VASOCARDOL CD diltiazem hydrochloride 180mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diltiazem hydrochloride, Quantity: 180 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

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

Administration route:

Oral

Units in package:

7 capsules, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VASOCARDOL CD is indicated for the treatment of hypertension. VASOCARDOL 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, blue opaque and light turquoise blue opaque hard gelatin capsule containing white to off-white beads.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1999-06-03

Patient Information leaflet

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

Summary of Product characteristics

vasocardol-cd-ccdsv13-piv20-11mar20
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
VASOCARDOL
® CD
(DILTIAZEM HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Diltiazem hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VASOCARDOL 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
VASOCARDOL 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
VASOCARDOL CD is indicated for the treatment of hypertension.
VASOCARDOL 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration.
vasocardol-cd-ccdsv13-piv20-11mar20
Page 2 of 19
Patients controlled on diltiazem alone or in combination with other
medications may be
safely switched to VASOCARDOL 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 needs to be adjusted by titration to individual patient needs.
Monitoring of trough BP
should be done initially to ensure BP control lasts over dosing
period. When used as
monothera