Minoxidil for men 5% w/v cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Minoxidil

Available from:

Careforsons Ireland Limited

ATC code:

D11AX01

INN (International Name):

Minoxidil

Dosage:

5 percent weight/volume

Pharmaceutical form:

Cutaneous solution

Therapeutic area:

minoxidil

Authorization status:

Marketed

Authorization date:

2021-04-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINOXIDIL FOR MEN 5% W/V CUTANEOUS SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Minoxidil cutaneous solution is and what it is used for
2.
What you need to know before you use Minoxidil cutaneous solution
3.
How to use Minoxidil cutaneous solution
4.
Possible side effects
5
How to store Minoxidil cutaneous solution
6.
Contents of the pack and other information
1.
WHAT MINOXIDIL CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR
Minoxidil cutaneous solution is a medicine for topical application to
the scalp that stimulates hair growth in
men aged 18 – 65 years with male-pattern hair loss (androgenetic
alopecia) when applied to the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MINOXIDIL CUTANEOUS SOLUTION
DO NOT USE MINOXIDIL CUTANEOUS SOLUTION
-
If you are allergic to minoxidil or any of the other ingredients of
this medicine (listed in section 6).
-
If you are female.
-
If you have high blood pressure (even if it is being treated).
-
If you have inflamed, infected, irritated or painful scalp skin.
-
If you have any condition that affects your scalp, including sunburn
and psoriasis.
-
If you have a shaved scalp.
-
If you have any kind of dressing or bandage on your scalp.
WARNINGS AND PRECAUTIONS
Your doctor must carry out a full medical examination before you start
treatment with Minoxidil cutaneous
solution. Talk to your doctor or pharmacist before using Minoxidil
cutaneous solution:
-
If you are at all unsure whether your scalp is normal and healthy.
-
If you suffer from heart disease, incl

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2022
CRN00D9W7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minoxidil for men 5% w/v cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 50 mg of minoxidil. One ml is equivalent to 10 sprays
(if using the pump).
Excipient(s) with known effect
Each ml contains 520 mg of propylene glycol.
Each ml contains 243 mg of ethanol (96%).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
The solution is transparent and colourless to slightly yellowish with
an alcohol aroma.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate androgenetic alopecia in men aged 18 – 65
years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men between 18 and 65 years of age_
Hair and scalp should be thoroughly dry prior to the application of
Minoxidil cutaneous solution. The recommended daily dose
is 1 ml twice daily (once in the morning and once in the evening),
applied to the total affected areas of the scalp starting in the
centre of the area to be treated. 1 ml is equivalent to 10 sprays
using the dosage pump.
Always apply the recommended daily dose, regardless of the extent of
the alopecia.
The maximum daily dose is 2 ml.
DURATION OF USE
It may take at least 2 to 4 months of twice a day treatment before
results are seen. Onset and degree of hair growth may be
variable among patients.
Continuous twice-daily usage is necessary to maintain the results of
treatment. Relapse to pre-treatment appearance following
discontinuation of medication has been reported to occur within 3-4
months (see section 5.1).
In the absence of any clear response, the treatment should be
discontinued after 4 months.
SPECIAL POPULATIONS
_Use in women_
Should not be used by women as the safety and effectiveness of
Minoxidil cutaneous solution in women has not been
established.
_Renal and hepatic impairment_
There are no specific recommendations for use in patients with renal
or hepatic