ALDACTONE 25 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

SPIRONOLACTONE

Beschikbaar vanaf:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-code:

C03DA01

farmaceutische vorm:

COATED TABLETS

Samenstelling:

SPIRONOLACTONE 25 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

PFIZER INC, USA

Therapeutische categorie:

SPIRONOLACTONE

Therapeutisch gebied:

SPIRONOLACTONE

therapeutische indicaties:

Congestive heart failure, cirrhotic ascites.

Autorisatie datum:

2022-07-31

Bijsluiter

.مقافتت دق كتلاحف ،يغبني امم ركبأ
ءاودلا لوانت نع تفقوت اذإ .نسحتب رعشت يئاودلا رادقملا نم دكأتلاو ءاودلا
عباط صيخشت بجي !ةمتعلا يف ةيودلأا
لوانت زوجي لا
.اهيلا ةجاحب تنك اذإ ةيبطلا تاراظنلا
عض .ءاود اهيف لوانتت ةرم لك يف
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ .
ةيبناجلا ضارعلأا
لا .نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ ببسي دق نوتكادلأ لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت
دعب ةيلاتلا ةيبناجلا ضارعلأا ىدحإ نم
يناعت تنك اذإ بيبطلا ىلإ
ً
لااح هجوتلا بجي
:ةريطخ نوكت دق ضارعلأا نإف ،ةردان
ضارعلأا هذه نأ نم مغرلا ىلع .ءاودلا
لوانت
•
رمحأ رشتنم حفط ،مسجلا يقاب يفو نيتفشلا
لوح نم دلجلا يف تلاصيوح روهظو ةكح
(نوسنوج - سنڤيتس ةمزلاتم) تلاصيوح لكشتو
يجسفنب وأ
•
رشقت) مسجلا لماك يف ،دلجلا نم ىلفسلا
تاقبطلا نع دلجلل ةيولعلا ةقبطلا
لاصفنإ
(toxic epidermal necrolysis ،يممستلا ةيورشبلا
ةتومتملا ةجسنلأا
•
يئاود لعافت -ةروطخ رثكأ ةلاحل اضارعأ
نوكت دق يتلا) خافتنإو ةنوخس ،يدلج حفط
،ةيزاهجلا ضارعلأاو تاضمحلا ةرثك عم
.(Drug Reaction with Eosinophilia and Systemic Symptoms
•
(ناقري) رفصلأاب نينيعلاو دلجلا نولت
•
دبكلا فئاظوب ءاودلا رضي دق
•
نادقف) للش ،زخوب روعش ،ةايحلا ىلع
ً
ارطخ لكشي دق يذ�

Productkenmerken

Aldactone 25mg, LPD, CC 270222
2021-0073945
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aldactone
®
25mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 25mg spironolactone
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Aldactone 25mg tablets are round buff, film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Congestive heart failure
•
Cirrhotic ascites
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Aldactone once daily with a meal is recommended.
Children should only be treated under guidance of a paediatric
specialist. There is limited
paediatric data available (see sections 5.1 and 5.2).
POSOLOGY
ADULTS CONGESTIVE CARDIAC FAILURE WITH OEDEMA
For management of oedema an initial daily dose of 100 mg of
spironolactone administered in
either single or divided doses is recommended, but may range from 25
mg to 200 mg daily.
Maintenance dose should be individually determined.
SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS III-IV)
Based on the Randomized Aldactone Evaluation Study (RALES: see also
section 5.1),
treatment in conjunction with standard therapy should be initiated at
a dose of spironolactone 25
mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine
is ≤2.5 mg/dL. Patients
who tolerate 25 mg once daily may have their dose increased to 50 mg
once daily as clinically
indicated. Patients who do not tolerate 25 mg once daily may have
their dose reduced to 25 mg
every other day. See section 4.4
for advice on monitoring serum potassium and serum
creatinine.
HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA
Aldactone 25mg, LPD, CC 270222
2021-0073945
Page 2 of 8
If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio
is less than 1.0, 200 mg/day to
400 mg/day. Maintenance dosage should be individually determined.
ELDERLY
It is recommended that treatment is started with the lowest dose and
titrated upwards as required
to achieve maximum benefit. Care should b