Cutaneous solution for the treatment of alopecia 60ml

Product Description

MINOVITAL 20 mg/ml cutaneous solution is indicated for the symptomatic treatment of androgenic alopecia.

Indications

The efficacy of MINOVITAL has not been established in the following forms: localized or generalized congenital alopecia, cicatricial alopecia of various kinds (post-traumatic, psychological or infectious origin); acute diffuse alopecia caused by toxic substances, by medications in which hair regrowth is conditioned by the suppression of the specific cause; androgenic alopecia.

Composition

Active ingredients

100 ml of cutaneous solution contains: Active ingredient: Minoxidil 2.00 g Excipient with known effects: propylene glycol. For a full list of excipients, see section 6.1.

Excipients

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

Directions for use and Dosage

For external use only. Use MINOVITAL only according to the instructions. A dose of 1 ml (20 drops) of MINOVITAL should be applied twice daily to the scalp, starting from the center of the affected area. The dose is independent of the size of the area to be treated. The total daily dose should not exceed 2 ml. After applying MINOVITAL, wash your hands thoroughly. Apply MINOVITAL only to completely dry hair and scalp. Do not apply MINOVITAL to other areas of the body. Do not use hair dryers to facilitate drying of MINOVITAL, as this may reduce the product's effect. Clinical experience with MINOVITAL indicates that twice-daily applications for 3–4 months may be necessary before there are evident signs of hair growth. The onset of these signs and their intensity vary from patient to patient. In all cases, the physician should evaluate the opportunity to suspend treatment if no therapeutic results are observed within this period. Relapse to the pre-treatment state, following suspension of therapy, occurs within 3–4 months.

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 thoroughly with fresh water. Accidental ingestion of the solution could lead to serious side effects (see section 4.9). Patients suffering from hypertension, including those being treated for this condition, must be kept under close medical supervision. The effects of MINOVITAL in patients with concomitant dermatological diseases or patients being treated with topical corticosteroids or other dermatological preparations are currently unknown. It is not yet entirely clear whether an occlusive dressing can increase the absorption of the drug. Keep out of reach of children. The safety and efficacy of MINOVITAL in patients under 18 years of age and over 55 years of age have not been established.

Contraindications

MINOVITAL is contraindicated in patients with a history of hypersensitivity to minoxidil, propylene glycol, or ethanol, or to any of the excipients listed in section 6.1. MINOVITAL should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure, or valvular heart disease. In the case of other cardiovascular disorders, the use of MINOVITAL is subject to the physician's judgment.

Side effects

The most frequently observed side effects during clinical trials with MINOVITAL were minor dermatological reactions. The most frequent side effect was local irritation, consisting of scaling, erythema, dermatitis, dry skin, hypertrichosis (in areas other than those treated), burning sensation, and rash. Other side effects, which occurred infrequently, included: allergic reactions (sensitization, urticaria, generalized erythema, and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eye irritation, taste disturbance, ear infection (particularly otitis externa), and visual disturbances. Rarely occurring side effects included hair abnormalities, chest pain, changes in blood pressure, changes in heart rate, hepatitis, and kidney stones. Allergic reactions, including angioedema – frequency unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Following accidental ingestion, minoxidil is completely absorbed through the gastrointestinal tract and can cause systemic effects related to its vasodilatory action (5 ml of MINOVITAL contain 100 mg of minoxidil, the maximum dose that can be administered in adults for the treatment of hypertension). The signs and symptoms of drug overdose would most likely be cardiovascular effects associated with fluid retention, lowering of blood pressure, and tachycardia. Fluid retention can cause systemic effects related to its vasodilatory action. be treated with appropriate diuretic therapy. Tachycardia can be controlled by administering a beta-blocking agent. Hypotension may be treated with intravenous administration of normal saline solution. Drugs with sympathomimetic action, such as norepinephrine and epinephrine, should be avoided due to their excessive cardiac stimulatory effect.

Pregnancy and breastfeeding

The effects of MINOVITAL used during pregnancy are unknown. Minoxidil administered systemically is excreted in breast milk. MINOVITAL should not be used in pregnant or breastfeeding women.

Storage

This medicinal product does not require any special storage conditions.

Format

60 ml