MINOXIDIL BIORGA SOL CUT60ML2%

MINOXIDIL BIORGA 2%, CUTANEA DEVELOPMENT

active ingredients

Minoxidil 20 mg/ml (2% p/v). A Minoxidil Biorga 2% supply, skin solution contains 2.8 mg of minoxidil. Seven dispenses are needed to apply about 1 ml of solution containing 20 mg of minoxidil. Excipient with known effects: propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Propylene glycol, Ethanol 96%, purified water.

Therapeutic indications

Minoxidil Biorga 2%, skin solution is indicated for the treatment of alopecia. Minoxidil Biorga 2%, skin solution is especially indicated in men who suffer from hair loss or hair weakening in the upper part of the head and in women who present a generalized hair weakening. Minoxidil Biorga 2%, skin solution is indicated in adult subjects, aged 18 to 65 years.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Minoxidil Biorga 2%, cutaneous solution is not indicated in the cases of alopecia areata (loss of improvised or unexplained hair) or alopecia cicatriziale (associated with a skin with features of scarring, like a burn or an ulcer). In addition, Minoxidil Biorga 2%, skin solution should not be used if hair loss is associated with pregnancy, birth or serious pathologies, such as thyroid malfunction, lupus, loss of hair sections associated with inflammation of the scalp or other pathologies.

Population

Posology: The dose of 1 ml of Minoxidil Biorga 2%, skin solution must be applied on the scalp twice a day ( once in the morning and once in the evening). This dose must 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 over 65 years of age due to lack of data on safety and effectiveness. Method of administration: Minoxidil Biorga 2%, skin solution is only for external use. It is not recommended under 18 years and over 65 years of age due to lack of data on safety and effectiveness. Minoxidil Biorga 2%, skin solution must be applied according to the instructions and only on the scalp. Minoxidil Biorga 2%, skin solution should be applied only on dry hair and scalp. After application of Minoxidil Biorga 2%, skin solution wash well hands. You may need to apply the product twice a day for four or more months. In any case, the doctor must assess the opportunity to stop treatment if results are not observed within 4 months. If you look at a hair regrowth, you must continue the application of Minoxidil Biorga 2%, skin solution twice a day, to maintain its effects. After the suspension of topical treatment with minoxidil, the interruption of hair regrowth was occasionally reported and the return to the previous appearance within 34 months after the termination of treatment.

Conservation

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

Warnings

Patients with cardiovascular pathology or noted heart arrhythmia should consult a doctor before using Minoxidil Biorga 2%, Minoxidil Biorga 2% skin solution is not indicated in the absence of familiarity for hair loss, sudden hair loss and/or hair loss, hair loss due to childbirth or when the cause of hair loss is not known. Minoxidil Biorga 2%, skin solution should be applied only on a normal and healthy scalp. Do not use if the scalp is red, inflamed, infected, irritated or sore or if you use other medicines on the scalp. Some excipients of Minoxidil Biorga 2%, 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. Don't swallow. The patient must stop using Minoxidil Biorga 2%, skin solution and consult the doctor if he detects hypotension or manifests a chest pain, an acceleration of the heartbeat, fainting or dizziness, sudden weight gain, swelling of the hands or feet and persistent redness or irritation of the scalp. Some patients have manifested changes in color and/or texture of hair with the use of Minoxidil Biorga 2%, skin solution. Pediatric population: Accidental ingestion can cause serious heart failure. Therefore, Minoxidil Biorga 2%, skin solution should be kept out of reach of children.

Interactions

Studies of pharmacokinetic interaction conducted in man have revealed that percutaneous absorption of minoxidil is increased by tretinoin and anthrain as a result of greater permeability of the corneo layer; dipropionate betamethasone increases the concentration of minoxidil in local tissues and reduces systemic absorption. Although not clinically proven, there is a theoretical possibility that absorbed minoxidil can enhance orthostatic hypotension in patients who take peripheral vasodilators simultaneously.

Effects

The frequency of adverse reactions to the minoxidil solution for topical use is defined according to the following convention: very common (≥ 1/10), common (≥ 1/100, Classification for systems and organs Frequency Reported side effect Psychiatric disorders Town Depression Diseases of the nervous system Very common Cefa Respiratory, chest and mediastinic pathologies Town Dispense Pathologies of skin and subcutaneous tissue Town Prurite, hypertricosis, rash, acneiform skin rash, dermatitis, inflammatory skin disorder Diseases of musculoskeletal system and connective tissue Town Musculoskeletal pain Systemic pathologies and conditions for administration Town Peripheral edema Various Town Pain The following adverse events were associated with the use of top solutions based on minoxidil during the post-commercialization period.

Classification for systems and organs	Frequency	Reported side effect
Immune system disorders	Frequency not known	Allergic reactions, including angioedema
Diseases of the nervous system	Rare	Cefa
Cardiovascular disease	Rare	Palpitations, increased heart rate, chest pain
	Very rare	Hypotension
Pathologies of skin and subcutaneous tissue	Not common	Skin dryness, skin exfoliation, skin rash, temporary hair loss, hypertricosis, hair consistency alterations, hair color changes
	Rare	Contact dermatitis
Systemic pathologies and conditions for administration	Not common	Prurito alla sede di application, irritazione alla sede di application
	Rare	Eritema to the application site

Reporting of suspicious adverse reactions. . The reporting of suspicious adverse reactions that occur 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms There are no evidence that minoxidil applied by topical means is absorbed in sufficient quantities to cause systemic effects. If used according to instructions, an overdose is unlikely. If the product is applied in an area where the epidermal barrier is not entirely integrated due to trauma, inflammation or pathological process to the skin, there is the possibility of an effect resulting from systemic overdose. Systemic effects of minoxidil can cause the following very rare adverse events:

Classification for systems and organs	Frequency	Reported side effect
Diseases of the nervous system	Very rare	Chief Minister
Cardiovascular disease	Very rare	Increased heart rate, hypotension
General pathologies and conditions for administration	Very rare	Liquid retention resulting in weight gain

Treatment Treatment of minoxidil overdose should be symptomatic and supportive. Liquid retention can be managed with adequate diuretic therapy. A clinically significant tachycardia can be controlled by the administration of a beta-blocker agent. Syntomatic hypotension should be treated by intravenous administration of physiological solution. The use of sympathomimetic agents, such as adrenaline and norepinephrine, must be avoided since such medicines cause excessive cardiac stimulation.

Pregnancy:

There have been no adequate and well-controlled studies in pregnant women. Animal studies showed a risk for fetus at exposure levels which are very high compared to exposure levels in humans. In man it is possible, although remote, a low risk of fetal damage (see paragraph 5.3 Preclinical safety data).

Nursing:

Systemic absorbed minoxidil is excreted in breast milk. Minoxidil on a topical basis should be used during pregnancy or nursing only if the benefit for the mother exceeds the potential risk for the fetus or infant.

Source: Farmadati