Minovital*cut Soluz 60ml 2%

NAME
MINOVITAL 20 MG / ML SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Dermatological preparations.

ACTIVE PRINCIPLES
Minoxidil.

EXCIPIENTS
Purified water, ethyl alcohol, propylene glycol.

INDICATIONS
Symptomatic treatment of androgenic alopecia. The efficacy of the drug in the following forms has not been ascertained: localized or generalized congenital alopecia, cicatricial alopecia of various kinds (posttraumatic, psychic or infectious origin); acute alopecia diffused by toxic substances, from medicaments in which hair regrowth is conditioned by the suppression of the specific cause; area celsi.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to minoxidil, propylene glycol or ethanol or to any of the listed excipients; it should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valvular heart disease; in the face of other cardiovascular disorders, the use of the drug is subject to the judgment of the doctor.

DOSAGE
For external use only. Use the drug only according to the instructions. A dose of 1 ml (20 drops) of the medicine should be applied twice a day to the scalp, starting in 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 the product, wash your hands carefully. Apply the drug only on completely dry hair and scalp. Do not apply the medicine to other areas of the body. Do not use hair dryers to facilitate drying of the product, as this system may decrease the effect of the product. Clinical experience with the drug indicates that bi-daily applications lasting 3 - 4 months may be required before there are obvious signs of hair growth. The onset of such signs and their intensity vary from patient to patient. In all cases, the doctor will have to evaluate the opportunity to suspend the treatment if no therapeutic result is observed within this period. The relapse to the pre-treatment state, following discontinuation of therapy, occurs within 3 to 4 months.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) the drug 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. Patients with hypertension, including those being treated for this condition, should be closely monitored. The effects of the medicinal product in patients with concomitant dermatological diseases or patients receiving topical corticosteroid therapy or other dermatological preparations are currently unknown. It is not yet fully clear whether an occlusive dressing can increase drug absorption. The safety and efficacy of the product in patients aged less than 18 and over 55 have not been established.

INTERACTIONS
No interactions associated with the use of the drug are currently known. Although not clinically demonstrated, there is a potential for increased orthostatic hypotension in patients receiving concomitant therapy with guanethidine.

SIDE EFFECTS
The undesirable effects most 'frequently occurring during clinical trials with the drug are represented by minor dermatological reactions. The most frequent side effect was local irritation, consisting of peeling, erythema, dermatitis, scalp, hypertrichosis (in areas other than those treated), burning sensation and rash. Other side effects, which occurred infrequently, included: allergic reactions (sensitization, hives, generalized erythema and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eye irritation, taste disturbance, ear infection (particularly otitis external) and visual disturbances. Rarely occurring side effects included hair abnormalities, chest pains, blood pressure changes, heart rate changes, hepatitis and kidney stones. Allergic reactions, including angioedema - frequency not known. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The effects of the medicine used in pregnancy are not known. Systemically administered minoxidil is excreted in breast milk. The product should not be used in pregnant or lactating women.