Cardizem

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Diltiazem hydrochloride 60mg

Διαθέσιμο από:

sanofi-aventis new zealand limited

INN (Διεθνής Όνομα):

Diltiazem hydrochloride 60 mg

Δοσολογία:

60 mg

Φαρμακοτεχνική μορφή:

Film coated tablet

Σύνθεση:

Active: Diltiazem hydrochloride 60mg Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Magnesium stearate Methyl hydroxybenzoate Microcrystalline cellulose Opadry Quinoline yellow Sunset yellow FCF

Μονάδες σε πακέτο:

Bottle, plastic, HDPE, sample pack, 7 tablets

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Finorga SA

Θεραπευτικές ενδείξεις:

Patients with moderate to severe angina pectoris due to atherosclerotic coronary artery disease or coronary artery spasm (vasospastic angina).

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, sample pack - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Bottle, plastic, HDPE - 90 tablets - 48 months from date of manufacture stored at or below 30°C protect from light and moisture - Bottle, plastic, HDPE - 100 tablets - 48 months from date of manufacture stored at or below 30°C protect from light and moisture

Ημερομηνία της άδειας:

1984-07-19

Φύλλο οδηγιών χρήσης

Cardizem® CD capsules and Cardizem® tablets
_1_
CARDIZEM® CD CAPSULES AND CARDIZEM® TABLETS
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.
•
Take these medicines exactl

Αρχείο Π.Χ.Π.

New Zealand Data Sheet
Cardizem - Diltiazem Hydrochloride
cardizem-ccdsv13-dsv11-20apr20
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Cardizem 60 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diltiazem hydrochloride 60 mg
Chemically, diltiazem hydrochloride is the hydrochloride salt of (2S,
3S)-5-(2-
dimethylaminoethyl)-2,3,4,5-tetrahydro-2-(4-methoxyphenyl)-4-oxo-1,5-benzothiazepin-3-yl
acetate.
Excipients with known effect: lactose monohydrate and methyl
hydroxybenzoate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cardizem 60 mg tablets are clear coated, light yellow, round double
(13/32” or 1.03 cm) convex
tablets with characteristic direct compression speckle. The word
“Marion” is engraved on one side
while the other side is scored and engraved with 1772.
Cardizem contains a white to off-white crystalline powder with a
bitter taste. It is freely soluble
in water, methanol, and chloroform.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients with moderate to severe angina pectoris due to
atherosclerotic coronary artery disease or
coronary artery spasm (vasospastic angina).
New Zealand Data Sheet
Cardizem - Diltiazem Hydrochloride
cardizem-ccdsv13-dsv11-20apr20
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_ANGINA _
Dosage must be adjusted to each patient's needs. Starting with 30 mg
four times daily, before
meals and at bedtime, dosage should be increased gradually (given in
divided doses three or four
times daily) at one to two day intervals until optimum response is
obtained. Although individual
patients may respond to any dosage level, the average optimum dosage
range appears to be 180 to
240 mg/day. The maximum recommended dose is 360 mg daily. There are no
available data
concerning dosage requirements in patients with impaired renal or
hepatic function. If the drug
must be used in such patients, titration should be carried out with
particular caution.
_USE IN THE ELDERLY _
Pharmacokinetics of diltiazem in elderly patients has not been full