Phalanx Spray 3 Bottles of 60ml 50mg / ml

Phalanx Spray

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

Dosage and method of use

Posology Apply 1 ml of Phalanx 50 mg / ml twice a day (in the morning and in the evening) on 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. Pediatric population below 18 years of age and patients aged 65 years and over Phalanx 50 mg / ml should not be used in these patient groups as no efficacy and safety results are available from controlled studies in these age groups. 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 should be followed carefully and applying the medicine to other parts of the body besides the scalp is contraindicated. Wash 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 about 4 hours. This will prevent Phalanx 50 mg / ml from being washed off. Each pack of Phalanx 50 mg / ml contains 2 different pump spray applicators: - A pre-assembled applicator for application over 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 1 ml dose, 6 puffs of the spray are required. Instructions for use / application The solution is sprayed directly on 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 nebulization. Duration of use The onset and extent of hair growth differ in individual patients. Generally, treatment done twice a day for 2-4 months is required before you can see an effect. 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 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 obtained after 4 months, the treatment should be stopped. 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 hair which causes the “old”, no longer active ones to fall out of the scalp. This creates the initial impression of hair loss. However, this event is accompanied by increased hair regrowth. This effect subsides within a few weeks and can be interpreted as the first sign of the effect of minoxidil. Too low dosage If too little Phalanx 50 mg / ml is applied or a dose is missed, the user does not need to make up for the missed dose. In this case, treatment should be continued with the recommended dose. It is necessary to continue the treatment to improve and maintain hair growth. Otherwise, hair loss may occur again.

Contraindications

Phalanx 50 mg / ml must not be used in the following cases: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1., - in women, due to possible signs of reversible and aesthetically traumatic growth of facial hair, during the treatment - concomitant use of occlusive dressing or other medical preparations for topical use on the scalp, - sudden or irregular hair loss, - in users with any scalp abnormality (including psoriasis, sunburn, shaved scalp or in the case of which the scalp is affected by burns or scars).

Side effects

The following frequencies are used for the assessment of adverse reactions: Very common (≥1 / 10) Common (≥1 / 100 to <1/10) Uncommon (≥1 / 1,000 to <1/100) Rare (≥1 / 1,000 to <1/100) ≥1 / 10,000 to <1/1000) Very rare (<1/10000) Not known (cannot be estimated from the available data). The safety of minoxidil for topical use established through clinical trials is based on data from 7 randomized placebo-controlled trials in adults evaluating both minoxidil 20 mg / ml solution and 50 mg / ml solution and 2 randomized placebo-controlled clinical trials in adults. which evaluate 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 suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

The patient must have a normal and healthy scalp. Phalanx 50 mg / ml should not be used if the cause of the 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 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 on antihypertensive treatment. The patient should stop treatment with the medicinal product and consult a physician if a decrease in blood pressure occurs (see section 4.8) or if one or more of the following 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. There have been isolated reports of minor hair color changes from patients with very light hair in conjunction with the use of hair care products or after swimming in high chlorine water. Inadvertent ingestion can cause severe cardiovascular adverse reactions. This medicinal product should therefore be kept out of the reach of children. When minoxidil treatment is stopped, hair loss can occur again. Due to the ethanol and propylene glycol content of Phalanx 50 mg / ml, repeatedly spraying Phalanx 50 mg / ml on the hair instead of the scalp can lead to increased dryness and / or stiffness of the hair. Phalanx 50 mg / ml contains 96% ethanol and may cause eye pain and irritation. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), these areas must be rinsed with plenty of water. Inhalation of the mist spray should be avoided. Propylene glycol can cause skin irritation.

Pregnancy and breastfeeding

Phalanx 50 mg / ml is indicated for male patients only and must 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 very high exposure levels compared to those considered for human exposure. There is potentially a risk of fetal harm in humans (see section 5.3). Breastfeeding Systemically absorbed minoxidil is excreted in human milk. The effect of minoxidil on newborns / infants is unknown.

Expiry and retention

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

Interactions with other drugs

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 absorption of minoxidil may potentiate orthostatic hypotension in patients concomitantly taking peripheral vasodilators. Phalanx 50 mg / ml should not be used together with other dermatological products (corticosteroids for external use, retinoids, anthralin, etc.), or with other agents that improve skin absorption.

Overdose

Symptoms of intoxication Application of Phalanx 50 mg / ml at a higher dosage than recommended and on a relatively large body surface or in areas other than the scalp may lead to a possible increase in systemic absorption of minoxidil. To date, there have been no known cases in which the topical use of monoxidil solution has caused intoxication. Following accidental ingestion, the concentration of the active component of minoxidil in Phalanx 50 mg / ml can determine 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: rapid heart rate, hypotension General disorders: fluid accumulation and subsequent sudden weight loss Nervous system disorders: dizziness Treatment of intoxication Clinically significant tachycardia may be controlled with β-blockers and edema with diuretics. An excessive increase in blood pressure can be treated with intravenous infusion of physiological saline. Sympathomimetics such as adrenaline and noradrenaline should be avoided due to their excessive cardiotonic effect.

Active principles

1 ml of solution contains 50 mg of minoxidil. Excipient with known effect: 509 mg / ml of propylene glycol. For the full list of excipients, see section 6.1.

Excipients

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

Format

3 bottles of 60ml.