Name
SCEVADIL, 50 mg/ml, cutaneous solution
Minoxidil


What it is and what it is used for
SCEVADIL is a cutaneous solution containing the active ingredient minoxidil for the symptomatic treatment of androgenetic hair loss in men aged 18 to 55 years.

In men, SCEVADIL stabilizes the course of androgenetic hair loss (androgenetic alopecia) in the tonsure area of ​​the scalp. The treatment is therefore able to counteract the progression of androgenetic hair loss.

The mechanism of action by which minoxidil and/or its metabolite stimulates hair growth is not yet clear. However, minoxidil is thought to act on hair follicles, increasing blood flow to the scalp through local vasodilation.
The onset and extent of this effect may vary from individual to individual and cannot be predicted.

SCEVADIL is for external use only and should be applied only to the scalp.


What you need to know before taking the medicine
Do not use SCEVADIL
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
- if you are a woman, since aesthetically traumatic, reversible signs of hair growth on the face appear during treatment;
- if you are using any other medicine on your scalp;
- if you use any type of dressing or bandage on your scalp;
- if you suffer from sudden or irregular hair loss;
- if you have any condition affecting the scalp, including psoriasis (a skin disease with inflammation and itching), sunburn, shaved scalp or if the skin on your scalp is damaged by scarring or burns, since there are no hair follicles;
- if you have signs of cardiovascular disease or heart rhythm problems such as coronary heart disease, arrhythmia, congestive heart failure or valvular heart disease;
- if you have high blood pressure (hypertension);
- if you are taking medicines to treat high blood pressure.


Warnings and precautions
Apply SCEVADIL to your normal, healthy scalp. You should not use SCEVADIL if the cause of your hair loss is unknown or if your scalp is red, inflamed or painful.

There is no clinical experience to date on the efficacy of hair loss in the temporal region (receding hairline).

SCEVADIL is for external use only on the scalp. Do not apply to other parts of the body.

Take special care if you have or have had cardiovascular disease or cardiac arrhythmia such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight loss or signs of water-sodium retention (swelling of hands or feet). In these conditions you should not use this medicine (see section "Do not use SCEVADIL").

Patients with low blood pressure should contact their doctor before using topical minoxidil and should be monitored at the start of treatment and at regular intervals thereafter.

You should stop using SCEVADIL and consult your doctor if:
- it is found that he has low blood pressure;
- has high blood pressure;
- are taking medicines to treat high blood pressure;
- if one or more of the following symptoms occur: chest pain, faster heartbeat, weakness or dizziness, sudden unexplained weight loss, swelling of the hands or feet, persistent redness or irritation of the scalp or if you develop any new unexpected symptoms (see section "If you use more SCEVADIL than you should").

Transferring the product to areas other than the scalp may cause unwanted hair growth.

There have been isolated reports of small changes in hair color in patients with very light hair in conjunction with the use of hair care products or after swimming in highly chlorinated water.

Inadvertent ingestion may cause serious cardiovascular adverse reactions. Therefore, you should keep this medicine out of the reach of children.

Avoid inhaling the mist spray.

Since SCEVADIL contains alcohol and propylene glycol, it may cause a burning sensation and/or irritation in case of accidental contact with sensitive areas (eyes, mucous membranes, abraded skin). In these cases, the affected area should be rinsed with plenty of running water. If the burning sensation and/or irritation persists, seek medical attention.

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


Possible side effects
Like all medicines, SCEVADIL can cause side effects, although not everybody gets them.

Contact your doctor as soon as possible if you experience any of the following side effects – you may need urgent medical treatment .
- swelling of the face, lips or throat which may make swallowing or breathing difficult. This may be a sign of a serious allergic reaction (frequency not known, cannot be estimated from the available data)
- generalized redness of the skin (frequency not known, cannot be estimated from the available data)
- generalized itching (frequency not known, cannot be estimated from the available data)
- throat tightness (frequency not known, cannot be estimated from the available data)

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

Common ( may affect up to 1 in 10 people ):
- Itching;
- Increased hair growth beyond the scalp (including facial hair growth in women), inflammatory skin reaction (including acneiform eruption, skin rash);
- Shortness of breath, difficulty breathing;
- Swollen legs and arms;
- Weight gain;
- High blood pressure;
- Scalp irritation with stinging, burning, itching, dryness, flaking and folliculitis.

Uncommon ( may affect up to 1 in 100 people ):
- Dizziness, nausea.

Not known ( frequency cannot be estimated from the available data ):
- Allergic dermatitis (skin inflammation related to an allergy);
- Depressed mood;
- Eye irritation;
- Rapid heartbeat, palpitations, low blood pressure;
- Vomit;
- Symptoms at the site of administration which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dryness of the skin and inflammatory rash up to possible peeling of the skin, inflammation of the skin (dermatitis), blistering, bleeding and ulceration of the skin;
- Temporary hair loss, changes in hair color, altered hair structure;
- Chest pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.