TREFOSTIL 50 mg /Ml Topical Solution

Зміст інструкції

1. TREFOSTIL 50 mg/ml, cutaneous solution
   1. What is TREFOSTIL 50 mg/ml, cutaneous solution and what is it used for
   2. What you need to know before you use 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. Package contents and other information

TREFOSTIL 50 mg/ml, cutaneous solution

Minoxidil

Read this leaflet carefully before using this medicine as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

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 you use 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 is TREFOSTIL 50 mg/ml, cutaneous solution and what is it used for

Trefostil is a cutaneous solution that contains 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 womendue to the high frequency of hypertrichosis (abnormal hair growth).

2. What you need to know before you use TREFOSTIL 50 mg/ml, cutaneous solution

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

• If you are allergic to the active ingredient (minoxidil) or to any of the other components of this medicine (listed in section 6).
• If you have experienced intolerance to the solution containing minoxidil 20 mg/ml.
• If the skin of the scalp is not intact.

Children and adolescents:
The efficacy and safety of Trefostil in patients under the age of 18 have not been established.
No data are available. Therefore TREFOSTIL is not recommended in patients under the age of 18.
years.

Elderly:
This medicine should not be used, because efficacy and safety have not been studied
in subjects over 65 years of age.

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

• Pay particular attention if you suffer from or have suffered from cardiovascular disease or heart rhythm abnormalities such as low blood pressure (hypotension), tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain or signs of fluid and sodium 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.

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, as the 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 (see section “How to use TREFOSTIL 50 mg/ml, cutaneous solution”). If the skin of the scalp 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 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 the eyes, wounds, skin or irritated mucous membranes, the medicine, which contains ethanol (alcohol), may cause a burning or irritating sensation: 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 and consult your doctor.
• Do not expose the treated scalp to the sun; a protection (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 the sight and reach of children. CONSULT A DOCTOR IMMEDIATELY.
• Do not inhale the nebulized medicine.
• A change in color and/or texture of the hair has been observed in some patients.

You must immediately stop treatment and consult a doctor:

• If you experience: lowering of 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. Other medicines and TREFOSTIL

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 that
reaches the bloodstream.
Tell your doctor or pharmacist if you are taking or have recently taken or plan to
take any other medicines, including those available without a prescription.

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

Pregnancy and breastfeeding
The use of this medicine is not recommended in women.
Avoid using this medicine during pregnancy or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Trefostil does not alter or negligibly alters the ability to drive vehicles and operate machinery.

TREFOSTIL 50 mg/ml, cutaneous solution contains propylene glycol and ethanol
This medicine contains 240 mg of propylene glycol in each unit dose which is equivalent to
240 mg/ml.
This medicine contains 520 mg of alcohol (ethanol) in each ml which is equivalent to 520 mg/ml.
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

Dosage
Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The recommended dose is 1 ml applied twice a day to the area of the scalp to be treated.
The daily dose should not exceed 2 ml, regardless of the extent 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, carefully respect the dose.

Route of administration
Cutaneous use. For external use only.
Wash your hands thoroughly before and after applying the solution.
Apply to hair and scalp that are perfectly dry.
Distribute the product with your fingertips over the entire area to be treated, starting from the central point
of the area to be treated.
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 it:
push the plastic cap down and simultaneously rotate the cap counterclockwise
(to the left). Only the tamper-evident ring should remain on the bottle.

Depending on the dispensing system used: Graduated pipette or spray

1 ml graduated pipette
The graduated pipette allows for precise dispensing of 1 ml of solution to be distributed over the entire area to be
treated, starting from the center of the area to be treated.

Metering 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 of the applicator.

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

• 3. Press the first time to prime the pump: the dispensing system is then ready for use.

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

6 sprays are required to apply a dose of 1 ml.
Wash the applicator with lukewarm water after each use.

Duration of treatment
The result is not immediate: the cessation of hair loss and/or the resumption of hair growth occurs
some time after the start of treatment. Continuity of treatment is necessary to
increase and maintain hair regrowth. A treatment of 2 to 4 months with
two applications a day may be necessary before stimulation of hair growth is visible. The time frame and degree of response vary from patient to patient.
If treatment is discontinued, a return to the initial state is likely to occur within 3-4
months, as shown by some observations.

If you use more TREFOSTIL 50 mg/ml, cutaneous solution than you should
If used as directed, overdose is unlikely. In case of application to damaged
scalp, absorption of the active ingredient may be increased 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 useTREFOSTIL 50 mg/ml, cutaneous solution
Do not apply a double dose to make up for the missed dose.
Continue application with the usual frequency: one application in the morning and one in the evening.

If you stop usingTREFOSTIL 50 mg/ml, cutaneous solution
Not applicable.
If you have any doubts about the use of 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
need urgent medical treatment.

• Swelling of the face, lips or throat that makes it difficult to swallow or breathe. This may be a sign of a severe allergic reaction (frequency not known, cannot be defined based on 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 according to their frequency:

Very common: may affect more than 1 in 10 people:
Hirsutism (abnormal hair growth) away from the application site, 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 (removal of
dead skin cells), itching, redness of the skin, dermatitis, dry skin, skin allergic reaction, inflammatory skin conditions, acneiform rash, musculoskeletal pain, peripheral edema (fluid infiltration into tissues), difficulty breathing and depression.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the bottle after “EXP”. The expiry
date refers to the last day of that month.
Flammable product. Do not use after 1 month from first opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TREFOSTIL 50 mg/ml, cutaneous solution contains

• The active ingredient is minoxidil. 1 ml of solution contains 50 mg of minoxidil.
• The other excipients are propylene glycol*, 96% ethanol*, purified water. *(see paragraph 2 “Trefostil 50 mg/ml, cutaneous solutioncontains”)

Description of the appearance of TREFOSTIL 50 mg/ml, cutaneous solution and package contents
This medicine is a transparent, light yellow-colored cutaneous solution.
60 ml bottle equipped with a child-resistant screw cap with a 1 ml graduated pipette and a dosing pump with an applicator.
Pack of 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:

Health education advice
What is androgenetic alopecia?
Normally, hair has a lifespan of 3 to 6 years and 50 to 100 hairs fall out every day.
More significant hair loss can occur seasonally (in autumn) or after childbirth: this is normal, transient and treatment is not necessary.
Alopecia is defined as hair loss of more than 100 hairs per day.
There are two types of alopecia:

• Acute alopecia,
• Chronic alopecia.

Acute alopecia (sudden hair loss over a short period of time) can be diffuse or patchy (alopecia) and is often due to known causes (aggressive hair care, poor general condition, poorly balanced 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 are of unknown origin, more often hereditary: this is androgenetic alopecia.
Only this type of alopecia can be treated with minoxidil.

How to recognise androgenetic alopecia in men?

Androgenetic alopecia begins with receding hairlines at the temples.
Subsequently, slight baldness appears on the top of the scalp.
These two hairless areas will gradually widen: androgenetic alopecia progressively evolves towards baldness.

Warnings for use
Use a mild shampoo (preferably silicone-free).
It is recommended to wait at least 4 hours after applying TREFOSTIL before shampooing.
If you apply minoxidil after shampooing, it is advisable to do so on well-dried scalp. A hairdryer can be used after applying minoxidil, preferably with warm air.
Styling foams, gels or sprays can be used, but it is necessary to wait at least 1 hour between applications.
There is no interaction between treatment with minoxidil and perms or coloring treatments, but it is preferable to limit them due to their aggressiveness on the hair.
If you intend to be exposed to the sun after applying minoxidil, it is advisable to cover your hair.

Some additional information
At the beginning of treatment, for a short period of time, it is possible that hair loss may increase. These hairs were already destined to fall out and are falling out more quickly. This is a normal phenomenon, continue the treatment.
The first hairs that grow will be soft, fluffy and barely visible. As you continue treatment, they may change and become thicker.