PHALANX SPRAY 3FL 60ML 20MG/ML

PHALANX 20 MG/ML SPRAY CUTANEO, DEAL

active ingredients

1 ml solution contains 20 mg of minoxidil. Excipients with known effects: 1 ml of solution contains 199 mg of propylene glycol (E 1520) and 494 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 20 mg/ml is indicated for the treatment of androgenic alopecia in women and men.

Contraindications

Phalanx 20 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. - use of occlusive bandage or other topical medical preparations on the scalp - sudden or irregular hair loss - in pregnant women - in case of breastfeeding - in users with any anomalous scalp (including psoriasis, solar erythema, shaved scalp or if the scalp is damaged by burns or scars).

Population

Population Apply 1 ml of Phalanx 20 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 20 mg/ml should not be used in these groups of patients, since there are no efficacy and safety results derived from studies controlled in these age groups. Method of administration Skin use. Before applying Phalanx 20 mg/ml you must ensure that the scalp is dry. Phalanx 20 mg/ml should not be applied in other parts of the body. Carefully wash your hands after applying Phalanx 20 mg/ml, to avoid accidental contact with mucosa and eyes. After applying Phalanx 20 mg/ml, hair can be hairstyled as usual. However, the scalp should not be wet for about 4 hours. This will prevent Phalanx 20 mg/ml from being washed away. Each Phalanx 20 mg/ml bottle contains 2 different pump spray applicators: - a pre-assembled applicator for application on an extended area - a separate applicator with an elongated end for smaller areas Both applicators can be exchanged by detaching an applicator and replacing it with the other. For a dose of 1 ml, 6 spray dispenses 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 extension of hair growth differ in individual patients. In general, treatment is required twice a day for 2-4 months before you can see an effect. To maintain the effect, it is recommended to continue the 2 applications per day, without interruption. No better results will be obtained by applying greater amounts of Phalanx 20 mg/ml or by applying it more frequently. Concerning the possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to 48 weeks. If you do not get the desired therapeutic response within 8 months, the treatment must be suspended. Too low dosage If a reduced amount of Phalanx 20 mg/ml is applied or if a dose is forgotten, the user should not compensate for the missed dose. In this case, you must continue the treatment with the recommended dose.

Conservation

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

Warnings

Before starting the treatment with Phalanx 20 mg/ml, the patient must be thoroughly examined and his anamnesi must be required. Endocrinological causes, underlying systemic diseases or malnutrition must be excluded. In these cases, if necessary, a specific treatment must be initiated. The patient must have a normal and healthy scalp. Phalanx 20 mg/ml should not be used if the cause of hair loss is not known, in case of post-partum alopecia, if the scalp is infected or if it is red or painful. Phalanx 20 mg/ml is to be considered only for external use on the scalp. Do not apply Phalanx 20 mg/ml on other parts of the body. The patient must stop the treatment with the medicinal product and consult a doctor if there is a reduction in blood pressure or if one or more of the following manifestations occur: chest pain, accelerated heartbeat, astenia or dizziness, sudden and inexplicable weight gain, swelling at hands or feet, persistent redness or irritation of the scalp or if new unexpected symptoms occur (see paragraph 4.8). In some patients, a temporary increase in hair loss from 2 to 6 weeks after treatment began. This effect is due to the fact that the rest phase (telogen phase) of the hair growth cycle is shortened in the hair follicles treated with minoxidil and the growth phase (anagen phase) is reached faster. This stimulates the growth of new hair that drop from the scalp those “old”, no longer active. This determines the initial impression of an increase in hair loss. However, this event is accompanied by a greater regrowth of hair. This effect is reduced within a few weeks and can be interpreted as a first signal of the effect of minoxidil. The contact of the medicinal product on areas other than scalp can cause unwanted growth of unnecessary hair. Treatment with Phalanx 20 mg/ml should not be undertaken in patients with signs of cardiovascular disease or heart arrhythmias or in hypertensive patients, including patients with antihypertensives. Insulated cases of small hair color changes were reported by patients with very clear hair in conjunction with the use of other hair care products or after swimming in high chlorine water. Involuntary ingestion can cause severe cardiovascular adverse reactions. This medicine must therefore be kept away from the reach of children. When treatment with minoxidil is stopped, a hair loss occurs again. Due to the content of ethanol and propilen glycol of Phalanx 20 mg/ml, repeatedly spray Phalanx 20 mg/ml on the hair instead of on the scalp can result in increased dryness and/or stiffness of the hair. Phalanx 20 mg/ml contains 96% ethanol and can cause burning and irritation to the eyes. In case of accidental contact at the level of sensitive areas (eyes, skin abrasions, mucous membranes), these must be rinsed with plenty of water. The inhalation of the spray must be avoided. This medicine contains 199 mg of propylene glycol (E 1520) in every ml of solution. This medicine contains 494 mg of alcohol (ethanol) in every ml of solution. It can cause burning sensation on damaged skin.

Interactions

Information on the interaction between Phalanx 20 mg/ml and other agents is not available today. Although not clinically proven, there is the theoretical possibility that absorbed minoxidil can enhance orthostatic hypotension in patients who take peripheral vasodilators simultaneously. Phalanx 20 mg/ml should not be used along with other dermatologic products, or with other agents that improve skin absorption. Studies of pharmacokinetic interaction in man have shown that percutaneous absorption of minoxidil is increased by tretinoin and ditranol as a result of an increased permeability of the corneo layer. Dipropionate betamethasone 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 side 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 20 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. As a result of an accidental ingestion, the concentration of the active ingredient of minoxidil in Phalanx 20 mg/ml can determine systemic effects corresponding to the pharmacological action of the active ingredient (2 ml Phalanx 20 mg/ml contain 40 mg of minoxidil, which is 40% of the recommended maximum daily dose for the treatment of hypertension). Signs and symptoms of intoxication from minoxidil would probably manifest as effects on the cardiovascular system along with salt and fluid retention, as well as tachycardia. If these symptoms occur as a result of accidental ingestion, the patient must seek immediate medical treatment. 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.

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). Phalanx 20 mg/ml should not be used in pregnant women.

Food

Systemic absorbed minoxidil is excreted in human milk. Minoxidil effect on infants/ infants is not known. Phalanx 20 mg/ml should not be used in nursing mothers.

Source: Farmadati