing diuretics)
• if you have severe renal impairment
• if you have severe hepatic impairment
• if you are taking antifungal 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 or telithromycin)
• if you are taking nefazodone for depression
• if you are simultaneously taking medicines used to treat certain heart conditions or high blood pressure (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)).

Warnings and precautions

Talk to your doctor or pharmacist before taking eplerenone:

• if you have kidney or liver disease (see also “Do not take Eplerenona Teva-ratio”)
• if you are taking lithium (commonly used for manic-depressive disorder, also known as 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)

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents has not been established.

Taking Eplerenona Teva-ratio with other medicines

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body.

• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of developing high levels of potassium in the blood.

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood.

• Lithium (commonly used for manic-depressive disorder, 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 may lead to the following adverse reactions: loss of appetite, vision disturbances, fatigue, 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 thus 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 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.

• 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 amitriptyline or amoxapine (for treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for 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.

• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with eplerenone.

• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in the effect of eplerenone in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (antiviral medicine for HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for treatment of heart problems and high blood pressure) reduce the metabolism of eplerenone, thereby prolonging its effect in the body.

• St. John’s wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of eplerenone and thereby reduce its effect.

Taking Eplerenona Teva-ratio with food and drinks

Eplerenona Teva-ratio can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine. The effect of eplerenone 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 to stop treatment.

Driving and using machines

After taking Eplerenona Teva-ratio, you may feel dizzy. If this occurs, do not drive or operate machinery.

Lactose

This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e., essentially “sodium-free”.

3. How to take Eplerenona Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Eplerenona Teva-ratio tablets may be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenona Teva-ratio is usually administered together with other medicines for heart failure, for example, beta-blockers. The recommended 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). The maximum dosage regimen is 50 mg per day.

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

If you have mild renal impairment, you should start treatment with one 25 mg tablet daily. If you have moderate renal impairment, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Eplerenone is not recommended in patients with severe renal disease.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, more frequent blood potassium measurements may be required (see also "Do not take Eplerenona Teva-ratio").

In elderly patients, no initial dose adjustment is required.

Use in children and adolescents

In children and adolescents, Eplerenona Teva-ratio is not recommended.

If you take more Eplerenona Teva-ratio than you should

If you take more Eplerenona Teva-ratio than you should, contact your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness or headache).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Teva-ratio

If 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 more than 12 hours remain before the time for taking the next tablet. Then continue taking your medicine as usual.

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

If you stop taking Eplerenona Teva-ratio

It is important to continue taking Eplerenona Teva-ratio as directed, unless your doctor advises you to stop treatment.

If you have any further questions about 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 everyone gets them.

If you experience any of the following, seek medical attention immediately:

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

These are symptoms of angioedema, an uncommon side effect (which may affect up to 1 in 100 people).

Other reported side effects include:

Common: may affect up to 1 in 10 people

• elevated levels of potassium in the blood (these symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• fainting
• dizziness
• elevated cholesterol levels in the blood
• insomnia (difficulty sleeping)
• headache
• heart-related discomfort, for example, irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasm
• increased levels of urea in the blood
• elevated creatinine levels in the blood, which may indicate kidney problems

Uncommon: may affect up to 1 in 100 people

• infection
• eosinophilia (increase in certain white blood cells)
• low levels of sodium in the blood
• dehydration
• elevated levels of triglycerides (fats) in the blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure which may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid gland
• increased blood glucose
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood test results

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Teva-ratio

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 packaging and blister after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Pack contents and additional information

Composition of Eplerenona Teva-ratio

• The active substance is eplerenone. Each tablet contains 25 mg of eplerenone.

• The other ingredients are monohydrate lactose, microcrystalline cellulose, crospovidone (type A), sodium lauryl sulfate, talc (E553b) and magnesium stearate. The coating contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and pack contents

Film-coated tablet.

Yellow, diamond-shaped, biconvex film-coated tablets, approximately 6.4 mm wide and 7.4 mm long, marked with "E25" on one side and smooth on the other.

Eplerenona Teva-ratio 25 mg film-coated tablets EFG is available in opaque PVC/PVdC/Al blisters containing 10, 20, 28, 30, 50, 90, 100 and 200 tablets, and in single-dose, pre-perforated, opaque PVC/PVdC/Al blisters containing 20 x 1, 30 x 1, 50 x 1, 90 x 1, 100 x 1 or 200 x 1 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava, Komárov

Czech Republic

Or

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren

Germany

This medicinal product is authorized in the following European Economic Area Member States under the following names:

Spain: Eplerenona Teva-ratio 25 mg film-coated tablets EFG

Date of the most recent review of this leaflet: November 2020

“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/”

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77324/P_77324.html

QR Code + URL