Phalanx 50 mg/ml - spray lotion for the treatment of alopecia 60 ml

Product Description

Topical treatment for the treatment of androgenetic alopecia.

Indications

Phalanx 50 mg/ml is indicated for the treatment of androgenetic alopecia in men aged 18 to 65 years.

Composition

Active ingredients: 1 ml of solution contains 50 mg of minoxidil.
Excipients: Ethanol 96% (v/v) Propylene glycol Purified water.

Directions for use and Dosage

Apply 1 ml of Phalanx 50 mg/ml twice a day (morning and evening) to the affected areas of the scalp. The amount applied daily, i.e. 2 x 1 ml of solution, should not be exceeded, regardless of the size of the affected scalp area.
Paediatric population under 18 years of age and patients aged 65 years and over: Phalanx 50 mg/ml should not be used in these patient groups, as efficacy and safety results from controlled studies in these age groups are not available.
Special populations: There are no specific recommendations for use in patients with renal or hepatic impairment.
Women: For women, Phalanx 20 mg/ml is available.

Method of administration
Cutaneous use. Phalanx 50 mg/ml is for external use on dry scalp. The instructions for use must be followed carefully and application of the medicine to other parts of the body besides the scalp is contraindicated. Wash your hands thoroughly after applying Phalanx 50 mg/ml to avoid accidental contact with mucous membranes and eyes. After applying Phalanx 50 mg/ml, the hair should be styled as usual. However, the scalp should not be wet for approximately 4 hours. This will prevent Phalanx 50 mg/ml from being washed away.

Each pack of Phalanx 50 mg/ml contains 2 different pump-action spray applicators:

• A pre-assembled applicator for application to a large area
• A separate applicator with an extendable tip for larger areas ... small

Both applicators can be interchanged by detaching one applicator and replacing it with the other. For a 1 ml dose, 6 sprays are required.

Instructions for use/application: The solution is sprayed directly onto the scalp in the area of ​​hair loss. To do this, press the pump 6 times. After each application, the liquid should be distributed over the affected area with the fingertips, thus avoiding inhalation of the mist.

Duration of use: The onset and extent of hair growth differs from patient to patient. In general, treatment twice a day for 2-4 months is required before an effect is seen. To maintain the effect, it is recommended to continue with 2 applications per day, without interruption. Better results will not be achieved by applying larger amounts of Phalanx 50 mg/ml or by applying it more frequently. Regarding the possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to 1 year. If no effect is achieved after 4 months, treatment should be discontinued. In some patients, a temporary increase in hair loss has been observed 2 to 6 weeks after starting treatment. This effect is due to the fact that the resting phase (telogen phase) of the hair growth cycle is shorter in hair follicles treated with minoxidil and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hairs, which causes the "old" and inactive hairs to fall out of the scalp. This gives the initial impression of hair loss. However, this event is accompanied by increased hair regrowth. This effect subsides within a few weeks and may be prolonged. This may be interpreted as the first sign of minoxidil taking effect.

Too low a dose: If too little Phalanx 50 mg/ml is applied or if a dose is missed, the user should not make up for the missed dose. In this case, treatment should be continued at the recommended dose. Treatment should be continued to improve and maintain hair growth. Otherwise, hair loss may recur.

Warnings

The patient must have a normal, healthy scalp. Phalanx 50 mg/ml should not be used if the cause of hair loss is unknown, if the scalp is inflamed, or if it is red or painful. Phalanx 50 mg/ml is for external use on the scalp only. Do not apply Phalanx 50 mg/ml to other parts of the body. There is no clinical experience to date on its effectiveness on hair loss in the temporal region (receding hairline). Treatment with Phalanx 50 mg/ml should be initiated in patients with signs of cardiovascular disease or cardiac arrhythmias or in hypertensive patients, including patients being treated with antihypertensives. The patient should discontinue treatment with the medicine and consult a doctor if a drop in blood pressure occurs or if one or more of the following symptoms occur: chest pain, rapid heartbeat, weakness or dizziness, sudden and unexpected weight loss, swelling of the hands or feet, persistent redness or irritation of the scalp. Isolated cases of minor changes in hair color have been reported in patients with very light hair in conjunction with the use of hair care products or after swimming in highly chlorinated water. Accidental ingestion can cause serious cardiovascular adverse reactions. This medicine should therefore be kept out of reach of children. When treatment with minoxidil is stopped, hair loss may recur. Due to the ethanol and propylene glycol content of Phalanx 50 mg/ml, repeatedly spraying Phalanx 50 mg/ml onto the hair instead of the scalp may result in increased dryness and/or stiffness. Phalanx 50 mg/ml contains 96% ethanol and may cause pain and irritation to the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), these areas should be rinsed with plenty of water. Inhalation of the spray mist should be avoided. Propylene glycol may cause skin irritation.
For all information, read the package leaflet carefully.

Pregnancy and Breastfeeding

Phalanx 50 mg/ml is indicated for male patients only and should not be used in pregnant or breastfeeding women. Pregnancy: There are no adequate and well-controlled studies in women. Animal studies have shown a risk to the fetus at exposure levels much higher than those considered for human exposure. There is a potential risk of fetal harm in humans. Breastfeeding: Systemically absorbed minoxidil is excreted in human milk. The effect of minoxidil on newborns/infants is unknown.

Format

60 ml.