This medication is indicated in case of hair loss, moderate (alopecia, androgenetic) of adult, male or female. It promotes hair growth and stabilizes the phenomenon of falling

Pathway, cutaneous.

RESERVED FOR THE ADULT.

Apply a dose of 1 ml twice a day to the scalp starting from the center of the area to be treated

The daily dose should not exceed 2 ml

Spread the product with your fingertips so as to cover the entire area to be treated.

Before and after application of the solution, wash hands thoroughly.

Apply to perfectly dry hair and scalp.

Using the pipette

A pipette makes it possible to sample with precision 1 ml of solution to be distributed over the entire area to be treated.

Using the pump with applicator

Remove the cap from the bottle and unscrew the cap that closes the bottle.
Screw the dosing pump to the flask.

For application: direct the pump to the center of the area to be treated, press once and spread the product with your fingertips so as to cover the entire area to be treated.

Repeat the procedure 6 times to apply a 1 ml dose.

Pharmacotherapeutic class

OTHER MEDICINAL PRODUCTS, DERMATOLOGICAL

ATC Code: D11AX01

Efficacy and tolerability in subjects less than 18 years of age and over 65 years have not been studied

Applied topically, minoxidil stimulates the growth of keratinocytes in vitro, and in vivo and hair growth in some individuals with androgenetic alopecia.



The occurrence of this phenomenon takes place after about 4 months (or more) of use of the product and varies according to the subjects.

When the treatment is stopped, the regrowth ceases and a return to the state is predictable within 3 or 4 months.

The precise mechanism of action is not known. Topical application of minoxidil in controlled clinical trials in normotensive or hypertensive patients did not result in the observation of systemic manifestations related to absorption of minoxidil

Effects on the ability to drive and use machines are unlikely.
Hypersensitivity to minoxidil or to any of the other components of the solution.

Warnings

An increased percutaneous absorption of minoxidil, which can cause systemic effects, is possible in case

· Of dermatosis or lesion of the scalp

· Increase of the applied dose and / or increase in the frequency of applications: it is imperative to respect the dosage and the method of administration.
Similarly, although extensive use of minoxidil solution has not revealed any systemic effects, it can not be ruled out that greater absorption due to unusual individual variability or sensitivity may cause systemic effects . Patients should be warned.

The patient should discontinue use of this medication and consult a physician if hypotension is found in chest pain, rapid heart beat, fainting or dizziness, sudden weight gain; Unexplained, edema of the hands or feet or reddening or persistent irritation of the scalp

In subjects with a cardiac history, the benefit of the treatment must be weighed. They should be more particularly aware of potential adverse effects in order to discontinue treatment at the onset of one of them and notify a doctor.
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Patients with known cardiovascular disease or cardiac arrhythmias should contact a physician before using minoxidil.


Do not apply minoxidil to any other part of the body.

Precautions for use

Minoxidil should only be used on normal, healthy scalp. It should not be used if the scalp has redness, inflammation, infection, irritation or, if it is painful, or if other treatments are applied to the scalp. Br>

Accidental ingestion is likely to cause serious adverse cardiac effects (see section Overdose). Therefore, this medication should be kept out of the reach of children.

In the event of accidental contact with sensitive surfaces (eye, injured skin, mucous membrane), solution containing ethanol may cause sensation, burning and irritation: rinse thoroughly with cold running water. Code>
Inhalation of mist, sprayed should be avoided.
Solar exposure is not recommended when minoxidil is applied.

This medicinal product contains propylene glycol and may cause skin irritation

Studies of pharmacokinetic interactions in humans have shown that the percutaneous absorption of minoxidil is increased by tretinoin and anthralin due to increased permeability of the stratum corneum, dipropionate of Betamethasone increases the local tissue concentrations of minoxidil and decreases its absorption systemic

Although not clinically proven, the risk of developing hypotension, orthostatic in patients otherwise treated with peripheral vasodilators, can not be excluded.

Dermally, the resorption of minoxidil is controlled and limited by the Stratum corneum. The concomitant use of dermal application drugs having an impact on the barrier constituted by the Stratum corneum may lead to an increase in the absorption of minoxidil. Therefore, concomitant use of Alopexy and other dermal drugs is not recommended.

Without object.

There is no data indicating that the locally applied minoxidil is absorbed in an amount sufficient to cause systemic effects. An overdose is unlikely when the drug is used in accordance with the instructions.
If this drug is applied to an area where the integrity of the skin barrier is diminished due to injury, inflammation or skin pathology, systemic effects of overdosage are possible. Code>
In case of overdose, very rare dizziness, fluid retention, weight gain, increased heart rate and hypotension may occur due to the systemic effects of minoxidil

Adverse ingestion may cause systemic effects due to vasodilator action: minoxidil (5 ml solution contains 100 mg minoxidil, the maximum dose used for oral administration in adults treated for hypertension; Arterial blood pressure).
Processing

In case of overdose with minoxidil, symptomatic treatment as well as additional measures must be put in place.

A hydrosodic retention may be treated with a suitable therapeutic, diuretic, tachycardia and angina by a beta blocker or other sympathetic nervous system inhibitor. Symptomatic hypotension could be treated by intravenous administration of isotonic sodium chloride solution. The use of sympathomimetics, such as norepinephrine and adrenaline due to excessive cardiac stimulation, should be avoided.

Pregnancy

Adequate controlled studies have not been conducted in pregnant women. Studies in animals have shown a risk to the fetus at levels of exposure well above those expected, in humans. A low, but unlikely, risk of deleterious effects on the fetus is possible in humans (see Preclinical Safety Data, Preclinical Safety Data).
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Breastfeeding

Minoxidil absorbed at the systemic level is excreted in maternal milk

As a result, topical minoxidil should not be used during pregnancy or breastfeeding unless the benefit to the mother is greater than the potential risk to the fetus or child. >

The most frequently observed reactions are minor skin reactions

Frequent applications on the skin can cause irritation and dryness of the skin due to the presence of ethanol

The following adverse reactions have been reported after use of the 2% and 5% minoxidil solution in men, and women with an incidence greater than 1% and superior to the placebo group in 7 clinical studies versus placebo .

Moreover, the undesirable events notified post-marketing have been reported with a frequency, undetermined.

The adverse reactions and their frequency are listed below according to the basis of MedDRA data by Organ System Classes and by frequency. Frequencies are defined using the following classification: Very common (≥ 1/10), frequent (≥ 1/100,