REGRO 5% LOTION

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

MINOXIDIL

Disponibil de la:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (nume internaţional):

MINOXIDIL

Unități în pachet:

80 ml

Produs de:

PT Actavis Indonesia

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
REGRO 5% LOTION
Minoxidil (5%)
WHAT IS IN THIS LEAFLET
1.
What Regro is used for
2.
How Regro works
3.
Before you use Regro
4.
How to take Regro
5.
While you are using Regro
6.
Side Effects
7.
Storage
and
Disposal
of
Regro
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT REGRO IS USED FOR
Regro is used topically for the
treatment
of
male
pattern
baldness
for
both
male
and
female.
HOW REGRO WORKS
Minoxidil, the active ingredient
in Regro, stimulates hair growth
and
slow
down
the
rate
of
balding
progression
by
aiding
blood flow to the cells of the
scalp which grow hair.
BEFORE YOU USE REGRO
_-When you must not take it _
Do not use the Regro if:-
•
you have a history of allergic
reaction to minoxidil, alcohol
and propylene glycol.
•
you
are
pregnant
or
breastfeeding.
•
you are under 18 years or over
65 years old.
•
your scalp is red, inflamed,
irritated, infected or painful.
•
you are using at the same time
with other topical preparation
on the same scalp area. Hair
spray
and
common
hair
products
can
be
used
after
Regro has been applied.
_-Before you start to take it _
Ask a doctor or pharmacist if
you:-
•
are
currently
using,
just
completed or about to start on
any other medicines.
•
have any
heart problems or
taking medicines to treat high
blood pressure. Using Regro
with
certain
blood
pressure
lowering
drugs
such
as
guanethidine may cause a fall
in blood pressure on standing.
_ _
_-Taking other medicines _
Using Regro with certain blood
pressure
lowering
medicines
may
cause
a
fall
in
blood
pressure
on
standing.
Your
treatment with Regro may not be
as effective if you take diethyl-
carbamazine
or
paracetamol
regularly.
HOW TO TAKE REGRO
_-How much to take _
Adults (18 to 65 years):
Apply one dose of 7 sprays (1ml)
of Regro to the areas of baldness
or hair loss two times a day. This
dose should be used regardless
of the size of the bald area. Do
not exceed two doses (14 sprays
or 2ml) per day. Massage sca

Caracteristicilor produsului

02
1.11.2021
InA
12.11.2021
InA
177x126 mm
Actavis Jakarta
9 pt
1.11.2021
9.11.2021
1.
2.
3.
1. C M Y K
2.
3.
4.
5.
6.
AAAN8793 - Minoxidil (Regro) All strengths, PIL, Malaysia
NAME AND STRENGTH OF ACTIVE SUBSTANCE: Minoxidil 5% w/v
PRODUCT DESCRIPTION: REGRO is a clear colourless to pale yellow
mixture
PHARMACODYNAMICS:
Following
topical
application,
REGRO
is
poorly
absorbed from normal intact skin, with only about 1-2% of the dosage
ultimately
reaching the systemic circulation.
PHARMACOKINETICS: It contains minoxidil which when applied topically
has
been shown to stimulate hair growth in individuals with alopecia
androgenetica
(male pattern baldness) for both male and female. The effectiveness of
minoxidil
can only be expected after 4 or more months of application on the
affected area.
INDICATION: REGRO is indicated for the treatment of male pattern
baldness for
both male and female. Observations of patients suggest that the rate
of balding
progression may be slowed by the use of this product. Onset and degree
of
hair growth stimulation vary among patients. An inverse relationship
may exist
between duration of follicular dormancy and favourable response to
treatment.
RECOMMENDED DOSAGE AND ADMINISTRATION: Apply 7 sprays (1ml) of
REGRO two times a day, preferably morning and night, to the areas of
baldness
or hair loss. This amount should be used regardless of the size of the
bald area.
Do not exceed two doses (14 sprays or 2ml) per day. Massage scalp
gently with
fingertips after each spray. Wash hands thoroughly after use.
CONTRAINDICATIONS: REGRO is contraindicated in patients with a history
of
hypersensitivity to minoxidil, alcohol and propylene glycol.
PREGNANCY AND LACTATION: REGRO should not be used during pregnancy
or lactation.
SIDE EFFECTS/ADVERSE REACTIONS: Local adverse reactions include
scaling,
dry
skin,
erythema/flushing,
dermatitis,
burning
sensation
and
rash.
Other
infrequent side effects include allergic reactions, allergic rhinitis,
facial swelling,
seborrhea, headache, light headedness, vertig