ADEFIN 10 nifedipine 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nifedipine

Available from:

Alphapharm Pty Ltd

Authorization status:

Registered

Patient Information leaflet

ADEFIN 10
ADEFIN 20
_nifedipine tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Adefin 10 and
Adefin 20 tablets (described below as
Adefin tablets).
It does not take the place of talking to
your doctor or pharmacist.
This leaflet is for Adefin tablets. It is
different from the leaflet for another
form of Adefin known as Adefin XL.
It is not to be used in relation to any
other product, which may also
contain the same active ingredient.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Adefin against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ADEFIN IS USED
FOR
Adefin tablets are used either to treat
high blood pressure or to prevent
chronic stable angina (chest pain).
ADEFIN TABLETS ARE NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF ANGINA
OR TO MANAGE UNSTABLE ANGINA.
Adefin tablets contain the active
substance nifedipine that belongs to a
group of medicines called calcium
channel blockers. They 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 ADEFIN HAVE
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Adefin for another reason.
Adefin is available only with a
doctor's prescription.
BEFORE YOU TAKE
ADEFIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ADEFIN IF YOU ARE
ALLERGIC TO:
•
medicines containing nifedipine
(eg. in Adalat, Adefin XL)
•
medicines similar to nifedipine
such as amlodipine (Norvasc),
felodipine (eg. Plendil, Felodur),
lercanidipine (Zanidip),
nimodipine (Nimotop)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Skin rash, itching or hives
•
Swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing
•
Wheez

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ADEFIN 10
ADEFIN 20
_Nifedipine tablets _
1
NAME OF THE MEDICINE
Nifedipine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADEFIN (nifedipine) 10 or 20 is a calcium ion influx inhibitor
(Calcium channel blocker or calcium
antagonist).
ADEFIN tablets contain micronised nifedipine 10 mg or 20 mg as the
active ingredient.
Excipients with known effect: ADEFIN tablets contain trace quantities
of lactose and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ADEFIN 10
:
Pink-grey biconvex lacquered tablets, one side marked “A 10”, the
reverse side is blank, each containing 10 mg nifedipine.
ADEFIN 20
:
Pink-grey lacquered tablets, one side marked “1 U”, the reverse
side with the
Bayer cross; 6mm diameter each containing 20 mg nifedipine.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADEFIN 10 and 20 are indicated for:
1.
the management of chronic stable angina pectoris and vasospastic
angina pectoris (Prinzmetal’s
angina, variant angina) due to coronary heart disease
2.
the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
should
be
individualised
depending
on
severity
of
disease,
patient's
tolerance
and
responsiveness to ADEFIN (nifedipine) 10 or 20 and to concurrent
antihypertensive medications (see
Section
4.5
INTERACTIONS
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 to 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.
Adefin 10 and Adefin 20 – PRODUCT INFORMATION
2
Due to its pronounced anti-ischaemic and antihypertensive action,
ADEFIN should be discontinued