Package leaflet: Information for the patient

Eplerenone Mylan 25 mg film-coated tablets, 50 mg film-coated tablets

Eplerenone
Generic medicine
Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Eplerenone Mylan is and what it is used for
What you need to know before taking Eplerenone Mylan
How to take Eplerenone Mylan
Possible side effects
How to store Eplerenone Mylan
Contents of the pack and other information

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

Eplerenone Mylan 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. High levels of aldosterone can cause changes in the body that lead to heart failure. Eplerenone Mylan is used to treat heart failure, to prevent its worsening, and to reduce hospitalisation, if:

You have recently had a heart attack, in combination with other medicines used to treat heart failure, or
You have moderate and persistent symptoms despite the treatment you have received so far.

2. What you need to know before taking Eplerenone Mylan

Do not take Eplerenone Mylan

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 eliminate excess body fluids (potassium-sparing diuretics)
If you have severe kidney disease
If you have severe liver disease
If you are taking antifungal medicines (ketoconazole or itraconazole)
If you are taking antiviral medicines for the treatment of HIV (nelfinavir or ritonavir)
If you are taking antibiotics for the treatment of bacterial infections (clarithromycin or telithromycin)
If you are taking nefazodone for the treatment of depression
If you are taking together medicines for the treatment of certain heart conditions or high blood pressure (called angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)).

Warnings and precautions
Talk to your doctor or pharmacist before taking Eplerenone Mylan:

If you have kidney or liver disease (see also “Do not take Eplerenone Mylan”)
If you are taking lithium (commonly used for manic-depressive disorder, also known as bipolar disorder)
If you are taking tacrolimus or ciclosporin (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection).

Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.
Other medicines and Eplerenone Mylan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
You must not take Eplerenone Mylan with the following medicines (see section “Do not take Eplerenone Mylan”):

Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for the treatment of HIV), clarithromycin, telithromycin (used for bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the elimination of Eplerenone Mylan, thereby prolonging its effect.
Potassium-sparing diuretics (medicines that help eliminate excess body fluids) and potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.
Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) taken together (used in the treatment of high blood pressure, heart diseases or certain kidney conditions), because these medicines can increase the risk of high potassium levels in the blood.
Inform your doctor if you are taking any of the following medicines:
Lithium (usually used for manic-depressive disorder, also known as bipolar disorder). The use of lithium together with diuretics and ACE inhibitors (used in the treatment of high blood pressure and heart disorders) has been shown to greatly increase lithium levels in the blood, which may cause the following side effects: loss of appetite, blurred vision, fatigue, muscle weakness, muscle cramps.
Ciclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection). These medicines can cause kidney problems and thus increase the risk of high potassium levels in the blood.
Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers such as ibuprofen, used to relieve pain, stiffness and inflammation). These medicines 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.
Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may cause a drop 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 in chemotherapy) and baclofen (used to treat muscle spasms). These medicines may cause a drop in blood pressure and dizziness when standing up.
Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammations and certain skin conditions) and tetracosactide (mainly used for the diagnosis and treatment of adrenal cortex disorders) may reduce blood pressure, thereby decreasing the effect of Eplerenone Mylan.
Digoxin (used in the treatment of heart disorders). Digoxin levels in the blood may increase when administered together with Eplerenone Mylan.
Warfarin (an anticoagulant medicine): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of Eplerenone Mylan.
Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart disorders and high blood pressure) reduce the elimination of Eplerenone Mylan, thereby prolonging its effect (see section 3 “How to take Eplerenone Mylan”).
St. John’s Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (also used to treat epilepsy) may increase the elimination of Eplerenone Mylan and thus reduce its effects.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. The effect of Eplerenone Mylan has not been evaluated during pregnancy in humans.
It is not known whether eplerenone is excreted in breast milk. You and your doctor will need to decide whether to stop breastfeeding or to discontinue taking the medicine.
Driving and using machines
After taking Eplerenone Mylan, you may experience dizziness. If this occurs, do not drive or operate machinery.
Eplerenone Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Eplerenone Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist.
Eplerenone Mylan is generally administered together with other medicines for heart failure, such as beta-blockers. The recommended starting dose is one 25 mg tablet once daily, increasing after approximately 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.
Blood potassium levels should be measured before starting treatment with Eplerenone Mylan, within the first week and within the first month of treatment, or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.
If you have mild kidney disease, treatment should be started with one 25 mg tablet once daily. If you have moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Your doctor may adjust these doses depending on your blood potassium levels.
Eplerenone Mylan is not recommended in patients with severe kidney disease.
No initial dose adjustment is required in patients with mild to moderate liver problems. If you have kidney or liver problems, you may require more frequent monitoring of blood potassium levels (see also section "Do not take Eplerenone Mylan").
If you are taking other medicines, your doctor may recommend a lower dose.
For elderly patients: no initial dose adjustment is required.
For children and adolescents: Eplerenone Mylan is not recommended.

How to take the medicine
Eplerenone Mylan tablets can be taken with or without food. Swallow the tablets whole with a full glass of water.

If you take more Eplerenone Mylan than you should
If you take more Eplerenone Mylan than prescribed, contact your doctor or pharmacist immediately. If you have taken too many tablets, the most likely symptoms are low blood pressure (feeling faint, dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may present as muscle cramps, diarrhoea, nausea, dizziness, or headache.

If you forget to take Eplerenone Mylan
If it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember, provided that at least 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 forgotten dose.

If you stop taking Eplerenone Mylan
It is important to take Eplerenone Mylan as prescribed unless your doctor tells you to stop.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you must inform your doctor immediately:

Common side effects (may affect up to 1 in 10 people):
Heart problems, such as irregular heartbeat and heart failure
Impaired kidney function. Symptoms include difficulty urinating, lack of urine production, or pain in the lower back area.

Uncommon side effects (may affect up to 1 in 100 people):
Inflammation of the gallbladder. Symptoms include sudden severe stomach pain that may radiate to the shoulders.
Thrombosis (blood clot) in the legs
Inflammation of the kidneys. Symptoms include pain in the lower back area, cloudy urine, or blood in the urine.
Swelling of the face, tongue, or throat
Difficulty swallowing
Hives and difficulty breathing.
These are symptoms of angioedema.

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

Elevated blood potassium levels (symptoms include muscle cramps, diarrhoea, nausea, dizziness, or headache)
Dizziness
Fainting
Infections
Cough
Constipation
Low blood pressure
Diarrhoea
Feeling unwell (nausea) or being unwell (vomiting)
Headache
Insomnia (difficulty sleeping)
Skin rash
Itching
Muscle pain and spasms
Back pain
Increased levels of urea in the blood
Unusual weakness
Increased levels of cholesterol or triglycerides (fats) in the blood
Increased levels of creatinine in the blood, which may indicate kidney problems.

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

Eosinophilia (increase in certain white blood cells)
Dehydration
Low levels of sodium in the blood
Rapid heartbeat
Decreased blood pressure which may cause dizziness when standing up
Sore throat
Flatulence
Reduced thyroid function
Increased blood sugar levels
Reduced sensitivity to touch
Increased sweating
Feeling unwell
Breast enlargement in men
Changes in certain blood test results.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eplerenone Mylan

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, bottle, or blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eplerenone Mylan contains

The active substance is eplerenone. Each film-coated tablet contains 25 mg or 50 mg of eplerenone.
The other components are: Tablet core Monohydrate lactose (see section 2 “Eplerenone Mylan contains lactose”), microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Film coating
Hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172), polysorbate.

Description of the appearance of Eplerenone Mylan and pack sizes
Eplerenone Mylan 25 mg film-coated tablets are yellow, film-coated, round, biconvex tablets, marked “EP1” on one side and “M” on the other.
Eplerenone Mylan 50 mg film-coated tablets are yellow, film-coated, round, biconvex tablets, marked “EP2” on one side and “M” on the other.
Eplerenone tablets are available in blisters or bottles containing 28 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Eplerenone Mylan 25 mg & 50 mg filmomhulde tabletten
Cyprus: Eplerenone Mylan 25 mg & 50 mg Film-coated tablets
France: Eplerenone Mylan 25 mg & 50 mg, comprimé pelliculé
Germany: Eplerenon Mylan 25 mg & 50 mg Filmtabletten
Hungary: Eplerenone Mylan 25 mg & 50 mg filmtabletta
Ireland: Eplerenone Mylan 25 mg & 50 mg Film-coated Tablets
Italy: Eplerenone Mylan
Luxembourg: Eplerenone Mylan 25 mg & 50 mg comprimés pelliculés
Netherlands: Eplerenon Mylan 25 mg & 50 mg, filmomhulde tabletten
Slovakia: Eplerenon Mylan 25 mg & 50 mg, filmom obalené tablety
Spain: Eplerenona Mylan 25 mg & 50 mg comprimidos recubiertos con pelicula
EFG
United Kingdom: Eplerenone 25 mg & 50 mg Film-coated tablets