APO-IVABRADINE ivabradine (as hydrochloride) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ivabradine hydrochloride, Quantity: 5.39 mg (Equivalent: ivabradine, Qty 5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; colloidal anhydrous silica; maltodextrin; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000

Administration route:

Oral

Units in package:

14, 56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of chronic stable angina Symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, OR in combination with atenolol 50mg once daily when angina is inadequately controlled.,Treatment of chronic heart failure Treatment of symptomatic chronic heart failure of NYHA Classes II or III and with documented left ventricular ejection fraction (LVEF) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

Product summary:

Visual Identification: Ivabradine 5 mg is light salmon, capsule shape (8.25 mm x 4 mm), biconvex film-coated tablet scored on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-01-11

Patient Information leaflet

APO-IVABRADINE
1
APO-IVABRADINE
_Ivabradine hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ivabradine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of taking ivabradine against the
benefits they expect it will have for
you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Ivabradine is used to treat:
•
symptomatic stable angina in
adult patients whose heart rate is
over or equal to 70 beats per
minute (bpm)
•
heart failure
Stable angina:
Stable angina typically occurs when
you exert yourself and is usually
relieved with medication or rest.
Angina is a pain or uncomfortable
feeling in the chest. This pain or
feeling can also spread to the arms
and neck and sometimes also to the
shoulders and back. Angina is caused
by too little blood and oxygen getting
to the heart.
Ivabradine relieves stable angina by
lowering the heart rate. Ivabradine is
not for the relief of a sudden attack of
angina. Your doctor will have given
you other medication to treat this.
Heart failure:
Heart failure means that the heart
muscle cannot pump blood strongly
enough to supply all the blood
needed throughout the body. Heart
failure is not the same as heart attack
and does not mean that the heart
stops working.
Some people develop heart failure
after having had a heart attack.
However, there are also other causes
of heart failure.
Heart failure may start off with no
symptoms, but as the condition
progresses, you may feel short of
breath or may get tired easily after
light physical activity such as
walking. You may wake up short of
breath at night. Fluid may collect in
different parts of the body, often first
noticed as swollen ankles a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-
IVABRADINE (IVABRADINE HYDROCHLORIDE) FILM
COATED TABLETS
1 NAME OF THE MEDICINE
Ivabradine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Ivabradine 5 mg film coated tablet contains 5 mg of
Ivabradine (as hydrochloride)
Each APO-Ivabradine 7.5 mg film coated tablet contains 7.5 mg of
Ivabradine (as
hydrochloride)
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars (as lactose monohydrate)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-Ivabradine 5 mg: light salmon, capsule shape, biconvex film-coated
tablet scored on
one side.
APO-Ivabradine 7.5 mg: light salmon, round, biconvex film-coated
tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF CHRONIC STABLE ANGINA
Symptomatic treatment of chronic stable angina due to atherosclerotic
coronary artery
disease in patients with normal sinus rhythm and heart rate at or
above 70 bpm, who are
unable to tolerate or have a contraindication to the use of
beta-blockers, OR in combination
with atenolol 50mg once daily when angina is inadequately controlled
TREATMENT OF CHRONIC HEART FAILURE
Treatment of symptomatic chronic heart failure of NYHA Classes II or
III and with
documented left
ventricular ejection fraction (LVEF) ≤ 35% in adult patients in
sinus
rhythm and with heart rate at or above 77 bpm, in combination with
optimal standard
chronic heart failure treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA:
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 for patients with stable angina, alone
or in combination with
atenolol 50 mg, should not exceed 5 mg twice daily (BD) in patients
aged below 75 years.
when heart rate is at or above 70 bpm.
After three to four weeks of treatment, if the patient is still
symptomatic, if the initial dose is
well tolerate