Finasteride 5mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Finasteride

Fáanlegur frá:

Somex Pharma

ATC númer:

G04CB01

INN (Alþjóðlegt nafn):

Finasteride

Skammtar:

5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06040200

Upplýsingar fylgiseðill

PHARMA CODE NO: 8770 >
GBR 726-7073-APIL
Patient Information Leaflet
Finasteride
5 MG 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.
SPECIAL PRECAUTIONS
4.
HOW TO TAKE FINASTERIDE TABLETS
5.
POSSIBLE SIDE EFFECTS
6.
HOW TO STORE FINASTERIDE TABLETS
7.
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 of the other
ingredients in Finasteride Tablets (see section 7);
•
are a woman;
•
are a child as finasteride tablets are not recommended for children.
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING FINASTERIDE TABLETS
IF YOU
•
have difficulty emptying your bladder completely or a greatly reduced
flow of urine. Your doctor should examine you before you start
taking Finasteride Tablets to exclude other obstructions in the
urinary tract;
•
have liver problems.
Finasteride Tablets can normally be taken with other medicines.
However, please ask your doctor or pharmacist
before you take other medicines at the same time or if you are taking
or have recently taken any other medicines,
including medicines obtained without a prescription.
3.
SPECIAL PRECAUT

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated 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. Blue, round biconvex 7 mm film-coated tablet with
“F5”
marking 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.
Finasteride 5 mg tablets should be administered in patients with an
enlarged
prostate (prostate volume above ca. 40 ml).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage in Adults_
_: _The recommended dosage is one 5 mg tablet daily with or
without food. The tablet should be swallowed whole and must not be
divided or
crushed (see section 6.6). Even though improvement can be seen within
a short
time, treatment for at least six months may be necessary in order to
determine
objectively whether a satisfactory response to the treatment has been
achieved.
_Dosage in Children:_ Finasteride is contraindicated in children (see
section 4.3).
_Dosage in the elderly:_ Dosage adjustments are not necessary although
pharmacokinetic studies have shown that the elimination rate of
Finasteride is
slightly decreased in patients over the age of 70.
_Dosage in hepatic insufficiency: _There are no data available in
patients with
hepatic insufficiency (See section 4.4).
_Dosage in renal insufficiency_: Dosage adjustments are not necessary
in patients
with varying degrees of renal insufficiency (starting from creatinine
clearance as
low as 9 ml/min) as in pharmacokinetic stud