Hair restorers.

Minoxidil

Minoxidil 20 mg/g (2% w/w).

Cutaneous Gel (to be applied to the scalp). for men.

Regaine for Men Gel is indicated for the treatment of alopecia androgenetica in men 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, 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 Gel, individual responses cannot be predicted.

Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Gel. A dose of 1 ml Regaine for Men Gel should be applied to the total affected areas of the scalp twice daily. The total daily 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 regrowth occurs, twice daily applications of Regaine for Men Gel are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Regaine for Men Gel application and the balding process will continue.

Users should discontinue treatment if there is no improvement after one year.

Children and the elderly

Not recommended. The safety and effectiveness of Regaine for Men Gel in users under 18 or over 65 years of age has not been established.

Regaine for Men Gel is contraindicated:

− in users with a history of sensitivity to minoxidil, ethanol, propylene glycol, carbomer and diisopropanolamine

− in users with treated or untreated hypertension

− in users with any scalp abnormality (including psoriasis and sunburn)

− in users with a shaved scalp

− if occlusive dressings or other topical medical preparations are being used.

Before using Regaine for Men Gel, the user should determine that the scalp is normal and healthy.

The user should stop using Regaine for Men Gel and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness.

Users with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Men Gel.

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

Hands should be washed thoroughly after applying the gel.

Regaine for Men Gel contains an alcohol base 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 for Men Gel contains propylene glycol, which may cause skin irritation.

Some users have experienced changes in hair colour and/or texture with use of Regaine for Men Gel.

Users should be advised to consult their doctor or pharmacist if they are concerned at any time during treatment with Regaine for Men Gel.

Users should be aware that, whilst extensive use of Regaine for Men Gel 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.

Topical drugs, such as corticosteroids, tretinoin, dithranol or petrolatum which alter the stratum corneum barrier, could result in increased absorption of minoxidil if applied concurrently. Although it has not been clinically demonstrated, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension in patients concurrently taking peripheral vasodilators.

In placebo controlled trials of Regaine, the overall frequency of medical events in females in all body system categories was approximately five times that of males.

Several thousand patients have used topical minoxidil in clinical trials where a comparison with an inactive solution was made. Dermatological reactions (e.g. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution. Regaine for Men Gel also contains propylene glycol.

Reactions reported in commercial marketing experience include: hypertrichosis (unwanted non-scalp hair including facial hair growth in women), local erythema, itching, dry skin/scalp flaking, and exacerbation of hair loss. Users should stop using Regaine for Men Gel if they experience persistent redness or irritation of the scalp.

Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Gel. This is most likely due to minoxidil's action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine for Men Gel and consult their doctor.

Particular attention has been paid to body systems, such as cardiovascular and metabolic, which might have some relevance based on the pharmacology of minoxidil. There was no increased risk to users due to drug related medical reactions in these, or other, body system categories.

Users should stop using Regaine for Men Gel if they experience chest-pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, or swollen hands or feet. Rare cases of hypotension have been reported.

McNeil Ltd

GSL

21 May 2009