MINOXIDIL

Posology Apply 1 ml Minoxidil 20 mg/ml twice daily (morning and evening) to the affected areas of the scalp. e. 2 x 1 ml solution, should not be exceeded, regardless of the size of the affected scalp area. Paediatric population under 18 years, patients aged 65 years and older Minoxidil 20 mg/ml must not be used in these patient groups, as no efficacy and safety results from controlled studies are available in these age groups.

Method of administration Cutaneous use Prior to applying Minoxidil 20 mg/ml, it must be ensured that the scalp is dry. Minoxidil 20 mg/ml should not be applied to other parts of the body. Hands should be washed carefully after applying Minoxidil 20 mg/ml, in order to avoid accidental contact with mucous membranes and eyes.

After applying Minoxidil 20 mg/ml, the hair can be styled as normal. However, the scalp should not be moistened for about 4 hours. This will prevent Minoxidil 20 mg/ml from being washed off. Each pack of Minoxidil 20 mg/ml 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.

For a dose of 1 ml 6 spray actuations are needed. Instructions for use/application The solution is sprayed directly onto the scalp within the area of hair loss. For this, depress the pump six times. After each actuation, the liquid should be distributed over the affected area with the fingertips, thereby avoiding inhalation of the spray mist.

Duration of use The onset and extent of hair growth are different in individual patients. In general, twice-daily treatment for 2 to 4 months is required before an effect is seen. In order to maintain the effect, it is recommended to continue the twice-daily application without interruption.

No better result will be achieved by applying Minoxidil 20 mg/ml in larger amounts or more frequently. Regarding a possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to 48 weeks. If hair re-growth occurs, twice daily applications of Minoxidil 20 mg/ml are necessary for continued hair growth.

Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Minoxidil 20 mg/ml application and the balding process will continue. If there is no desired therapeutic response within 12 months, treatment should be discontinued.

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 postmarketing experience with minoxidil are included in the table below by System Organ Class (SOC). System Organ Class (SOC) Frequency Adverse Drug Reaction (ADR) Common Hypersensitivity (including facial oedema, generalised skin rash, general pruritus, facial swelling and throat tightness) Immune system disorders Not known Allergic reactions including angioedema (with symptoms such as oedema of the lips, mouth, tongue and throat, swelling of the lips,tongue and oropharynx) Psychiatric disorders Not known Depressed mood Very common HeadacheNervous system disorders Uncommon Dizziness Eye disorders Not known Eye irritation Common Chest Pain Uncommon Palpitations Cardiac disorders Not known Heart rate increased Common HypertensionVascular disorders Not known Hypotension Respiratory, thoracic and mediastinal disorders Common Dyspnoea Uncommon NauseaGastrointestinal disorders Not known Vomiting Common Pruritus (including rash pruritic generalised and eye pruritus), hypertrichosis (including facial hair growth in women), dermatitis (including contact, allergic, atopic and seborrhoeic dermatitis), dermatitis acneiform, skin rash (including pustular, papular, generalised, vestibular and macular rash) Local side effects on the scalp: stinging, burning, itching, dryness, scaling and folliculitis Rare Changes in hair texture Skin and subcutaneous tissue disorders Not known Temporary hair loss, Changes in hair colour Dry skin Skin exfoliation (including exfoliative rash and dermatitis exfoliative) Acne (acneiform rash) General disorders and administration site Common Peripheral oedema 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.

Prior to treatment with Minoxidil 20 mg/ml, 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 20 mg/ml should not be used if the cause of hair loss is not known, in cases of post-partum alopecia, if the scalp is infected or if the scalp is red 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 20 mg/ml is intended only for external use only on the scalp. Do not apply Minoxidil 20 mg/ml to other parts of the body. 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. If shedding persists (>2 weeks), users should stop using Minoxidil 20 mg/ml and consult their doctor.

Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.

Hypertrichosis in children following inadvertent topical exposure to minoxidil:

1, - if occlusive dressings or other topical medical preparations are being used, - sudden or uneven hair loss, - in pregnant women, - in breast-feeding mothers, - in users with any scalp abnormality (including psoriasis, sunburn, or if the scalp is damaged by burns or scarring).

- in users with a shaved scalp - in users with treated or untreated hypertension