Carexidil 5% 60 ml cutaneous spray solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

100 ml of carexidil 5% skin spray, solution contains 5 g of minoxidil. Excipients with known effects: ethyl alcohol For the full list of excipients, see section 6.1.

EXCIPIENTS

Ethyl alcohol (96%), glycerol, 2-butenedioic acid polymer with methoxyethene, monobutyl ester and purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to minoxidil or to any of the excipients listed in paragraph 6.1 Carexidil must not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valve disease. Do not use during pregnancy and breastfeeding.

DOSAGE

Dosage Apply a dose of 1 ml of Carexidil twice a day, preferably in the morning and evening, to the affected areas of the scalp. The dose is independent of the size of the area to be treated. The total daily dose should not exceed 2 ml. Before evidence of hair growth can be expected, it may be necessary to wait 3-4 months of twice daily applications. The onset of these signs and their intensity vary from patient to patient. In all cases, the doctor must evaluate the opportunity to suspend treatment if no therapeutic result is observed within 4 months. If regrowth occurs, you must continue applying Carexidil twice daily for hair growth to continue. Relapse to the pre-treatment state following discontinuation of therapy occurs within 3-4 months. Special populations The use of Carexidil is not recommended in patients over 55 years of age due to a lack of data on safety and efficacy. Pediatric population The use of Carexidil is not recommended in children under 18 years of age, due to a lack of data on safety and efficacy. Method of administration Use Carexidil only as directed. Apply Carexidil only to completely dry hair and scalp. Hair should not be washed after applying Carexidil. Do not apply Carexidil to other areas of the body. After applying Carexidil, wash your hands carefully. During treatment with Carexidil, other cosmetic hair products can be used, following the instructions below: - use a delicate shampoo. - it is necessary to allow Carexidil to penetrate the scalp before using hair styling products. Do not mix with other preparations to be applied to the scalp. - there is no information available on whether treatments with hair dye or permanent alter the effect of Carexidil. However, to avoid possible scalp irritation, the patient should ensure that Carexidil has been completely washed off the hair and scalp before using these chemicals. Instructions for use 10 pulses are equivalent to 1 ml of solution delivered. Unscrew 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. Direct the extender towards the area to be treated, spray once and distribute Carexidil with your fingertips on the area to be treated. Repeat the operation a total of 10 times to achieve the application of a dose of 1 ml of solution. Avoid inhaling vapours.

CONSERVATION

No special precautions for storage.

WARNINGS

Patients who are scheduled to undergo therapy with Carexidil should have a medical history and undergo physical examinations. The doctor should determine that the patient has a normal, healthy scalp, such as not red, inflamed, infected, irritated, or painful. Minoxidil is not indicated when there is no family history of hair loss, the hair loss is sudden and/or patchy, caused by childbirth, or when its cause is unknown. With the use of minoxidil, some patients have experienced changes in the color and/or texture of their hair. Increased hair loss may occur due to minoxidil's action of changing hair from the resting telogen phase to the anagen growth phase (old hair falls out as new hair grows in its place). Generally this temporary increase in hair loss occurs between two and six weeks after starting treatment and reduces within a couple of weeks (first sign of minoxidil's effectiveness). If hair loss persists, users should stop using Carexidil and consult their doctor. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, stop treatment and consult your doctor to institute suitable therapy. Although extensive clinical studies with minoxidil have not demonstrated that there is sufficient absorption of this active ingredient to cause systemic effects, some absorption of minoxidil occurs through the scalp and there is a potential risk of systemic effects such as salt and fluid retention, generalized and local edema, pericardial effusion, pericarditis, cardiac tamponade, tachycardia, angina or increased orthostatic hypotension induced by antihypertensive drugs such as guanethidine and derivatives. In the presence of cardiovascular disorders, including hypertension, careful medical evaluation is necessary. The patient should stop using Carexidil and consult a doctor if hypotension is detected or if the patient experiences chest pain, rapid heartbeat, weakness, dizziness, sudden and unexplained weight gain, swollen hands or feet, persistent redness, dermatological reactions or scalp irritation, or if other unexpected new symptoms occur (see section 4.8). Patients with a history of underlying cardiac disorders should be warned that Carexidil may worsen these disorders. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. Accidental ingestion may cause serious cardiac adverse events. Patients should avoid inhaling the product when using the spray applicator. In the event of systemic side effects or dermatological reactions, discontinue administration of the drug. Unwanted hair growth may be caused by transfer of the product to areas other than the scalp. Important information about some excipients Carexidil 5% skin spray, solution contains: § ethyl alcohol: may cause burning and irritation of the eyes. In case of accidental contact with sensitive surfaces (eyes, abraded skin and mucous membranes), the area should be wetted with large quantities of fresh tap water

INTERACTIONS

Carexidil should not be used concomitantly with other medicines applied topically to the scalp (corticosteroids, tretinoin and antralin). No other interactions associated with the use of minoxidil are currently known. Although not demonstrated clinically, there is a potential for increased orthostatic hypotension in patients receiving concomitant therapy with peripheral vasodilators.

SIDE EFFECTS

The frequency of adverse reactions to minoxidil for topical use is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data). Adverse reactions reported during clinical trials The safety of minoxidil for cutaneous use is based on data from 7 randomized placebo-controlled clinical trials in adults evaluating minoxidil 2% and 5% solution (Table 1), and two randomized placebo-controlled clinical trials in adults evaluating minoxidil cutaneous foam 5% (Table 2).Table 1: Adverse reactions recorded with a frequency ≥1% in adult subjects treated with Minoxidil with 2% or 5% solution topically, in randomized placebo-controlled clinical trials are reported.

Adverse reactions - Frequency: Frequency.

Systemic pathologies and conditions relating to the administration site.

Peripheral edema - Frequency: Common.

Nervous system disorders.

Headache - Frequency: Very common.

Respiratory, thoracic and mediastinal disorders.

Dyspnea - Frequency: Common.

Pathologies of the skin and subcutaneous tissue.

Dermatitis, Dermatitis acneiform, Hypertrichosis, Pruritus, Rash - Frequency: Common.

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

Adverse reactions - Frequency: Frequency.

Diagnostic tests.

Weight gain - Frequency: Common.

Nervous system disorders.

Headache - Frequency: Common.

Pathologies of the skin and subcutaneous tissue.

Itching, Rash - Frequency: Common.

Adverse reactions reported during post-marketing experience Nella Table 3, the adverse reactions collected in post-marketing experience are reported, frequency based on the incidence of spontaneous reports

Nervous system disorders.

Frequency: Uncommon. Adverse reactions: Dizziness, Vertigo, Tingling, Neuritis, Taste changes, Burning sensation.

Eye pathologies.

Frequency: Uncommon. Adverse reactions: Visual disturbances.

Frequency: Rare. Adverse reactions: Eye irritation.

Ear and labyrinth disorders.

Frequency: Uncommon. Adverse reactions: Ear infection, Otitis externa.

Vascular pathologies.

Frequency: Municipalities. Adverse reactions: Hypertension.

Frequency: Uncommon. Adverse reactions: Hypotension.

Cardiac diseases.

Frequency: Rare. Adverse reactions: Palpitations, Tachycardia.

Gastrointestinal disorders.

Frequency: Very rare. Adverse reactions: Nausea, Vomiting.

Hepatobiliary disorders.

Frequency: Rare. Adverse reactions: Hepatitis.

Renal and urinary disorders.

Frequency: Rare. Adverse reactions: Kidney stones.

Reproductive system and breast disorders.

Frequency: Rare. Adverse reactions: Sexual dysfunction.

Pathologies of the skin and subcutaneous tissue.

Frequency: Uncommon. Adverse reactions: Irritation, Pain, Erythema, Edema Skin scaling, Eczema, Allergic reaction, Sensitization, Urticaria, Generalized erythema and Edema of the face. Dermatitis (including contact, application site, allergic, atopic and seborrheic dermatitis). Dry skin (including application site dryness), Blisters, Acne.

Frequency: Rare. Adverse reactions: Bleeding and ulceration, Vesiculation, Exacerbation of hair loss, Alopecia.

Frequency: Very rare. Adverse reactions: Temporary hair loss, Changes in hair color, Abnormal hair structure.

Immune system disorders.

Frequency: Very rare. Adverse reactions: Angioedema, Hypersensitivity, Contact dermatitis.

Systemic pathologies and conditions relating to the administration site.

Frequency: Uncommon. Adverse reactions: Weakness.

Frequency: Very rare. Adverse reactions: Chest pain.

The nature and severity of the reactions detected are similar in the treatment with 2% and 5% minoxidil, but their incidence is higher in the latter. 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 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-sospetti-reazione-avversa

OVERDOSE

If higher than recommended doses of Carexidil are applied or to areas of the body other than the scalp, increased 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 gastrointestinal tract and can cause systemic effects related to its vasodilatory action. The signs and symptoms of minoxidil overdose are mainly cardiovascular associated with sodium and fluid retention and tachycardia, hypotension, weakness and dizziness may also occur. Treatment Treatment of minoxidil overdose should be symptomatic and supportive. Fluid retention can be treated with appropriate diuretic therapy. Tachycardia can be controlled by administering a beta-blocking agent. Hypotension can be treated with intravenous administration of normal saline. Drugs with sympathomimetic action, such as norepinephrine and adrenaline, must be avoided due to their excessive cardiac stimulating activity.

PREGNANCY AND BREASTFEEDING

Carexidil should not be used during pregnancy and breastfeeding and in women of childbearing age who do not use contraceptives. Pregnancy There are no adequate and well-controlled studies in pregnant women. Animal studies have shown a risk to the fetus at exposure levels much higher than those intended for human exposure (see section 5.3). The potential risk in humans is unknown. Breastfeeding Systemically absorbed minoxidil is excreted in breast milk. The effect of minoxidil on newborns/children is unknown. Fertility There are no adequate and well-controlled studies regarding female fertility. Animal studies have shown fertility toxicity, a reduction in conception and implantation rates, as well as a reduction in the number of live offspring at exposure levels much higher than those intended for human exposure (see section 5.3). The potential risk in humans is unknown.

EFFECTS ON DRIVING ABILITY

Based on the pharmacodynamics and overall safety profile of minoxidil, Carexidil is not expected to interfere with the ability to drive or use machinery.