TREFOSTIL*CUT SOLUTION60ML50MG/ML

TREFOSTIL 50 mg/ml, cutaneous solution
Minoxidil

What it is and what it is used for
Trefostil 50 mg/ml, cutaneous solution is a cutaneous solution containing minoxidil, an active ingredient that stimulates hair growth.

This medicine is indicated in some cases of a condition called androgenetic alopecia in men (excessive hair loss), of moderate intensity.
It is not recommended for women due to the high frequency of hypertrichosis (abnormal hair growth).

What you need to know before taking the medicine
Do not use Trefostil 50 mg/ml, cutaneous solution:
• if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• if you have experienced intolerance to the solution containing minoxidil 20 mg/ml.
• if the skin of your scalp is not intact.

Children and adolescents:
The efficacy and safety of Trefostil 50 mg/ml, cutaneous solution in patients under 18 years of age have not been established. No data are available. Therefore, Trefostil 50 mg/ml, cutaneous solution is not recommended in patients under 18 years of age.

Elderly:
This medicine is not recommended for individuals over 65 years of age, as efficacy and safety have not been studied.

Warnings and precautions
Talk to your doctor or pharmacist before using Trefostil 50 mg/ml cutaneous solution.

• Pay particular attention if you suffer or have suffered from low blood pressure (hypotension) or a cardiovascular condition or cardiac arrhythmias such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of water-salt retention (swelling of the hands or feet).
In these conditions, consult a doctor before using this medicine. Monitoring should be carried out at the beginning of treatment and then on a regular basis.
• The risk of hypertrichosis (abnormal hair growth) justifies the recommendation that this medicine should not be used by women.

Cases of excessive hair growth on the body of young children have been reported following contact with the minoxidil application sites of caregivers using topical minoxidil. Hair growth returned to normal within a few months once the young children were no longer exposed to minoxidil. Care must be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.

Consult a doctor if you notice excessive hair growth on your child's body while using topical minoxidil products.

Do not apply this medicine:
• if you have no family history of hair loss, if hair loss is sudden and/or in patches, if hair loss is due to childbirth, or if the cause of hair loss is unknown. In these cases, contact a doctor before using Trefostil 50 mg/ml, cutaneous solution 50 mg/ml, as the treatment may not be suitable for this type of hair loss;
• if the scalp is red, inflamed, infected, irritated, or painful. This medicine should only be applied to a healthy scalp (see section How to use Trefostil 50 mg/ml, cutaneous solution 50 mg/ml, cutaneous solution). If the scalp skin is damaged, the passage of the active ingredient (minoxidil) into the bloodstream may be higher (see section Do not use Trefostil 50 mg/ml, cutaneous solution);
• do not apply this medicine simultaneously with other dermatological treatments applied to the scalp;
• do not apply to other parts of your body.

During treatment:
• In case of accidental contact with eyes, wounds, irritated skin or mucous membranes, the medicine, which contains ethanol (alcohol), may cause a burning sensation or irritation: the affected area should be washed thoroughly with cold tap water. Consult your doctor if symptoms persist.
• A temporary increase in hair loss may occur during the first 2-6 weeks of treatment. If hair loss persists after 6 weeks or worsens, stop applying Trefostil 50 mg/ml, cutaneous solution and consult your doctor.
• Do not expose the treated scalp to the sun; protection (a hat) must be worn.
• Do not ingest. Accidental ingestion can cause effects due to the cardiovascular action of minoxidil. Therefore, the product must be kept out of sight and reach of children. CONSULT A DOCTOR IMMEDIATELY.
• Do not inhale the nebulized medicine.
• A change in hair color and/or texture has been observed in some patients.

You must immediately stop treatment and consult a doctor:
• If you experience: low blood pressure, chest pain, increased heart rate,
• In case of fainting or dizziness,
• In case of sudden and unexplained weight gain, swelling of hands or feet (edema),
• In case of persistent redness or irritation of the scalp.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following symptoms, as you may need urgent medical treatment.

• Swelling of the face, lips or throat that makes swallowing or breathing difficult. This can be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from the available data).

The most commonly observed reactions consist of minor skin reactions.

Frequent cutaneous use can cause skin irritation and dryness due to the presence of alcohol.
The following side effects have been reported and are classified by frequency:

Very common: may affect more than 1 in 10 people:
Hypertrichosis (abnormal hair growth) away from the application site, especially if the product is used by women.
Headache.

Common: may affect up to 1 in 10 people:
Local skin reactions at the application site, such as irritation with exfoliation (elimination of dead skin cells), itching, skin redness, dermatitis, dry skin, allergic skin reaction, inflammatory skin conditions, acneiform eruption, musculoskeletal pain, peripheral edema (fluid retention in tissues), breathing difficulties, depression and pain.

Not known: frequency cannot be estimated from the available data
Ear infections, otitis externa, rhinitis, hypersensitivity, neuritis, tingling sensation, altered sense of taste, burning sensation of the skin, visual problems, eye irritation, dizziness, low blood pressure, increased heart rate, palpitations, chest pain, asthenia, facial edema (fluid retention in tissues), generalized erythema, hair loss, uneven scalp coverage, change in hair color, change in hair texture, hepatitis and kidney stones.
In the presence of these conditions, you must stop treatment and notify your doctor promptly.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.