Finasteride 1mg Film-coated Tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

FINASTERIDE

Dostopno od:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Koda artikla:

D11AX10

INN (mednarodno ime):

FINASTERIDE 1 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

FINASTERIDE 1 mg

Tip zastaranja:

POM

Terapevtsko območje:

OTHER DERMATOLOGICAL PREPARATIONS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2011-04-01

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 1 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 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 1 mg Tablets are and what they are used for
2. What you need to know before you take Finasteride 1 mg Tablets
3. How to take Finasteride 1 mg Tablets
4. Possible side effects
5. How to store Finasteride 1 mg Tablets
6. Contents of the pack and other information
1. WHAT FINASTERIDE 1 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Finasteride 1 mg Tablets contain finasteride. Finasteride belongs to
the group of medicines called 5-
alpha reductase inhibitors.
Your doctor has prescribed Finasteride 1 mg Tablets because you have
male pattern hair loss (also
known as androgenetic alopecia). Finasteride 1 mg Tablets prevent
further hair loss in men. Men
with mild to moderate, but not complete hair loss, can benefit from
using Finasteride 1 mg Tablets.
Finasteride 1 mg Tablets block an important enzyme (Type II
5α-reductase), which is involved in
the regulation of the hair follicle.
In the scalp, Finasteride 1 mg Tablets specifically lower the levels
of DHT, a major cause of male
pattern hair loss. In this way, Finasteride 1 mg Tablets help to
reverse the balding process and
prevent further hair loss.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE 1 MG TABLETS
DO NOT TAKE FINASTERIDE 1 MG TABLETS:
•
If you are allergic to finasteride or any of the other ingredients of
this medicine (listed in Section
6).
•
If you are a child or adole

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride 1 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1 mg of Finasteride.
Excipient(s): Lactose monohydrate 95.58 mg.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Reddish brown, round, biconvex, film coated tablets, marked ‘F1’
on one side and plain on
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride 1 mg is indicated for treatment of the first stage of the
hair loss (androgenetic
alopecia) in males. Finasteride 1 mg stabilizes the process of the
androgenetic alopecia in the
18-41 year old males. Its effectiveness in bitemporary recession nor
in the loss of hair has not
been determined.
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 recommended dosage is one 1 mg tablet daily. Finasteride Accord
1mg may be taken
with or without food. The tablet should be swallowed whole and must
not be divided or
crushed (See section 6.6).
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
stabilization 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 to 12 months.
Method of administration
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For oral use only.
_DOSAGE IN RENAL INSUFFICIENCY _
No dosage adjustment is required in patients with renal insufficiency.
_DOSAGE IN HEPATIC INSUFFICIENCY _
There are no data available in patients with hepatic insufficiency
4.3
CONTRAINDICATIONS
Finasteride should not be used in children / adolescents.
Contraindicated in women and children (see section 4.4 ‘special
warning