Ivabradine 7.5 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Ivabradine

Dostupné s:

Key Pharmaceuticals Ltd

ATC kód:

C01EB17

INN (Mezinárodní Name):

Ivabradine

Dávkování:

7.5 milligram(s)

Léková forma:

Film-coated tablet

Terapeutické oblasti:

ivabradine

Stav Autorizace:

Marketed

Datum autorizace:

2020-07-17

Informace pro uživatele

intending to breast-feed as breast-feeding should be discontinued if
you take Ivabradine.
If you are pregnant or breast-feeding, think you may be pregnant or
are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
DRIVING AND USING MACHINES
Ivabradine
may
cause
temporary
luminous
visual
phenomena
(a
temporary brightness in the field of vision, see "Possible side
effects").
If this happens to you, be careful when driving or using machines at
times when there could be sudden changes in light intensity,
especially
when driving at night.
IVABRADINE CONTAINS LACTOSE
If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicine.
3.
HOW TO TAKE IVABRADINE
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Ivabradine should be taken during meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one tablet of Ivabradine 5 mg
twice daily. If you still have angina symptoms and if you have
tolerated
the 5 mg twice daily dose well, the dose may be increased. The
maintenance dose should not exceed 7.5 mg twice daily. Your doctor
will prescribe the right dose for you. The usual dose is one tablet in
the
morning and one tablet in the evening. In some cases (e.g. if you are
elderly), your doctor may prescribe half the dose i.e., one half 5 mg
tablet of Ivabradine 5 mg (corresponding to 2.5 mg Ivabradine) in the
morning and one half 5 mg tablet in the evening.
If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradine 5 mg
twice daily increasing if necessary to one tablet of Ivabradine 7.5 mg
twice daily. Your doctor will decide the right dose for you. The usual
dose is one tablet in the morning and one tablet in the evening. In
some
cases (e.g. if you are elderly), your doctor may prescribe half the
dose
i.e., one half 5 mg tablet of Ivabradine 5 m

Charakteristika produktu

Health Products Regulatory Authority
21 July 2020
CRN008MFF
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 resting