Adalat Retard 20mg Modified Release Tablets

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

NIFEDIPINE

Sẵn có từ:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

Mã ATC:

C08CA05

INN (Tên quốc tế):

NIFEDIPINE 20 mg

Dạng dược phẩm:

MODIFIED-RELEASE TABLET

Thành phần:

NIFEDIPINE 20 mg

Loại thuốc theo toa:

POM

Khu trị liệu:

CALCIUM CHANNEL BLOCKERS

Tình trạng ủy quyền:

Withdrawn

Ngày ủy quyền:

2006-11-23

Tờ rơi thông tin

PMR 85987860 (H3/01-C/MU-0201710565) Pantone: Black, Orange 021
85987860
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
ADALAT
® RETARD 20 MG
Modified-release tablets
NIFEDIPINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT ADALAT RETARD IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT
RETARD
3
HOW TO TAKE ADALAT RETARD
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ADALAT RETARD
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT ADALAT RETARD IS AND
WHAT IT IS USED FOR
Adalat retard contains nifedipine, which belongs to a
group of medicines called_ calcium antagonists._
ADALAT RETARD IS USED TO TREAT HIGH BLOOD PRESSURE OR
ANGINA (_chest pain_).
For high blood pressure: Adalat retard works by relaxing
and expanding the blood vessels. This makes the blood
flow more easily and lowers blood pressure. Lower blood
pressure reduces the strain on your heart.
For angina: Adalat retard works by relaxing and
expanding the arteries supplying the heart. This allows
more blood and oxygen to reach the heart and decreases
the strain on it. Your angina attacks will be less severe and
less frequent if there is less strain on the heart.
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ADALAT RETARD
DO NOT TAKE ADALAT RETARD:
•
IF YOU HAVE HAD A HEART ATTACK within the last
month.
•
IF YOU GET A SUDDEN ANGINA ATTACK. Adalat retard
will not help relieve symptoms of angina quickly.
•
IF YOU HAVE UNSTABLE ANGINA.
•
IF YOU ARE ALLERGIC to nifedipine, any other similar
medicines (known as_ dihydropyridines_) o

Đặc tính sản phẩm

V023_0
1
1.3.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adalat retard 20 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 20 mg nifedipine.
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablets.
Grey-pink, round, modified-release tablets marked with 1U on one side
and a Bayer cross on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis of chronic stable angina pectoris and the
treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of Adalat retard is 10 mg every 12 hours
swallowed with water with
subsequent titration of dosage according to response. Adalat retard
tablets permit titration of the initial
dosage, which may be adjusted to 40 mg every 12 hours, to a maximum
daily dose of 80 mg.
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).
_Duration of treatment_
_ _
Treatment may be continued indefinitely.
_Additional information on special populations_
_ _
_Paediatric population_
The safety and efficacy of Adalat retard in children below 18 years of
age has not been established.
Currently available data for the use of nifedipine in hypertension are
described in section 5.1
_Older people (>65 years)_
The pharmacokinetics of Adalat retard are altered in the older people
so that lower maintenance doses of
nifedipine may be required
_Patients with hepatic impairment_
Nifedipine is metabolised primarily by the liver and therefore
patients with mild, moderate or severe liver
dysfunction should be carefully monitored and a dose reduction may be
necessary. The pharmacokinetics
of nifedipine has not been investigated in patients with severe
hepatic impairment (see section 4.4 and
5.2).
V023_0
2
1.3.1
2
_Patients with renal impairment_