Regaine for Men Extra Strength Scalp Foam 5%w/w

 

Shelf life increase from 2 to 3 year.

Changes made to the text has been highlighted in red, text that has been added has been underlined, text that has been removed has been struck through:

4.8       Undesirable effects

        [...]

Body system	Incidence	Reported adverse event
Immune System Disorders	Not known	Allergic reactions including aAngioedema Hypersensitivity Allergic contact dermatitis

        [...]

10.       DATE OF REVISION OF THE TEXT

November 2015January 2017

Section 4.1

 

Treatment of androgenetic alopecia in men

 

To

 

Treatment of androgenetic alopecia in adult men

 

Section 4.2

 

Posology

Regaine is for external use only. Do not apply to areas of the body other than the scalp.

 

Hair and scalp should be thoroughly dry prior to topical application of the foam.  A dose of 1 g (equivalent to the volume of half a capful) of Regaine should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2 g.

 

It may take twice-daily applications for 8 to 16 weeks before evidence of hair growth can be expected. Users should discontinue use if there is no improvement seen after 16 weeks.

 

If hair regrowth occurs, twice daily applications of Regaine are necessary for continued hair growth.

 

Special populations

There are no specific recommendations for use in elderly patients or in patients with renal or hepatic impairment.

 

TO

 

Posology

Regaine is for topical use only. Do not apply to areas of the body other than the scalp.

 

Hair and scalp should be thoroughly dry prior to topical application of the foam.  For men aged 18 years or above a dose of 1 g (equivalent to the volume of half a capful) of Regaine should be applied to the total affected areas of the scalp twice daily (once in the morning and once in the evening). The maximum total daily recommended dose of topical minoxidil in men is 100mg, administered as up to 2 g foam per day.

 

Duration of use

 

It may take twice-daily applications for 2 to 4 months before evidence of hair growth can be expected. Users should discontinue use if there is no improvement seen after 4 months.

 

If hair regrowth occurs, twice daily applications of Regaine are necessary for continued hair growth.

 

Section 4.4

 

Regaine should be used when the scalp is normal and healthy. i.e it is not red or inflamed or not infected or irritated or painful.

 

Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth, or the reason for hair loss is unknown.

           

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine.

 

The patient should stop using Regaine and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp.

 

Regaine contains ethanol (alcohol), which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water.

 

Regaine also contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes or mucous membranes, and cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

 

Some patients have experienced changes in hair colour and/or texture with Regaine use.

 

Increased hair shedding can occur due to minoxidil’s action of shifting hairs in the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place).  This temporary increase in shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks (first sign of action of minoxidil). If shedding persists users should stop using Regaine and consult their doctor.

 

Users should be aware that, whilst extensive use of Regaine has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

 

Accidental ingestion may cause serious cardiac adverse events. Therefore this product has to be kept out of the reach of children.

 

TO

 

Regaine should be used when the scalp is normal and healthy. i.e. it is not inflamed or not infected or irritated or painful.

 

Regaine is not indicated when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown.

           

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine.

 

Regaine should not be used concurrently with any other medicines on the scalp.

 

The patient should stop using Regaine and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp, or other unexpected new symptoms (see section 4.8).

 

Regaine contains ethanol (alcohol), which may cause burning and/or irritation. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water.

 

Regaine also contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes or mucous membranes, and cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

 

Some patients have experienced changes in hair colour and/or texture with Regaine use.

 

Increased hair shedding can occur due to minoxidil’s action of shifting hairs in the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place).  This temporary increase in shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks (first sign of action of minoxidil). If shedding persists users should stop using Regaine and consult their doctor.

 

Users should be aware that, whilst extensive use of Regaine has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

 

Accidental ingestion may cause serious cardiac adverse events. Therefore this product has to be kept out of the reach of children.

 

Using more than the recommended dose or applying more often will not improve results.

 

Continued use is necessary to increase and maintain hair re-growth, or hair loss will begin again.

 

Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.

 

Section 4.7

 

Based on the pharmacodynamic and overall safety profile of minoxidil, it is not expected that Regaine would interfere with the ability to drive or operate machinery.

 

TO

 

Minoxidil may cause dizziness or hypotension. If patients are affected they should not drive or operate machinery.

 

Section 4.8

 

Data from several clinical trials are available with a total population of 590 people treated with minoxidil foam 5 % where adverse events were assessed. Additionally, adverse events reported in post-marketing are included.

 

TO

 

The safety of topical minoxidil from clinical trials data is based on data from two placebo-controlled randomized clinical trials in adults evaluating a 5% foam formulation.

 

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with minoxidil are included in the table by system Organ Class (SOC).

 

Dizziness frequency changed from ‘Not known’ to ‘Uncommon’

 

Tachycardia added after Heart rate increase: Heart rate increase (Tachycardia)

 

Hypertension* deleted.

 

Hypotension frequency changed from ‘Not known’ to ‘Uncommon’

 

Nausea frequency changed from ‘Not known’ to ‘Uncommon’

 

Added:

 

Skin and subcutaneous tissue disorders	Common	Pruritus Rash
	Not known	Temporary hair loss Hair colour changes Hair texture abnormal

 

Deleted:

 

Pruritus (including rash pruritic and application site, generalized and eye pruritus, pain, temporary hair loss (see section 4.4), changes in hair texture and hair colour, skin exfoliation (including application site),  rash (including application site, pustular, papular, generalized and macular rash), acne, dermatitis (including contact, application site, allergic, atopic and seborrhoeic dermatitis) and dry skin (including application site dryness), blistering, bleeding and ulceration.

 

Added:

 

General disorders and administration site conditions	Common	Weight increase
	Uncommon:	Oedema peripheral, Application site irritation (including skin irritation), application site erythema (including erythema and rash erythematous)
	Not known	Application site reactions (these sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation, pain, rash, oedema, dry skin and erythema but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration.

 

Deleted:

 

* This adverse event was observed during the clinical trial (590 subjects)

 

 

Section 6.4:

Caution extremely flammable: Pressurized container. Protect from sunlight and do not expose to temperatures above 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition – No smoking. Do not use near or place container on polished or painted surfaces

 

Changed to:

 

Danger extremely flammable aerosol: Pressurised container: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight and keep can in the outer packaging. Do not expose to temperatures exceeding 50ºC.

Section 2:
Term 'with knwon effect' added and '(BHT)' deleted after butylyhydroxytoluene

Section 3:
Description changed from  'White to off white foam' to 'White to yellowish, unscented foam'

Section 4.2:
Header 'Posology' added.

Section 4.3:
'see section 6.1' added.

Section 4.6:
Term 'Lactation' changed to 'Breast feeding'

Section 4.8:
Reporting of side effect section added

Section 5.2:

Headings 'Absorption, Distribution, Biotransformation, Elimination' added

Section 4.8

Update to Section 4.8: addition of new side effects and change to frequency of some side effects.

Correct SPC loaded.

None provided