CORALAN ivabradine (as hydrochloride) 5 mg tablets 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:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

Ivabradine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; maltodextrin; colloidal anhydrous silica; glycerol; hypromellose; iron oxide yellow; iron oxide red; macrogol 6000; titanium dioxide

Administration route:

Oral

Units in package:

14 tablets, 56 tablets

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) less than or equal to 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: Salmon-pink coloured, rod-shaped, film-coated tablet scored on both edges, engraved with "5" on one face and Servier logo on the other face; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2006-10-31

Patient Information leaflet

CORALAN
®
_ivabradine (as the hydrochloride) 5mg & 7.5mg film coated tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CORALAN (Coh'-
rah-lan).
It does not contain all the available
information.
Reading this leaflet 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 CORALAN 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 CORALAN IS
The name of your medicine is
CORALAN. It contains the active
ingredient ivabradine (I-vab'-rah-
deen).
WHAT CORALAN IS
USED FOR
YOU MAY BE PRESCRIBED
CORALAN FOR:
•
SYMPTOMATIC STABLE ANGINA IN
ADULT PATIENTS WHOSE HEART RATE
IS OVER OR EQUAL TO 70 BEATS PER
MINUTE (BPM) OR
•
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.
CORALAN relieves stable angina by
lowering the heart rate. CORALAN
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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CORALAN (IVABRADINE AS THE
HYDROCHLORIDE)
Version: 13
1/31
AUSTRALIAN PI – CORALAN (IVABRADINE AS THE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Ivabradine (as the hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CORALAN 5 mg film-coated tablet contains 5 mg of ivabradine (as
the hydrochloride)
Each CORALAN 7.5 mg film-coated tablet contains 7.5 mg of ivabradine
(as the hydrochloride)
The active component of CORALAN is ivabradine which has the chemical
name (3-(3-{[((7S)-3,4-
Dimethoxybicyclo[4,2,0]octa-1,3,5-trien-7-yl) methyl]
methylamino}propyl)-1,3,4,5-tetrahydro-7,8-
dimethoxy-2H-3-benzazepin-2-one, hydrochloride).
It contains two rings: one benzazepinone and one benzocyclobutane
linked with an azapentane
chain. The structural form of ivabradine includes one asymmetric
carbon and ivabradine
corresponds to the S enantiomer. The hydrochloride salt is a white
hygroscopic powder, soluble in
water (50 mg/mL) and in 0.9% saline solution (14 mg/mL). The pH is 5.1
- 5.4 in aqueous solutions at
concentration of 10 mg/mL
Excipients with known effect:
Each CORALAN 5 mg tablet contains 63.91 mg of lactose. Each CORALAN
7.5 mg tablet contains
61.215 mg of lactose. For the full list of excipients, _see section
6.1 - List of excipients_
3
PHARMACEUTICAL FORM
CORALAN 5 mg: salmon-pink coloured, rod-shaped, film-coated tablet
scored on both edges,
engraved with “5” on one face and the company logo “
” on the other.
CORALAN 7.5 mg: salmon-pink coloured, triangular, film-coated tablet
engraved with “7.5” on one
face and the company logo “
”on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 controll