CAREXIDIL SOLUZ CUT 60ML 2%

CAREXIDIL 2% SPRAY CUTANEO, SOLUTION

active ingredients

100 ml of Carexidil 2% skin spray, solution contain 2 g of minoxidil. Excipients with known effects: ethyl alcohol, propylene glycol For the full list of excipients, see paragraph 6.1.

Excellent

Ethyl alcohol 96%, propylene glycol and purified water.

Therapeutic indications

Carexidil is indicated in the symptomatic treatment of androgenic alopecia in men and women. Carexidil's effectiveness has not been determined in the following forms: localized or generalized congenital alopecia; alopecia cicatriziale of various nature (post-traumatic, of psychic or infectious origin); alopecia acute diffused by toxic substances, from medicines in which the regrowth of hair is conditioned by the suppression of the specific cause; celtic area.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Carexidil should not be used in the presence of coronaropathy, arrhythmia, congestive heart failure or valvulopathies. Do not use pregnant and nursing.

Population

Population Apply a dose of 1 ml of Carexidil twice a day, preferably in the morning and evening, on the affected areas of the scalp. The dose is independent from the size of the area to be treated. The total daily dose should not exceed 2 ml. Before you can expect evidence of hair growth, you may need to wait 3-4 months of applications twice a day. The beginning of these signs and their intensity vary from patient to patient. In all cases the doctor will have to assess the opportunity to suspend treatment if no therapeutic results are observed within 4 months. If a regrowth occurs, it is necessary to continue with the application of Carexidil twice a day so that hair growth continues. Relapse in pre-treatment after suspension of therapy occurs within 3-4 months. Special popularity The use of Carexidil is not recommended in patients over 55 years of age due to lack of data on safety and effectiveness. Pediatric population The use of Carexidil is not recommended in children under 18 years of age, due to the lack of data on safety and effectiveness. Method of administration Use Carexidil only by following the instructions. Apply Carexidil only on hair and scalp completely dry. Hair should not be washed after applying Carexidil. Do not apply Carexidil in other areas of the body. After applying Carexidil wash your hands carefully. During treatment with Carexidil, other hair cosmetic products can be used, following the instructions below: - use a delicate shampoo. - it is necessary to let Carexidil penetrate into the scalp before using products for hairstyle. Do not mix with other preparations to be applied on the scalp. - there is no information available on the possibility of treatment with hair dye or permanent alter the effect of Carexidil. However, in order to avoid possible irritation of the scalp, the patient must ensure that Carexidil was completely washed away from the hair and scalp before using these chemicals. Instructions for use 10 pulses equal to 1 ml of solution provided. Avoid the white polypropylene cap. Insert the spray applicator onto the bottle and screw firmly. Apply the extender to the stem, press to secure it firmly. Orient the extender to the area to be treated, spray once and distribute Carexidil with the fingertips on the area to be treated. Repeat the operation for a total of 10 times to reach the application of a dose of 1 ml solution. Avoid inhaling vapours.

Conservation

No special precaution for conservation.

Warnings

Patients who are expected to be subjected to Carexidil therapy must have an amnesium and be subjected to physical examinations. The doctor must understand that the patient has a normal and healthy scalp, for example not reddened, inflamed, infected, irritated or painful. Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or pizzas, caused by childbirth or when its cause is unknown. With the use of minoxidil, some patients have manifested changes in color and/or hair structure. An increase in hair loss may occur due to the action of hair mutation minoxidil from the rest telogen phase to the growth anagen phase (the old hair falls when new hair grows in their place). Generally this temporary fall increase occurs between two and six weeks after the start of treatment and is reduced within a couple of weeks (first sign of the effectiveness of minoxidil). If the fall persists, users must stop using Carexidil and consult the doctor. The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. In this case, stop the treatment and consult your doctor to establish suitable therapy. Although extensive clinical studies carried out with minoxidil have not shown that there is an absorption of this active ingredient sufficient to cause systemic effects, there is a certain absorption of minoxidil through the scalp and there is the potential risk of systemic effects such as salt and liquid retention, generalized and local edema, pericardial effusion, pericarditis, heart failure, tachycardia, angina or increase of blood pressure. In the presence of cardiovascular disorders, including hypertension, careful medical evaluation is necessary. The patient must stop using Carexidil and consult a doctor if hypotension is detected or if the patient manifests chest pain, acceleration of the heartbeat, weakness, dizziness, sudden and unexplained weight increase, swollen hands or feet, persistent redness, dermatological reactions or irritation of the scalp, or if other unexpected new symptoms occur (see paragraph 4). Patients with latent heart disease anamnesis should be warned that Carexidil may worsen these disorders. Patients must be periodically monitored to detect any suspicion of systemic effects caused by minoxidil. Accidental interference can cause serious heart failure. Patients should avoid inhaling the product when using the spray applicator. In the event of systemic side effects or dermatological reactions, suspend the administration of the drug. The growth of unnecessary hair can be caused by product transfer on areas other than scalp. Important information about some excipients Carexidil 2% skin spray, solution contains: § ethyl alcohol: can cause burning and irritation to the eyes. In case of accidental contact with sensitive surfaces (eyes, escoriate skin and mucous membranes), the area should be wet with large amounts of fresh tap water; § propylene glycol: may cause skin irritation.

Interactions

Carexidil should not be used in conjunction with other medicines applied at a topical level on the scalp (corticosteroids, tretinoin and antralin). Other interactions associated with the use of minoxidil are not currently known. Although it has not been clinically demonstrated, there is the possibility of increased orthostatic hypotension in patients with concomitant therapy with peripheral vasodilators.

Effects

The frequency of adverse reactions to minoxidil for topical use is defined by the following convection: very common (≥ 1/10); common (≥ 1/100, Reactions reported during clinical studies Minoxidil safety for skin use is based on data from 7 randomized clinical trials controlled with placebo in adults evaluating minoxidil solution 2% and 5% (Tabella1), and two randomized clinical trials controlled with placebo in adults evaluating a minoxidil skin foam 5% (Tabella 2).Table 1: reported adverse reactions recorded with a frequency ≥1% in adult subjects in treatment with Minoxidil with 2% or 5% solution per topical way, in randomized placebo trials.

Classification Organ Systems	Frequency
Adverse reactions
Systemic pathologies and conditions for administration
Peripheral edema	Municipalities
Diseases of the nervous system
Cefa	Very common
Respiratory, chest and mediastinic pathologies
Dispense	Municipalities
Pathologies of skin and subcutaneous tissue
Dermatitis, acneiform dermatitis, Hypertricosis, Prurite, Skin rash	Municipalities

Table 2: reported adverse reactions recorded with a frequency ≥1% in adult subjects in treatment with Minoxidil with 5% foam topic, in randomized placebo-controlled clinical trials.

Classification Organ Systems	Frequency
Adverse reactions
Diagnostic examinations
Increase in weight	Municipalities
Diseases of the nervous system
Cefa	Municipalities
Pathologies of skin and subcutaneous tissue
Prurito, Skin rash	Municipalities

Reactions reported during post-marketing experience In Table 3, the adverse reactions collected in the post-marketing experience frequenziate according to the incidence of spontaneous reports

Systemic organ classification	Frequency	Adverse reactions
Diseases of the nervous system
	Not common	Capogiro, Vertigine, Formicolio, Neurite, Alterations of taste, Sensation of burning.
Pathologies of the eye
	Not common	Visual disturbances
	Rare	Irritation of eyes
Ear and labyrinth pathologies
	Not common	Ear infection, Otite external.
Vascular diseases
	Municipalities	Hypertension
	Not common	Hypotension
Heart disease
	Rare	Palpitations, Tachycardia.
Gastrointestinal diseases
	Very rare	Nausea, Vomito.
Hepato-biliary diseases
	Rare	Hepatitis
Kidney and urinary pathologies
	Rare	Renal calculations
Pathologies of the reproductive apparatus and of the breast
	Rare	Sexual disorder
Pathologies of skin and subcutaneous tissue
	Not common	Irritation, Pain, Erythema, Edema Skin dequamation, Eczema, allergic reaction, Awareness, Orticaria, Generalized Erythema and Edema of the face. Dermatitis (including contact dermatitis, application location, allergic, atopic and seborrheic). Dryness of the skin (including dryness of the seat of application), Bubbles, Acne.
	Rare	Bleeding and ulceration, Vesiculation, Hair loss exacerbation, Alopecia.
	Very rare	Temporary loss of hair, Cambi in hair color, Abnormal hair structure.
Immune system disorders
	Very rare	Angioedema, hypersensitivity, contact dermatitis.
Systemic pathologies and conditions for administration
	Not common	Boldness
	Very rare	Thoracic pain

The nature and severity of the reactions detected are similar in the treatment with minoxidil at 2% and 5%, but their incidence is higher in the latter. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

If doses of Carexidil are higher than those recommended or on areas of the body other than scalp, an increase in systemic absorption of minoxidil may potentially occur. Accidental ingestion of minoxidil can lead to serious side effects. Following accidental ingestion, minoxidil is totally absorbed through the gastroenteric tract and can cause systemic effects related to its vasodilating action. Signs and symptoms of overdose from minoxidil are mainly cardiovascular type associated with hydro-sodium retention and can also occur tachycardia, hypotension, weakness and dizziness. Treatment Treatment of overdose from minoxidil must be symptomatic and supportive. Liquid retention can be treated with appropriate diuretic therapy. Tachycardia can be kept under control by administering a beta-blocking agent. Hypotension can be treated with intravenous administration of normal saline solution. Sympathomimetic action drugs, such as norepinephrine and adrenaline, should be avoided for their excessive heart stimulation activity.

Minoxidil should not be used in pregnancy and during breastfeeding and in women of fertile age who do not use anti-inflammatory drugs.

Pregnancy

There are no adequate and well-controlled studies on pregnant women. Animal studies showed a risk for fetus at much higher exposure levels than for human exposure (see paragraph 5.3). Potential risk in humans is not known.

Food

Systemic absorbed minoxidil is excreted in breast milk. The effect of minoxidil on infants/children is not known.

Fertility

There are no adequate and well-controlled studies on female fertility. Animal studies showed fertility toxicity, a reduction in conceptions and plant rates, as well as a reduction in the number of live offspring at much higher exposure levels than those intended for human exposure (see paragraph 5.3). Potential risk in humans is not known.

Source: Farmadati