REGIONS SOLUZ 60ML 5%

REGIONS OF THE CUTAN

active ingredients

REGAINE 2% skin solution: 100 ml contain 2 g minoxidil. Excipients with known effects: ethyl alcohol, propylene glycol REGAINE 5% cutaneous solution 100 ml contain 5 g of minoxidil. Excipients with known effects: ethyl alcohol, propylene glycol REGAINE 5% skin foam 1 g contains 50 mg of minoxidil. Excipients with known effects: anidro ethanol, butylhydroxytoluene, cetilic alcohol, stearilic alcohol. For the full list of excipients, see paragraph 6.1.

Excellent

REGAINE 2% and 5% cutaneous solution: propylene glycol, , ethyl alcohol, purified water. REGAINE 5% skin foam: anidro ethanol, purified water, butylhydroxytoluene (E321), lactic acid, citric acid anidro, glycerol, cetidal alcohol, , steariric alcohol, polysorbate 60, propellant: propane/butane/isobutane.

Therapeutic indications

REGAINE is indicated in the symptomatic treatment of androgenic alopecia in men and women. REGAINE's effectiveness has not been determined in the following forms: localized or generalized congenital alopecia; alopecia cicatriziale of various nature (post-traumatic, of psychic or infectious origin); alopecia acute diffused by toxic substances, from medicines in which the regrowth of hair is conditioned by the suppression of the specific cause; celtic area. REGAINE 5% skin solution and REGAINE 5% skin foam are not recommended in women (see paragraph 4.4).

Contraindications

Hypersensitivity to minoxidil or any of the excipients listed in paragraph 6.1. REGAINE should not be used in the presence of coronaropathy, arrhythmia, congestive heart failure or valvulopathy. Do not use pregnant and nursing.

Population

Population REGAINE skin solution Apply a dose of 1 ml of REGAINE twice a day, preferably in the morning and in the evening, on the affected areas of the scalp. The dose is independent from the size of the area to be treated. The total daily dose should not exceed 2 ml. REGAINE skin foam Apply a dose of 1 g (equivalent to half cap volume) of REGAINE twice a day, preferably in the morning and in the evening, on the affected areas of the scalp. The dose is independent from the size of the area to be treated. The total daily dose should not exceed 2 g. Use more product or more often does not increase the results. Before you can expect evidence of hair growth, you may need to wait 3-4 months of applications twice a day. The beginning of such 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 4 months. If a regrowth occurs, it is necessary to continue with the application of REGAINE twice a day so that hair growth continues. Relapse in pre-treatment after suspension of therapy occurs within 3-4 months. Special popularity The use of REGAINE is not recommended in patients over 55 years of age due to lack of data on safety and effectiveness. Pediatric population The use of REGAINE is not recommended in children under 18 years of age due to the lack of data on safety and effectiveness. Method of administration Use REGAINE only by following the instructions. Apply REGAINE only on hair and scalp completely dry. Hair should not be washed after applying REGAINE. Do not apply REGAINE to other areas of the body. After applying REGAINE wash your hands carefully. During treatment with REGAINE, other hair cosmetic products can be used, following the instructions below: -use a delicate shampoo. -It is necessary to let REGAINE penetrate into the scalp before using products for hairstyle. Do not mix with other preparations to be applied on the scalp. -there is no information available on the possibility that treatments with dye for hair or permanent alter the effect of REGAINE. However, in order to avoid possible irritation of the scalp, the patient must ensure that REGAINE has been completely washed away from the hair and scalp before using these chemicals. REGAINE skin solution Remove the external protection capsule and the internal screw cap and insert the selected applicator on the bottle. A) Graded droppers This type of applicator is suitable for distributing REGAINE on small bald areas of the scalp. • Place the graduated dropper on the bottle and after filling it up to the sign of 1 ml, apply some drops of REGAINE on the scalp and distribute the liquid with the tip of the fingers on the entire bald area; • repeat until all dose of 1 ml has been applied; • at the end of use, firmly screw the dropper on the bottle and put the protective capsule. B) Spray applicator This type of applicator is suitable for distributing REGAINE on large bald areas of the scalp. • Insert the spray applicator onto the bottle and screw firmly; • remove the transparent cap, direct the spray to the center of the bald area, spray once and distribute REGAINE with the fingertips on the entire bald area; • repeat the operation for a total of 6 times to reach the application of the dose of 1 ml solution; • avoid inhaling vapours; • at the end of use, put the protective capsule back. C) Extensor for spray applicator • The extender, which must be inserted on the spray applicator, is suitable for distributing REGAINE under the hair; • insert the spray applicator on the bottle and screw firmly. Remove the transparent cap and the dispenser head. Apply the extender on the stem, press to secure it firmly and remove the capsule from the nozzle; • direct the extender to the area to be treated, spray once and distribute REGAINE with the fingertips on the area to be treated; • repeat the operation for a total of 6 times to reach the application of the dose of 1 ml solution; • avoid inhaling vapours; • at the end of use, put the capsule on the nozzle. REGAINE skin foam Keep the tank head down and press the spout to get the foam out. Use the cap as a dispenser (half cap equals a dose of 1 g). Spread the product with your fingers across the bald area. After application, wash your hands thoroughly.

Conservation

REGAINE 2% and 5% cutaneous solution Special precautions for conservation are not required.REGAINE 5% skin foam Please note: extremely flammable, pressurized container. Protect from sunlight and not expose at temperatures above 50°C. Do not pierce or burn, even after use. Do not spray on free flames or glowing materials. Keep away from combustion sources. Don't smoke. Do not use near or place the container on polished or painted surfaces

Warnings

If symptoms persist or worsen, or if new symptoms appear, patients must stop treatment. Patients who are planning to be treated with REGAINE must have an analogy and be subjected to physical examinations. The doctor must understand that the patient has a normal and healthy scalp, for example not reddened, inflamed, infected, irritated or painful. Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or pizzas, caused by childbirth or when its cause is unknown. With the use of REGAINE, some patients have manifested changes in color and/or hair structure. An increase in hair loss may occur due to the action of hair mutation minoxidil from the rest telogen phase to the growth anagen phase (the old hair falls when new hair grows in their place). Generally this temporary fall increase occurs between two and six weeks after the start of treatment and is reduced within a couple of weeks (first sign of the effectiveness of minoxidil). If the fall persists, users must stop using REGAINE and consult the doctor. The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. In this case, stop the treatment and consult your doctor to establish suitable therapy. Although extensive clinical studies carried out with REGAINE have not shown that there is sufficient absorption of minoxidil to cause systemic effects, there is a certain absorption of minoxidil through the scalp and there is the potential risk of systemic effects such as salt and liquid retention, generalized and local edema, pericardial effusion, pericarditis, heart failure, tachycardia, angina or increase of blood pressure. In the presence of cardiovascular disorders, including hypertension, careful medical evaluation is necessary. The patient must stop using REGAINE and consult a doctor if hypotension is detected or if the patient manifests chest pain, acceleration of the heartbeat, weakness, dizziness, sudden and unexplained weight increase, hands or feet swollen, persistent redness, dermatological reactions or irritation of the scalp, or if other unexpected new symptoms occur (see paragraph 48). Patients with latent heart disease anamnesis should be warned that REGAINE can worsen these disorders. Patients must be periodically monitored to detect any suspicion of systemic effects caused by minoxidil. Accidental interference can cause serious heart failure. Patients should avoid inhaling the product when using the spray applicator. Therefore this medicine must be kept away from the reach of children. In the event of systemic side effects or dermatological reactions, suspend the administration of the drug. The growth of unnecessary hair can be caused by product transfer on areas other than scalp. Studies carried out in women with REGAINE 5% solution applied twice a day, showed no significant increase in effectiveness compared to 2% applied twice a day; on the other hand, there has been a greater incidence of dermatologic side effects, such as hypertricosis and local irritation. Therefore REGAINE 5% solution is not recommended in women (see paragraph 4.2). REGAINE should not be used in conjunction with other medicines applied at a topical level on the scalp (see paragraph 4.5). Important information about some excipients REGAINE 2% and 5% cutaneous solution contain: • ethyl alcohol. REGAINE 2% skin solution contains 474.4 mg of alcohol (ethanol) in a 1 ml solution, equivalent to 6.76 mg/Kg for an adult of 70 Kg, while REGAINE 5% skin solution contains 237 mg of alcohol (ethanol) in a 1 ml solution, equivalent to 3.38 mg/Kg for an adult of 70Kg. Ethanol can cause burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, escoriate skin and mucous membranes), the area should be wet with large amounts of fresh tap water; • propylene glycol. REGAINE 2% contains 207 mg of glycol propylene per single application (1 ml cutaneous solution) equivalent to 2.95 mg/kg, while REGAINE 5% contains 518 mg of glycol propylene per single application (1 ml cutaneous solution) equivalent to 7.4 mg/kg. REGAINE 5% skin foam contains: • butylhydroxytoluene: it can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes or mucous membranes; • cetilic alcohol and stearilic alcohol: can cause local skin reactions (e.g. contact dermatitis); 536.3 mg of ethanol in 1 g of skin foam (1 dose), equivalent to 7.66 mg/Kg for an adult of 70 Kg: it can cause burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, escoriate skin and mucous membranes), the area should be wet with large amounts of fresh tap water. For ethanol content, REGAINE 5% skin foam can be flammable, therefore it should not be used near free flames, cigarettes on or some devices (e.g. hairdryer). For sportsmen, the use of medicines containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations.

Interactions

REGAINE should not be used in conjunction with other medicines applied at a topical level on the scalp (corticosteroids, tretinoin and antralin). Other interactions associated with the use of REGAINE are not currently known. Although it has not been clinically demonstrated, there is the possibility of increased orthostatic hypotension in patients with concomitant therapy with peripheral vasodilators.

Effects

The frequency of adverse reactions to minoxidil for topical use is defined by the following convection: very common (≥ 1/10); common (≥ 1/100, Reactions reported during clinical studies Minoxidil safety for skin use is based on data from 7 randomized clinical trials controlled with placebo in adults evaluating minoxidil solution 2% and 5% (Tabella1), and two randomized clinical trials controlled with placebo in adults evaluating a minoxidil skin foam 5% (Tabella 2).Table 1: reported adverse reactions recorded with a frequency ≥1% in adult individuals in treatment with Minoxidil with 2% or 5% solution per topical, in randomized placebo controlled clinical trials.

Table 2: reported adverse reactions recorded with a frequency ≥1% in adult subjects in treatment with Minoxidil with 5% foam topic, in randomized placebo controlled clinical trials.

Reactions reported during post-marketing experience In Table 3, the adverse reactions collected in the post-marketing experience frequenziate according to the incidence of spontaneous reports

The nature and severity of the reactions detected are similar in the treatment with minoxidil at 2% and 5%, but their incidence is higher in the latter. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

If doses of REGAINE higher than those recommended or on areas of the body other than scalp, an increase in systemic absorption of minoxidil may potentially occur. Accidental ingestion of REGAINE can lead to serious side effects. Following accidental ingestion, minoxidil is totally absorbed through the gastroenteric tract and can cause systemic effects related to its vasodilating action. Signs and symptoms of overdose from minoxidil are mainly cardiovascular type associated with hydro-sodium retention and can also occur tachycardia, hypotension, weakness and dizziness. Treatment Treatment of overdose from minoxidil must be symptomatic and supportive. Liquid retention can be treated with appropriate diuretic therapy. Tachycardia can be kept under control by administering a beta-blocking agent. Hypotension can be treated with intravenous administration of normal saline solution. Sympathomimetic action drugs, such as norepinephrine and adrenaline, should be avoided for their excessive heart stimulation activity.

REGAINE should not be used during pregnancy and during breastfeeding and in pregnant women who do not use contraceptives.

Pregnancy

There are no adequate and well-controlled studies in pregnant women.Animal studies have shown a risk to the foetus at exposure levels much higher than those intended for human exposure (see section 5.3).The potential risk in humans is unknown.

Breastfeeding

Systemically absorbed minoxidil is excreted in breast milk.The effect of minoxidil on newborns/infants is unknown.

Fertility

There are no adequate and well-controlled studies on female fertility.Animal studies have shown toxicity to fertility, a reduction in conceptions and implantation rates, as well as a reduction in the number of live offspring at exposure levels much higher than those intended for human exposure (see section 5.3).The potential risk in humans is unknown.

Source: Farmadati