Finasteride Ascend 5 mg film-coated tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC code:

G04CB01

INN (International Name):

FINASTERIDE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FINASTERIDE 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-09-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE ASCEND 5 MG FILM-COATED TABLETS
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 Finasteride Ascend is and what it is used for
2.
What you need to know before you take Finasteride Ascend
3.
How to take Finasteride Ascend
4.
Possible side effects
5.
How to store Finasteride Ascend
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE ASCEND IS AND WHAT IT IS USED FOR
Finasteride Ascend contains the active substance finasteride. It is a
5α-reductase inhibitor and reduces the
size of an enlarged prostate gland. This medicine is for use in male
patients.
FINASTERIDE ASCEND IS USED
•
to treat benign enlargement of the prostate gland (benign prostatic
hyperplasia – BPH).
•
to reduce the risk of acute urinary retention (inability to
voluntarily pass urine) and BPH-related
surgical procedures in patients with moderate to severe signs of BPH.
This medicine should be used in patients with an enlarged prostate
(volume of about 40 cm
3
or more).
BENIGN ENLARGEMENT OF THE PROSTATE GLAND
BPH is benign enlargement of the prostate gland, which often occurs in
men over 50 years. The prostate is
located at the cross-over point where the bladder leads into the
urethra, which it surrounds. Any
enlargement will therefore lead to problems in urination. The
following symptoms can occur in benign
enlargement of the prostate gland (BPH):
•
Frequent urination, especially at night
•
Sudden urge to urinate
•
Difficulty starting to ur

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride Ascend 5 mg film-coated tablets
Active ingredient: Finasteride
For use in male patients
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 5 mg finasteride.
Excipient with known effect:
Each film coated tablet contains 90.1 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Blue colored, 7 mm round, biconvex, film-coated tablets, marked "F5"
on one side and plain
on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of benign prostatic hyperplasia (BPH).
For reducing the risk of acute urinary retention and BPH-related
surgical procedures in patients
with moderate to severe symptoms of BPH (see section 5.1).
Finasteride Ascend 5 mg tablet should be used in patients with an
enlarged prostate (prostate
volume of approximately 40 cm
3
or more).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One film-coated tablet of 5 mg finasteride per day is recommended.
_Combination therapy with doxazosin _
The following dosage is recommended:
1 film-coated tablet (5 mg finasteride) daily
Doxazosin:
Week 1: 1 mg doxazosin daily
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Week 2: 2 mg doxazosin daily
Week 3: 4 mg doxazosin daily
From week 4: 4 mg or 8 mg doxazosin daily
Dose titration to at least 4 mg doxazosin daily is required to
significantly reduce the risk of
clinical progression of BPH (MTOPS study, see section 5.1).
_Hepatic impairment _
To date, no information is available regarding the use of finasteride
in patients with impaired
hepatic function.
_Renal impairment _
Pharmacokinetic studies have shown that no dose adjustment is required
when creatinine
clearance is above 9 ml/min/1.73 m
2
. No information is available regarding the use of
finasteride in patients requiring dialysis.
_Elderly _
Elimination of finasteride is slightly reduced in patients over 70
years of age. However, no dose
adjustment is required.
Method of administration
Finasteride Ascen