MINOXIDIL

Posology Men aged 18 – 65 years The recommended daily dose is 1 ml applied to the total affected areas of the scalp twice daily. 1 ml is equivalent to 10 sprays using the dosage pump. The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.

Special populations Elderly patients Not recommended. The safety and effectiveness of Minoxidil solution in adults over 65 years has not been established. Paediatric population (< 18 years old) Not recommended. The safety and effectiveness of Minoxidil solution in children and adolescents below the age of 18 years has not been established.

Patients with renal or hepatic impairment There are no specific recommendations for use in patients with renal or hepatic impairment. Method of administration For cutaneous use only. Apply to a completely dry scalp, starting from the centre of the area to treat.

Spread the solution using your fingertips to the treatment area. Do not ingest. Do not apply Minoxidil solution to other parts of the body. Response to treatment with minoxidil is on an individual basis for each patient, therefore a 4-month course of treatment may be necessary before any signs of hair growth appear.

Hair growth may stop when treatment with Minoxidil solution is interrupted, returning to the initial state of alopecia within 3-4 months. 1). It is recommended to wash hands thoroughly with water before and after application of Minoxidil solution.

The safety of topical minoxidil from clinical trial data is based on data from 7 placebocontrolled 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 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 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.

Before using Minoxidil solution, the user should determine that the scalp is normal and healthy. 3). Minoxidil solution is only indicated for the treatment of alopecia androgenetica in adult male subjects 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 or the reason for hair loss is unknown.

8). Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Minoxidil solution. Some patients have experienced changes in hair colour and/or texture with use of Minoxidil solution. Minoxidil solution 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 topical minoxidil products. 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 Minoxidil solution 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, in particular in children under 18 years old. Therefore, this product has to be kept out of the reach of children.

Hypertrichosis in children following inadvertent topical exposure to minoxidil:

1. • In women. • 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.