Ivabradine 7.5 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Ivabradine

제공처:

Lexon Pharmaceuticals (Ireland) Limited

ATC 코드:

C01EB17

INN (국제 이름):

Ivabradine

복용량:

7.5 milligram(s)

약제 형태:

Film-coated tablet

치료 영역:

ivabradine

승인 상태:

Marketed

승인 날짜:

2020-07-17

환자 정보 전단

PACKAGE LEAFLET
KEY PHARMACEUTICALS LTD.
IVABRADINE 5 MG FILM-COATED TABLETS
PL 34424/0046 PA23176/008/001
IVABRADINE 7.5 MG FILM-COATED TABLETS
PL 34424/0047 PA23176/008/002
VERSION NO.: 07 (MARCH 2021)_MM
Page 1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
IVABRADINE 5 MG FILM-COATED TABLETS
IVABRADINE 7.5 MG FILM-COATED TABLETS
ivabradine
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 symptoms 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 Ivabradine is and what it is used for
2. What you need to know before you take Ivabradine
3. How to take Ivabradine
4. Possible side effects
5. How to store Ivabradine
6. Contents of the pack and other information
1. WHAT IVABRADINE IS AND WHAT IS IT USED FOR
Ivabradine is a heart medicine used to treat:
−
Symptomatic stable angina pectoris (which causes chest pain) in adult
patients whose
heart rate is over or equal to 70 beats per minute. It is used in
adult patients who do not
tolerate or cannot take heart medicines called beta-blockers. It is
also used in combination
with beta blockers in adult patients whose condition is not fully
controlled with a beta-
blocker.
−
Chronic heart failure in adult patient whose heart rate is over or
equal to 75 beats per
minute. It is used in combination with standard therapy, including
beta-blocker therapy or
when beta blockers are contraindicated or not tolerated.
About stable angina pectoris (usually referred to as "angina"):
Stable angina is a heart disease which happens when the heart does not
receive enough oxygen. It
usually appears between 40 and 50 years of ag

제품 특성 요약

Health Products Regulatory Authority
03 February 2022
CRN00CS1D
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine 7.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ivabradine hydrochloride equivalent
to 7.5 mg ivabradine.
Excipient with known effect
91.1 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Salmon-coloured, circular, film-coated tablet engraved with "7.5" on
one face. Dimensions: 3.6 x 7.6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic stable angina pectoris
Ivabradine is indicated for the symptomatic treatment of chronic
stable angina pectoris in coronary artery disease adults with
normal sinus rhythm and heart rate ≥ 70 beats per minute (bpm).
Ivabradine is indicated:
- in adults unable to tolerate or with a contra-indication to the use
of beta-blockers
- or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-blocker dose.
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class
with systolic dysfunction, in patients in sinus rhythm and
whose heart rate is ≥ 75 bpm, in combination with standard therapy
including beta-blocker therapy or when beta-blocker
therapy is contraindicated or not tolerated. (See section 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the different doses, film-coated tablets containing 5 mg and 7.5
mg ivabradine are available.
Symptomatic treatment of chronic stable angina pectoris
It is recommended that the decision to initiate or titrate treatment
takes place with the availability of serial heart rate
measurements, ECG or ambulatory 24-hour monitoring.
The starting dose of ivabradine should not exceed 5 mg twice daily in
patients aged below 75 years. After three to four weeks
of treatment, if the patient is still symptomatic, if the initial dose
is well tolerated and if res