PHALANX 50 MG/ML SKIN SPRAY SOLUTION 1 60 ML HDPE BOTTLE WITH 2 APPLICATORS

Name
PHALANX 50 mg/ml cutaneous spray, solution
Minoxidil
Equivalent medicine


What is it and what is it for?
PHALANX 50 mg/ml prevents hereditary hair loss in men aged 18 to 65 and stimulates hair growth. It also promotes new hair growth in already weakened or bald spots and thickens existing hair.
After application, PHALANX 50 mg/ml penetrates the scalp and reaches the hair roots.
The mechanism by which hair growth is stimulated has not yet been clarified. However, the active ingredient in PHALANX 50 mg/ml can stop hereditary hair loss through:
• the increase in the diameter of the hair shaft
• growth stimulation
• the prolongation of growth phases

However, at least four months are required before any results are seen. If the hair roots are still present, thin, weak hair may regrow, becoming 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 that has been present for more than 10 years are less sensitive to PHALANX 50 mg/ml.

The following figures show the stages of male pattern hair loss for which the effectiveness of minoxidil, the active ingredient in PHALANX 50 mg/ml, could be demonstrated.

Children and adolescents under 18 years of age, patients aged 65 years and over
PHALANX 50 mg/ml should not be used in these patient groups, as no efficacy and safety results from controlled studies in these age groups are available.

Women
For women, PHALANX 20 mg/ml is available (see also "What you need to know before you use PHALANX 50 mg/ml").


What you need to know before taking the medicine
Do not use PHALANX 50 mg/ml
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6)
- if you are a woman, as signs of facial hair growth, aesthetically traumatic and reversible, appear during treatment
- 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 any condition affects your scalp, including psoriasis (an itchy inflammatory skin condition), sunburn, if your scalp is shaved, or if the skin on your scalp is damaged by scarring or burns, as there are no hair roots.


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

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

Apply PHALANX 50 mg/ml only to a healthy, normal scalp. You should not use PHALANX 50 mg/ml if the cause of your hair loss is unknown or if your scalp is red, inflamed, or painful.
To date, there is no clinical experience regarding the effectiveness of the drug on hair loss in the temporal region (receding hairline).
If effects on internal organs (systemic effects) occur or if severe skin reactions occur, treatment should be discontinued.
PHALANX 50 mg/ml is for external use only on the scalp. Do not apply PHALANX 50 mg/ml to other parts of the body.

You should not use PHALANX 50 mg/ml
• if you experience any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are using medicines to treat high blood pressure (antihypertensive agents).

You should stop treatment with PHALANX 50 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 unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp or if any other new unexpected symptoms appear (see section “if you use more PHALANX 50 mg/ml than you should”).

Contact of the product on areas other than the scalp may cause unwanted hair growth.

Isolated cases of small changes in hair color have been reported in patients with very light hair or in case of concomitant use of hair care products, or after swimming in highly chlorinated water.

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

Avoid inhaling the mist spray.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as 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 once young children are no longer exposed to minoxidil. Care should 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 your child's body while using topical minoxidil products.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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 that may make swallowing or breathing difficult. This may be a sign of a serious allergic reaction (frequency not known, cannot be estimated from the available data).
• Generalized redness of the skin (frequency not known, cannot be estimated from the available data)
• Generalized itching (frequency not known, cannot be estimated from the available data)
• Throat tightening (frequency not known, cannot be estimated from the available data)

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

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, skin rash)
• Shortness of breath, difficulty breathing
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning, stinging, dryness, itching, flaking 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 (inflammation of the skin due to an allergy)
• Depressed mood
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Vomit
• Symptoms at the site of administration which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dryness of the skin and inflammatory rash up to possible peeling of the skin, inflammation of the skin (dermatitis), blistering, bleeding and ulceration of the skin
• Temporary hair loss, changes in hair color, altered hair texture
• Chest pain.

Reporting of side effects
If you experience 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.