Adalat 10
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
22-06-2012
Summary of Product characteristics
(SPC)
04-01-2021
Active ingredient:
Nifedipine 10mg
Available from:
Bayer New Zealand Limited
INN (International Name):
Nifedipine 10 mg
Dosage:
10 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Nifedipine 10mg Excipient: Hypromellose Iron oxide red Lactose monohydrate Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Polysorbate 80 Titanium dioxide
Units in package:
Blister pack, PA/Al/PVC, PVC/PVDC/Al or PP/Al, 60 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Therapeutic indications:
Indicated for treatment of coronary heart disease, chronic stable angina pectoris (angina of effort) and hypertension.
Product summary:
Package - Contents - Shelf Life: Blister pack, PA/Al/PVC, PVC/PVDC/Al or PP/Al - 60 tablets - 48 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
1984-12-20
Patient Information leaflet
New Zealand Consumer Medicine Information
121107AdalatNZCMI
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
is different from the leaflet for
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
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.
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, tongue
or other parts of the body
rash, itching or hives
Read the complete document
Summary of Product characteristics
190214 Adalat DS
Page 1 of 16
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ADALAT 10 (nifedipine) modified release tablets
ADALAT 20 (nifedipine) modified release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ADALAT 10 modified release tablet contains 10 mg nifedipine
Each ADALAT 20 modified release tablet contains 20 mg nifedipine
3
PHARMACEUTICAL FORM
Tablet: Round to convex, grey-pink coated
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
Dose
As far as possible the treatment must be tailored to the needs of the
individual according to the
severity of the disease and the patient's response.
Depending on the clinical picture in each case, the basic dose must be
introduced gradually. In
patients with mild, moderate or severe impaired liver function,
careful monitoring and a dose
reduction may be necessary. The pharmacokinetics of nifedipine has not
been investigated in patients
with severe hepatic impairment (see Special warnings and precautions
for use and Pharmacokinetic
properties).
ADALAT 10 is particularly suitable for dose titration. Dose titration
is recommended for hypertensives
with severe cerebrovascular disease and for patients who, because of
low body weight or multiple
therapies with other antihypertensive drugs, are likely to have an
excessive reaction to nifedipine. In
addition, for patients who experience adverse effects in response to
the nifedipine treatment, a finer
dose adjustment is desirable and should be individually stabilised
with ADALAT 10.
Unless otherwise prescribed, the following dosage guidelines apply for
adults:
In Coronary Heart Disease:
Chronic stable angina pectoris
One ADALAT 10 tablet twice daily
(angina of effort)
(2 x 10 mg/day)
One ADALAT 20 tablet twice daily
190214 Adalat DS
Page 2 of 16
(2 x 20 mg/day)
If higher dosages are necessary, the dose can be increased in stages
up to maximum
60 mg daily.
In Hype
Read the complete document
