Name
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 in 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 shown intolerance to the solution containing minoxidil 20 mg/ml.
• if the scalp skin 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 people:
This medicine is not recommended for people over 65 years of age, because its efficacy and safety have not been studied.


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

• Take special care if you suffer or have suffered from low blood pressure (hypotension) or cardiovascular disease or cardiac arrhythmias such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain or signs of water-sodium retention (swelling of the hands or feet).
In these conditions, consult a doctor before using this medicine. Monitoring should be done 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 minoxidil application sites of caregivers using topical minoxidil. Hair growth returned to normal within a few months after the young children were no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with areas of the body to which 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 use this medicine :
• if you have no family history of hair loss, if the hair loss is sudden and/or patchy, if the hair loss is due to childbirth or if the cause of the 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 your scalp is red, inflamed, infected, irritated or painful. This medicine should only be applied to healthy scalp (see section "How to use Trefostil 50 mg/ml, cutaneous solution 50 mg/ml, cutaneous solution"). If the skin of the scalp is damaged, the passage of the active substance (minoxidil) into the bloodstream may be higher (see section "Do not use Trefostil 50 mg/ml, cutaneous solution");
• do not apply this medicine at the same time as 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, skin or irritated mucous membranes, the medicine, which contains ethanol (alcohol), may cause a burning or irritation sensation: the affected area must 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 using Trefostil 50 mg/ml, cutaneous solution and consult your doctor.
• Do not expose the treated scalp to the sun; protection (hat) must be worn.
• Do not ingest . Accidental ingestion may cause effects due to the cardiovascular action of minoxidil. Therefore, the product must be kept out of the sight and reach of children. CONSULT YOUR DOCTOR IMMEDIATELY.
• Do not inhale the nebulized medicine.
• A change in hair color and/or texture has been observed in some patients.

You should stop treatment immediately 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 everybody 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 which makes it difficult for you to swallow or breathe. This may be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).

The most commonly observed reactions consist of minor skin reactions.

Frequent skin use may cause irritation and dryness of the skin 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, particularly if the product is used by women.
Heachache.

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

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

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.