Phalanx 50mg/ml spray - alopecia treatment 3 bottles 60 ml

Product Description

Treatment of androgenetic alopecia in men aged 18 to 65 years.

Indications

Phalanx 50 mg/ml cutaneous spray, solution for the treatment of androgenetic alopecia.

Composition

Active ingredients

1 ml of solution contains 50 mg of minoxidil.

Excipients

Ethanol 96% (v/v)
Propylene glycol
Purified water

Excipient with known effect: 509 mg/ml of propylene glycol.

Directions for use and Dosage

Dosage Apply 1 ml of Phalanx 50 mg/ml twice daily (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 smaller areas Both applicators can be interchanged by detaching one applicator and replacing it with the other.
For a dose of 1 ml, 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 daily 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 obtained by applying larger quantities 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 no longer active hairs to fall out from 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. be interpreted as the first sign of minoxidil taking effect.
Too low 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 occur again.

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 the efficacy of Phalanx on temporal hair loss (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 decrease in blood pressure occurs or if one or more of the following symptoms occur: chest pain, rapid heartbeat, asthenia or dizziness, sudden and unexpected weight loss, swelling of the hands or feet, persistent redness or irritation of the scalp.
Isolated cases of small 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.
Inadvertent ingestion can cause serious cardiovascular adverse reactions.
This medicine should therefore be kept out of the 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 of the hair.
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 irritation. cause skin irritation.

Contraindications

Phalanx 50 mg/ml should not be used in the following cases:

• hypersensitivity to the active substance or to any of the excipients.
• in women, due to possible signs of reversible and aesthetically traumatic facial hair growth during treatment.
• concomitant use of occlusive dressings or other topical medical preparations on the scalp,
• sudden or irregular hair loss.
• in users with any scalp abnormalities (including psoriasis, sunburn, shaved scalp or if the scalp is affected by sunburn or scarring).

Interactions

To date, no information is available on the interaction between Phalanx 50 mg/ml and other agents.
Although not clinically proven, there is a theoretical possibility that minoxidil absorption may potentiate orthostatic hypotension in patients concomitantly taking peripheral vasodilators.
Phalanx 50 mg/ml should not be used in conjunction with other dermatological products (external corticosteroids, retinoids, anthralin, etc.), or with other agents that enhance absorption from the skin.

Undesirable effects

The following frequencies are used to evaluate adverse reactions:

Very common (>1/10)
Common (>1/100 to <1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10000)
Not known (frequency cannot be estimated from the available data).

The safety of topical minoxidil established through clinical studies is based on data from 7 randomized, placebo-controlled clinical studies in adults evaluating both minoxidil 20 mg/ml solution and 50 mg/ml solution and 2 randomized, placebo-controlled clinical studies in adults evaluating the 50 mg/ml foam formulation.
Adverse drug reactions during clinical trials and post-marketing experience with minoxidil are included in the table below.

Reporting of adverse reactions suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdose

Symptoms of intoxication The application of Phalanx 50 mg/ml at a higher dose than recommended and over a relatively large body surface area or in areas other than the scalp may lead to a possible increase in the systemic absorption of minoxidil.
To date, there have been no known cases in which topical use of minoxidil solution has caused intoxication.
Following accidental ingestion, the concentration of the active minoxidil component in Phalanx 50 mg/ml may cause systemic effects corresponding to the pharmacological action of the active ingredient (2 ml of Phalanx 50 mg/ml contain 100 mg of minoxidil, which is equivalent to the maximum recommended daily dose for the treatment of hypertension).
Due to the systemic effects of minoxidil, the following adverse reactions may occur: Cardiac disorders: accelerated heartbeat, hypotension Systemic disorders: fluid accumulation and subsequent sudden weight loss Nervous system disorders: dizziness.
Treatment of intoxication Clinically significant tachycardia can be controlled with beta-blockers and edema with diuretics.
An excessive increase in blood pressure can be treated with intravenous infusion of physiological saline solution.
Sympathomimetics such as adrenaline and noradrenaline should be avoided due to their excessive cardiotonic effect.

Pregnancy and breastfeeding

Phalanx 50 mg/ml is indicated in 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.

Storage

Do not refrigerate.
Contains ethanol, which is flammable.
Keep away from heat sources or naked flames.

Format

Skin Spray Solution 3 60 ml HDPE Bottles with 2 Applicators.