Finasteride Aristo 5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FINASTERIDE 5 mg/stuk

INN (Algemene Internationale Benaming):

FINASTERIDE 5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; DOCUSAAT NATRIUM ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2023-06-13

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE ARISTO 5 MG FILM-COATED TABETS
Finasteride
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Finasteride Aristo is and what it is used for
2.
What you need to know before you take Finasteride Aristo
3.
How to take Finasteride Aristo
4.
Possible side effects
5.
How to store Finasteride Aristo
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE ARISTO IS AND WHAT IT IS USED FOR
Finasteride belongs to the group of medicines called 5-alpha reductase
inhibitors.
They act by reducing the size of the prostate gland in men.
Finasteride Aristo is used in the treatment and control of benign (i.
e., non-cancerous) enlargement of the
prostate (benign prostatic hyperplasia - BPH). It reduces the risk of
you developing a sudden inability to pass
urine (known as acute urinary retention) and the need for surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE ARISTO
DO NOT TAKE FINASTERIDE ARISTO
-
if you are pregnant or may become pregnant (see also under
‘Pregnancy and breast-feeding’);
-
if you are allergic to finasteride or any of the other ingredients of
this medicine (listed in section 6).
Finasteride must not be used by women or children.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Finasteride
Aristo.
Tell your doctor:
-
If you have or have had a large amount of residual urine in your
bladder after urinating and/or
severely reduced urinary flow, you should be closely monitored for
narr

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride Aristo 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of finasteride.
Excipient with known effect
:
Contains 80 mg
lactose (as lactose monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue colour, round shaped film coated tablets with a diameter of 6.5
mm, debossed with ‘H’ on one side and
‘37’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride is indicated for the treatment and control of benign
prostatic hyperplasia (BPH). To reduce the
incidence of acute urinary retention and reduce need for surgery
including transurethral resection of the
prostate (TURP) and prostatectomy. Finasteride should only be
administered in patients with an enlarged
prostate (prostate volume above ca. 40 ml).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 5 mg tablet daily with or without food.
Finasteride can be administered alone or in combination with the
alpha-blocker-doxazosin (see section 5.1).
_ _
_Dosage in the elderly _
_ _
Dosage adjustments are not necessary although pharmacokinetic studies
have shown that the elimination rate
of finasteride is slightly decreased in patients over the age of 70.
_Dosage in hepatic insufficiency _
_ _
There are no data available in patients with hepatic insufficiency
(See section 4.4).
Text Specification ARI FI 1357000-01/Common/0723
FINASTERIDE ARISTO 5 MG FILM-COATED TABLET
Wording for Summary of Product Characteristics
2
_Dosage in renal insufficiency _
_ _
Dosage adjustments are not necessary in patients with varying degrees
of renal insufficiency (starting from
creatinine clearance as low as 9 ml/min) as in pharmacokinetic studies
renal insufficiency was not found to
affect the elimination of finasteride. Finasteride has not been
studied in patients on haemodialysis.
_Paediatric population _
_ _
Finasteride is not indic