Minoxidil Biorga 2% laboratoires Bailleul Soluz Cutanea 3 Bottles

NAME
MINOXIDIL BIORGA 2%, SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Dermatological preparations.

ACTIVE PRINCIPLES
Minoxidil.

EXCIPIENTS
Propylene glycol; 96% ethanol; purified water.

INDICATIONS
The 2% cutaneous solution of minoxidil is indicated for the treatment of alopecia; particularly indicated in men suffering from hair loss or weakening of the hair in the upper part of the head and in women with generalized weakening of the hair; indicated in adults, aged between 18 and 65 years.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; the 2% cutaneous solution is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with skin with scarring characteristics, such as a burn or ulcer). In addition, the drug should not be used if hair loss is associated with pregnancy, childbirth or serious medical conditions, such as thyroid malfunction, lupus, loss of hair sections associated with inflammation of the scalp or other conditions.

DOSAGE
The dose of 1 ml of 2% cutaneous solution should be applied to the scalp twice a day (once in the morning and once in the evening). This dose should be administered regardless of the size of the affected area. The total daily dose should not exceed 2 ml. Pediatric population and elderly population: it is not recommended under 18 years and above 65 years of age due to the lack of data on safety and efficacy. Method of administration: for external use only. The 2% skin solution should be applied according to the instructions and on the scalp only. The 2% skin solution should only be applied to dry hair and scalp. After applying the skin solution, wash your hands thoroughly. It may be necessary to apply the product twice a day for four or more months. In any case, evaluate the opportunity to stop treatment if no results are observed within 4 months. If hair regrowth is observed, the application of the 2% cutaneous solution should be continued twice a day to maintain its effects. After discontinuation of topical treatment with minoxidil, interruption of hair regrowth and return to previous appearance have occasionally been reported within 3-4 months after discontinuation of treatment.

STORAGE
Flammable product; protect from heat; keep container tightly closed.

WARNINGS
Patients with known cardiovascular disease or cardiac arrhythmia should consult a physician before using the drug. The cutaneous solution is not indicated in the absence of familiarity for hair loss, sudden and / or patchy hair loss, hair loss due to childbirth or when the cause of the hair loss is unknown. applied only to a normal and healthy scalp. Do not use if the scalp is red, inflamed, irritated or painful or if you use other medicines to apply to the scalp. Some of the ingredients in the skin solution can cause burning and irritation. In case of accidental contact with sensitive surfaces (eyes, abraded skin and mucous membranes), the area must be washed with plenty of fresh tap water. You should avoid inhaling the spray. Do not swallow. The patient should stop using the drug if he senses hypotension or experiences chest pain, rapid heart rate, fainting or dizziness, sudden weight gain, swelling of the hands or feet, and persistent redness or irritation of the scalp. Some patients have experienced changes in hair color and / or texture with the use of the skin solution. Pediatric population: accidental ingestion can cause serious cardiac adverse events.

INTERACTIONS
Pharmacokinetic interaction studies conducted in humans revealed that the percutaneous absorption of minoxidil is increased by tretinoin and anthralin as a consequence of the greater permeability of the stratum corneum; betamethasone dipropionate increases the diminoxidil concentration in local tissues and reduces its systemic absorption.

SIDE EFFECTS
The frequency of adverse reactions to minoxidil solution for topical use is defined using the following convention: very common (> = 1/10), common (> = 1/100, <1/10), uncommon (> = 1 / 1,000, <1/100), rare (> = 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000), not known. The following adverse events have been associated with the use of minoxidil-based solutions (2% and 5% associated) in both genders, with an incidence greater than 1% and higher than in placebo-controlled clinical trials. Disorders of the immune system. Not known: allergic reactions, including angioedema. Psychiatric disorders. Common: depression. Nervous system disorders. Very common: headache. Respiratory, thoracic and mediastinal disorders. Common: dyspnoea. Skin and subcutaneous tissue disorders. Common: pruritus, hypertrichosis, rash, acneiform rash, dermatitis, inflammatory skin disorder. Musculoskeletal and connective tissue disorders. Common: musculoskeletal pain. General disorders and administration site conditions. Common: peripheral edema. Various. Common: pain. The following adverse events have been associated with the use of minoxidil-based topical solutions during the post-marketing period. Nervous system disorders: Rare: headache. Cardiovascular pathologies. Rare: palpitations, increased heart rate, chest pain; very rare: hypotension. Skin and subcutaneous tissue disorders. Uncommon: skin dryness, skin exfoliation, rash, temporary hair loss, hypertrichosis, changes in hair texture, changes in hair color; rare: contact dermatitis. General disorders and administration site conditions. Uncommon: application site itching, application site irritation; rare: application site erythema. 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
There have been no adequate and well-controlled studies in pregnant women to date. Animal studies have revealed a risk to the fetus at exposure levels that are very high compared to those intended for human exposure. A low risk of fetal harm is possible in humans, although remote. Systemically absorbed minoxidil is excreted in breast milk. Topical Minoxidil should only be used during pregnancy or breastfeeding if the benefit to the mother outweighs the risks to the fetus or infant.