PHALANX*SPRAY 1FL 60ML 20MG/ML

PHALANX 20 mg/ml cutaneous spray, solution
Minoxidil
Generic medicine

What it is and what it is used for
PHALANX 20 mg/ml prevents hereditary hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair on already weakened or bald areas and thickens existing hair.
After application, PHALANX 20 mg/ml penetrates the scalp and reaches the hair roots.
The mechanism by which hair growth is stimulated has not yet been fully clarified. In any case, the active ingredient in PHALANX 20 mg/ml can stop hereditary hair loss by:
• increasing the diameter of the hair shaft
• stimulating growth
• prolonging the growth phases

However, at least 4 months are required before any results can be seen. If the hair roots are still present, thin and weak hair can regrow, which becomes longer, thicker, and darker over time. The initial hair growth rate or the amount of hair that regrows varies from patient to patient.
Large bald areas or hair loss present for more than 10 years are less sensitive to PHALANX 20 mg/ml.

The following figures show the stages of female and male pattern hair loss for which minoxidil, the active ingredient in PHALANX 20 mg/ml, has been shown to be effective.

Children and adolescents under 18 years of age, patients aged 65 and over
PHALANX 20 mg/ml should not be used in these patient groups, as no efficacy and safety results from controlled studies are available for these age groups.

What you need to know before taking the medicine
Do not use PHALANX 20 mg/ml:
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6)
- if you are using any other medicine on your scalp
- if you have any type of dressing or bandage on your scalp
- if you suffer from sudden or irregular hair loss
- if you are pregnant or breastfeeding
- if any condition affects your scalp, including psoriasis (an itchy inflammatory skin condition), sunburn, if your scalp is shaved or if the skin of your scalp is damaged by scars or burns, as hair roots are not present.

Warnings and precautions
Talk to your doctor or pharmacist before using PHALANX 20 mg/ml.

Hormonal causes, underlying diseases, or malnutrition must be ruled out. In these cases, you need specific treatment.

Apply PHALANX 20 mg/ml only to a normal and healthy scalp. You should not use PHALANX 20 mg/ml if the cause of your hair loss is unknown, or if your hair loss is due to childbirth, or if your scalp is red, inflamed, or sore.

If systemic effects or severe skin reactions occur, treatment should be discontinued.

PHALANX 20 mg/ml is for external use on the scalp only. Do not apply PHALANX 20 mg/ml to other parts of the body.

You should not use PHALANX 20 mg/ml:
• if you show any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are using medicines for the treatment of high blood pressure (antihypertensive agents).

You should stop treatment with PHALANX 20 mg/ml and contact a doctor:
• if you have been diagnosed with low blood pressure
• if one or more of these symptoms appear: chest pain, rapid heartbeat, weakness or dizziness, sudden and unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp, or if other unexpected new symptoms occur (see the section if you use more PHALANX 20 mg/ml than you should).

Product contact on areas other than the scalp may cause unwanted hair growth.

Isolated cases of slight changes in hair color have been reported in patients with very light hair or when using other hair care products at the same time, or after swimming in water with a high chlorine content (slight blonde discoloration).

Accidental ingestion can cause serious adverse effects on the cardiovascular system.
Therefore, you should keep this medicine out of the reach of children.

Avoid inhaling the nebulized spray.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as the safety and efficacy in this patient group have not been established.

Cases of excessive body hair growth in young children have been reported following contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returns to normal within a few months when young children are no longer exposed to minoxidil. Care should 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 body hair growth in your child while you are using topical minoxidil products.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor as soon as possible if you experience any of the following side effects - you may need urgent medical treatment.
• Swelling of the face, lips or throat which may make swallowing or breathing difficult. This may be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data)
• Generalized skin redness (frequency not known, cannot be estimated from the available data)
• Generalized itching (frequency not known, cannot be estimated from the available data)
• Narrowing of the throat (frequency not known, cannot be estimated from the available data)

Very common (may affect more than 1 in 10 people)
• Headache

Common (may affect up to 1 in 10 people)
• Itching
• Increased hair growth beyond the scalp (including facial hair growth in women)
• Inflammatory skin reaction (including acneiform eruption, rash)
• Shortness of breath, difficulty breathing
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning sensation, burning, dryness, itching, scaling and folliculitis

Uncommon (may affect up to 1 in 100 people)
• Dizziness, nausea

Not known (frequency cannot be estimated from the available data)
• Contact dermatitis (skin inflammation due to an allergy)
• Depressed mood
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Vomiting
• Symptoms at the administration site that may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin and inflammatory rash up to possible skin peeling, skin inflammation (dermatitis), blistering, bleeding and skin ulceration
• Temporary hair loss, changes in hair color, altered hair structure
• Chest pain.

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.