Finasteride 1mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Finasteride

Verfügbar ab:

Relonchem Ltd

ATC-Code:

D11AX10

INN (Internationale Bezeichnung):

Finasteride

Dosierung:

1mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Invalid to prescribe in NHS primary care

Produktbesonderheiten:

BNF: 13090000; GTIN: 5055144201375 5055144201382

Gebrauchsinformation

ARTWORK LEGEND
PRODUCT NAME
PRODUCT LICENCE NO.
COMPONENT
DIMENSION
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY
MANUFACTURER
SOFTWARE
ARTIST
FINASTRIDE 1 MG FILM-COATED TABLETS
20395-0068
Pil
296 x 210 mm
1 mg
Nil
Arial Regular (14.6pt, 9pt)
NA
Comments received from Kulkarni on 21.06.2021.
UK (English)
Steril Gene
Adobe illustrator CC
Gurukiran
NO. OF COLORS
01
██
Black
██ Dieline
1.6
VERSION
XXXXX
DATE
21.06.2021
FINASTERIDE 1MG FILM-COATED TABLETS
FINASTERIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
MALE PATTERN HAIR LOSS
DHT
_HEALTHY HAIR_
_(THICK, ACTIVELY_
_GROWING & _
_FULLY PIGMENTED)_
_PROGRESSIVE HAIR THINNING_
_(THINNER, SHORTER,_
_& LESS PIGMENTED)_
_MALE PATTERN _
_HAIR LOSS_
_NO MALE PATTERN_
_HAIR LOSS_
HOW DOES THE HAIR ON YOUR HEAD GROW?
On average your hair grows about 1
centimetre (half an inch) each month. Hair
grows from hair follicles, which are located
under your skin.
A single scalp hair grows continuously for
2-4 years (growth phase) and then stops
growing for 2-4 months (rest phase). After
this the hair falls out. In its place a new
healthy hair begins to grow, and the cycle is
repeated. The hairs on your scalp are
always in different stages of this cycle so it is
normal to lose scalp hair every day.
WHAT IS MALE PATTERN HAIR LOSS?
Male pattern hair loss is a common
condition in which men experience
thinning of the hair on the scalp, often
resulting in a receding hairline and/or
balding on the top of the head. This
condition is thought to be caused by a
combination of genetic factors and a particular
hormone, DHT (dihydrotestosterone).
DHT causes a decrease in the growth phase
and thinning of the hair (see picture). This
leads to male pattern hair loss. These
changes can start to occur in some men in
their 20s and become more common with
age. Once hair loss has occurred over a long
period of time, the hair may be permanently
lost.
•
Symptoms of an allergic reaction: swelling
of your lips, face, tongue and throat;
difficulty swallowing; lumps under your
ski

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride 1 mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg finasteride.
Excipient(s) with known effect:
Each film-coated tablet contains 95.55 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Round biconvex, reddish brown tablets 7 mm in diameter, marked
“F1”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride is indicated for the treatment of men with male pattern
hair loss
(androgenetic alopecia) to increase hair growth and prevent further
hair
loss.
Finasteride is NOT indicated for use in women or children and
adolescents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral use only
The tablet should be swallowed whole and must not be divided or
crushed (see
section 6.6).
_Androgenetic alopecia _
The recommended dosage is 1 mg daily. Finasteride may be taken with or
without
food.
There is no evidence that an increase in dosage will result in
increased efficacy.
Efficacy and duration of treatment should continuously be assessed by
the
treating physician. Generally, three to six months of once daily
treatment are required
before evidence of stabilisation of hair loss can be expected.
Continuous use is recommended to sustain benefit. If treatment is
stopped, the
beneficial effects begin to reverse by six months and return to
baseline by 9
to12 months.
No data are available on the concomitant use of Finasteride and
topical minoxidil in
male pattern hair loss.
_Use in renal insufficiency _
No adjustment in dosage is required in patients with varying degrees
of renal
insufficiency (creatinine clearances as low as 9 ml/min), as
pharmacokinetic studies
did not indicate any change in the disposition of finasteride.
_Dosage in hepatic insufficiency _
There are no data available in patients with hepatic insufficiency
(see section 4.4).
_Use in the elderly _
No dosage adjustment is required in elderly pati