MINOXI 2

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MINOXIDIL

Available from:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC code:

D11AX01

Pharmaceutical form:

SOLUTION

Composition:

MINOXIDIL 2 %W/V

Administration route:

TOPICAL- SCALP

Prescription type:

Not required

Manufactured by:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutic group:

MINOXIDIL

Therapeutic area:

MINOXIDIL

Therapeutic indications:

Androgenetic alopecia in females.

Authorization date:

2017-12-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed without a doctor’s prescription
MINOXI 2
SCALP SOLUTION
ACTIVE INGREDIENT: minoxidil 2%
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this medicine’s ingredients’, and
section 6
‘Additional information’.
READ
THE
ENTIRE
LEAFLET
CAREFULLY
BEFORE
YOU
START
USING
THIS
MEDICINE. This leaflet contains concise information about this
medicine.
If you have any further questions, consult your doctor or pharmacist.
You must use this medicine according to the instructions in the dosage
section in this leaflet. Consult your pharmacist if you need further
information.
MINOXI 2 IS INTENDED FOR WOMEN AGED 18-65 YEARS IN CASES OF
HEREDITARY HAIR LOSS ONLY.
If you experience no improvement in your hair growth after one year of
use, you should discontinue treatment.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Minoxi 2 is intended for scalp hair growth in healthy women aged
18-65 years, in cases of hereditary hair loss only. Consult your
doctor
to ensure that your type of hair loss is suitable for treatment with
this
medicine.
THERAPEUTIC GROUP: vasodilators in local administration for treatment
of hair loss.
The medicine contains minoxidil, which is considered a substance that
works by helping the blood flow to the scalp hair follicles.
The medicine is intended for women aged 18-65 years.
Minoxi 2 works best in women with thinning hair on the scalp.
Women who are younger, have been losing hair for a short period
of time or have a small area of baldness are likely to experience the
best results.
You are unlikely to benefit from Minoxi 2 if you have been bald for
many years or have a large area of hair loss.
HEREDITARY HAIR LOSS is recognisable according to the following signs:
The pattern of hair loss (see diagrams).
It starts gradually and progresses.
You have a family history of hair loss.
No other symptoms are present with your hair loss.
P00001348
0722H
PIL-1022

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minoxi 2
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 2% w/v.
Contains propylene glycol 207 mg/ml and alcohol 488 mg/ml.
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Solution (to be applied to the scalp)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minoxi 2i s indicated for the treatment of alopecia androgenetica in
women
aged between 18 and 65.
Onset and degree of hair regrowth may be variable among users.
Although trends in
the data suggest that those users who are younger, whose hair has been
thinning for a
shorter period of time or who have a smaller area of thinning on the
vertex are more
likely to respond to Minoxi 2, individual responses cannot be
predicted.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Women aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application
of Minoxi 2.
A dose of 1 ml Minoxi 2 cutaneous solution should be applied to the
total affected
areas of the scalp twice daily. The total dosage should not exceed 2
ml. If
fingertips are used to facilitate drug application, hands should be
washed
afterwards.
It may take twice daily applications for four months or more before
evidence of hair
growth can be expected.
If hair re-growth occurs, twice daily applications of Minoxi 2 are
necessary for
continued hair growth. Anecdotal reports indicate that re- grown hair
may disappear
three to four months after stopping minoxidil application and the
balding process will
continue.
Users should discontinue treatment if there is no improvement after
one year.
SPECIAL POPULATIONS
There are no specific recommendations for use in patients with renal
or hepatic
impairment.
PAEDIATRIC AND ELDERLY POPULATIONS
Not recommended. The safety and effectiveness of minoxidil in children
and
adolescents below the age of 18 years or adults over the age of 65
years has not been
established.
METHOD OF ADMINISTRATION
For topical use only.
The method of application varies according to the dispo