EPLERENONE 25 mg Фильм-Coated Таблетки

Содержание инструкции

1. Eplerenone Accord 25 mg film-coated tablets, 50 mg film-coated tablets
   1. What is Eplerenone Accord and what it is used for
   2. What you need to know before taking Eplerenone Accord
   3. How to take Eplerenone Accord
   4. Possible side effects
   5. How to store Eplerenone Accord
   6. Package contents and other information

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

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

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

Eplerenone Accord belongs to the class of medicines known as selective aldosterone blockers.
These blockers 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 Accord is used to treat your heart failure, to prevent it from 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 taking Eplerenone Accord

Do not take Eplerenone Accord

• 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 fluids from the body (potassium-sparing diuretics)
• if you have a severe kidney disease
• if you have a severe liver disease
• 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

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• 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, pharmacist or nurse before taking Eplerenone Accord

• if you have a kidney or liver disease (see also “Do not take Eplerenone Accord”)
• if you are taking lithium (usually used for manic-depressive disorder, also called bipolar disorder)
• if you are taking tacrolimus or ciclosporin (used for the treatment of skin conditions such as psoriasis or eczema and to prevent rejection after organ transplantation)

For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may still result in a positive doping test.

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

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

• Itraconazole or ketoconazole (used 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 (used for the treatment of depression), because these medicines reduce the elimination of Eplerenone Accord, prolonging its effect.
• Potassium-sparing diuretics (medicines that help to eliminate excess fluids from the body) and potassium supplements (salt tablets) because these medicines increase the risk of high levels of potassium in the blood.
• Angiotensin converting enzyme (ACE) inhibitors together with angiotensin II receptor blockers (ARBs) (used in the treatment of high blood pressure, heart disease or particular kidney conditions), because these medicines can increase the risk of high levels of potassium in the blood.
• Lithium (usually used for manic-depressive disorder, also called bipolar disorder). 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) causes an excessive increase in lithium levels in the blood which can cause the following side effects: loss of appetite, reduced vision, fatigue, muscle weakness, muscle cramps.
• Ciclosporin 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 levels of potassium 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 particular prostate problems) can cause a drop in blood pressure and dizziness when getting up.

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• 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 cancer 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 some skin conditions) and tetracosactide (mainly used for the diagnosis and treatment of adrenal cortex disorders) can reduce blood pressure, decreasing the effect of Eplerenone Accord.
• Digoxin (used for the treatment of heart disorders). Digoxin levels in the blood can increase when administered together with Eplerenone Accord.
• Warfarin (a medicine that prevents blood clotting): caution is recommended when taking warfarin, as high levels of warfarin in the blood can alter the effects of Eplerenone Accord on the body.
• Erythromycin (used to treat 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 Accord prolonging its effect on the body.
• St John's Wort (herbal medicine), rifampicin (used for the treatment of bacterial infections), carbamazepine, phenytoin and phenobarbital (also used for the treatment of epilepsy) can increase the elimination of Eplerenone Accord and therefore decrease its effects.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The effect of Eplerenone Accord has not been evaluated during pregnancy.
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 using machines
After taking Eplerenone Accord you may experience dizziness. If this happens do not drive vehicles and do not use machines.

Eplerenone Accord contains lactose monohydrate
Eplerenone Accord contains lactose monohydrate (a type of sugar). If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine

3. How to take Eplerenone Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Eplerenone Accord tablets can be taken with or without food. The tablets should be
swallowed whole with a sufficient amount of water.
Eplerenone Accord is generally administered together with other medicines for heart
failure, such as beta-blockers. Generally, the initial dose is one 25 mg tablet once
daily, then increased after 4 weeks to 50 mg once daily (one 50 mg tablet or
two 25 mg tablets). The maximum dose is 50 mg per day.
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Blood potassium levels must be measured before starting therapy with Eplerenone Accord,
within the first week and within the first month of treatment, or after a dose change. The dosage
may be adjusted by your doctor based on blood potassium levels.
If you suffer from mild kidney disease, you should start therapy with one 25 mg tablet once daily. If
your kidney disease is moderate, you should start therapy with one 25 mg tablet every other day. If
your doctor recommends it and based on blood potassium levels, these doses may be adjusted.
Eplerenone Accord is not recommended in patients with severe kidney disease.
In patients with mild-to-moderate liver dysfunction, no dosage adjustments are required. If you have kidney or
liver problems, you may need more frequent checks of your blood potassium levels (see also “Do not take Eplerenone Accord”).
For the elderly: no initial dose adjustment is required.
For children and adolescents: Eplerenone Accord is not recommended.

If you take more Eplerenone Accord than you should
If you have taken more Eplerenone Accord tablets 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 Accord
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 Accord
It is important to continue taking Eplerenone Accord as prescribed unless your doctor
tells you to stop treatment.
If you have any further questions on 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:

Tell 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 (affects up to 1 in 100 people).
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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)
• dizziness
• fainting
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, e.g. irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• altered 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):

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• increased amount of cholesterol or triglycerides (fats) in the blood
• low levels of sodium 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 blood sugars
• reduced sensitivity to touch
• increased sweating
• musculoskeletal pain
• feeling generally unwell
• kidney inflammation
• breast enlargement in men
• changes in blood test values

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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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 Accord

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 which is stated on the packaging and on the blister after SCAD.
The expiry date refers to the last day of that month.
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. Package contents and other information

What Eplerenone Accord contains
The active ingredient of the film-coated tablets of Eplerenone Accord is eplerenone. Each tablet
contains 25 mg or 50 mg of eplerenone.
The other ingredients are: Monohydrate lactose, Microcrystalline cellulose, Hypromellose, Croscarmellose
sodium, Talc and Magnesium stearate.
The Opadry 13B52001 yellow coating of Eplerenone Accord contains:
Hypromellose, Titanium dioxide (E171), Macrogol 400, Polysorbate 80, Yellow iron oxide (E172), Red iron
oxide (E172).

Description of the appearance of Eplerenone Accord and package contents
Eplerenone Accord 25 mg is a yellow, biconvex, diamond-shaped, film-coated tablet, with “E1” imprinted on one side and smooth on the other side. The length, width and thickness of the film-coated tablet are respectively 7.20 ± 0.3 mm, 6.40 ± 0.3 mm and 3.15 ± 0.3 mm.
Eplerenone Accord 50 mg is a yellow, biconvex, diamond-shaped, film-coated tablet, with “E2” imprinted on one side and smooth on the other side. The length, width and thickness of the film-coated tablet are respectively 9.00 ± 0.3 mm, 8.10 ± 0.3 mm and 4.25 ± 0.3 mm.
The film-coated tablets of Eplerenone Accord 25 mg and 50 mg are available in blisters containing
10, 28, 30, 90 or 100 tablets or in perforated blisters for unit dose of 10x1, 28x1, 30x1, 90x1 or 100x1
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
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Accord Healthcare Limited
Sage House, 319
Pinner Road, Harrow,
Middlesex, HA1 4HF
United Kingdom
Wessling Hungary Kft.
Fóti út 56, 1047 Budapest,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area:
CountryName of the medicinal product

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