MINOXIMEN SOLUZ FL 60ML 2%

MINOXIMEN 2% CUTAIN DEAL

active ingredients

100 ml of skin solution contain: Active ingredient: minoxidil 2 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 or generalized congenital alopecia; 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 subjects under the age of 18 and in patients over the age of 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 presence of other cardiovascular disorders, including hypertension, the use of MINOXIMEN is subordinate to the judgement of the doctor. Do not use in case of pregnancy and nursing.

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 up to the sign of 1 ml, apply some drops of MINOXIMEN on the scalp and distribute the liquid with the fingertips on the entire bald area. Repeat until the whole dose of 1 ml has been applied. At the end of use, firmly screw the dropper on the bottle. Useful tips • Apply MINOXIMEN twice a day, preferably in the morning and in the evening. • Distribute the specialty throughout the area concerned. • In case of hair washing, it must be carried out exclusively before the application of MINOXIMEN. • Before applying MINOXIMEN, make sure the scalp is perfectly dry. • During treatment with MINOXIMEN it is not necessary to change their hygiene habits regarding the scalp. However, it is advisable to use a delicate shampoo. • If inadvertently the application of MINOXIMEN was interrupted for 1 or 2 days, resume the treatment following the posological scheme provided in the illustrative sheet (1 ml of MINOXIMEN twice a day).

Conservation

This medicine does not require any special condition of conservation.

Warnings

Before starting treatment with MINOXIMEN, the user must check that the scalp is intact and healthy. Stop the treatment and consult a doctor if they show up: chest pain, tachycardia, weakness or dizziness, sudden and unexplained weight gain or swelling in the hands and/or feet, or in case of persistent redness or irritation of the scalp. Despite the extensive experience of using minoxidil on a topical basis, it has not shown an absorption of the drug to produce systemic effects, incorrect use or individual variability or particular sensitivity, could cause increased absorption with potential systemic effects. MINOXIMEN contains alcohol that causes burning and irritation. Therefore, in case of accidental contact with sensitive surfaces (eyes, abraded skin, mucous membranes), wash the area with plenty of fresh water. The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization. In such a case, stop treatment and consult your doctor to establish adequate therapy.

Interactions

No interactions associated with the use of MINOXIMEN. The extent of the absorption of topical minoxidil is controlled and limited by the corneo layer. Topical medications, such as tretinoin and antranil, which alter the cornea barrier, could cause an increase in the absorption of minoxidil when applied simultaneously.

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. 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 otitis) 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 cause adverse reactions related to its systemic pharmacological activity. The signs and symptoms of overdose of minoxidil would, likely, cardiovascular effects associated with sudden weight gain, tachycardia, weakness or dizziness. If any of these effects occur, consult a doctor.

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