REGAINE FOR MEN EXTRA STRENGTH SCALP

Men aged 18-49:

Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. A dose of 1 g (equivalent to the volume of half a capful) Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam should be applied to the total affected areas of the scalp twice daily.

The total daily dosage should not exceed 2 g. It may take twice-daily applications for 8 weeks or more before evidence of hair growth can be expected. Users should discontinue treatment if there is no improvement seen after 16 weeks.

If hair regrowth occurs, twice daily applications of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam are necessary for continued hair growth. Clinical Trials have not investigated the efficacy of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam beyond 16 weeks.

Special populations There are no specific recommendations for use in patients with renal or hepatic impairment Paediatric and Elderly Populations Not recommended. The safety and effectiveness of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam in children and adolescents below the age of 18 years or adults over 49 years old has not been established.

Method of administration For topical use only. Hold can upside down and press nozzle to dispense foam onto the hand. Spread with fingertips over entire bald area. Hands should be washed thoroughly after application.

The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled randomised 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 below by System Organ Class (SOC).

The frequencies are provided according to the following convention:

Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 4) Changes in hair colour Common Oedema peripheralGeneral disorders and administration site conditions 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, erythema and rash erythematous but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration).

Investigations Common Weight increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Before using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam, the user should determine that the scalp is normal and healthy. 3). Topical 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.

8). Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. Some patients have experienced changes in hair colour and/or texture with this product use.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is for external use only. Do not apply to areas of the body other than the scalp. Using more than the recommended dose or more often will not improve results. Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.

Hands should be washed thoroughly after applying the foam. Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. 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 Extra Strength Scalp Foam 5% w/w Cutaneous Foam and consult their doctor.

Users should be aware that, whilst extensive use of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam 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 (eg.

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.

3 mg of alcohol (ethanol) in each 1 g. It may cause burning sensation on damaged skin. Ethanol may 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.

g. g. contact dermatitis).

Hypertrichosis in children following inadvertent topical exposure to minoxidil:

Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil.

Contact between children and minoxidil application sites should therefore be avoided.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is contraindicated: − in women − in users with a history of sensitivity to Minoxidil or any of the other ingredients − 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.