PHALANX SPRAY 1FL 60ML 50MG/ML

PHALANX 50 MG/ML SPRAY CUTANEO, DEAL

active ingredients

1 ml solution contains 50 mg of minoxidil. Excipients with known effects 1 ml of solution contains 509 mg of propylene glycol (E 1520) and 248 mg of ethanol. For the full list of excipients, see paragraph 6.1.

Excellent

Ethanol 96% (v/v), propylene glycol (E 1520), purified water

Therapeutic indications

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

Contraindications

Phalanx 50 mg/ml should not be used in the following cases: - hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1., - in women, due to possible signs of reversible and aesthetically distressing growth of facial hair during treatment - use of occlusive bandage or other topical medical preparations on the scalp, - sudden or irregular hair loss, - in users with any abnormality of the scalp (including psoriasis, solar erythema, scalp shaker or if the scalp is damaged).

Population

Population Apply 1 ml of Phalanx 50 mg/ml twice a day (mattin and evening) on the affected areas of the scalp. The quantity applied daily, i.e. 2 x 1 ml solution, should not be exceeded, regardless of the size of the scalp area concerned. Pediatric population under 18 years and patients aged 65 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. Method of administration Cutaneous use.Before applying Phalanx 50 mg/ml, ensure that the scalp is dry.Phalanx 50 mg/ml should not be applied to other parts of the body.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 can 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 bottle of Phalanx 50 mg/ml contains 2 different pump spray applicators: - A pre-assembled applicator for application to a large area - A separate applicator with an elongated tip for smaller areas Both applicators can be exchanged by detaching one applicator and replacing it with the other.For a dose of 1 ml, 6 spray actuations 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 must be distributed on the affected area with the tip of the fingers, thus avoiding the inhalation of the nebulization. Duration of use The onset and extent of hair growth differs in individual patients.In general, treatment 2 times daily for 2-4 months is required before an effect can be 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 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, treatment should be discontinued. Too low dosage 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.

Conservation

Don't refrigerate. Contains ethanol that is flammable. Store away from free heaters or flames.

Warnings

Before starting treatment with Phalanx 50 mg/ml, the patient should be thoroughly examined and his/her medical history should be taken.Endocrinological causes, underlying systemic diseases or malnutrition should be excluded.In these cases, specific treatment should be started if necessary.The patient should have a normal and healthy scalp.Phalanx 50 mg/ml should not be used if the cause of hair loss is unknown, if the scalp is infected or if it is red, inflamed 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.To date, there is no clinical experience on the efficacy of Phalanx 50 mg/ml on hair loss in the temporal region (receding hairline).The patient should stop treatment with the medicinal product and consult a doctor if a reduction in blood pressure is observed or if one or more of the following occurs: chest pain, rapid heartbeat, asthenia or dizziness, sudden and unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp or if new unexpected symptoms appear (see section 4.8).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 shortened in hair follicles treated with minoxidil and the growth phase (anagen phase) is reached more quickly.This stimulates the growth of new hairs, causing the “old”, no longer active, hairs to fall out of the scalp.This gives the initial impression of increased hair loss.However, this event is accompanied by increased hair regrowth.This effect wears off within a few weeks and can be interpreted as a first sign of the effect of minoxidil.Contact of the medicinal product on areas other than the scalp may cause unwanted hair growth.Treatment with Phalanx 50 mg/ml should not be undertaken in patients with signs of cardiovascular disease or cardiac arrhythmias or in hypertensive patients, including patients treated with antihypertensives.Isolated cases of small changes in hair colour have been reported in patients with very light hair in conjunction with the use of hair care products or after swimming in water with a high chlorine content.Inadvertent ingestion may cause serious cardiovascular adverse reactions.This medicinal product should therefore be kept out of the reach of children.When treatment with minoxidil is stopped, hair loss recurs.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 burning and irritation of the eyes.In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), these should be rinsed with plenty of water.Inhalation of the spray mist should be avoided.This medicinal product contains 509 mg of propylene glycol (E 1520) in each ml of solution.This medicinal product contains 248 mg of alcohol (ethanol) in each ml of solution.It may cause a burning sensation on damaged skin.

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 absorbed minoxidil may potentiate orthostatic hypotension in patients receiving concomitant peripheral vasodilators.Phalanx 50 mg/ml should not be used in conjunction with other dermatological products, or with other agents that enhance cutaneous absorption.Pharmacokinetic interaction studies in humans have shown that percutaneous absorption of minoxidil is increased by tretinoin and dithranol as a result of increased permeability of the stratum corneum.Betamethasone dipropionate increases the local tissue concentration of minoxidil and reduces systemic absorption.

Effects

The following frequencies are used for the evaluation of adverse reactions: Very common (≥ 1/10) Municipality (from ≥ 1/100 to Classification for systems and organs Frequency Action against Immune system disorders Notable Adverse reactions included angioedema (with symptoms such as lip edema, mouth, tongue and throat, swelling of lips, tongue and oropharynx) Hypersensitivity (including facial edema, generalized skin rash, generalized itching, swelling of the face and narrowing of the throat) Contact dermatitis Psychiatric disorders Notable Depressed humor Diseases of the nervous system Very common Cefa Not common Heads Pathologies of the eye Notable Eye irritation Heart disease Notable Tachycardia Palpitations Vascular diseases Town Hypertension Notable Hypotension Respiratory, chest and mediastinic pathologies Town Dispense Gastrointestinal diseases Not common Nausea Notable Vote Pathologies of skin and subcutaneous tissue Town Prurite, hypertricosis (including growth of facial hair in women), dermatitis, acneiform dermatitis, rash Local undesirable effects on scalp: pungent pain, burning, itching, dryness, desquamation and follicles Notable Symptoms in the home of administration that can also involve the ears and the face, such as itching, skin irritation, pain, redness, edema, skin dryness and rash until exfoliation, dermatitis, vesicles formation, bleeding and ulceration. Notable Temporary loss of hair Change of hair color Alteration of hair structure Systemic pathologies and conditions for administration Town Peripheral edema Notable Thoracic pain Diagnostic examinations Town Increase in weight Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms of Intoxication The application of Phalanx 50 mg/ml to a higher dosage than recommended and on a relatively large body surface or in areas other than scalp can lead to a possible increase in systemic absorption of minoxidil. To date, there were no known cases in which topical use of minoxidil solution caused an intoxication. Following an accidental ingestion, the concentration of the active ingredient 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: Heart disease: accelerated heartbeat, hypotension Systemic pathologies: fluid accumulation and consequent sudden weight gain Diseases of the nervous system: headmen Treatment of intoxication Clinically significant tachycardia can be controlled with β-blockers and edema with diuretics. Excessive increase in blood pressure can be treated with intravenous infusion of saline physiological solution. Sympathomimetics such as adrenaline and norepinephrine should be avoided due to their excessive cardiotonic effect.

Phalanx 50 mg/ml is indicated only in male patients and should not be used in pregnant women or nursing mothers.

Pregnancy

No adequate and well-controlled studies are available in pregnant women. Animal studies have shown a risk for fetus at very high exposure levels compared to those considered for human exposure. There is potentially a risk of fetal damage in man (see paragraph 5.3).

Food

Systemic absorbed minoxidil is excreted in human milk. Minoxidil effect on infants/ infants is not known.

Source: Farmadati