IMDUR 60MG PROLONGED RELEASE TABLETS

Quốc gia: Síp

Ngôn ngữ: Tiếng Hy Lạp

Nguồn: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Thành phần hoạt chất:

ISOSORBIDE MONONITRATE

Sẵn có từ:

TOPRIDGE PHARMA (IRELAND) LIMITED (0000010452) 6-9 TRINITY STREET, DUBLIN 2, D02EY47

Mã ATC:

C01DA14

INN (Tên quốc tế):

ISOSORBIDE MONONITRATE

Liều dùng:

60MG

Dạng dược phẩm:

PROLONGED RELEASE TABLETS

Thành phần:

ISOSORBIDE MONONITRATE (0016051777) 60MG

Tuyến hành chính:

ORAL USE

Loại thuốc theo toa:

Εθνική Διαδικασία

Khu trị liệu:

ISOSORBIDE MONONITRATE

Tóm tắt sản phẩm:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (880027902) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Tờ rơi thông tin

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ
IMDUR DURULES 60 MG
PATIENT INFORMATION LEAFLET
IMDUR DURULES 60 MG
ΔΙΑΒΆΣΤΕ ΜΕ ΠΡΟΣΟΧΉ ΑΥΤΌ ΤΟ ΦΥΛΛΆΔΙΟ
ΠΡΙΝ ΠΆΡΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ.

Φυλάξτε αυτό το φυλλάδιο. Ίσως
χρειαστεί να το διαβάσετε ξανά.

Αν έχετε άλλες απορίες, ρωτήστε το
γιατρό ή το φαρμακοποιό σας.

Αυτό το φάρμακο έχει συνταγογραφηθεί
για σας προσωπικά και δεν
πρέπει να το δώσετε σε άλλους. Μπορεί
να τους προκαλέσει βλάβη,
ακόμα και αν έχουν τα ίδια συμπτώματα
με εσάς.
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 further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not
pass it on to others. It may harm them, even if their symptoms are the
same as yours.
ΜΕ ΤΟ ΠΑΡΌΝ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΘΑ
ΕΝΗΜΕΡΩΘΕΊΤΕ ΓΙΑ ΤΑ ΑΚΌΛΟΥΘΑ
1.
Τι είναι το Imdur Durules και ποιά είναι η
χρήση του
2.
Τι πρέπει να γνωρίζετε προτού πάρετε
το Imdur Durules
3.
Πώς να πάρετε το Imdur Durules
4.
Πιθανές παρενέργειες
5.
Φύλαξη του Imdur Durules
6.
Άλλες πληροφορίες
IN THIS LEAFLET
1.
What Imdur Durules is and what it is used for
2.
Before you take Imdur Durules
3.
How to take Imdur Durules
4.
Possible side effects
5.
Storing Imdur Durules
6.
Further information
Το δραστικό συστατικό είναι το
isosorbide-5-mononitrate.
Τα άλλα συστατικά είναι: sodium aluminium
silicate, paraffin,
hydroxypropyl cellulose, magnesium stearate, colloidal silicon
dioxide,
h

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imdur® 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains isosorbide-5-mononitrate 60 mg in a prolonged
release formulation
- Durules®. For excipients see ”List of excipients”.
3.
PHARMACEUTICAL FORM
Imdur Durules 60 mg is yellow, oval, scored, marked A/ID, 7 x 13 mm.
The Durules formulation provides gradual release of the active
ingredient over a long
period of time. The plastic matrix in Imdur Durules is completely
inert in the digestive
juice but generally disintegrates under the influence of intestinal
peristalsis when all
active ingredient has been released.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
60 mg once daily to be taken in the morning. The dose may be increased
to 120 mg
daily, taken once daily in the morning. The dose can be titrated to
minimize the
possibility of headache by initiating treatment with 30 mg for the
first 2-4 days. The
tablets can be taken with or without food.
The 60mg depottablets are scored and dividable. The whole tablets or
if needed the
divided halves, should not be chewed or crushed and should be
swallowed together with
half a glass of fluid. Imdur is not indicated for the relief of acute
attacks. In these
situations sublingual or buccal nitroglycerine tablets or spray
formulations should be
used.
Children
The safety and efficacy of Imdur in children has not been established.
Elderly
No evidence of a need for routine dosage adjustment in the elderly has
been found, but
special care may be needed in those with increased susceptibility to
hypotension or
marked hepatic or renal insufficiency.
- 1 -
The matrix of the tablet is insoluble but disintegrates when the
active substance is
released. Occasionally the matrix may pass through the
gastrointestinal tract without
disintegrating and may be visible in the stool but this does not
indicate that the drug has
had a reduced effect.
4.3 CONTRAINDICA