Adefin XL
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
27-06-2019
Active ingredient:
Nifedipine 60mg (plus a 10% overage)
Available from:
Viatris Limited
INN (International Name):
Nifedipine 60 mg (plus a 10% overage)
Dosage:
60 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Nifedipine 60mg (plus a 10% overage) Excipient: Cellulose acetate Hypromellose Iron oxide red Macrogol 3350 Magnesium stearate Opacode black S-1-17823 Opadry pink OY-S-24914 Polyethylene oxide Sodium chloride
Units in package:
Blister pack, PA/Al/PVC (Alu/Alu), 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Therapeutic indications:
For the treatment of coronary heart disease.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVdC or PA/Al/PVC (Alu/Alu) - 30 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PP or PVC/Aclar blisters with aluminium foil - 30 tablets - 60 months from date of manufacture stored at or below 30°C
Authorization date:
2005-11-11
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ADEFIN XL
_NIFEDIPINE 30 MG & 60 MG MODIFIED RELEASE TABLETS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using ADEFIN XL.
This leaflet answers some common
questions about ADEFIN XL.
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 ADEFIN XL
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 ADEFIN XL IS
USED FOR
ADEFIN XL is used either to treat
high blood pressure or to prevent
chronic stable angina, one of a
number of types of angina.
ADEFIN XL IS NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF
ANGINA.
ADEFIN XL contains the active
substance nifedipine which 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.
Your doctor may have prescribed
ADEFIN XL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADEFIN XL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU USE
ADEFIN XL
_WHEN YOU MUST NOT USE_
_IT_
Do not use ADEFIN XL if you have
an allergy to:
nifedipine, the active
ingredient in ADEFIN XL
any of the ingredients listed
at the end of this leaflet
active substances similar to
nifedipine such as:
amlodipine, felodipine,
lercanidipine, nimodipine
and isradipine
Some of the symptoms of an
allergic reaction may include:
shortness of breath, wheezing or
difficulty breathing, swelling of the
face, lips, tongue or other parts of
the body, and rash, itching or hives
on the skin.
DO NOT USE ADEFIN XL IF YOU ARE
PREGNANT OR PLAN TO BECOME
PREGNANT.
It may affect your developing baby if
you take i
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Summary of Product characteristics
Page 1 of 15
NEW ZEALAND DATA SHEET
ADEFIN XL
1. PRODUCT NAME
ADEFIN XL, 30 mg and 60 mg modified release tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ADEFIN XL 30 mg modified release tablet contains 30 mg of
nifedipine.
Each ADEFIN XL 60 mg modified release tablet contains 60 mg of
nifedipine.
_EXCIPIENTS WITH KNOWN EFFECT:_
Each ADEFIN XL 30 mg modified release tablet
contains 23.9 mg sodium chloride, see section
4.4.
Each ADEFIN XL 60 mg modified release tablet
contains 47.8 mg sodium chloride, see section
4.4.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ADEFIN XL 30 mg tablet: Round, pink, biconvex coated tablet marked
with “30” on one side.
ADEFIN XL 60 mg tablet: Round, pink, biconvex coated tablet marked
with “60” on one side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Treatment of coronary heart disease.
Chronic stable angina pectoris (angina of effort).
Treatment of hypertension.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
As far as possible the treatment must be tailored to the needs of the
individual.
DOSE
Depending on the clinical picture in each case, the basic dose must be
introduced gradually.
Unless otherwise prescribed, the following dosage guidelines are
recommended for adults:
FOR CORONARY HEART DISEASE:
CHRONIC STABLE ANGINA PECTORIS
One ADEFIN XL 30 tablet once daily
Page 2 of 15
(ANGINA OF EFFORT)
(1 x 30 mg/day)
One ADEFIN XL 60 tablet once daily
(1 x 60 mg/day)
FOR HYPERTENSION:
One ADEFIN XL 30 tablet once daily
(1 x 30 mg/day)
One ADEFIN XL 60 tablet once daily
(1 x 60 mg/day)
In general, therapy should be initiated with 30 mg once daily.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may
result in the recommendation
to adapt the nifedipine dose or not to use nifedipine at all (see
section 4.5).
The attending doctor will determine the duration of use.
_SPECIAL POPULATIONS_
ELDERLY
Based on the pharmacokinetic data for nifedipine, no dose adaptation
in elderly people above
65 years is necessary.
RENAL IMP
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