Diltiazem CD

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diltiazem hydrochloride 120.12mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Diltiazem hydrochloride 120.12 mg

Dosage:

120 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Diltiazem hydrochloride 120.12mg Excipient: Capsugel light blue turquoise blue 0588 Methacrylic acid copolymer Methylcellulose Microcrystalline cellulose Polysorbate 80 Purified talc Tributyl citrate

Units in package:

Blister pack, PVC/PVDC; PVC/PE/PVDC;, 100 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Piramal Enterprises Limited

Therapeutic indications:

Diltiazem CD is indicated for the treatment of hypertension either alone or in combination with other antihypertensive medications such as diuretics.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC; PVC/PE/PVDC; - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, HDPE, blue PP cap; - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, HDPE, white PP cap - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, HDPE, blue PP cap; - 500 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, HDPE, white PP cap - 500 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2000-08-29

Patient Information leaflet

DILTIAZEM CD MODIFIED RELEASE CAPSULES
1
DILTIAZEM CD MODIFIED
RELEASE CAPSULES
_Contains the active ingredient Diltiazem hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using DILTIAZEM
CD
This leaflet answers some common
questions about DILTIAZEM CD. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DILTIAZEM
CD against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
DILTIAZEM CD contains the active
ingredient diltiazem hydrochloride.
DILTIAZEM CD is designed to
release the active ingredient slowly
so that it works over 24 hours and
can be taken once a day (CD stands
for “controlled delivery”).
This medicine belongs to a group of
medicines called calcium channel
blockers or calcium antagonists.
They work by opening up blood
vessels, which lowers blood pressure
and lets more blood and oxygen
reach the heart. They do not change
the amount of calcium in your blood
or bones.
DILTIAZEM CD capsules are used
to:
•
prevent angina
•
or treat hypertension (high blood
pressure).
Angina is a pain or uncomfortable
sensation in the chest, often
spreading to the arms or neck and
sometimes to the shoulders and back.
The pain of angina is due to a
shortage of oxygen to the heart.
High blood pressure can have many
different causes, including kidney
disease, hardening of the arteries and
some hormone imbalances. However,
the vast majority of people with high
blood pressure have no identifiable
cause for it. If left untreated, high
blood pressure can lead to serious
health problems such as a stroke or
heart attack.
Your
doctor
may
have
prescribed
DILTIAZEM CD for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
DILTIAZEM CD CAPSULES
DILTIAZEM CD 120mg modified release capsules
DILTIAZEM CD 180mg modified release capsules
DILTIAZEM CD 240mg modified release capsules
DILTIAZEM CD 300mg modified release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diltiazem hydrochloride 120mg
Diltiazem hydrochloride 180mg
Diltiazem hydrochloride 240mg
Diltiazem hydrochloride 300mg
EXCIPIENT WITH KNOWN EFFECT:
Gluten: DILTIAZEM CD is gluten free.
Lactose: DILTIAZEM CD is lactose free.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
DILTIAZEM CD 120mg capsules are size 2 gelatin capsules with a light
turquoise body and light turquoise
cap, imprinted APO 120. Each capsule contains 120mg diltiazem
hydrochloride and typically weighs 244mg.
DILTIAZEM CD 180mg capsules are size 1 gelatin capsules with a light
turquoise body and light blue cap,
imprinted APO 180. Each capsule contains 180mg diltiazem hydrochloride
and typically weighs 350mg.
DILTIAZEM CD 240mg capsules are size 0 gelatin capsules with a light
blue body and light blue cap, imprinted
APO 240. Each capsule contains 240mg diltiazem hydrochloride and
typically weighs 460mg.
DILTIAZEM CD 300mg capsules are size 0 elongated capsules with a light
grey body and light blue cap,
imprinted APO 300. Each capsule contains 300mg diltiazem hydrochloride
and typically weighs 562mg.
4
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
DILTIAZEM CD is indicated for the treatment of hypertension either
alone or in combination with other
antihypertensive agents such as diuretics.
DILTIAZEM CD is also indicated for the management of chronic stable
angina and angina resulting from
coronary artery spasm.
2 DOSE AND METHOD OF ADMINISTRATION
Patients controlled on diltiazem alone or in combination with other
medications may be safely switched to
DILTIAZEM CD capsules 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