MINOXICUTAN

MINOXICUTAN Men 50 mg/ml Spray

Important notes (mandatory information)

Minoxicutan Men 50 mg/ml Spray for application to the skin (scalp), solution. Active ingredient: Minoxidil. Areas of application: Stabilises the course of hereditary hair loss (androgenetic alopecia) in the tonsure area of the scalp from 3 - 10 cm in diameter in men between 18 and 49 years of age and can thus counteract the progression of androgenetic alopecia. The onset and extent of the effect can vary individually and cannot be predicted. Warning: Contains propylene glycol (E 1520). Contains highly flammable ethanol. Avoid fire, flames or smoking until the spray has dried. Excessive hair growth in children after accidental topical exposure to minoxidil.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Minoxicutan Men 50 mg/ml, Spray for the treatment of hair loss in men
Active ingredients: Minoxidil

Read the entire package leaflet carefully before you start using this medicine, as it contains important information.

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If your symptoms worsen or do not improve, contact your doctor.

What is in this leaflet

1. WHAT IS MINOXICUTAN MEN 50 MG/ML AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MINOXICUTAN MEN 50 MG/ML?
3. HOW TO USE MINOXICUTAN MEN 50 MG/ML?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MINOXICUTAN MEN 50 MG/ML?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS MINOXICUTAN MEN 50 MG/ML AND WHAT IS IT USED FOR?

Minoxicutan Men 50 mg/ml is a medicine for the treatment of male pattern hair loss (androgenetic alopecia).
Minoxicutan Men 50 mg/ml stabilises the course of hereditary hair loss (androgenetic alopecia) in the tonsure area of the scalp from 3 - 10 cm in diameter in adult men between 18 and 49 years of age.
The treatment can thus counteract the progression of hereditary hair loss. The onset and extent of this effect can vary individually and cannot be predicted.
The onset of androgenetic alopecia in men is characterised by the receding of the forehead hairline at the temples with the formation of receding hairlines. This is followed by increasing hair thinning in the crown area (tonsure area).
The following illustrations show the stages of hereditary hair loss.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MINOXICUTAN MEN 50 MG/ML?

Minoxicutan Men 50 mg/ml must not be used,

• if you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6
• in women, due to occasional reports of cosmetically disturbing reversible facial hair growth during treatment
• if you are using other medicines on your scalp
• if you are wearing a bandage or dressing on your scalp
• if you have sudden or uneven hair loss
• if your scalp is damaged by a condition such as psoriasis (an itchy, inflammatory skin condition), sunburn or head shaving, or if it has scars or burns, as there are no hair roots

Warnings and precautions

Please talk to your doctor or pharmacist before using Minoxicutan Men 50 mg/ml. Hormonal causes, underlying diseases or malnutrition must be ruled out. In these cases, you must receive targeted treatment.

Only use Minoxicutan Men 50 mg/ml on normal, healthy scalp. You should not use Minoxicutan Men 50 mg/ml if the cause of your hair loss is unknown or if your scalp is red, inflamed or painful. There is no clinical experience with the efficacy of treatment for hair loss in the temple area (receding hairline). If effects on internal organs (systemic effects) or severe skin reactions occur, the preparation must be discontinued. Minoxicutan Men 50 mg/ml is for external use on the scalp only. Do not apply Minoxicutan Men 50 mg/ml to other parts of the body.

You should not use Minoxicutan Men 50 mg/ml:

• if you have signs of cardiovascular disease or heart rhythm disorders
• if you have high blood pressure
• if you are taking medicines to treat high blood pressure (antihypertensives)

You should stop using Minoxicutan Men 50 mg/ml and see a doctor:

• if your blood pressure drops, or
• if one or more of the following symptoms occur: chest pain, rapid heartbeat, feeling faint or dizzy, sudden and unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp, or if other unexpected new symptoms occur (see section "If you have used more Minoxicutan Men 50 mg/ml than you should").

Unwanted hair growth may occur if you apply the product to areas of the body other than the scalp. In rare cases, patients with very light hair have reported slight changes in hair colour when using hair care products at the same time or after swimming in heavily chlorinated water.

Accidental ingestion can cause serious side effects in the cardiovascular system. Therefore, you must keep this medicine out of the reach of children. Cases of excessive body hair growth have been reported in young children after skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returned to normal within months when the toddlers were no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with areas of your body where you have applied minoxidil.

Contact a doctor if you notice excessive body hair growth in your child while using minoxidil-containing medicines. Avoid inhaling the spray vapours.

Children and adolescents

Do not use this medicine in children or adolescents under 18 years of age as safety and efficacy in this age group have not been established.

Use of Minoxicutan Men 50 mg/ml with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines.

There is currently no evidence of interactions between Minoxicutan Men 50 mg/ml and other agents. Although not clinically proven, there is a theoretical possibility that absorption of the active ingredient of Minoxicutan Men 50 mg/ml (minoxidil) into the body could increase orthostatic hypotension (drop in blood pressure when changing from lying to standing) in patients who are taking peripheral vasodilators (certain vasodilators to lower blood pressure) at the same time.

Minoxicutan Men 50 mg/ml should not be used together with other dermatological preparations (topical preparations with active ingredients such as corticosteroids, retinoids, dithranol) or with agents that increase the absorption of active ingredients through the skin (skin absorption).

Pregnancy and breast-feeding

Minoxicutan Men 50 mg/ml is only indicated for male patients. To date, there is only limited experience with the use of Minoxicutan Men 50 mg/ml in pregnant women. Minoxidil absorbed into the body can pass into breast milk. Therefore, Minoxicutan Men 50 mg/ml must not be used by pregnant or breastfeeding women.

Driving and operating machinery

This product can cause dizziness or low blood pressure (see section 4.). If this is the case, patients should not drive or operate machinery.

Minoxicutan Men 50 mg/ml contains propylene glycol (E 1520) and ethanol 96%

(alcohol)

This medicine contains 509 mg of propylene glycol per 1 ml of solution. This medicine contains 248 mg of alcohol (ethanol) per 1 ml of solution.

It can cause a burning sensation on damaged skin. Ethanol can cause burning and eye irritation. In case of accidental contact with sensitive areas (eyes, abrasions, mucous membranes), these must be rinsed thoroughly with plenty of water. If you repeatedly apply Minoxicutan Men 50 mg/ml to your hair instead of your scalp, this can lead to increased dryness and/or stiffness of the hair due to the content of Minoxicutan Men 50 mg/ml in ethanol and propylene glycol.

3. HOW TO USE MINOXICUTAN MEN 50 MG/ML?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Minoxicutan Men 50 mg/ml is intended for external use on dry scalp. Please only use Minoxicutan Men 50 mg/ml on healthy, intact scalp and always follow the instructions for use below exactly. Do not apply Minoxicutan Men 50 mg/ml to areas of the body other than the scalp.

The recommended dose is

Apply 1 ml of Minoxicutan Men 50 mg/ml (morning and evening) to the affected areas in the tonsure area of the scalp twice a day. The daily dose of 2 x 1 ml of solution should not be exceeded, regardless of the size of the affected skin area.

Use in children and adolescents Minoxicutan Men 50 mg/ml must not be used in children and adolescents under 18 years of age, as there are no results on efficacy and safety from controlled clinical studies for this patient group.

Method of administration

Application to the skin (scalp)

Each pack of Minoxicutan Men 50 mg/ml contains 2 different pump spray applicators:

• pre-assembled applicator for large-area application - separately enclosed applicator with extended tip for smaller areas.

The two applicators can be changed by pulling off one applicator and attaching the other. 6 sprays are required for the dose of 1 ml.

Instructions for use

The solution is sprayed directly onto the scalp in the area of hair loss. To do this, press the pump six times. After each pumping process, distribute the liquid with your fingertips over the affected area. Avoid inhaling spray vapours.

What else do you need to pay attention to when using it?

After applying Minoxicutan Men 50 mg/ml, wash your hands thoroughly to avoid accidental contact with mucous membranes and eyes. After applying Minoxicutan Men 50 mg/ml, you can style your hair as usual. However, you should not wet your scalp for about 4 hours. This will prevent Minoxicutan Men 50 mg/ml from being washed off.

Duration of use

The onset and extent of hair growth varies from patient to patient. In general, twice-daily treatment for 2 to 4 months is required before an effect is noticeable. To maintain the effect, it is recommended to continue twice-daily use continuously. You will not achieve a better result if you use Minoxicutan Men 50 mg/ml in larger quantities or more often. Sufficient clinical experience is available for a duration of use of up to one year regarding a possible therapeutic effect. If no effect is seen after 4 months, treatment should be discontinued.

Notes on increased hair loss

When treating hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair. This pushes the "old" inactive hair out of the scalp. Initially, this gives the impression of increased hair loss. This reaction was observed in some patients two to six weeks after starting treatment with the active ingredient minoxidil. However, this need not worry you, as this reaction is accompanied by increased hair regrowth. The effect subsides within a few weeks and can be a first sign of the minoxidil effect.

Please talk to your doctor or pharmacist if you have the impression that the effect of Minoxicutan Men 50 mg/ml is too strong or too weak.

If you have used more Minoxicutan Men 50 mg/ml than you should

Using Minoxicutan Men 50 mg/ml in a higher dose than recommended and on larger areas of the body or areas other than the scalp can potentially lead to increased absorption of minoxidil into the body. To date, there have been no known cases of external application of minoxidil solution leading to poisoning. After accidental ingestion, the concentration of minoxidil in Minoxicutan Men 50 mg/ml may lead to effects on internal organs that are comparable to the pharmacological effect when the active ingredient is swallowed, such as in a tablet.

This can cause the following side effects:

• rapid heartbeat, drop in blood pressure, fluid retention and resulting sudden weight gain, dizziness

In case of accidental ingestion or signs of overdose, please contact a doctor immediately so that he/she can decide on the further course of action. Please have the medicine package ready so that the doctor can find out about the active ingredient taken.

If you forget to use Minoxicutan Men 50 mg/ml

Do not apply twice the amount to make up for the missed dose, but continue treatment with the recommended dose. It does not make sense to make up for the missed application and could lead to undesirable effects.

If you stop using Minoxicutan Men 50 mg/ml

It is necessary to continue treatment continuously to improve and maintain hair growth. Otherwise, hair loss will occur again. If treatment is interrupted, a condition will develop within 3 to 4 months as would have been achieved without therapy with Minoxicutan Men 50 mg/ml. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor immediately if you notice any of the following symptoms - you may need urgent medical treatment

Swelling of the face, lips or throat, making it difficult to swallow or breathe. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).
Redness of the skin all over the body (frequency not known, cannot be estimated from the available data)
Itching all over the body (frequency not known, cannot be estimated from the available data)
Tightness in the throat (frequency not known, cannot be estimated from the available data)

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Itching
• Increased hair growth outside the scalp (including facial hair growth in women), inflammatory skin reaction (including acne-like dermatitis, rash)
• Shortness of breath, shortness of breath
• Swelling of the arms and legs
• Weight gain
• High blood pressure
• Scalp irritation such as stinging, burning, dryness, itching, flaking, hair follicle inflammation

Uncommon (may affect up to 1 in 100 people):

• Dizziness, nausea

Not known (frequency cannot be estimated from the available data):

• Contact dermatitis (allergic inflammation of the skin)
• Depressive mood
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Vomiting
• Discomfort at the application site, which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin and inflammatory rash up to possible skin peeling, dermatitis, blistering, bleeding and ulceration
• Temporary hair loss, change in hair colour, change in hair structure
• Chest pain

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet