CUT SOLUZ 60ML 2%

MINOVITAL 20 MG/ML CUTAN EDUCATION

active ingredients

100 ml of skin solution contain: Active ingredient: Minoxidil 2,00 g Excipient with known effects: propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

100 ml of solution contain: purified water, ethyl alcohol, propylene glycol.

Therapeutic indications

MINOVITAL 20 mg/ml skin solution, is indicated in the symptomatic treatment of androgenic alopecia. The effectiveness of MINOVITAL has not been understood in the following forms: alopecia congenita localized or generalized, alopecia cicatriziale of various nature (traumatic post, 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

MINOVITAL is contraindicated in patients with anamnesi of hypersensitivity to minoxidil, propylene glycol or ethanol or any of the excipients listed in paragraph 6.1. MINOVITAL should not be used in the presence of coronaropathy, arrhythmia, congestive heart failure or valvulopathies. In the face of other cardiovascular disorders, the use of MINOVITAL is subject to the medical judgement.

Population

Only for external use. Use MINOVITAL only by following the instructions. A dose of 1 ml (20 drops) of MINOVITAL must be applied twice a day on the scalp, starting from the center of the affected area. The dose is independent from the size of the area to be treated. The total daily dose should not exceed 2 ml.Dopo have applied MINOVITAL, wash your hands carefully. Apply MINOVITAL only on hair and scalp completely dry. Do not apply MINOVITAL in other areas of the body. Do not use hair dryers to facilitate drying of MINOVITAL, since this system could decrease the effect of the product. The clinical experience gained with MINOVITAL indicates that bi daily applications lasting 3 to 4 months may be required before there are obvious signs of hair growth. 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 the treatment if no therapeutic results are observed within that period. Relapse in the pre-treatment state, following the suspension of therapy, occurs within 3– 4 months.

Conservation

This medicine does not require any special condition of conservation.

Warnings

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) MINOVITAL causes burning and irritation. Therefore the area must be washed abundantly with fresh water. Accidental ingestion of the solution could lead to serious side effects (see paragraph 4.9). Patients with hypertension, including those in treatment for such pathology, must be kept under strict medical control. The effects of MINOVITAL in patients with concomitant dermatological diseases or patients in treatment with topical corticosteroid therapy or other dermatological preparations, are for the moment unknown. It is not entirely clear if an occlusive bandage can increase the absorption of the drug. Keep out of reach of children. The safety and effectiveness of MINOVITAL in patients under the age of 18 and over 55 have not been established.

Interactions

You do not know for the moment interactions associated with the use of MINOVITAL. Although it has not been clinically demonstrated, there is the possibility of increased orthostatic hypotension in patients with guanetidine therapy.

Effects

The most frequently occurring side effects during clinical studies with MINOVITAL are represented by minor dermatological reactions. The most common side effect was the local irritation, consisting of desquamation, erythemitis, dermatitis, dry skin, hypertricosis (in areas other than those treated), burning sensation and rash. Other side effects, which were not frequently verified, included: allergic reactions (sensitivity, hives, generalized erythema and facial edema), dizziness, formicolii, headache, weakness, neuritis, edema, irritation to the eyes, alteration of taste, ear infection (particularly external otis) and visual disorders. Side effects rarely verified included abnormal hair, chest pain, blood pressure variations, heart rate variations, hepatitis and kidney stones. Allergic reactions, including angioedema – unknown frequency 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 www.aifa.gov.it/content/segnalazioni–reactions–adverse

Overdosing

Following accidental ingestion, minoxidil is totally absorbed through the gastroenteric tract and can cause systemic effects related to its vasodilating action (5 ml of MINOVITAL contain 100 mg of minoxidil, maximum administerable dose in adult subjects for the treatment of hypertension). Signs and symptoms of overdose of the drug would be with all probability cardiovascular effects associated with fluid retention, lowering blood pressure and tachycardia. Liquid retention can be treated with appropriate diuretic therapy. Tachycardia can be kept under control by administering a beta blocker agent. Hypotension could be treated with intravenous administration of normal saline solution. Sympathomimetic drugs, such as norepinephrine and epinephrine, should be avoided due to their excessive heart stimulating activity.

The effects of MINOVITAL used during pregnancy are not known. Minoxidil administered by systemic means is excreted in breast milk. MINOVITAL should not be used in pregnant or nursing women.

Source: Farmadati