MINOXIDIL

Men aged 18-65:

Posology 1 ml Minoxidil should be applied twice daily (morning and evening) to the affected areas of the scalp. The daily amount applied of 2 x 1 ml solution should not be exceeded, regardless of the size of the affected scalp area.

Too low dosage If too little minoxidil has been applied or a dose has been missed, the patient must not make up for the missing amount. In this case, treatment should be continued at the recommended dose. 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 Minoxidil 5% w/v cutaneous spray, solution in children and adolescents below the age of 18 years or adults over 65 years has not been established. Method of administration Minoxidil should only be used on the scalp.

Each pack of Minoxidil solution contains 2 different pump spray applicators: - pre-assembled applicator for large-area application - separate applicator with extended tip for smaller areas Both applicators can be swapped by detaching the one applicator and replacing it with the other.

Prior to applying minoxidil, it must be ensured that the scalp is dry. Minoxidil should not be applied to other parts of the body. Hands should be washed carefully after applying minoxidil, in order to avoid accidental contact with mucous membranes and eyes.

After applying minoxidil, the hair can be styled as normal. However, the scalp should not be moistened for about 4 hours. This will prevent minoxidil from being washed off. Instructions for use/application According to the affected area and the application device provided.

A. Spray pump Fig. 1 1. The outer cap of the bottle should be removed. 2. 1 ml of solution should be applied, by pressing the spray pump 6 times (Fig. 1). After each pumping action, the patient should spread the liquid over the affected area with their fingertips.

At the same time, inhalation of the spray mist should be avoided. For a more localised application (small areas of the scalp or under the hair), the applicator provided with the pack should be used. B. Applicator Fig. 2 Fig 3 Fig. 4 Fig.

5 1. The outer cap of the bottle should be removed. 2. The top part of the spray head (piece with the orifice) should be removed by pulling it up (Fig. 2), and the applicator should be inserted (Fig. 3 and 4). 3. 1 ml of solution should be applied by pressing the applicator 6 times (Fig.

The following frequencies are used for the evaluation of adverse reactions:

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) The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 20 mg/ml or 50 mg/ml minoxidil solution, and two placebo-controlled randomised clinical trials in adults evaluating a 50 mg/ml 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). 4) Changes in hair colour Rare Changes in hair texture Skin and subcutaneous tissue disorders 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 System Organ Class (SOC) Frequency Adverse Drug Reaction (ADR) be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration) Common Peripheral oedemaGeneral disorders and administration site conditions Not known Chest pain 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.

Prior to treatment with minoxidil, the patient should be thoroughly examined, and her/his medical history taken. Endocrinological causes, underlying systemic diseases or malnutrition must be excluded. In these cases, if necessary, a specific treatment should be initiated.

The patient should have a normal, healthy scalp. Minoxidil should not be used if the cause of hair loss is not known, if the scalp is infected or if the scalp is red, inflamed or painful. 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.

Minoxidil is intended only for external use on the scalp and should not be applied to other parts of the body. There is no clinical experience to date with regard to efficacy for hair loss in the temporal region (receding hairline).

8). In some patients, a transient increase in the amount of hair shedding has been observed two to six weeks after the start of treatment. This effect is due to the fact that the resting phase (telogen phase) of the hair cycle is shortened in hair follicles treated with minoxidil and the growth phase (anagen phase) is reached more quickly.

This stimulates new hair growth, which pushes the “old”, no longer active hairs out of the scalp. This gives the initial impression of increased hair loss. However, it is accompanied by increased hair regrowth. This effect regresses within a few weeks and can be interpreted as a first sign of the minoxidil effect.

Using more than the recommended dose or more often will not improve results. If shedding persists (>2 weeks), users should stop Minoxidil 5% w/v cutaneous spray, solution application and consult their doctor. Unwanted hair growth may be caused by the transfer of the medicinal product to areas other than the scalp.

1, - in users with treated or untreated hypertension - in women, due to occasional signs of cosmetically distressing, reversible, facial hair growth during treatment, - use of occlusive dressings or other topical medical preparations on the scalp, - sudden or uneven hair loss - in patients with any scalp abnormality (including psoriasis, sunburn, shaved scalp or if the scalp is damaged by burns or scarring).