Trefo stil

PACKAGE LEAFLET: INFORMATION FOR THE USER

TREFOSTIL 50 mg/ml, cutaneous solution

Minoxidil
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if hair loss persists or worsens after 6 weeks.

Contents of this leaflet:

1. What Trefostil 50 mg/ml, cutaneous solution is and what it is used for
2. What you need to know before using Trefostil 50 mg/ml, cutaneous solution
3. How to use Trefostil 50 mg/ml, cutaneous solution
4. Possible side effects
5. How to store Trefostil 50 mg/ml, cutaneous solution
6. Contents of the pack and other information

1. What Trefostil 50 mg/ml cutaneous solution is and what it is used for

Trefostil 50 mg/ml cutaneous solution is a topical solution containing minoxidil, an active substance that stimulates hair growth.
This medicinal product is indicated in men for androgenetic alopecia (excessive hair loss) of moderate severity.
It must not be used in women due to the high frequency of hypertrichosis (abnormal hair growth) away from the site of application.

2. What you should know before using Trefostil 50 mg/ml, cutaneous solution

Do not use Trefostil 50 mg/ml, cutaneous solution:

• If you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced intolerance to a solution containing minoxidil 20 mg/ml.
• If the skin of the 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 in 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.

• Take particular care if you have or have had low blood pressure (hypotension), cardiovascular disease, or cardiac arrhythmias such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of fluid and sodium retention (swelling of 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) away from the application site justifies the recommendation that this medicine should not be used by women. Cases of excessive body hair growth in infants and young children have been reported following contact with application sites of minoxidil in patients being cared for by individuals using topical minoxidil. Hair growth returned to normal within a few months after the infants were no longer exposed to minoxidil. Care must be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.

Consult a doctor if you notice excessive hair growth on a child’s body during the period when topical minoxidil products are being used.

Do not apply this medicine:

• If you do not have a family history of hair loss, if hair loss is sudden and/or patchy, 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 treatment may not be appropriate for this type of hair loss.
• If the scalp is red, inflamed, infected, irritated, or painful. This medicine should only be applied to healthy scalp skin (see section “How to use Trefostil 50 mg/ml, cutaneous solution”). If the scalp skin is damaged, the passage of the active ingredient (minoxidil) into the bloodstream may be increased (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 or irritating sensation: the affected area should be thoroughly washed 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 beyond 6 weeks or worsens, discontinue use of Trefostil 50 mg/ml, cutaneous solution and consult your doctor.
• Do not expose the treated scalp to sunlight; protective covering (e.g. a hat) should 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 sight and reach of children. CONSULT A DOCTOR IMMEDIATELY.
• Do not inhale nebulized medicine.
• Changes in hair color and/or hair structure have 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,
• You experience fainting or dizziness,
• You experience sudden and unexplained weight gain, swelling of hands or feet (edema),
• You experience persistent redness or irritation of the scalp.

Other medicines and Trefostil 50 mg/ml, cutaneous solution
Do not apply this medicine together with other dermatological products such as tretinoin, anthralin, or betamethasone dipropionate, as these products may alter the amount of minoxidil reaching the bloodstream.
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines, including those without a prescription.

Trefostil 50 mg/ml, cutaneous solution with food and drink
Not applicable.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine is not indicated for use in women.
Pregnancy:
Although the risk is low, a risk to the fetus cannot be excluded.
Trefostil is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive methods.
Breastfeeding:
Minoxidil is excreted in breast milk. A risk to newborns/infants cannot be excluded.
Trefostil must not be used during breastfeeding.

Driving and using machines
Trefostil does not affect or affects negligibly the ability to drive or use machinery.

Trefostil 50 mg/ml, cutaneous solution contains propylene glycol and ethanol
This medicine contains 240 mg of propylene glycol per single dose, equivalent to 240 mg/ml.
This medicine contains 520 mg of alcohol (ethanol) per ml, equivalent to 520 mg/ml.
It may cause a burning sensation on damaged skin.
This medicine contains ethanol and is therefore flammable.

3. How to use Trefostil 50 mg/ml, cutaneous solution

WARNING:
Flammable product.
Keep away from heat sources, hot surfaces, sparks, open flames, and other sources of
ignition. Do not smoke while using or handling this product.
Use this medicine exactly as directed by your doctor or
pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is 1 ml applied twice daily to the scalp area to be treated.
The daily dose must not exceed 2 ml, regardless of the size of the area to be treated.

Frequency of application
One application of 1 ml in the morning and 1 ml in the evening.
Do not increase the dose or frequency of application.
In any case, strictly follow the recommended dosage.

Route of administration
Cutaneous use. For external use only.
Wash your hands thoroughly before and after applying the solution.
Apply to completely dry hair and scalp.
Distribute the product with the fingertips over the entire area to be treated, starting from the center of the area.
Do not apply the product to any other part of the body.

Method of application
Opening the bottle: the bottle is equipped with a child-resistant cap. Instructions for opening: press the plastic cap downwards while simultaneously turning it counterclockwise (to the left). Only the tamper-evident ring should remain on the bottle.

Depending on the delivery system used: Graduated pipette or spray
Graduated pipette of 1 ml
The graduated pipette allows precise delivery of 1 ml of solution to be distributed over the entire area to be treated, starting from the center of the area.

Dosage pump with applicator
This device is suitable for application to small areas or under the hair.

1. Attach the applicator to the pump: hold the pump body firmly while pressing the top part of the applicator.

2. Insert the spray device attached to the applicator into the bottle and screw it on tightly.

3. Press once to prime the pump: the delivery system is now ready for use.

4. For application: direct the spray towards the center of the area to be treated or under the hair, press once, and distribute the product with the fingertips.

Six sprays are required to apply a dose of 1 ml.

5. Wash the applicator with warm water after each use.

Duration of treatment
Results are not immediate: stopping hair loss and/or resumption of hair growth occurs some time after starting treatment. Continuous treatment is necessary to increase and maintain hair regrowth. Treatment for 2 to 4 months with two daily applications may be required before hair growth stimulation becomes visible. The time required and the degree of response vary from patient to patient.
If no improvement in symptoms is observed after 4 months from the start of treatment, you must contact your doctor and consider the possibility of discontinuing treatment.

If you use more Trefostil 50 mg/ml, cutaneous solution than you should
When used as directed, overdose is unlikely. If applied to damaged scalp, absorption of the active substance may increase and adverse events may occur (see section 2 “What you need to know before using Trefostil 50 mg/ml, cutaneous solution”).

If you forget to use Trefostil 50 mg/ml, cutaneous solution
Do not apply a double dose to make up for the missed dose.
Continue applying as usual: one application in the morning and one in the evening.

If you stop treatment with Trefostil 50 mg/ml, cutaneous solution
Not applicable.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. 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 require urgent medical treatment.

• Swelling of the face, lips or throat making swallowing or breathing difficult. 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 are minor skin reactions.
Frequent topical use may cause skin irritation and dryness due to the presence of alcohol.
The following adverse reactions have been reported and are classified according to frequency:
Very common: may affect more than 1 in 10 people:
Hypertrichosis (abnormal hair growth) away from the site of application, particularly 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 (shedding of dead skin cells), itching, redness of the skin, dermatitis, dry skin, skin allergic reaction, inflammatory skin disorders, acneiform rash, musculoskeletal pain, peripheral edema (fluid infiltration into tissues), breathing difficulties, depression and pain.
Not known: frequency cannot be estimated from the available data
Ear infections, external otitis, rhinitis, hypersensitivity, neuritis, tingling sensation, taste disturbances, burning sensation of the skin, visual problems, eye irritation, dizziness, decreased blood pressure, increased heart rate, palpitations, chest pain, asthenia, facial edema (fluid infiltration into tissues), generalized erythema, hair loss, uneven scalp coverage, change in hair color, change in hair texture, hepatitis and kidney stones (calculi).
If you experience any of these conditions, you must stop treatment and contact your doctor promptly.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trefostil 50 mg/ml, cutaneous solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of that month.
Flammable product. Keep away from heat sources, hot surfaces, sparks, open flames, and other sources of ignition. Do not smoke.
Do not use after 1 month from first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Trefostil 50 mg/ml, cutaneous solution contains

• The active substance is minoxidil. 1 ml of solution contains 50 mg of minoxidil.
• The other excipients are propylene glycol*, ethanol 96%*, purified water.

* (see section 2 “Trefostil 50 mg/ml, cutaneous solution contains”)
Description of the appearance of Trefostil 50 mg/ml, cutaneous solution and contents of the pack
This medicinal product is a clear, light yellow cutaneous solution.
60 ml bottle equipped with a child-resistant screw cap, a 1 ml graduated pipette, and a dosing pump with applicator. Pack containing 1 or 3 bottles.
60 ml bottle equipped with a child-resistant screw cap and a graduated pipette. Pack containing 1 bottle.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE ITALIA S.p.A.
Via G. Washington, 70
20146 Milan - Italy
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
Rue du Lycée
45500 Gien - France
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Health Education Advice
What is androgenetic alopecia?

Normally, hair has a lifespan of 3 to 6 years, and every day between 50 and 100 hairs fall out.
More significant hair loss may occur seasonally (in autumn) or after childbirth: this is normal, temporary, and treatment is not necessary.
Alopecia is defined as hair loss exceeding 100 hairs per day.
There are two types of alopecia:

• Acute alopecia,
• Chronic alopecia.

Acute alopecia (sudden hair loss over a short period) may be diffuse or patchy (alopecia areata) and is often due to known causes (aggressive hair care, poor general health, unbalanced weight-loss diet, certain medications, psychological shock, stress, etc.).
These forms of acute alopecia should not be treated with this medicine.
Chronic alopecia (long-term) is almost always diffuse.
Sometimes these forms of alopecia are due to a specific disease (thyroid, metabolic, etc.) and should not be treated with this medicine.
In the vast majority of cases, these types of chronic alopecia have poorly understood origins, most often hereditary in nature: this is androgenetic alopecia.
Only this type of alopecia can be treated with minoxidil.

How to recognize androgenetic alopecia in men?

Androgenetic alopecia begins with hair loss at the temples.
Subsequently, slight baldness appears on the top of the scalp.
These hairless areas will progressively enlarge: androgenetic alopecia gradually progresses toward baldness.

Precautions for use
Use a gentle shampoo (preferably silicone-free).
It is recommended to wait at least 4 hours after applying Trefostil 50 mg/ml, cutaneous solution, before shampooing.
If minoxidil is applied after shampooing, it is recommended to apply it to a thoroughly dry scalp.
You may use a hairdryer after applying minoxidil, preferably with warm air.
Styling foams, gels, or sprays may be used, but you must wait at least 1 hour between applications.
There is no interaction between minoxidil treatment and permanent wave or hair dye treatments; however, such treatments should be limited due to their aggressive effects on hair.
If you intend to be exposed to sunlight after applying minoxidil, it is advisable to cover your hair.

Additional information
At the beginning of treatment, for a short period, hair loss may temporarily increase. These hairs were already destined to fall out and are now shedding more quickly. This is a normal phenomenon—continue the treatment.
The first hairs to grow will be soft, fine, and barely visible. As you continue treatment, they may change and become thicker.