Finasteride 1mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Finasteride

Commercializzato da:

DE Pharmaceuticals

Codice ATC:

D11AX10

INN (Nome Internazionale):

Finasteride

Dosaggio:

1mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Invalid to prescribe in NHS primary care

Dettagli prodotto:

BNF: 13090000

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 1MG FILM-COATED TABLETS
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 1mg Tablets are and what they are used for
2. What you need to know before you take Finasteride 1mg Tablets
3. How to take Finasteride 1mg Tablets
4. Possible side effects
5. How to store Finasteride 1mg Tablets
6. Contents of the pack and other information.
1. WHAT FINASTERIDE 1MG TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE 1MG TABLETS
Your doctor has prescribed these tablets because you have the early
stages of male hair loss, which is
also known as androgenetic alopecia (AGA). Finasteride 1mg Tablets are
used to prevent hair loss and
to encourage hair growth in men.
The active substance (which makes this medicine work) is finasteride.
Finasteride is a type of medicine
called a 5-alpha-reductase inhibitor.
DO NOT TAKE FINASTERIDE 1MG TABLETS IF YOU
- are ALLERGIC to finasteride or any of the other ingredients in these
tablets, listed in Section 6.
- are a WOMAN (because this medicine is for men). It has been shown in
clinical trials that Finasteride does not work in
women with hair loss
- are already taking finasteride or dutasteride used for a prostate
problem called benign prostatic hyperplasia (BPH).
Do not take Finasteride if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist.
WARNING AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING FINASTERIDE 1MG TABLETS
• if you are

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride 1mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of finasteride.
Excipient(s):
Each tablet also contains 44mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Light brown, round biconvex film-coated tablet debossed with “FIN”
on one side and
“1” on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early stages of androgenetic alopecia in men, Finasteride 1mg
Film-coated Tablets
stabilizes the process of androgenetic alopecia in men 18-41 years of
age. Efficacy in
bitemporal recession and end-stage hair loss has not been established.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
Men: 1mg once daily with or without food for 3-6 months before any
noticeable
difference is
evident. There is no evidence that higher doses of finasteride result
in
increased efficacy.
Efficacy and duration should be continuously assessed by the treating
physician.
Generally, continued treatment for 3-6 months is required before
stabilisation of hair
loss can be expected. Continued treatment is advised to sustain
benefit. If treatment
is stopped, the beneficial effects begin to reverse after about 6
months, and return to
baseline after 9-12months.
No data are available on the concomitant use of Finasteride with
topical minoxidil for
the treatment of male hair loss.
_Dosage in the elderly. _ _No dosage adjustment is required in the
elderly (see section _
_5.2)._
_Dosage in renal insufficiency._ _ Dosage adjustments are not
necessary (see section _
_5.2)_
_Dosage in hepatic insufficiency._ There are no data available for the
use of finasteride
in patients with hepatic insufficiency (see section 4.4 and 5.2).
_ _
_Children: _ This medicine should not be administered to children (see
section 4.3).
Finasteride 1 mg Film-coated Tablets is contraindicated in children
(see section 4.3)
4.3
CONTRAINDICATIONS
Contra-indicated
in
w