Finasteride 1mg Film-coated Tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

FINASTERIDE

可用日期:

Accord Healthcare Limited

ATC代码:

D11AX10

INN（国际名称）:

FINASTERIDE

药物剂型:

FILM-COATED TABLET

组成:

FINASTERIDE 1 mg

处方类型:

POM

治疗领域:

OTHER DERMATOLOGICAL PREPARATIONS

授权状态:

Authorised

授权日期:

2011-04-01

资料单张

Page 1 of 5
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

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Finasteride 1 mg Tablets are and what they are used for
2. 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. Further 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. BEFORE YOU TAKE FINASTERIDE 1 MG TABLETS
DO NOT TAKE FINASTERIDE 1 MG TABLETS:

If you are allergic (hypersensitive) to finasteride or any of the
other ingredients of Finasteride 1 mg
Tablets.

If you are a child or adolescent.

If you are a woman (see also under ‘Pregnancy and
breast-feeding’). Finasteride 1 mg Tablets have
been found t

产品特点

Page 1 of 10 

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 

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). 
Page 2 of 10 

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