Adalat LA 30mg Prolonged-Release Tablets

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

NIFEDIPINE

Sẵn có từ:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

Mã ATC:

C08CA05

INN (Tên quốc tế):

NIFEDIPINE 30 mg

Dạng dược phẩm:

PROLONGED-RELEASE TABLET

Thành phần:

NIFEDIPINE 30 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Withdrawn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 85620355 (SF/00-C) Pantone: Black, 021
PACKAGE LEAFLET - INFORMATION FOR THE USER
0
ADALAT
® LA 30 MG
PROLONGED RELEASE TABLETS
nifedipine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms
are
the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1
WHAT ADALAT LA IS
2
BEFORE YOU TAKE ADALAT LA
3
HOW YOU TAKE ADALAT LA
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ADALAT LA
6
FURTHER INFORMATION
1
WHAT ADALAT LA IS
Adalat LA contains nifedipine, which belongs to a group of medicines
called_ calcium antagonists._
ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA_ (chest
pain)._
For high blood pressure: Adalat LA 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 LA 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
BEFORE YOU TAKE ADALAT LA
DO NOT TAKE ADALAT LA:
•
IF YOU HAVE HAD A HEART ATTACK within the last month.
•
IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA will not help relieve
symptoms of angina quickly.
•
IF YOU HAVE UNSTABLE ANGINA.
•
IF YOU ARE ALLERGIC to the active ingredient (nifedipine), to any
other
similar medicines (known as_ dihydropyridines)_ or to any of the
other ingredients. The ingredients of Adalat LA are listed in section
6.
•
IF YOU ARE TAKING RIFAMPICIN, an antibiotic.
•
IF YOU HAVE A LIVER DISEASE that prevents your liver from working
properly.
•
IF YOU HAVE INFLAMMATION OF

Đặc tính sản phẩm

Bayer Limited
Adalat LA 30 mg
February 2020
20010
1 of 16
1. NAME OF THE MEDICINAL PRODUCT
Adalat LA 30 mg Prolonged-Release Tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 30 mg nifedipine.
Each tablet contains 9.4 mg sodium.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
Pink, circular convex tablets with Adalat 30 marked on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of all grades of hypertension.
For the management of chronic stable angina pectoris either as
monotherapy or in combination
with a beta-blocker.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
ORAL USE
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)
1 Adalat LA 30 mg tablet once daily (1 x 30 mg/day)
•
For
HYPERTENSION:
1 Adalat LA 30 mg tablet once daily (1 x 30 mg/day)
In general therapy should be initiated with 30 mg once daily.
Bayer Limited
Adalat LA 30 mg
February 2020
20010
2 of 16
Where registered a starting dose of 20 mg once daily may be considered
when medically indicated.
Interim doses i.e. 40 mg, 50 mg etc. can be applied by combinations of
i.e. 20 mg + 20 mg or 20 mg
+ 30 mg tablets.
Depending on the severity of the disease and the patient's response
the dose can be increased in
stages up to 90 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 "Interaction with _
_other medicinal products other forms of interaction")_
.
_ _
_Duration of Treatment _
The attending doctor will determine the duration of use.
_Administration _
As a rule Adalat LA tablets are swallowed whole with a l