Finasteride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Finasteride

Available from:

Actavis UK Ltd

ATC code:

G04CB01

INN (International Name):

Finasteride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200; GTIN: 5012617015655

Patient Information leaflet

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FINASTERIDE 5MG TABLETS PIL - UK
Black
Code Area
BBBA1092
S.Anson
31.07.17
140 x 210
7.5pt
Intas
31.07.17
31.07.17
1
FINASTERIDE 5MG TABLETS
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 any further questions, ask your doctor or
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 TABLETS ARE AND WHAT THEY ARE
USED FOR
2.
BEFORE YOU TAKE FINASTERIDE TABLETS
3.
HOW TO TAKE FINASTERIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FINASTERIDE TABLETS
6.
FURTHER INFORMATION
1. WHAT FINASTERIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Finasteride belongs to a group of medicines called
5-alpha reductase inhibitors. They act by reducing the
size of the prostate gland in men.
Finasteride is used in the treatment and control of
benign (not cancerous) enlargement of the prostate.
2. BEFORE YOU TAKE FINASTERIDE TABLETS
DO NOT TAKE FINASTERIDE TABLETS IF YOU
–
are ALLERGIC (hypersensitive) to finasteride or any
other ingredients in Finasteride tablets (see section 6)
–
are a WOMAN who is pregnant, or who may
potentially be pregnant
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE
TAKING FINASTERIDE TABLETS IF YOU
–
have DIFFICULTY EMPTYING YOUR BLADDER COMPLETELY
or a greatly REDUCED FLO

Summary of Product characteristics

OBJECT 1
FINASTERIDE 5 MG TABLETS
Summary of Product Characteristics Updated 28-Nov-2017 | Accord-UK Ltd
1. Name of the medicinal product
Finasteride 5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of finasteride
Excipients:
Each tablet contains 90.95 mg of lactose monohydrate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablets
Film-coated, Blue, round biconvex tablets. Diameter 7mm. Marked
“F5” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Finasteride is indicated for the treatment and control of benign
prostatic hyperplasia (BPH) in patients
with an enlarged prostate to:
− cause regression of the enlarged prostate, improve urinary flow
and improve the symptoms associated
with BPH
− reduce the incidence of acute urinary retention and the need for
surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
4.2 Posology and method of administration
Route of administration:
Oral use
The recommended adult dose is one 5 mg tablet daily, taken orally with
or without food.
Finasteride can be administered alone or in combination with the
alpha-blocker doxazosin (see section 5.1
'Pharmacodynamic properties').
Although early improvement in symptoms may be seen, treatment for at
least six months may be
necessary to assess whether a beneficial response has been achieved.
Thereafter, treatment should be
continued long term.
No dosage adjustment is required in the elderly or in patients with
varying degrees of renal insufficiency
(creatinine clearances as low as 9 ml/min).
There are no data available in patients with hepatic insufficiency.
Finasteride is contra-indicated in children.
4.3 Contraindications
Finasteride 5 mg Tablets are not indicated for use in women or
children.
Finasteride 5 mg Tablets are contraindicated in the following:
• Hypersensitivity to any component of this product
• Pregnancy - Use in women when they are or may potentially be
pregnant (see 4.6 Pregnancy and
lactation, _Expos