Solution for the treatment of alopecia 60ml

Product Description

Solution

Composition:

REGAINE 2% cutaneous solution 100 ml contain: minoxidil 2 g. REGAINE 5% cutaneous solution 100 ml contain: minoxidil 5 g. For the full list of excipients, see section 6.1.

Excipients

REGAINE 2% and 5% Cutaneous solution: propylene glycol, ethyl alcohol, purified water.

Therapeutic indications

REGAINE is indicated for the symptomatic treatment of androgenetic alopecia. The efficacy of REGAINE has not been established in the following forms: localized or generalized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychological, or infectious); acute diffuse alopecia caused by toxic substances or medications in which hair regrowth depends on the removal of the specific cause; celsi area.

Contraindications

Hypersensitivity to minoxidil or to any of the excipients. REGAINE should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure, or valvular heart disease. In the presence of other cardiovascular disorders, including hypertension, the use of REGAINE is subject to the doctor's judgment. Do not use during pregnancy and breastfeeding.

Dosage

Apply a dose of 1 ml of REGAINE twice a day to the scalp of all affected areas. The dose is independent of the size of the area to be treated. The total daily dose should not exceed 2 ml. Using more product or more frequently does not increase the results. It may be necessary to wait 3–4 months of twice-daily applications before evidence of hair growth can be expected. The onset of these signs and their intensity varies from patient to patient. In all cases, the doctor will evaluate the possibility of discontinuing treatment if no therapeutic results are observed within 4 months. If regrowth occurs, it is necessary to continue applying REGAINE twice daily to ensure continued hair growth. Relapse to the pre-treatment state following discontinuation of therapy occurs within 3–4 months. For external use only. Use REGAINE only as directed. Apply REGAINE only to completely dry hair and scalp. Do not apply REGAINE to other areas of the body. Wash your hands thoroughly after applying REGAINE. Special populations The use of REGAINE is not recommended in patients over 55 years of age due to a lack of data on safety and efficacy. Paediatric population The use of REGAINE is not recommended in children under 18 years of age due to a lack of data on safety and efficacy. Method of administration Remove the outer protective cap and the inner screw cap and insert the chosen applicator onto the bottle. A) Graduated dropper This type of applicator is suitable for dispensing REGAINE onto small bald areas of the scalp. – Insert the graduated dropper onto the bottle and, after filling it to the 1 ml mark, apply a few drops of REGAINE to the scalp and distribute the liquid with the fingertips over the entire bald area. – Repeat until the entire 1 ml dose has been applied. – After use, screw the dropper tightly onto the bottle and replace the protective cap. B) Spray applicator This type of applicator is suitable for distributing REGAINE over large bald areas of the scalp. – Insert the spray applicator into the bottle and screw tightly. – Remove the transparent cap, direct the spray towards the center of the bald area, spray once, and distribute REGAINE over the entire bald area with your fingertips. – Repeat this operation a total of 6 times to apply a dose of 1 ml of solution. – Avoid inhaling the vapors. – After use, replace the protective cap. C) Spray applicator extender – The extender, which must be inserted onto the spray applicator, is suitable for distributing REGAINE under the hair. – Insert the spray applicator into the bottle and screw tightly. Remove the clear cap and the spray head. Place the extender on the stem, press firmly, and remove the capsule from the nozzle. – Aim the extender at the treatment area, spray once, and distribute REGAINE over the treatment area with your fingertips. – Repeat a total of 6 times to apply a dose of 1 ml of solution. – Avoid inhaling the vapors. – After use, replace the capsule on the nozzle.

Warnings and Precautions

Patients who are considering REGAINE therapy should have a medical history and undergo a physical examination. The physician should determine that the patient has a normal, healthy scalp, i.e., not red, inflamed, infected, irritated, or painful. Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or patchy, caused by childbirth, or when the cause is unknown. With the use of REGAINE, some patients have experienced changes in hair color and/or texture. Increased hair loss may occur due to minoxidil's effect on hair from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair loss generally occurs between two and six weeks after starting treatment and subsides within a couple of weeks (the first sign of minoxidil's effectiveness). If hair loss persists, users should discontinue use of REGAINE and consult their doctor. Use of topical products, especially if prolonged, may cause sensitization. If this occurs, discontinue treatment and consult your doctor to initiate appropriate therapy. The patient should discontinue use of REGAINE and consult a physician if hypotension is detected or if the patient experiences chest pain, rapid heartbeat, weakness, dizziness, sudden unexplained weight gain, swelling of the hands or feet, persistent redness, dermatological reactions, or scalp irritation. Although extensive clinical studies with REGAINE have not demonstrated sufficient absorption of minoxidil to cause systemic effects, some absorption of minoxidil through the scalp occurs, and there is a potential risk of systemic effects such as salt and fluid retention, generalized and local edema, pericardial effusion, pericarditis, cardiac tamponade, tachycardia, angina, or increased orthostatic hypotension induced by antihypertensive drugs such as guanethidine and derivatives. Patients with a history of underlying cardiac disorders should be warned that REGAINE may worsen these conditions. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. Patients with known cardiovascular disease, including hypertension, should consult a physician before using REGAINE. Accidental ingestion could cause serious cardiac adverse events. Avoid inhaling the product when using the spray applicator. REGAINE contains ethanol (alcohol), which causes burning and eye irritation. In case of accidental contact with sensitive surfaces (eyes, broken skin, and mucous membranes), the area should be flushed with large amounts of cool tap water. If systemic side effects or dermatological reactions occur, discontinue use of the drug and consult a physician. For athletes, the use of medications containing ethyl alcohol may result in positive doping tests in relation to the blood alcohol concentration limits indicated by some sports federations. Keep this medicine out of the reach of children.

Interactions

REGAINE should not be used concomitantly with other medications applied topically to the scalp (corticosteroids, tretinoin, and antralin). No other interactions associated with the use of REGAINE are currently known. Although not clinically demonstrated, there is a possibility of increased orthostatic hypotension in patients receiving concomitant therapy with peripheral vasodilators.

Undesirable effects

The frequency of adverse reactions to topical minoxidil is defined using the following convention: very common (