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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Minoxidil

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/04/19

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Summary of Product Characteristics last updated on medicines.ie: 5/4/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

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1 - 0 of 67 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 5 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 5 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 15 October 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 15 October 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 26 September 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Updated on 26 September 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 3 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 3 October 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Shelf life increase from 2 to 3 year.

Updated on 7 March 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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


Updated on 1 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 June 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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)

 

 

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to dosage and administration

Updated on 20 October 2015 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

Updated on 23 September 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 21 September 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 15 April 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 9 March 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to further information section
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 19 December 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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

Updated on 24 May 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8

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

Updated on 20 May 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 September 2012 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Correct SPC loaded.

Updated on 24 August 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 22 August 2012 PIL

Reasons for updating

  • New PIL for new product