Adalat 10mg Soft capsules

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 10 mg

Dạng dược phẩm:

SOFT CAPSULE

Thành phần:

NIFEDIPINE 10 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Withdrawn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 86015161 (AB/00-C/MU-201711970) Pantone: Black, Orange 021
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
ADALAT
® 10 MG
Soft capsules
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 CAPSULES ARE AND WHAT THEY ARE
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT
CAPSULES
3
HOW TO TAKE ADALAT CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ADALAT CAPSULES
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT ADALAT CAPSULES ARE AND WHAT
THEY ARE USED FOR
Adalat capsules contain nifedipine, which belongs to a group of
medicines
called_ calcium antagonists._
ADALAT CAPSULES ARE USED TO TREAT HIGH BLOOD PRESSURE, ANGINA_ (chest_
_pain)_ OR A CONDITION CALLED_ RAYNAUD’S PHENOMENON_ which causes
discolouration (often whitening) of the fingers and toes.
For high blood pressure: Adalat capsules work 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 capsules work 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.
Adalat capsules can increase the risk of serious heart problems in
patients
with high blood pressure or angina. Because of this, Adalat capsules
are
only used in these patients if no other treatments are appropriate.
For Raynaud’s phenomenon: Adalat capsules

Đặc tính sản phẩm

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Page 1 of 13
1.3.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adalat 10 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg nifedipine.
Excipient with known effect: Yellow orange S (E110)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
Orange, softgel capsule (6 minims, oblong) containing a yellow viscous
fluid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis of chronic stable angina pectoris, the treatment
of Raynaud's
phenomenon and essential hypertension.
For patients suffering from essential hypertension or chronic stable
angina pectoris,
and treated with fast release forms of nifedipine (Adalat capsules), a
dose dependent
increase in the risk of cardiovascular complications (e.g., myocardial
infarction) and
mortality may occur. Due to this, Adalat capsules should only be used
for treatment of
patients with essential hypertension or chronic stable angina pectoris
if no other
treatment is appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_ _
The maximum total daily dose is 60 mg. The recommended starting dose
is 5 mg
every eight hours with subsequent titration of dose according to
response permitting
an increase to a maximum of 20 mg every eight hours.
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_
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Page 2 of 13
1.3.1
2
Treatment may be continued indefinitely.
_Additional information for special populations _
_Paediatric population_
The safety and efficacy of Adalat capsules 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 capsules are altered in the older
people so that lower
maintenance doses of nifedipine may be required.
_Patients with