MINOXIMEN SOLUZ FL 60ML 5%

MINOXIMEN 5% CUTANEA DEVELOPMENT

active ingredients

100 mL of skin solution contain: Active ingredient: minoxidil 5 g Excipient with known effects: propylene glycol For the full list of excipients see paragraph 6.1.

Excellent

Propylene glycol, alcohol, purified water.

Therapeutic indications

MINOXIMEN is indicated in the symptomatic treatment of androgenic alopecia. The effectiveness of MINOXIMEN in the following forms: localized congenital alopecia or ge–neralized; alopecia cicatritial of various nature (post–traumatic, of psychic or infectious origin); alopecia acute diffused by toxic substances, from medicines in which hair regrowth is conditioned by the suppression of the specific cause; celtic area. Moreover, the tolerance and effectiveness of MINOXIMEN in patients under the age of 18 and in patients over 55.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. MINOXIMEN should not be used in the presence of coronaropathy, arrhythmia, congestive heart failure or valvulopathy. In the face of other cardiovascular disorders, the use of MINOXIMEN is subordinate to the judgement of the doctor. Patients with hypertension, including those in treatment for such pathology, must be kept under strict medical control.

Population

ONLY FOR EXTERNAL USE. Use MINOXIMEN just following the instructions. Population A dose of 1 mL MINOXIMEN must be applied twice a day on the scalp, starting from the center of the sliced area. The dose is independent from the size of the area to be treated. The total daily dose should not exceed 2 mL. After applying MINOXIMEN wash your hands carefully. Apply MINOXIMEN only on hair and scalp completely dry. Do not apply MINOXIMEN in other areas of the body. The clinical experience gained with MINOXIMEN indicates that two-day applications lasting 3–4 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 pre-treatment after the suspension of therapy occurs within 3–4 months. Method of administration Precautions to be taken before the handling or administration of the medicinal product Unscrew the cap and insert the dropper. After filling it until 1 mL sign, apply some drops of MINOXIMEN on the scalp and distribute the liquid with the fingertips on the entire bald area. Repeat until all dose of 1 mL has been applied. At the end of use, firmly screw the dropper on the bottle.

Conservation

This medicine does not require any special condition of conservation. .

Warnings

Patients who are expected to subject to therapy with MINOXIMEN, must have a history and be subjected to physical examinations. The doctor should know that the patient has a normal scalp. Although extensive clinical studies carried out with MINOXIMEN have not shown that there is sufficient absorption of minoxidil to cause systemic effects, there is a certain absorption of minoxidil through the scalp and there is the potential risk of systemic effects such as salt and liquid retention, generalized and local edema, pericardial effusion, pericarditis, heart failure, tachycardia, angina orthostatic hypotension induced by anti-inflammatory drugs. Patients with latent heart disease anamnesis should be warned that MINOXIMEN can make these problems worse. Patients should be periodically monitored to detect any suspicion of systemic effects caused by minoxidil. In the event of systemic side effects or dermatological reactions, suspend the administration of the drug and consult your doctor. In experiments of carcinogenesis performed on rats and mice were reported cases of breast cancer in female mice and tumors of the adrenal glands and of the foreskin in male rats. However, there is no evidence that such results are predictives of similar risk to man. Keep the medicine out of reach of children. The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. In this case stop treatment and consult your doctor to establish suitable therapy. In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) Minoximen causes burning and irritation. Therefore, the area should be washed with plenty of fresh water.

Interactions

The effects of MINOXIMEN in patients with concomitant dermatological diseases, or patients in treatment with topical corticosteroid therapy or other dermatological preparations, are for the moment unknown. You do not know for the moment interactions associated with the use of MINOXIMEN. Although it has not been clinically demonstrated, there is the possibility of increased orthostatic hypotension in patients with concomitant therapy with peripheral vasodilators.

Effects

The most frequently occurring side effects during clinical studies with MINOXIMEN were minor dermatological reactions. The most common side effect was the local irritation, consisting of dequamation, erythitis, dermatitis, itching, dry skin, hypertricosis (in areas other than those treated with MINOXIMEN), burning sensation and rash. In a clinical study conducted with MINOXIMEN Skin solution at 5%, MINOXIMEN 2% cutaneous solution and placebo dermatological reactions, usually moderate entities, were more frequent in the group treated with the Solution at 5%. The nature and severity of the reactions in groups treated with the Solution at 2% and with the Solution at 5% were similar, but their incidence was higher in the latter. Other side effects, which are not frequently verified, include: allergic reactions (sensitivity, hives, generalized erythema and facial edema), dizziness, formicolii, cephalee, weakness, neuritis, edema, eczema, eye irritation, alteration of taste, ear infections (particularly external otititis) and visual disorders. Undesirable effects rarely verified include hair abnormality, hair loss exacerbation, alopecia, chest pain, blood pressure variations, heart rate variations, hepatitis, kidney stones and sexual dysfunctions. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Accidental ingestion of MINOXIMEN could lead to serious side effects. Following accidental ingestion, minoxidil is totally absorbed through the gastroenteric tract and can cause systemic effects related to its vasodilating action. The 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 b–blocker agent. Hypotension could be treated with intravenous administration of normal saline solution. Sympathomimetic action drugs, such as norepinephrine and adrenaline, should be avoided for their excessive heart stimulation activity.

The effects of MINOXIMEN pregnant are not known. Minoxidil administered by systemic means is excreted in human milk. MINOXIMEN should not be used in pregnant or nursing women.

Source: Farmadati