Regaine for Men Extra Strength 5% scalp solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Minoxidil

Available from:

Johnson & Johnson Ltd

ATC code:

D11AX01

INN (International Name):

Minoxidil

Dosage:

50mg/1ml

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 13090000; GTIN: 5012882004583 5012882004590

Patient Information leaflet

1
scalp solution 5% w/v minoxidil
cutaneous solution to be applied to the scalp
■ This medicine is used to treat hereditary hair loss in
men aged 18 – 65 years.
■ This product is for men only and should NOT be
used by women.
■ Do not apply to other areas of the body other than
the scalp. If accidentally applied rinse thoroughly
with plenty of water. _See section 2 _c
■ THERE ARE 2 DIFFERENT WAYS YOU CAN APPLY THIS
PRODUCT, CHOOSE THE BEST OPTION FOR YOU AND
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS
PRODUCT CAREFULLY. _See section 3 _c
■ THIS MEDICINE IS FOR EXTERNAL USE ONLY AND SHOULD
ONLY BE APPLIED TO YOUR SCALP. _See section 3 _c
■ THIS PRODUCT IS FLAMMABLE AND SHOULD BE USED AND
DISPOSED OF CAREFULLY. See Special Warnings Relating
to Regaine for Men Extra Strength Scalp Solution
5% w/v. _See section 2 _c
IN THIS LEAFLET
1
WHAT THE MEDICINE IS AND WHAT IT IS USED FOR _page 2_
2
WHAT YOU NEED TO KNOW BEFORE YOU USE THIS
MEDICINE _page 3_
3
HOW TO USE THIS MEDICINE _page 5_
4
POSSIBLE SIDE-EFFECTS _page 8_
5
HOW TO STORE THIS MEDICINE _page 10_
6
CONTENTS OF THE PACK AND OTHER INFORMATION _page 10 _
NOW READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. Keep the leaflet: you may need to
read it again.
1 WHAT THE MEDICINE IS AND
WHAT IT IS USED FOR
Regaine for Men Extra Strength Scalp Solution 5% w/v
is a medicine used to treat common hereditary hair loss
in men aged 18-65 years, by preventing further hair loss
and helping hair re-growth. It contains minoxidil which
is thought to work by aiding the blood flow to the hair
follicles on your scalp.
■ The medicine is ONLY for use in MEN aged
between 18 AND 65 YEARS.
■ Regaine for Men Extra Strength Scalp Solution
5% w/v works best in men with hair loss or
thinning at the top of the scalp.
■ Those 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 Re

Summary of Product characteristics

OBJECT 1
REGAINE FOR MEN EXTRA STRENGTH SCALP SOLUTION
5% W/V CUTANEOUS SOLUTION
Summary of Product Characteristics Updated 10-May-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Regaine for Men Extra Strength Scalp Solution 5% w/v Cutaneous
Solution
2. Qualitative and quantitative composition
Minoxidil 50 mg/ml (5%w/v).
Contains propylene glycol. For full list of excipients, see section
6.1.
3. Pharmaceutical form
Cutaneous Solution
4. Clinical particulars
4.1 Therapeutic indications
Regaine for Men Extra Strength Scalp Solution 5% w/v Cutaneous
Solution is indicated for the treatment
of alopecia androgenetica in men.
Onset and degree of hair regrowth may be variable among users.
Although trends in the data suggest that
those users who are younger, who have been balding for a shorter
period of time or who have a smaller
area of baldness on the vertex are more likely to respond to Regaine
for Men Extra Strength Scalp
Solution 5% w/v Cutaneous Solution, individual responses cannot be
predicted.
4.2 Posology and method of administration
Men aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine for Men Extra Strength
Scalp Solution 5% w/v Cutaneous Solution. A dose of 1 ml Regaine for
Men Extra Strength Scalp
Solution 5% w/v 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 2 months or more before
evidence of hair growth can be expected.
If hair regrowth occurs, twice daily applications of Regaine for Men
Extra Strength Scalp Solution 5%
w/v Cutaneous Solution are necessary for continued hair growth.
Anecdotal reports indicate that regrown
hair may disappear three to four months after stopping Regaine for Men
Extra Strength Scalp Solution
5% w/v Cutaneous Solution application and the balding process will
continue.
Users should discontinue treatment if there