ReGen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Finasteride 1mg

Available from:

Viatris Limited

INN (International Name):

Finasteride 1 mg

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Finasteride 1mg Excipient: Docusate sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry brown OY-S-36500 Polyvidone 30 Pregelatinised maize starch Sodium starch glycolate

Units in package:

Blister pack, PVC/aluminium; 28 tablets, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

· ReGen is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. · ReGen is not indicated for use in women (see WARNINGS AND PRECAUTIONS, PREGNANCY) or children. ReGen is not effective in postmenopausal women with androgenetic alopecia.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/aluminium - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2008-04-30

Patient Information leaflet

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
REGEN
_FINASTERIDE FILM-COATED TABLET 1 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ReGen.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ReGen
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT REGEN IS USED
FOR
ReGen is used to treat men with
male pattern hair loss to increase
hair growth on the scalp and to
prevent further hair loss.
Male pattern hair loss (also known
as androgenetic alopecia) is a
common condition in which men
experience thinning of hair on the
scalp. This often results in a
receding hair line and/or balding on
the top of the head. These changes
typically start to occur in some men
in their twenties and become more
common with age. Once hair loss
has occurred over a long period of
time, the hair may be permanently
lost.
Male pattern hair loss is thought to
be caused by a combination of
family history (heredity) and
production of a particular male
hormone called dihydrotestosterone
(DHT). Men with male pattern hair
loss have more of the hormone
(DHT) in the balding part of their
scalp than in other parts, resulting in
increased hair loss.
ReGen contains the active
ingredient finasteride. It works by
lowering the levels of DHT in the
scalp, thus helping to reverse the
balding process.
ReGen does not affect hair on other
parts of the body.
Men with mild to moderate, but not
complete, hair loss can expect to
benefit from the use of ReGen.
REGEN IS FOR USE BY MEN ONLY.
It is NOT effective in the treatment of
hair loss in women (androgenetic
alopecia).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.

Summary of Product characteristics

Page 1 of 8
NEW ZEALAND DATA SHEET
REGEN
1. PRODUCT NAME
ReGen, 1 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 1 mg of finasteride.
ReGen tablets contain lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ReGen tablets are brown, round, biconvex film-coated tablets, 7.6 mm
in diameter.
ReGen tablets should not be halved. Dose equivalence when the tablet
is divided has not been
established.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
ReGen is indicated for the treatment of men with male pattern hair
loss (androgenetic
alopecia) to increase hair growth and prevent further hair loss.
•
ReGen is NOT indicated for use in women (see section 4.6) or children.
ReGen is not effective
in postmenopausal women with androgenetic alopecia.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
The recommended dosage is one 1 mg tablet daily.
In general, daily use for 3 months or more is necessary before
increased hair growth and/or
prevention of further hair loss is observed. Continued use is
recommended to obtain maximum
benefit. Withdrawal from the treatment leads to reversibility of
effect within 12 months.
METHOD OF ADMINISTRATION
ReGen may be taken with or without food.
_4.3 _
_CONTRAINDICATIONS _
Finasteride is contraindicated in the following:
•
Use in women when they are or may potentially be pregnant (see section
4.6)
•
Hypersensitivity to any component of this product listed in section
6.1.
•
Finasteride is not indicated for use in women or children.
Page 2 of 8
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
In clinical studies with finasteride in men 18-41 years of age, the
mean value of serum prostate-
specific antigen (PSA) decreased from 0.7 nanograms/mL at baseline to
0.5 nanograms/mL at Month
12. When finasteride is used for treatment of male pattern hair loss
in older men who also have
benign prostatic hyperplasia (BPH), consideration should be given to
the fact that, in older men with
BPH, PSA levels are