Finasteride Sandoz 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FINASTERIDE

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G04CB01

INN (Algemene Internationale Benaming):

FINASTERIDE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; DOCUSAAT NATRIUM ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON (E 1201) ; PROPYLEENGLYCOL (E 1520) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; DOCUSAAT NATRIUM ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON (E 1201) ; PROPYLEENGLYCOL (E 1520) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Finasteride

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); DOCUSAAT NATRIUM; HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON (E 1201); PROPYLEENGLYCOL (E 1520); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2005-04-25

Bijsluiter

Sandoz B.V.
Page 1/4
Finasteride Sandoz
®
5 mg, filmomhulde tabletten
V17
RVG 31778
1.3.1.3 Bijsluiter
Juni 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINASTERIDE SANDOZ
® 5 MG, FILMOMHULDE TABLETTEN
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is used for men to treat and control:
•
BENIGN PROSTATE ENLARGEMENT,
which is a nonaggressive prostate growth.
[nationally completed name] belongs to a group of medicines called
5-alpha reductase inhibitors. It
reduces the size of the prostate gland, improving urinary flow and
other symptoms of prostate
enlargement. [nationally completed name] decreases the risk of
suddenly being unable to pass urine
and needing surgery.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are
ALLERGIC TO FINASTERIDE
or any of the other ingredients of this medicine (listed in section
6)
•
FEMALE
(see also under "Pregnancy and breast-feeding")
•
a
CHILD
under 18 years
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking [nationally completed name].
Inform your doctor if any of the following apply to

Productkenmerken

Sandoz B.V.
Page 1/9
Finasteride Sandoz 5 mg, filmomhulde tabletten
RVG 31778
V15
1.3.1.1 Summary of Product Characteristics
Juni 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride Sandoz 5 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of finasteride.
Excipient with known effect
Each film-coated tablet contains 85.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, round, biconvex, film-coated tablet, plain on both sides.
Diameter approx. 8 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and control of benign prostatic hyperplasia (BPH) to cause
regression of the enlarged
prostate, improve urinary flow and symptoms associated with BPH,
reduce the incidence of acute
urinary retention and reduce need for surgery.
[Nationally completed name] should 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.
Even though improvement can be seen within a short time, treatment for
at least 6 months may be
necessary in order to determine objectively whether a satisfactory
response to treatment has been
achieved.
Dosage in hepatic insufficiency
There are no data available in patients with hepatic insufficiency
(see section 4.4).
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
hemodialysis.
Dosage in older people
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.
_Method of administr