Minoximen*soluz Fl 60ml 5%

NAME
MINOXIMEN 5% SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Dermatological preparations.

ACTIVE PRINCIPLES
100 mL of cutaneous solution contains: minoxidil 5 g.

EXCIPIENTS
Propylene glycol, alcohol, purified water.

INDICATIONS
Symptomatic treatment of androgenic alopecia. The efficacy in the following forms has not been ascertained: localized ogeA-neralized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychic or infectious origin); acute alopecia diffused by toxic substances, by medicaments in which hair regrowth is conditioned by the suppression of the specific cause; area celsi. Furthermore, the tolerability and efficacy in diet patients under the age of 18 and in patients over the age of 55 have not been established.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. The medicine should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valvulopathies. In contrast to other cardiovascular disorders, its use is subject to the judgment of the physician. Patients with hypertension, including those being treated for this condition, should be closely monitored.

DOSAGE
For external use only. Use only in accordance with the instructions. A 1mL dose 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 wash your hands carefully. Apply only to completely dry hair and scalp. Do not apply to other areas of the body. Clinical experience indicates that bi-daily applications lasting 3-4 months may be required before there are obvious signs of hair growth. The onset of these 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. Relapse to the pretreatment state following discontinuation of therapy occurs within 3-4 months. Unscrew the cap and insert the dropper. After filling it up to the 1 mL mark, apply a few drops to the scalp and distribute the liquid with your fingertips over the entire bald area. Repeat until the full 1 mL dose has been applied. After use, screw the dropper firmly onto the bottle.

STORAGE
This medicine does not require any special storage conditions..

WARNINGS
Patients who are planned to undergo therapy with the drug must have a medical history and undergo physical examinations. The doctor should ascertain that the patient has a normal scalp. Although extensive clinical studies have not shown that there is sufficient absorption of minoxidil 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 edema and local, pericardial effusion, pericarditis, cardiac tamponade, tachycardia, angina or increased orthostatic hypotension induced by antihypertensive drugs such as guanethidine and derivatives. Patients with a history of underlying heart disease should be warned that the drug may worsen these disorders. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. In the event of undesirable systemic effects or dermatological reactions, discontinue administration of the drug and consult your doctor. Cases of mammary tumors in female mice and tumors of the adrenal glands and foreskin in male rats have been reported in carcinogenicity experiments performed on rats and mice. However, there is no evidence that these results predict a similar risk for humans. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, interrupt the treatment and consult the doctor to establish a suitable therapy. In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) the product causes burning and irritation. Therefore, the area should be washed with plenty of fresh water.

INTERACTIONS
The effects in patients with concomitant dermatological diseases, or patients receiving topical corticosteroid therapy or other dermatological preparations, are currently unknown. No interactions associated with the use of the product are currently known. Although not clinically demonstrated, there is a potential for increased orthostatic hypotension in patients receiving concomitant therapy with peripheral vasodilators.

SIDE EFFECTS
The most frequent side effects that occurred during clinical studies were minor dermatological reactions. The most frequent side effect was local irritation, consisting of peeling, erythema, dermatitis, itching, dry skin, hypertrichosis (in areas other than those treated), burning sensation and rash. In a clinical study conducted with the 5% cutaneous solution, the 2% cutaneous solution and placebo, dermatological reactions, generally of moderate entity, were more frequent in the group treated with the 5% solution. The nature and severity of the reactions arising in the groups treated with the 2% Solution and with the 5% Solution were similar, but their incidence was higher in the latter. Other undesirable effects, occurring infrequently, include: allergic reactions (sensitization, hives, generalized erythema and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eczema, eye irritation, taste disturbance, ear infections (particularly otitis externa) and visual disturbances. Rarely unwanted effects include hair abnormalities, exacerbation of hair loss, alopecia, chest pain, blood pressure changes, heart rate changes, hepatitis, kidney stones and sexual dysfunction. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
Effects in pregnancy are not known. Systemically administered minoxidil is excreted in human milk. The product should not be used in pregnant or lactating women.