Adalat nifedipine 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nifedipine

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

Adalat® CMI vX1.0
1
ADALAT
®
(ADD·A·LAT)
_nifedipine _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Adalat tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet is for Adalat tablets. It
work by opening up blood vessels
in the body to lower blood pressure
and improve the supply of blood
and oxygen to the heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
It may affect your developing baby
if you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
The active ingredient in Adalat
passes into breast milk and there is
a possibility that your baby may be
affected.
DO NOT TAKE THIS MEDICINE AFTER
is different from the leaflet for
THE EXPIRY DATE PRINTED ON THE
another form of Adalat known as
Adalat Oros.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Adalat
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 ADALAT IS
USED FOR
Adalat tablets are used either to
treat high blood pressure or to
manage a type of angina (chest
pain), known as chronic stable
angina.
ADALAT TABLETS ARE NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF ANGINA
OR TO MANAGE UNSTABLE ANGINA
.
Adalat tablets contain the active
substance nifedipine which belongs
to a group of medicines called
calcium channel blockers. They
BEFORE YOU TAKE
ADALAT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADALAT IF YOU HAVE AN
ALLERGY TO:
•
nifedipine, the active ingredient
in Adalat
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, t

Summary of Product characteristics

ADALAT® PI VX1.0, CCDS23
1
AUSTRALIAN PRODUCT INFORMATION
ADALAT
 10, ADALAT
 20 (NIFEDIPINE) TABLETS
1
NAME OF THE MEDICINE
Nifedipine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADALAT tablets are round, pink-grey, film-coated tablets containing
micronised nifedipine
10 mg or 20 mg.
EXCIPIENTS WITH KNOWN EFFECT:
Contains lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
ADALAT tablets are film-coated tablets.
ADALAT 10:
Pink-grey biconvex lacquered tablets, one side marked A10, each
containing
10 mg nifedipine.
ADALAT 20:
Pink-grey biconvex lacquered tablets, one side marked 1U, the reverse
side
with the Bayer cross, each containing 20 mg nifedipine.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ADALAT 10 and 20 are indicated for:
i.
the management of chronic stable angina pectoris and vasospastic
angina pectoris
(Prinzmetal’s angina, variant angina) due to coronary heart disease.
ii.
the treatment of hypertension.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage should be individualised depending on severity of disease,
patient's tolerance and
responsiveness to Adalat (nifedipine) 10 or 20 and to concurrent
antihypertensive
medications (see Section 4.5 Interaction with Other Medicines and
other forms of
interactions).
Depending on the clinical picture in each case, the basic dose must be
introduced gradually.
The recommended initial dose is 10-20 mg twice daily swallowed with a
little fluid, with or
without food. The tablets must not be chewed or broken up. Grapefruit
juice is to be avoided.
The usual adult dose is 20 mg twice daily. If required, the dose may
be increased up to 40 mg
twice daily. The maximum daily dose of 80 mg should not be exceeded.
The recommended
dose interval is about 12 hours.
Due
to
its
pronounced
anti-ischaemic
and
antihypertensive
action,
Adalat
should
be
discontinued gradually, particularly when high doses are used.
ADALAT® PI VX1.0, CCDS23
2
Adalat 10 tablets permit dosage titration. Dose titration is
particular