DILTIAZEM SANDOZ CD diltiazem hydrochloride 360mg capsule bottle (unprinted)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diltiazem hydrochloride, Quantity: 360 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

diltiazem hydrochloride

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: purified talc; sodium lauryl sulfate; methacrylic acid copolymer; povidone; simethicone; diethyl phthalate; tributyl acetylcitrate; maize starch; sucrose; titanium dioxide; brilliant blue FCF; potable water; Gelatin; silicon dioxide

Administration route:

Oral

Units in package:

30 capsules, 10 capsules, 7 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DILTIAZEM SANDOZ CD is indicated for the treatment of hypertension. DILTIAZEM SANDOZ 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.

Product summary:

Visual Identification: Size 00, light blue opaque cap and white opaque body; locking, hard gelatin capsule containing white to off white beads.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2007-02-26

Patient Information leaflet

DILTIAZEM SANDOZ CD
®
D
i
l
t
i
a
z
e
m
S
a
n
d
o
z
C
D
®
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 DILTIAZEM SANDOZ CD?
Diltiazem Sandoz CD capsules contains the active ingredient diltiazem
hydrochloride. Diltiazem Sandoz CD is used to prevent
angina or to treat hypertension (high blood pressure).
For more information, see Section 1. Why am I using Diltiazem Sandoz
CD? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DILTIAZEM SANDOZ CD?
Do not use if you have ever had an allergic reaction to Diltiazem
Sandoz CD capsules 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
Diltiazem Sandoz CD? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Diltiazem Sandoz CD 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 DILTIAZEM SANDOZ CD?
•
Diltiazem Sandoz CD capsules can be taken once a day, preferably at
the same time every 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 many Diltiazem Sandoz CD
capsules to take.
More instructions can be found in Section 4. How do I use Diltiazem
Sandoz CD? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DILTIAZEM SANDOZ CD?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Diltiazem Sandoz CD.
•
If you are taking these medicines for angina, tell your doctor if you
continue to have angina attacks or if
they become more frequent.
•
Take these medicines exactly as your doctor has prescribed.
THINGS YOU
SHOULD NOT DO
•
Do not use these medicines t

Summary of Product characteristics

diltiazem-sandoz-cd-ccdsv13-piv16-11mar20
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
DILTIAZEM SANDOZ
® CD (DILTIAZEM HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Diltiazem hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diltiazem Sandoz 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
Diltiazem Sandoz CD is registered 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
Diltiazem Sandoz CD is indicated for the treatment of hypertension.
Diltiazem Sandoz 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.
diltiazem-sandoz-cd-ccdsv13-piv16-11mar20
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 Diltiazem Sandoz 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