Dilzem

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Diltiazem hydrochloride 60mg;  ;  ;  ;  

Disponibbli minn:

Douglas Pharmaceuticals Limited

INN (Isem Internazzjonali):

Diltiazem hydrochloride 60 mg

Dożaġġ:

60 mg

Għamla farmaċewtika:

Film coated tablet

Kompożizzjoni:

Active: Diltiazem hydrochloride 60mg         Excipient: Aluminium hydroxide gel Hydrogenated castor oil Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Opadry white Y-1R-7000B Purified talc

Unitajiet fil-pakkett:

Blister pack, 1x30, 30 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Teva API India Ltd

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 1000 tablets - 36 months from date of manufacture stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

1986-11-27

Fuljett ta 'informazzjoni

CONSUMER MEDICINE INFORMATION
1
DILZEM®
_diltiazem hydrochloride _
30 mg and 60 mg tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING DILZEM.
This
leaflet
answers
some
common
questions
about
DILZEM.
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
DILZEM 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 DILZEM IS USED FOR
DILZEM belong to a group of medicines called
calcium channel blockers. DILZEM is used to treat
(long
term)
and
prevent
angina
pectoris.
Diltiazem acts by relaxing the muscles around the
blood
vessels
and
so
relaxes
and
widens
the
blood vessels. This makes it easier for the heart
to do its work and allows more blood to flow to
the heart, relieving angina (chest pain due to an
inadequate blood supply to the heart). DILZEM
also
has
an
effect
on
the
heart
muscle
itself,
helping the heart to slow down and reduce the
amount of work it is doing.
Your
doctor
may
have
prescribed
DILZEM
for
another reason. ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
DILZEM
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE DILZEM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DILZEM IF YOU HAVE AN ALLERGY TO:
•
any
medicine
containing
diltiazem
hydrochloride or a class of medicines called
calcium channel blockers.
•
any of the ingredients listed at the end of this
leaflet. DILZEM tablets contain lactose, if you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicine.
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing.
•
shortness of breath.
•
swelling of the face, tongue, lips, or other
parts

Karatteristiċi tal-prodott

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Dilzem® 30 mg film coated tablets
Dilzem® 60 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diltiazem hydrochloride 30 mg
Diltiazem hydrochloride 60 mg
EXCIPIENT(S) WITH KNOWN EFFECT:
Dilzem tablets contain lactose. For the full list of excipients, _see
section 6.1_.
3.
PHARMACEUTICAL FORM
Dilzem 30 mg tablet: a white, circular, film-coated, biconvex tablet
of approximately 6mm
diameter embossed "D" one side.
Dilzem 60 mg tablet: a white capsule shaped, film-coated tablet, 10mm
in length and 5mm wide;
with a breakline and ‘DL60’ engraved on one face.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Angina pectoris due to coronary artery spasm and chronic stable
angina.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
Initially 30 mg three to four times daily increasing to 240 mg daily
in divided doses. The maximum
recommended dose is 360 mg daily.
_SPECIAL POPULATIONS _
Elderly population
Pharmacokinetics of diltiazem in elderly patients has not been fully
elucidated. Preliminary results
in elderly patients (over 65 years old) suggest that a lower dosage
might be required in this age
group, _see Section 4.4_.
2 | P a g e
Hepatic and renal impairment
Dilzem should be used with caution in patients with hepatic or renal
impairment. If diltiazem must
be used in these patients, the dosage should be carefully and
gradually adjusted depending on
patient tolerability and responses,_ see Section 4.4_.
Concomitant use with other cardiovascular agents
SUBLINGUAL GLYCERYL TRINITRATE may be taken as required to abort acute
anginal attacks during
Dilzem therapy. Diltiazem may be safely co-administered with short-
and long-acting nitrates but
there
have
been
no
controlled
studies
to
evaluate
the
antianginal
effectiveness
of
this
combination.
BETA-BLOCKERS- _see Section 4.4._
ANTIHYPERTENSIVES- Diltiazem has an additive antihypertensive effect
when used with other
antihypertensive agents. Therefore, the dosage of diltiazem or the
concomitant an