Diltiazem CD

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Diltiazem hydrochloride 240.1mg

MAH:

Clinect NZ Pty Limited

INN:

Diltiazem hydrochloride 240.1 mg

dosage:

240 mg

pharmaceutical_form:

Modified release capsule

composition:

Active: Diltiazem hydrochloride 240.1mg 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_indication:

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

leaflet_short:

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

PIL

New Zealand Consumer Medicine Information
APO-DILTIAZEM CD
_DILTIAZEM HYDROCHLORIDE _
120mg, 180mg, 240mg and 300mg capsules
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Diltiazem CD.
This leaflet answers some common questions about Apo-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 using
Apo-Diltiazem CD against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-DILTIAZEM CD IS USED FOR
Apo-Diltiazem
CD
contains
the
active
ingredient
diltiazem
hydrochloride.
Apo-
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.
Apo- 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,
2
high blood pressure can lead to serious health problems such as a
stroke or heart
attack.
Your doctor may have prescribed Apo-Diltiazem CD for another reason.
Ask your doctor if you have any questions about wh

SPC

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