Eplerenone 25mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Eplerenone

Sẵn có từ:

Aspire Pharma Ltd

Mã ATC:

C03DA04

INN (Tên quốc tế):

Eplerenone

Liều dùng:

25mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02020300; GTIN: 5060209731070

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPLERENONE 25MG AND 50MG
FILM-COATED TABLETS
eplerenone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or
pharmacist.
− This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
− If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Eplerenone is and what it is used for
2. What you need to know before you take Eplerenone
3. How to take Eplerenone
4. Possible side effects
5. How to store Eplerenone
6. Contents of the pack and other information
1. WHAT EPLERENONE IS AND WHAT IT IS USED FOR
Eplerenone belongs to a group of medicines known as
selective aldosterone blocking agents. These blocking
agents inhibit the action of aldosterone, a substance
produced within the body, which controls your blood
pressure and heart function. High levels of aldosterone can
cause changes in your body that lead to heart failure.
Eplerenone is used to treat your heart failure to prevent
worsening and reduce hospitalisations if you have:
1. had a recent heart attack, in combination with other
drugs that are used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment
you have been receiving so far.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPLERENONE
DO NOT TAKE EPLERENONE
•
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
(hyperkalemia)
•
if you are taking groups of drugs which help you to
excrete excessive body fluid, (potassium sparing
diuretics) or ‘salt tablets’ (potassium supplements)
•
if you have severe kidney disease
•
if you have sev

Đặc tính sản phẩm

OBJECT 1
EPLERENONE 25MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 09-May-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Eplerenone 25 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 25 mg of eplerenone.
Excipients with known effect:
Each 25mg tablet contains 35.7mg of lactose monohydrate (see section
4.4).
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
25 mg tablet: yellow, round biconvex tablets, 6.1mm in diameter and
2.6mm in thickness engraved with
“E25” on one side
4. Clinical particulars
4.1 Therapeutic indications
Eplerenone is indicated:
• in addition to standard therapy including beta-blockers, to reduce
the risk of cardiovascular (CV)
mortality and morbidity in stable patients with left ventricular
dysfunction (LVEF ≤40 %) and clinical
evidence of heart failure after recent myocardial infarction (MI).
• in addition to standard optimal therapy, to reduce the risk of CV
mortality and morbidity in adult
patients with New York Heart Association (NYHA) class II (chronic)
heart failure and left ventricular
systolic dysfunction (LVEF ≤30%) (see section 5.1).
4.2 Posology and method of administration
Posology
For the individual adjustment of dose, the strengths of 25 mg and 50
mg are available.
The maximum dose regimen is 50 mg daily.
_For post MI heart failure patients: _
The recommended maintenance dose of eplerenone is 50 mg once daily
(OD). Treatment should be
initiated at 25 mg once daily and titrated to the target dose of 50 mg
once daily preferably within 4 weeks,
taking into account the serum potassium level (see Table 1).
Eplerenone therapy should usually be started
within 3-14 days after an acute MI.
_For patients with NYHA class II (chronic) heart failure: _
For chronic heart failure NYHA class II patients, treatment should be
initiated at a dose of 25 mg once
daily and titrated to the target dose of 50 mg once daily preferably
within 4 weeks; taking into account the
serum