Scevadil 50 mg/ml cutaneous solution 3x60 ml

Product Description

SCEVADIL is a drug used to stimulate hair growth in cases of hair loss (androgenetic alopecia).

Indications

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 one individual to another and cannot be predicted.

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

Directions for use and Dosage

Unless otherwise specified, follow the instructions on the product packaging.

Warnings

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

To date, there is no clinical experience on the effectiveness of the product on 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 fluid and sodium retention (swelling of the 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:

• You detect that you have low blood pressure.
• You have high blood pressure.
• You are taking medicines to treat high blood pressure.
• One or more of the following symptoms appear: chest pain, rapid heartbeat, or heart failure. rapid onset, weakness or dizziness, sudden and unexplained weight loss, swelling of the hands or feet, persistent redness or irritation of the scalp, or if new unexpected symptoms appear (see section "If you use more SCEVADIL than you should").

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

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

Accidental ingestion can 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 hair loss. 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 must 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.

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 become red or tingly. make swallowing or breathing difficult. This can This may be a sign of a serious allergic reaction (frequency not known, cannot be estimated from the available data).
• General redness of the skin (frequency not known, cannot be estimated from the available data).
• General itching (frequency not known, cannot be estimated from the available data).
• Tightening of the throat (frequency not known, cannot be estimated from the available data).

Other possible side effects:

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

• Headache.

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, rash).
• Shortness of breath, difficulty breathing.
• Swollen legs and arms.
• Weight gain.
• High blood pressure.
• Irritation of the scalp 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 (inflammation of the skin related to an allergy).
• Depressed mood.
• Eye irritation.
• Rapid heartbeat, palpitations, low blood pressure.
• Vomiting.
• Symptoms at the site of administration which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry 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 colour, altered hair texture.
• Chest pain.

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 tell your doctor or pharmacist if you experience any side effects. You can also report side effects directly via the national reporting system.

By reporting side effects you can help provide more information on the safety of this medicine.

Format

3 x 60 ml solution with applicator