EPLERENONE 25 mg Film-Coated Tablets

Зміст інструкції

1. EPLERENONE DOC Generici 25 mg film-coated tablets, 50 mg film-coated tablets
   1. What is EPLERENONE DOC Generici and what it is used for
   2. What you need to know before taking EPLERENONE DOC Generici
   3. How to take EPLERENONE DOC Generici
2. EPLERENONE DOC Generici is generally administered together with other medicines for
   1. POSSIBLE SIDE EFFECTS
   2. How to store EPLERENONE DOC Generici
   3. Package Contents and Other Information

EPLERENONE DOC Generici 25 mg film-coated tablets, 50 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What EPLERENONE DOC Generici is and what it is used for
• 2. What you need to know before you take EPLERENONE DOC Generici
• 3. How to take EPLERENONE DOC Generici
• 4. Possible side effects
• 5. How to store EPLERENONE DOC Generici
• 6. Contents of the pack and other information

1. What is EPLERENONE DOC Generici and what it is used for

EPLERENONE DOC Generici belongs to a class of medicines known as selective aldosterone blockers. These agents inhibit the action of aldosterone, a substance produced by the body, which controls blood pressure and cardiac function. High levels of aldosterone can cause changes in the body that lead to heart failure. EPLERENONE DOC Generici is used to treat heart failure, to prevent worsening and to reduce hospitalization if:

• 1. you have recently had a heart attack, in association with other medicines used to treat heart failure, or
• 2. you have moderate and persistent symptoms despite the treatment you have been receiving until now.

2. What you need to know before taking EPLERENONE DOC Generici

Do not take EPLERENONE DOC Generici

• 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 (hyperkalaemia)
• if you are taking medicines that help to eliminate excess fluids from the body (potassium-sparing diuretics)
• if you have severe kidney problems
• if you have severe liver problems
• if you are taking medicines used for the treatment of fungal infections (ketoconazole and 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 medicines for the treatment of certain heart conditions or high blood pressure (called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs)) together.

Warnings and precautions
Talk to your doctor or pharmacist before taking EPLERENONE DOC Generici

• if you have a kidney or liver problem (see also “Do not take EPLERENONE DOC Generici”)
• if you are taking lithium (usually used for manic-depressive disorders, also called bipolar disorders)
• if you are taking tacrolimus or ciclosporin (used to treat skin conditions such as psoriasis or eczema and to prevent rejection after organ transplantation).

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

Other medicines and EPLERENONE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take EPLERENONE DOC Generici with the following medicines (see section “Do not
take EPLERENONE DOC Generici”):

• itraconazole or ketoconazole (for the treatment of fungal infections), ritonavir, nelfinavir (antiviral medicines for the treatment of HIV), clarithromycin, telithromycin (used for the treatment of bacterial infections) or nefazodone (for depression), as these medicines reduce the elimination of EPLERENONE DOC Generici, prolonging its effect
• potassium-sparing diuretics (medicines that help to eliminate excess fluids from the body) and potassium supplements (salt tablets) as these medicines increase the risk of high levels of potassium in the blood
• angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) together (used in the treatment of high blood pressure, heart disease or certain kidney conditions) because these medicines can increase the risk of high levels of potassium in the blood.

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

• lithium (usually used for manic-depressive disorders, also called bipolar disorders). It has been shown that the use of lithium together with diuretics and ACE inhibitors (used in the treatment of high blood pressure and heart disorders) increases the levels of lithium in the blood which can cause the following side effects: loss of appetite, reduced vision, fatigue, muscle weakness, muscle cramps
• cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection after organ transplantation). These medicines can cause kidney problems and therefore increase the risk of high levels of potassium 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 therefore increase the risk of high potassium levels in the blood
• trimethoprim (used to treat bacterial infections) can 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 problems) can 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 can cause drops in blood pressure and dizziness when standing up
• glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used for the diagnosis and treatment of adrenal cortex disorders) can reduce blood pressure, decreasing the effect of EPLERENONE DOC Generici
• digoxin (used in the treatment of heart disorders). Digoxin levels in the blood may increase when administered together with EPLERENONE DOC Generici
• warfarin (a blood-thinning medicine): caution is recommended with warfarin, as high levels of warfarin in the blood can alter the effects of EPLERENONE DOC Generici
• erythromycin (used to treat bacterial infections), saquinavir (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 DOC Generici prolonging its effect
• St. John's wort (herbal medicine), rifampicin (used for the treatment

of bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, for the
treatment of epilepsy) can increase the elimination of EPLERENONE DOC Generici and therefore
decrease its effects

EPLERENONE DOC Generici with food and drink
EPLERENONE DOC Generici can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The effect of
eplerenone has not been evaluated during pregnancy in humans.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor you must decide whether to stop
breastfeeding or to stop taking the medicine.

Driving and operating machinery
After taking EPLERENONE DOC Generici you may experience dizziness. If this happens do not drive or
operate machinery.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

EPLERENONE DOC Generici contains lactose monohydrate
EPLERENONE DOC Generici contains lactose monohydrate (a type of sugar). If your doctor has
diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

EPLERENONE DOC Generici contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially “sodium-free”.

3. How to take EPLERENONE DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The EPLERENONE DOC Generici tablets can be taken with or without food. The
tablets must be swallowed whole with a sufficient amount of water.

EPLERENONE DOC Generici is generally administered together with other medicines for

heart failure, such as beta-blockers. Generally, the initial dose is one
25 mg tablet once a day, then increase the dose after 4 weeks to 50 mg once a
day (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.
Blood potassium levels must be measured before starting therapy with EPLERENONE
DOC Generici, within the first week and within the first month of treatment or after a change in
dose. The dose may be adjusted by the doctor based on blood potassium levels.

Patients with kidney or liver problems
If you have mild kidney problems, you should start therapy with one 25 mg tablet once a
day. If the kidney problem is moderate, you should start therapy with one 25 mg tablet on alternate
days. Based on blood potassium levels and if your doctor recommends it, these doses may be
adjusted.
EPLERENONE DOC Generici is not recommended in patients with severe kidney problems.
In patients with mild-moderate liver problems, no dose adjustments are required. If
you have kidney or liver problems, you may need more frequent checks of blood potassium levels
(see also “Do not take EPLERENONE DOC Generici”).

Elderly patients
No dose adjustment is required.

Use in children and adolescents
The use of EPLERENONE DOC Generici is not recommended.

If you have taken more EPLERENONE DOC Generici than you should
If you have taken more EPLERENONE DOC Generici than you should, contact your doctor or pharmacist immediately.
If you have taken too many tablets, the most likely symptoms will be low blood pressure (feeling
dizzy, lightheaded, blurred vision, weakness, sudden loss of consciousness) or
hyperkalemia, high levels of potassium in the blood (which manifests with muscle cramps, diarrhea,
nausea, dizziness or headache).

If you forget to take EPLERENONE DOC Generici
If it is almost time to take your next tablet, skip the missed dose and take
the next tablet at the scheduled time. Otherwise, you can take it as soon as you remember, keeping
in mind that at least 12 hours must pass before taking the next dose. Then resume the
medicine normally.
Do not take a double dose to make up for a missed dose.

If you stop taking EPLERENONE DOC Generici
It is important to take EPLERENONE DOC Generici as prescribed unless your doctor tells you to
stop treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing These are symptoms of angioedema, an uncommon side effect (affecting up to 1 in 100 people).

Other side effects reported include:

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

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
• fainting
• dizziness
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, for example irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• skin rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may be an indication of kidney problems

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

• infections
• eosinophilia (increased number of certain white blood cells)
• low levels of sodium in the blood
• dehydration
• increased amount of triglycerides (fat) in the blood
• fast heartbeat
• inflammation of the gallbladder
• decrease in blood pressure which can cause dizziness when standing up
• thrombosis (blood clots) in the legs
• sore throat
• flatulence
• reduced thyroid function
• increased glucose in the blood
• reduced sensitivity to touch
• increased sweating
• musculoskeletal pain
• kidney inflammation
• breast enlargement in men
• changes in the values of some blood tests

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system, at the address
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EPLERENONE DOC Generici

Keep this medicine out of 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 box and blister after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What EPLERENONE DOC Generici contains
The active ingredient of the film-coated tablets of EPLERENONE DOC Generici is eplerenone.
Each tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose
(Type A), hypromellose (Benecel E3), talc and magnesium stearate.
The yellow opadry coating of the film-coated tablets of EPLERENONE DOC Generici 25 mg and 50 mg
contains macrogol/PEG 6000, HPMC 2910/hypromellose 5cP, talc (E553b), titanium dioxide (E171),
yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of EPLERENONE DOC Generici and package contents
EPLERENONE DOC Generici 25 mg tablets are yellow, round, biconvex, with
“E25” inscribed on one side.
EPLERENONE DOC Generici 50 mg tablets are yellow, round, biconvex, with
“E50” inscribed on one side.
EPLERENONE DOC Generici 25 mg and 50 mg film-coated tablets are available in cardboard cartons containing opaque PVC/Al blister packs of 10, 20, 28, 30, 50, 90, 100, and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l, Via Turati 40, 20121 Milan

Manufacturer responsible for batch release
Pharmathen S.A., 6 Dervenakion Str, 15351, Pallini, Greece
Pharmathen International S.A, Sapes Industrial Park Block 5, 69300 Rodopi, Greece

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark Eplerathen
United Kingdom Eplerenone 25 mg film-coated tablets
Eplerenone 50 mg film-coated tablets
Italy EPLERENONE DOC Generici
Germany Eplerenon Heumann 25 mg Filmtabletten
Eplerenon Heumann 50 mg Filmtabletten
Slovakia Aldepla 25 mg
Aldepla 50 mg
France Eplerathen 25 mg coated tablet
Eplerathen 50 mg coated tablet