Minoxidil Biorga 5% Soluzione Cutanea 3 Flaconi 60 ml

Therapeutic indications

The 5% cutaneous solution of Minoxidil Biorga is indicated for the treatment of alopecia.

Dosage

Posology The dose of 1 ml of Minoxidil Biorga 5% 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 Not recommended under 18 years and above 65 years of age due to the lack of data on safety and efficacy. Method of administration Minoxidil Biorga 5% cutaneous solution is for external use only. It is not recommended under 18 and above 65 years of age due to the lack of data on safety and efficacy. The 5% cutaneous solution of Minoxidil Biorga must be applied following the instructions and only on the scalp. The 5% Minoxidil Biorga skin solution should only be applied to dry hair and scalp. After applying the 5% Minoxidil Biorga skin solution, wash your hands well. You may need to apply the product twice a day for four or more months. In any case, the physician should consider stopping the treatment if no results are observed within 4 months. If hair regrowth is observed, the skin solution of 5% Minoxidil Biorga should continue to be applied twice a day, to maintain its effects. After discontinuation of topical minoxidil treatment, hair regrowth has occasionally stopped and returned to its former appearance within 3–4 months after discontinuation of treatment.

Overdose

Symptoms There is no evidence that topically applied minoxidil is absorbed in sufficient quantities to cause systemic effects. If used as directed, an overdose is unlikely. If the product is applied to an area where the epidermal barrier is not fully intact due to trauma, inflammation or a pathological process affecting the skin, there is the possibility of an effect resulting from systemic overdose. The systemic effects of minoxidil can result in the following very rare adverse events:

Body system	Incidence	Side effect reported
Nervous system disorders	Very rare	Dizziness
Cardiovascular pathologies	Very rare	Increased heart rate, hypotension
General disorders and administration site conditions	Very rare	Fluid retention resulting in weight gain

Fluid retention can be managed with adequate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-blocking agent. Symptomatic hypotension should be treated by intravenous administration of physiological saline. The use of sympathomimetic agents, such as epinephrine and noradrenaline, should be avoided as these drugs cause an excessive cardiac pacing effect.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The 5% cutaneous solution of Minoxidil Biorga is not indicated in cases of sudden or unexplained hair loss. In addition, Minoxidil Biorga 5% cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth or serious medical conditions, such as thyroid malfunction, lupus, loss of sections of hair associated with inflammation of the scalp or others. pathologies.

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 to <1/10), uncommon (≥ 1 / 1,000 to <1/100), rare (≥ 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000), not known (cannot be estimated from the available data). The following adverse events have been associated with the use of minoxidil solutions (2% and 5% associated) in both genders, with an incidence greater than 1% and higher than in placebo-controlled clinical trials.

System and organ classification	Incidence	Side effect reported
Disorders of the immune system	frequency not known	Allergic reactions, including angioedema
Psychiatric disorders	Common	Depression
Nervous system disorders	Very common	Headache
Respiratory, thoracic and mediastinal disorders	Common	Dyspnea
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	Ache

The following adverse events have been associated with the use of minoxidil-based topical solutions during the post-marketing period.

System and organ classification	Incidence	Side effect reported
Nervous system disorders	Rare	Headache
Cardiovascular pathologies	Rare	Palpitations, increased heart rate, chest pain
	Very rare	Hypotension
Skin and subcutaneous tissue disorders	Uncommon	Dry skin, skin peeling, 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

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili

Pregnancy and breastfeeding

Pregnancy 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, although remote, in humans (see section 5.3 Preclinical safety data). Breastfeeding 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.

Special warnings

Patients with known cardiovascular disease or cardiac arrhythmia should consult a physician before using Minoxidil Biorga 5% cutaneous solution. Minoxidil Biorga 5% 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 hair loss is unknown. The 5% Minoxidil Biorga skin solution should only be applied to a normal and healthy scalp. Do not use if the scalp is red, inflamed, irritated or painful or if you are using other medicines to apply to the scalp. Some excipients of Minoxidil Biorga 5% cutaneous solution can cause burning and irritation. In case of accidental contact with sensitive surfaces (eyes, abraded skin and mucous membranes), the area should be washed with plenty of fresh tap water. You should avoid inhaling the spray. Do not swallow. The patient should stop using Minoxidil Biorga 5% cutaneous solution and consult the physician if they detect hypotension or experience 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 the color and / or texture of their hair with the use of the 5% cutaneous solution of Minoxidil Biorga. Pediatric population Accidental ingestion can cause serious cardiac adverse events. Therefore, the 5% cutaneous solution of Minoxidil Biorga should be kept out of the reach of children.

Expiry and Retention

Flammable product. Protect from heat. Keep container tightly closed.

Active principles

Minoxidil 50 mg / ml (5% w / v). One delivery of 5% cutaneous solution of Minoxidil Biorga contains 7 mg of minoxidil. Seven puffs are required to apply approximately 1 ml of solution containing 50 mg of minoxidil. Excipient with known effects : propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Propylene glycol Ethanol 96% Purified water