TREFOSTIL SOLUZ CUT60ML50MG/ML

TREFOSTIL 50 MG/ML CUTANEA SOLUTION

active ingredients

1 ml solution contains 50 mg of minoxidil. Excipients with known effects: Propylene glycol (E1520) 240 mg Ethanol 96 (%) 520 mg For the complete list of excipients, see paragraph 6.1.

Excellent

Propylene glycol, ethanol (96%), purified water.

Therapeutic indications

Alopecia androgenic moderate intensity in male individuals. Note: This medicine is not recommended for women, due to its limited effectiveness and high incidence of hypertricosis (37% of cases) in areas far from application.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • scalp diseases. • Poor tolerance for 2% formulation, regardless of symptoms.

Population

Population A 1 ml dose must be applied on the scalp starting from the center of the affected area, twice a day. Respect the dosage regardless of the size of the area to be treated. The total dosage must not exceed 2 ml. Duration of use: It is necessary a continuous treatment to increase and maintain hair regrowth. The first results can appear from 2 to 4 months after repeated applications twice a day. The beginning and extent of the response differ in individual patients. If there is no improvement in the symptoms 4 months after the start of treatment, patients must stop using Trefostil. During the first 2-6 weeks of treatment a temporary increase in hair loss may occur. If hair loss persists over 6 weeks, the patient must stop using Trefostil and consult his physician (see paragraph 4.4). The beginning and degree of hair regrowth may vary in individual patients. Although the trend of data suggests that younger individuals, who have manifested shortcomings for a shorter time or who have a smaller area of baldness on the head's apex, are more likely to respond to the treatment, no predictions can be made on the individual response. Some data suggest that you can observe a return to the initial situation after 3 or 4 months if the treatment is discontinuous. Special popularity Seniors Trefostil is not recommended in patients over 65 years of age due to lack of data on safety and effectiveness. Pediatric Population Trefostil’s safety and effectiveness in patients under the age of 18 have not been established. There are no available data. Therefore Trefostil is not recommended in patients under the age of 18. Method of administration Skin use. Each package contains two different types of release systems: - 1 graduated pipette for precise application on small surfaces, - 1 pump applicator for application on small areas or under hair. Use one of the release systems (see below) to apply TREFOSTIL. Apply the product using the fingertips, across the affected area. Before and after applying the solution, thoroughly wash your hands. Before application, hair and scalp must be completely dry. Do not apply the product to other parts of the body. Application mode The child-proof cap must be removed by pushing it down and simultaneously rotating it counterclockwise (left). Only the tampering ring must remain on the bottle. Based on the application system used: Use of pipette: A graduated pipette allows to provide exactly 1 ml of solution, to be spread over the entire area to be treated. Use of pump with applicator: Screw the dosing pump to the bottle. For the application: direct the pump to the center of the area to be treated, press once and distribute the product with the fingertips across the affected area. 6 pump pressures are required to apply a 1 ml dose. After each use, rinse the applicator with hot water.

Conservation

Flammable product.

Warnings

Warnings In subjects with dermatosis of the scalp it is possible a greater percutaneous absorption of minoxidil (see paragraph 4.3). Although the appearance of systemic effects related to minoxidil has not been observed during the use of the solution, the possible appearance of such effects should not be excluded. Patients must be warned of potential side effects. Patients with cardiovascular disease or known heart arrhythmias should contact a doctor before using minoxidil topic. In these subjects should be assessed the benefit of treatment. A monitoring must be carried out at the beginning of the treatment and subsequently regularly. Especially, these patients should be warned of possible side effects (tachycardia, water retention/sodium or weight gain or other systemic effects) in order to stop treatment as soon as one of them appears. For other patients, in case of severe systemic effects or dermatological reactions: should stop the use of the drug and consult a doctor if it is detected hypotension or if the subject manifests chest pain, accelerated heartbeat, lack or dizziness, sudden and inexplicable weight increase, hands or feet swelling or persistent redness or irritation of the scalp. If the symptoms of hair loss persist over 6 weeks of treatment with minoxidil or worsen, or if you develop new symptoms, patients should stop treatment and ask for advice to your doctor. Due to the risk of hypertricosis in areas far from that of application, the use of this medicine cannot be justified in women. Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or pizzas, hair loss is due to childbirth or reason of hair loss is not known. Precautions of employment Minoxidil should only be used on normal, healthy scalp. Do not use if the scalp is reddened, inflamed, infected, irritated or sore or if you are using other medications on the scalp. It is necessary a continuous treatment to increase and maintain hair regrowth. During the first 2-6 weeks of treatment a temporary increase in hair loss may occur. If hair loss persists over 6 weeks, the patient must stop using minoxidil and consult his physician (see paragraph 4.2). In case of contact with the eyes, the solution (which contains ethanol in particular) can induce a burning sensation and irritation. In case of contact with sensitive areas (eyes, abraded skin, mucosa) rinse thoroughly with cold tap water. The inhalation of the spray must be avoided. Accidental ingestion may cause severe heart failure (see paragraph 4.9). Therefore this product must be kept out of the reach of children. This medicine contains ethanol. It can cause burning sensation on damaged skin. Some patients observed a change in color and/or hair structure. Sun exposure is not recommended during the application of the product.

Interactions

Drug interaction studies in man have revealed that percutaneous absorption of minoxidil is increased by tretinoin and anthrain as a result of an increase in permeability of the corneo layer; dipropionate betamethasone increases the local tissue concentrations of minoxidil and decreases the systemic absorption of minoxidil. Although not clinically tested, it is not possible to exclude the risk of orthostatic hypotension in patients undergoing treatment with peripheral vasodilators. Minoxidil reabsorption applied by topical means is controlled and limited by the corneo layer. The concomitant use of medicinal products applied by topical means with impact on the barrier of the corneo layer can lead to an increase in the absorption of minoxidil applied by topical means. Therefore the concomitant use of TREFOSTIL and other medicinal products applied by topical means is not recommended.

Effects

The undesirable effects and their frequency were determined on the basis of a randomized, double-blind, placebo-controlled trial of 393 patients, minoxidil comparison to 5% (157 patients), 2% minoxidil (158 patients) and placebo (78 patients). The frequencies of unwanted effects reported during the marketing of minoxidil with skin application are not known. Adverse reactions are listed below according to the Classification for MedDRA Systems and Organs and according to frequency. The frequency is defined using the following convention: very common (≥ 1/10), common (≥ 1/100, Classification for Systems and Organs MedDRA Terms / Frequency Very common Town Notable Infections and Infestations     External Otite ear infections Immune system disorders     Hypersensitivity allergic reactions included Angioedema Psychiatric disorders   Depression   Nervous System pathologies Cefa   Neurite Sensation of tingling altered taste Burning sensation Pathologies of the eye     Visual disorders Eye irritation Ear and labyrinth pathologies     Chief Minister Heart disease     Tachycardia Thoracic Pain Palpitations Vascular diseases     Hypotension Respiratory, chest and mediastinic pathologies   Dispense   Hepatobiliary diseases     Hepatitis Pathologies of skin and subcutaneous tissue Hypertricosis (near the application area) Contact dermatitis Prurito Skin inflammatory pathologies Skin rash acneiforme Eritema generalized Alopecia Irregular cover of scalp Changes in hair structure Changes in hair color Skeletal muscle system and connective tissue pathologies   Musculoskeletal pain   Kidney and urinary pathologies     Renal calculations Systemic pathologies and conditions for administration   Local reactions in the application area: irritation, skin exfoliation, dermatitis, erythema, dry skin, itching Peripheral Edema Pain Edema Face Edema Astenia Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms There is no evidence that minoxidil applied locally is absorbed in sufficient amount to cause systemic effects. When used according to instructions, overdose is unlikely. If the product is applied in an area with reduced integrity of the epidermal barrier caused by trauma, inflammation or a pathological process of the skin, there is the potential for a systemic overdose effect. Due to the systemic effects of minoxidil, the following very rare adverse events can occur:

Classification for Systems and Organs	References
Diseases of the nervous system
Very rare	Chief Minister
Systemic pathologies and conditions for administration
Very rare	Liquid retention resulting in weight gain
Heart disease
Very rare	Increased heart rate Hypotension

Accidental ingestion can cause systemic effects due to the vasodilating action of minoxidil (5 ml of solution contain 250 mg of minoxidil, or 2.5 times the maximum dose used for oral administration in adults treated for arterial hypertension). Treatment Treatment of minoxidil overdose should be symptomatic and supportive. Hydro/sodium retention can be treated with appropriate diuretics and tachycardia and angina with a beta-blocker or another sympathetic nervous system inhibitor. Syntomatic hypotension can be treated with an intravenous physiological solution. The use of sympathomimetics such as norepinephrine and adrenaline must be avoided due to excessive heart stimulation.

This drug is not indicated in women in fertile age. It should not be used in women who are, or may be, pregnant or nursing (see paragraph 4.1).

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Animal studies have shown a risk for fetus at exposure levels that are very high compared to those intended for human exposure. A low, although remote, risk of fetal damage is possible in man (see paragraph 5.3, Preclinical Safety Data). Minoxidil topical should be used during pregnancy only if the benefit for the mother justifies the potential risk for the fetus.

Food

Minoxidil absorbed by systemic way is excreted in breast milk. Minoxidil topical should be used during breastfeeding only if the benefit for the mother justifies the potential risk for the infant.

Fertility

In a fertility study conducted on male and female rats a dose-dependent reduction of the conception rate was observed (see paragraph 5.3). The potential risk in man is not known.

Source: Farmadati