CARDIZEM CD 240mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diltiazem hydrochloride, Quantity: 240 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: Gelatin; ethylcellulose; methacrylic acid copolymer; colloidal anhydrous silica; titanium dioxide; white beeswax; tributyl acetylcitrate; Castor Oil; stearic acid; purified talc; simethicone; brilliant blue FCF; fumaric acid; maize starch; sucrose

Administration route:

Oral

Units in package:

28 capsules, 7 capsules, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CARDIZEM CD is indicated for the treatment of hypertension. CARDIZEM CD is also indicated for the management of chronic stable angina (effort-associated angina) where there is no evidence of vasospastic or unstable angina. Since the safety and efficacy of CD capsules in the management of unstable or vasospastic angina have not been substantiated, use of this formulation for these indications is not recommended.

Product summary:

Visual Identification: Size 0 (elongated), blue opaque hard gelatin capsule containing white to off-white beads.; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-11-10

Patient Information leaflet

CARDIZEM® CD CAPSULES AND CARDIZEM® TABLETS
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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 CARDIZEM?
Cardizem CD capsules or Cardizem tablets both contain an active
ingredient diltiazem hydrochloride. Cardizem tablets are used to
prevent angina. Cardizem CD capsules are used to prevent angina or to
treat hypertension (high blood pressure).
For more information, see Section 1. Why am I using Cardizem? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARDIZEM?
Do not use if you have ever had an allergic reaction to Cardizem CD
capsules or Cardizem tablets 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
Cardizem? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cardizem 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 CARDIZEM?
•
Cardizem CD capsules can be taken once a day, preferably at the same
time every day.
•
Cardizem tablets can be taken three or four times a day.
•
Swallow the capsules or the tablets with a glass of water. Do not chew
them.
•
Your doctor will tell you how often and how much Cardizem CD or
Cardizem tablets to take.
More instructions can be found in Section 4. How do I use Cardizem? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARDIZEM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cardizem CD or Cardizem tablets.
•
If you are taking these medicines for angina, tell your doctor if you
continue to have angina attacks or if
they become more frequent.
•

Summary of Product characteristics

cardizem-cd-ccdsv13-piv15-11mar20
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION – CARDIZEM
® CD
(DILTIAZEM HYDROCHLORIDE)
1
NAME OF THE MEDICINE
CARDIZEM CD (diltiazem hydrochloride) 180 mg modified release capsules
CARDIZEM CD (diltiazem hydrochloride) 240 mg modified release capsules
CARDIZEM CD (diltiazem hydrochloride) 360 mg modified release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARDIZEM CD capsules contain a blend of beads with controlled
dissolution characteristics
for once-a-day administration. The capsules are available as either
180 mg, 240 mg or 360
mg diltiazem hydrochloride in sustained release form.
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
freely soluble in water, methanol, and chloroform.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Modified release capsule
CARDIZEM CD is available in 3 strengths:
180 mg:
Light turquoise blue/blue capsule
240 mg:
Blue/blue capsule
360 mg:
Light blue/white capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CARDIZEM CD is indicated for the treatment of hypertension.
CARDIZEM CD is also indicated for the management of chronic stable
angina (effort-
associated angina) where there is no evidence of vasospastic or
unstable angina. Since the
safety and efficacy of CD capsules in the management of unstable or
vasospastic angina has
not been substantiated, use of this formulation for these indications
is not recommended.
cardizem-cd-ccdsv13-piv15-11mar20
Page 2 of 20
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration.
Patients controlled on diltiazem alone or in combination with other
medications may be
safely switched to CARDIZEM CD at the nearest equivalent total daily
dose. Subsequent
titration to higher or lower doses may be necessary and should be
initiated as clinically
warranted. There is limited clinical experience with doses above 360
mg. Therefore,
treatment with doses exceeding 360 mg/day is not recommended.
HYPERTENSION
Dosage need