CORDILOX 180 SR verapamil hydrochloride 180mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

verapamil hydrochloride, Quantity: 180 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium alginate; povidone; magnesium stearate; hypromellose; macrogol 400; macrogol 6000; purified talc; glycol/butylene glycol montanate; titanium dioxide; iron oxide red

Administration route:

Oral

Units in package:

30 tablets, 15 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cordilox SR (verapamil hydrochloride) is indicated for the management of hypertension and angina pectoris.

Product summary:

Visual Identification: Old rose, oval film coated tablet. KNOLL on one face and 'SR' score '180' on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-12-04

Patient Information leaflet

CORDILOX
® SR
C
O
R
D
I
L
O
X
S
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CORDILOX SR?
CORDILOX SR contains the active ingredient verapamil hydrochloride.
CORDILOX SR is used for high blood pressure
(hypertension) and angina (chest pain). For more information, see
Section 1. Why am I using CORDILOX SR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CORDILOX SR?
Do not use if you have ever had an allergic reaction to CORDILOX SR or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CORDILOX SR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CORDILOX SR and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE CORDILOX SR?
•
The usual dose of CORDILOX SR is once daily or they may be taken twice
daily. More instructions can be found in Section 4.
How do I use CORDILOX SR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CORDILOX SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CORDILOX SR.
•
Tell your doctor if you become pregnant while taking CORDILOX SR.
•
If you are being treated for angina, tell your doctor if the medicine
is not helping.
•
Visit your doctor regularly so that they can check on your progress.
THINGS YOU
SHOULD NOT DO
•
Do not stop using CORDILOX SR or lower the dosage without checking
with your doctor.
•
Do not take CORDILOX SR with grapefruit or its juice.
•
Do not give CORDILOX SR to anyone else, even if they have the same
condition as you.
•
Do not take CORDILOX SR to treat any other complaints unless your
doctor tells you to.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CORDILOX
®
SR
_Verapamil hydrochloride tablets _
1
NAME OF THE MEDICINE
Verapamil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verapamil hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium ion antagonist).
Each CORDILOX SR film-coated tablet contains 180 mg or 240 mg of
verapamil hydrochloride as the active
ingredient.
Excipients with known effect: Trace quantities of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CORDILOX SR is available for oral administration as light green,
oblong shaped, scored, film-coated tablets
(score and 2 logos on one face and score on the other face) containing
240 mg verapamil hydrochloride and
as old rose, oval shaped, scored, film-coated tablets (‘KNOLL’ on
one face and ‘SR’; score; ‘180’ on the other
face) containing 180 mg verapamil hydrochloride. The tablets are
designed for sustained release of the drug
in the gastrointestinal tract; sustained release characteristics are
not altered when the tablet is divided in half.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CORDILOX SR is indicated for the management of hypertension and angina
pectoris.
4.2
DOSE AND METHOD OF ADMINISTRATION
Hypertension
The dose of CORDILOX SR should be individualised by titration and the
drug should be administered with
food. The usual daily dose of sustained release verapamil, CORDILOX
SR, in clinical trials has been 240 mg
given by mouth once daily in the morning. Some patients may respond to
initial therapy of one 180 mg tablet
once daily. However, initial doses of 120 mg (½ 240 mg tablet) a day
may be warranted in patients who may
have an increased response to verapamil (e.g. elderly, small people
etc.). Upward titration should be based on
therapeutic efficacy and safety evaluated approximately 24 hours after
dosing. The antihypertensive effects of
CORDILOX SR are evident within the first week of therapy.
If adequate response is not obtained, the dose may be