EPLERENONE 25 mg Фильм-Coated Таблетки

Содержание инструкции

1. Eplerenone Krka 25 mg film-coated tablets, 50 mg film-coated tablets
   1. What is Eplerenone Krka and what it is used for
   2. What you need to know before you take Eplerenone Krka
   3. Understanding Eplerenone Krka
   4. Possible side effects
   5. How to store Eplerenone Krka
   6. Contents of the pack and other information

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

eplerenone

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, 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 Krka is and what it is used for
• 2. What you need to know before you take Eplerenone Krka
• 3. How to take Eplerenone Krka
• 4. Possible side effects
• 5. How to store Eplerenone Krka
• 6. Contents of the pack and other information

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

Eplerenone Krka 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 Krka 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 up to now.

2. What you need to know before you take Eplerenone Krka

Do not take Eplerenone Krka

• 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 to 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 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 hypertension (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 Krka.

• if you have a kidney or liver problem (see also “Do not take Eplerenone Krka”)
• if you are taking lithium (usually used for manic-depressive disorders, also called bipolar disorders)
• if you are taking tacrolimus or cyclosporine (used for the treatment of 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 has not been established.

Other medicines and Eplerenone Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

• 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 Krka, prolonging its effect.
• potassium-sparing diuretics (medicines that help to eliminate excess body fluids) 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.
• 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 undesirable effects: loss of appetite, reduced vision, fatigue, muscle weakness, muscle cramps
• cyclosporine or tacrolimus (used for the treatment of 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 for the treatment of bacterial infections) can increase the risk of high levels of potassium in the blood
• alpha-1-blockers, such as prazosin or alfuzosin (used for the treatment of high blood pressure and for certain prostate problems) may cause a drop in blood pressure and dizziness when getting 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 for the treatment of muscle spasms). These medicines can cause drops in blood pressure and dizziness when getting up
• glucocorticoids, such as hydrocortisone or prednisone (used for the treatment of inflammation and certain skin conditions) and tetracosactide (mainly used for the diagnosis and treatment

of adrenal cortex disorders) can lower blood pressure, decreasing the effect
of Eplerenone Krka

• digoxin (used in the treatment of heart disorders). Digoxin levels in the blood may increase when given together with Eplerenone Krka
• warfarin (a medicine that prevents blood clotting): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of Eplerenone Krka
• erythromycin (used for the treatment of bacterial infections), saquinavir (antiviral medicine for the treatment of HIV), fluconazole (used for the treatment of fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart disorders and high blood pressure) reduce the elimination of Eplerenone Krka prolonging its effect
• St. John's Wort (herbal medicine), rifampicin (used for the treatment of bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, also for the treatment of epilepsy) may increase the elimination of Eplerenone Krka and therefore decrease its effects

Eplerenone Krka with food and drink
Eplerenone Krka can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, 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. You and your doctor must decide whether
to stop breastfeeding or to stop taking the medicine.

Driving and operating machinery
After taking Eplerenone Krka you may feel dizzy. If this happens do not drive or operate
machinery.

Eplerenone Krka contains lactose and sodium
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially
“sodium-free”.

3. Understanding Eplerenone Krka

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your doctor or pharmacist.
Eplerenone Krka tablets can be taken with or without food. The tablets should be
swallowed whole with a sufficient amount of water.
Eplerenone Krka 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 Krka,
within the first week and within the first month of treatment, or after a dose change. The dose
may be adjusted by the doctor based on blood potassium levels.
If you suffer from 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 every other day. Based on blood potassium levels and if your doctor recommends it, these doses may
be adjusted.
Eplerenone Krka is not recommended in patients with severe kidney problems.
In patients with mild-moderate liver problems, no dose adjustments are required.
If you suffer from kidney or liver problems, you may need more frequent checks of your
blood potassium levels (see also “Do not take Eplerenone Krka”).
For the elderly: no initial dose adjustment is required.
For children and adolescents: Eplerenone Krka is not recommended.

If you take more Eplerenone Krka than you should
If you take more Eplerenone Krka 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 of
dizziness, lightheadedness, 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 Krka
If it is almost time to take your next tablet, skip the dose you forgot to take and
take your 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 Krka
It is important that you take Eplerenone Krka 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 occur:

You should inform your doctor immediately

• Swelling of the face, tongue and 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, diarrhoea, 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
• diarrhoea
• nausea
• vomiting
• abnormal kidney function
• skin rash
• itching
• back pain
• feeling weak
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may be a sign of kidney problems

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

• infections
• eosinophilia (increased number of certain white blood cells)
• low blood levels of sodium
• dehydration
• increased amount of triglycerides (fat) in the blood
• fast heartbeat
• inflammation of the gallbladder
• decreased 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
• feeling unwell
• 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 or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/content/come-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 Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after Scad and on the blister
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eplerenone Krka contains

• The active ingredient is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate and sodium lauryl sulfate in the tablet core and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 and yellow iron oxide (E172) in the tablet coating. See section 2 “Eplerenone Krka contains lactose and sodium”.

Description of the appearance of Eplerenone Krka and contents of the pack
25 mg: film-coated tablets, yellow, round, biconvex, marked with 25 on one side.
Dimensions: diameter 6 mm.
50 mg: film-coated tablets, yellow, round, biconvex, marked with 50 on one side.
Dimensions: diameter 7.5 mm.
Eplerenone Krka is available in packs containing:

• 10, 20, 28, 30, 50, 90 and 100 film-coated tablets in blisters.
• 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann - Straβe 5, 27472 Cuxhaven, Germany

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) under the following names:
More detailed information on this medicinal product is available on the AIFA website
(https://www.aifa.gov.it)