REGAINE FOR MEN EXTRA STRENGTH

Men aged 18-65:

Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Extra Strength. A dose of 1 ml Regaine for Men Extra Strength cutaneous solution should be applied to the total affected areas of the scalp twice daily.

The total 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 2 months or more before evidence of hair growth can be expected.

If hair re-growth occurs, twice daily applications of Regaine for Men Extra Strength are necessary for continued hair growth. Anecdotal reports indicate that re-grown hair may disappear three to four months after stopping Regaine for Men Extra Strength application and the balding process will continue.

Users should discontinue treatment if there is no improvement after one year. 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 in children and adolescents below the age of 18 years or adults over the age of 65 years has not been established. Method of Administration For topical use only.

The method of application varies according to the disposable applicator used:

Pump spray applicator: this is useful for large areas. Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area. Repeat for a total of 6 times to apply a dose of 1 ml. Avoid breathing spray mist.

Extended spray-tip applicator: this is useful for small areas, or under hair. The pump spray applicator must be in place in order to use this additional applicator. Use in the same way as the pump spray.

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 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000, including isolated reports 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 Regaine for Men Extra Strength, the user should determine that the scalp is normal and healthy. 3). Topical minoxidil is only indicated for the treatment of alopecia androgenetica and should not be used in other types of hair loss for example 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. Some patients have experienced changes in hair colour and/or texture with use of Regaine for Men Extra Strength.

Regaine for Men Extra Strength 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 solution. Inhalation of the spray mist should be avoided. Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Extra Strength. 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 and consult their doctor.

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.

53 mg of alcohol (ethanol) in each 1 ml. 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.

Regaine for Men Extra Strength is contraindicated: - in women - in users with a history of sensitivity to minoxidil, ethanol, or propylene glycol - 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.