Eplerenone Doc Generici

Package leaflet: Information for the user

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

Generic medicine
Please 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:

1. What EPLERENONE DOC Generici is and what it is used for
2. What you need to know before taking 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 EPLERENONE DOC Generici is 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 that controls blood pressure and heart 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 its worsening, and to reduce hospitalization when:

1. you have recently had a heart attack, in combination with other medicines used to treat heart failure, or
2. you have moderate and persistent symptoms despite the treatment you have received up to 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 to 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 eliminate excess body fluids (potassium-sparing diuretics)
• if you have severe kidney problems
• if you have severe liver problems
• if you are taking medicines used to treat 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 inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) together.

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

• if you have kidney or liver problems (see also “Do not take EPLERENONE DOC Generici”)
• if you are taking lithium (commonly used for manic-depressive disorders, also known as bipolar disorders)
• if you are taking tacrolimus or cyclosporine (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 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must 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), because these medicines reduce the elimination of EPLERENONE DOC Generici, thereby prolonging its effect
• potassium-sparing diuretics (medicines that help eliminate excess body fluids) and potassium supplements (salt tablets), because 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 (commonly used for manic-depressive disorders, also known as 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 lithium levels in the blood, which may cause the following side effects: loss of appetite, blurred vision, fatigue, muscle weakness, muscle cramps
• cyclosporine 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 inflammation 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 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 (an anticoagulant medicine): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of EPLERENONE DOC Generici
• 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 DOC Generici, thereby prolonging its effect
• St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, for the treatment of epilepsy) may increase the elimination of EPLERENONE DOC Generici and thus reduce 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. The effect of eplerenone has not been evaluated in humans during pregnancy.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you must decide whether to discontinue breastfeeding or to stop taking the medicine.

Driving and using machines
After taking EPLERENONE DOC Generici, you may experience dizziness. If this occurs, do not drive or operate machinery.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

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 them before taking this medicine.

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

3. How to take EPLERENONE DOC Generici

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
EPLERENONE DOC Generici tablets can be taken with or without food. Swallow the tablets whole with a
sufficient amount of water.
EPLERENONE DOC Generici is generally administered together with other medicines for heart failure,
such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is then increased
after 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 must be measured before starting treatment with EPLERENONE DOC Generici,
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.

Patients with kidney or liver problems
If you have mild kidney problems, treatment should be started at a dose of one 25 mg tablet once daily.
If you have moderate kidney problems, treatment should be started at a dose of one 25 mg tablet every
other day. Depending on your blood potassium levels and your doctor's recommendation, these doses
may be adjusted.
EPLERENONE DOC Generici is not recommended in patients with severe kidney problems.
In patients with mild to moderate liver problems, no adjustment of the initial dose is required. If you have
kidney or liver problems, you may require more frequent monitoring of blood potassium levels (see also
“Do not take EPLERENONE DOC Generici").

Elderly patients
No adjustment of the initial dose 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 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, which is high levels
of potassium in the blood (which may cause muscle cramps, diarrhoea, nausea, dizziness or headache).

If you forget to take EPLERENONE DOC Generici
If it is almost time for your next dose, skip the missed dose and take the next tablet at the scheduled
time. Otherwise, take it as soon as you remember, making sure that at least 12 hours have passed before
taking the next 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 DOC Generici
It is important to take EPLERENONE DOC Generici as prescribed, unless your doctor tells you to stop
treatment.
If you have any questions about how to use this medicine, 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 symptoms, tell your doctor immediately:

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

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

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

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness, or headache)
• fainting
• dizziness
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• 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 indicate 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 levels of triglycerides (fat) in the blood
• fast heartbeat
• inflammation of the gallbladder
• decreased blood pressure which may cause dizziness when standing up
• blood clots (thrombosis) in the legs
• sore throat
• flatulence
• reduced thyroid function
• increased blood glucose levels
• reduced sensitivity to touch
• increased sweating
• musculoskeletal pain
• kidney inflammation
• breast enlargement in men
• changes in the results of certain blood tests

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the website
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 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 and 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 DOC Generici contains
The active substance in EPLERENONE DOC Generici film-coated tablets is eplerenone.
Each tablet contains 25 mg or 50 mg of eplerenone.
The other components are: monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose (Type A), hypromellose (Benecel E3), talc, and magnesium stearate.
The yellow opadry coating of the 25 mg and 50 mg EPLERENONE DOC Generici film-coated tablets 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
The 25 mg EPLERENONE DOC Generici tablets are yellow, round, biconvex, with "E25" engraved on one side.
The 50 mg EPLERENONE DOC Generici tablets are yellow, round, biconvex, with "E50" engraved on one side.
EPLERENONE DOC Generici 25 mg and 50 mg film-coated tablets are available in cardboard boxes containing opaque PVC/Al blisters of 10, 20, 28, 30, 50, 90, 100, and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

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 authorized in the European Economic Area countries under the following names:
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 comprimé pelliculé
Eplerathen 50 mg comprimé pelliculé