REGAINE FOR WOMEN ONCE A DAY SCALP

Women aged 18-65:

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

It may take once-daily applications for 12 to 24 weeks before evidence of hair growth can be expected. Users should discontinue treatment if there is no improvement seen after 24 weeks. If hair regrowth occurs, once daily applications of this product are necessary for continued hair growth.

Clinical Trials have not investigated the efficacy of this product beyond 24 weeks. 1). Special populations There are no specific recommendations for use in older people or in patients with renal or hepatic impairment. Paediatric population Not recommended.

The safety and effectiveness of this product in children and adolescents below the age of 18 years has not been established. Method of administration Hold can upside down and press nozzle to dispense foam onto the hand. Spread with fingertips over the affected areas and gently massage the foam into the scalp working from the back to the front of the scalp.

Hands should be washed thoroughly after application.

The safety of topical minoxidil from clinical trials 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). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Before using this product, 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 this product. Some patients have experienced changes in hair colour and/or texture with this product use. This product 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 this product. 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 this product and consult their doctor.

Users should be aware that, whilst extensive use of this product 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.

This product is contraindicated: − in men − 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.