Eplerenone medical valley

Patient Information Leaflet

Eplerenon Medical Valley, 25 mg, film-coated tablets
Eplerenon Medical Valley, 50 mg, film-coated tablets
Eplerenonum
Please read all of this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Eplerenon Medical Valley is and what it is used for

Eplerenon Medical Valley belongs to a group of medicines known as selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced by the body that regulates blood pressure and heart function. Elevated levels of aldosterone may cause changes in the body leading to heart failure.
Eplerenon Medical Valley is a medicine used in the treatment of heart failure to prevent worsening of the disease and to reduce the number of hospitalizations in patients following:

1. Myocardial infarction – in combination with other medicines used for heart failure, or
2. Persistent, mild symptoms despite ongoing treatment.

2. Important information before using Eplerenon Medical Valley

When not to use Eplerenon Medical Valley

• if the patient is allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high potassium levels in the blood (hyperkalaemia);
• if the patient is taking medicines that remove excess fluid from the body (potassium-sparing diuretics) or potassium supplements;
• if the patient has severe kidney disease;
• if the patient has severe liver disease;
• if the patient is taking antifungal medicines (ketoconazole or itraconazole);
• if the patient is taking antiviral medicines for HIV (nelfinavir or ritonavir);
• if the patient is taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin);
• if the patient is taking nefazodone, used to treat depression;
• if the patient is concurrently taking medicines used to treat certain heart conditions or high blood pressure (so-called angiotensin-converting enzyme inhibitors - ACE inhibitors in combination with angiotensin receptor blockers - ARBs).

Warnings and precautions
Before starting treatment with Eplerenon Medical Valley, discuss this with your doctor, pharmacist,
or nurse.

• if the patient has kidney or liver disease (see also section "When not to use Eplerenon Medical Valley");
• if the patient is taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders);
• if the patient is 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 have not been established.

Eplerenon Medical Valley and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or might take in the future.
Do not take Eplerenon Medical Valley together with the following medicines (see section "When not to use Eplerenon Medical Valley"):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines against HIV), clarithromycin, telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression). These medicines slow down the metabolism of Eplerenon Medical Valley, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements. These medicines increase the risk of high potassium levels in the blood.
• Angiotensin-converting enzyme (ACE) inhibitors in combination with angiotensin receptor blockers (ARBs) (used to treat high blood pressure, heart conditions, and certain kidney diseases), because these medicines may increase the risk of high potassium levels in the blood.

Inform your doctor if the patient is taking any of the following medicines:

• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders). Concomitant use of lithium with diuretics and angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart conditions) has increased lithium levels in the blood, which could lead to adverse effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle tremors.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection of transplanted organs). These medicines may impair kidney function and thereby increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs – painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may lead to kidney dysfunction and thereby 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-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may cause low blood pressure and dizziness upon standing.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics), such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tone). These medicines may cause low blood pressure and dizziness upon standing.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases), and tetracosactide (mainly used in the diagnosis and treatment of adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eplerenon Medical Valley.
• Digoxin (used to treat heart conditions). Concomitant use with Eplerenon Medical Valley may increase digoxin blood levels.
• Warfarin (an anticoagulant): caution is advised when using warfarin, as increased warfarin blood levels may interfere with the effect of Eplerenon Medical Valley on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) slow down the metabolism of Eplerenon Medical Valley, thereby prolonging its effect in the body.
• St. John's wort (a herbal remedy), rifampicin (an antibiotic used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may accelerate the metabolism of Eplerenon Medical Valley, thereby reducing its effectiveness.

Eplerenon Medical Valley with food, drink, and alcohol
Eplerenon Medical Valley may be taken with or without food.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. The effects of Eplerenon Medical Valley during pregnancy have not been evaluated in humans.
It is not known whether eplerenone passes into human breast milk. Consult your doctor to decide whether to discontinue breastfeeding or to stop taking the medicine.

Driving and operating machinery
Dizziness may occur after taking Eplerenon Medical Valley. In such cases, patients should not drive or operate machinery.

Eplerenon Medical Valley contains lactose monohydrate
Eplerenon Medical Valley contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Eplerenon Medical Valley contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Eplerenon Medical Valley

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Eplerenon Medical Valley tablets may be taken with or without food. Swallow the tablets whole with
a large amount of water.
Eplerenon Medical Valley is usually taken together with other medicines used for heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is increased after approximately 4 weeks to 50 mg once daily (as one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.
Before starting treatment with Eplerenon Medical Valley, and during the first week and one month after starting treatment or changing the dose, blood potassium levels should be measured.
The physician may adjust the dose depending on the blood potassium concentration.
If the patient has mild kidney disease, treatment should be initiated with one 25 mg tablet once daily. If the patient has moderate kidney disease, treatment should be initiated with one 25 mg tablet every other day. The physician may recommend dose adjustment based on blood potassium levels.
Eplerenon Medical Valley is not recommended in patients with severe kidney disease.
In patients with mild or moderate liver disease, no initial dose adjustment is necessary. However, in case of liver or kidney disease, more frequent monitoring of blood potassium levels may be required (see also "When not to use Eplerenon Medical Valley").
Elderly patients: no initial dose adjustment is required in elderly patients.
Use of a higher than recommended dose of Eplerenon Medical Valley
If a higher than recommended dose of Eplerenon Medical Valley has been taken, contact your doctor or pharmacist immediately. The most likely symptoms of overdose are: low blood pressure (causing dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia, increased blood potassium levels (causing muscle cramps, diarrhea, nausea, dizziness or headache).
Missed dose of Eplerenon Medical Valley
If it is almost time for the next dose, skip the missed tablet and take the next dose at the usual time.
Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Then continue taking the medicine as usual.
Do not take a double dose to make up for a missed dose.
Stopping Eplerenon Medical Valley
It is important to take Eplerenon Medical Valley as directed, unless the doctor advises stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur:
Seek immediate medical help

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria (hives) and difficulty breathing

These are symptoms of angioedema, an uncommon adverse reaction (may occur in less than 1 in 100 people).

Other reported adverse reactions include:
Common adverse reactions (may occur in up to 1 in 10 patients):

• increased potassium levels in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• dizziness
• fainting
• increased cholesterol levels in the blood
• insomnia (difficulty sleeping)
• headache
• heart disorders, e.g. heart rhythm disorders and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• kidney function disorders
• rash
• itching
• back pain
• fatigue
• muscle cramps
• increased blood urea levels
• increased blood creatinine levels, which may indicate impaired kidney function

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• infection
• eosinophilia (increased number of one type of white blood cells)
• dehydration
• increased triglyceride (fat) levels in the blood
• low sodium levels in the blood
• rapid heart rate
• inflammation of the gallbladder
• decreased blood pressure, which may cause dizziness when changing position to standing
• deep vein thrombosis (blood clots) in the lower limbs
• sore throat
• bloating
• hypothyroidism
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• malaise (general feeling of being unwell)
• kidney inflammation
• breast enlargement in males
• changes in certain blood test results

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Eplerenon Medical Valley

Keep this medicine out of the sight and reach of children.
There are no special requirements for the storage of this medicinal product.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"Expiry date" or "EXP". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in 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

What Eplerenon Medical Valley contains
The active substance is eplerenone. Each film-coated tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are:
Tablet core:
Lactose monohydrate
Microcrystalline cellulose (type 101)
Sodium croscarmellose
Hypromellose (type 2910)
Microcrystalline cellulose (type 102)
Sodium lauryl sulfate
Talc
Magnesium stearate
Tablet coating:
Lactose monohydrate
Hypromellose (type 2910)
Titanium dioxide (E 171)
Macrogol 4000

What Eplerenon Medical Valley looks like and contents of the pack
Eplerenon Medical Valley 25 mg is a white or almost white, round, biconvex film-coated tablet with a diameter of 6 mm, marked "CG3" on one side and smooth on the other.
Eplerenon Medical Valley 50 mg is a white or almost white, round, biconvex film-coated tablet with a diameter of 8 mm, marked "CG4" on one side and smooth on the other.
The tablets are packed in blisters made of PVC/aluminium foil, contained in cardboard boxes with 20, 30, 50, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer/Importer
Laboratorios LICONSA, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany: Epleraxiro 25mg 50mg Filmtabletten
Poland: Eplerenon Medical Valley