Adalat Oros
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
29-03-2012
Summary of Product characteristics
(SPC)
29-03-2012
Active ingredient:
Nifedipine 20mg (Plus 10% overage)
Available from:
Bayer New Zealand Limited
INN (International Name):
Nifedipine 20 mg (Plus 10% overage)
Dosage:
20 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Nifedipine 20mg (Plus 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, PP blister with Al foil, 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Therapeutic indications:
Treatment of coronary heart disease
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVdC or PA/Al/PVC (Alu/Alu) - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PP blister with Al foil - 30 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1970-01-01
Patient Information leaflet
New Zealand Consumer Medicine Information
131112AdalatOrosNZCMI
1
ADALAT
® OROS
(ADD·A·LAT OR·US)
_nifedipine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Adalat Oros. 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 Oros. It is
different from the leaflet for other
forms of Adalat products.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Adalat Oros
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 OROS
IS USED FOR
Adalat Oros is used either to treat
high blood pressure or to prevent a
type of angina (chest pain), known
as chronic stable angina.
ADALAT OROS IS NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF
ANGINA OR TO MANAGE UNSTABLE
ANGINA
.
Adalat Oros 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.
Adalat Oros is specially designed
to allow the slow release of the
active substance from the tablet
after it is taken. It is composed of a
strong outer shell which does not
dissolve in the body and is
excreted in the faeces. It is normal
to find these “ghost-tablets” in the
faeces. The active substance
contained in them has been
absorbed by the body before
excretion.
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.
BEFORE YOU TAKE
ADALAT OROS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADALAT OROS IF YOU
HAVE AN ALLERGY TO:
•
nifedipine, the active
ingredient in Adalat Oros
•
any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
a
Read the complete document
Summary of Product characteristics
170626 Adalat OROS DS
Page 1 of 19
DATA SHEET
1.
ADALAT OROS
® (30 MG, 60 MG MODIFIED RELEASE TABLET)
Adalat OROS nifedipine 30 mg modified release tablets
Adalat OROS nifedipine 60 mg modified release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Adalat OROS 30 modified release tablet contains 30 mg nifedipine
Each Adalat OROS 60 modified release tablet contains 60 mg nifedipine
EXCIPIENTS WITH KNOWN EFFECT
Each Adalat OROS 30 modified release tablet contains 23.9 mg sodium
chloride, see Section
4.4.
Each Adalat OROS 60 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
Round, convex extended release tablet, with pink coat, laser hole on
one side.
4.
CLINICAL PARICULARS
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.
4.2.1
DOSE
As far as possible the treatment must be tailored to the needs of the
individual.
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 (angina of effort)
170626 Adalat OROS DS
Page 2 of 19
One Adalat OROS 30 tablet once daily (1 x 30 mg/day)
One Adalat OROS 60 tablet once daily (1 x 60 mg/day)
For hypertension:
One Adalat OROS 30 tablet once daily (1 x 30 mg/day)
One Adalat OROS 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 Adalat OROS dose or not to use Adalat OROS
at all (see Section
4.5).
The attending doctor will determine the duration of use.
4.2.1.1
SPECIAL POPULATIONS
4.2.1.1.1
ELDERLY
Based on the pharmacokinetic data for Adalat OROS, no dose adaptation
in elderly people
above 65 years
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