Carexidil 5% - solution for alopecia - 4 bottles of 60 ml

Product Description

5% minoxidil-based drug for use on the scalp for the treatment of baldness.

Indications

Carexidil is indicated for the symptomatic treatment of androgenic alopecia in men and women. The efficacy of Carexidil has not been established in the following forms: localized or generalized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychological or infectious origin); acute diffuse alopecia caused by toxic substances or medications in which hair regrowth is conditioned by the suppression of the specific cause; celsi area.

Composition

Active ingredients

100 ml of Carexidil 2% cutaneous spray, solution contain 2 g of minoxidil. Excipients with known effects: ethyl alcohol, propylene glycol.

Excipients

96% ethyl alcohol, propylene glycol, and purified water.

Directions for use and Dosage

Dosage

Apply a dose of 1 ml of Carexidil twice daily, preferably in the morning and evening, to the affected areas of the scalp. The dose is independent of the size of the area to be treated. The total daily dose should not exceed 2 ml. Before evidence of hair growth can be expected, it may be necessary to wait 3-4 months of twice-daily applications. The onset of these signs and their intensity vary from patient to patient. In all cases, the doctor should evaluate whether to discontinue treatment if no therapeutic results are observed within 4 months. If regrowth occurs, Carexidil should be applied twice daily to ensure continued hair growth. Relapse to the pre-treatment state following discontinuation of therapy occurs within 3-4 months. Carexidil is not recommended for patients over 55 years of age due to a lack of data on safety and efficacy. Carexidil is not recommended for children under 18 years of age due to a lack of data on safety and efficacy. Use Carexidil only according to the instructions. Apply Carexidil only to completely dry hair and scalp. Hair should not be washed after applying Carexidil. Do not apply Carexidil to other areas of the body. Wash hands thoroughly after applying Carexidil. While using Carexidil, other hair care products can be used, following the instructions below: use a gentle shampoo; allow Carexidil to penetrate the scalp before using styling products. Do not mix with other preparations intended for use on the scalp. However, to avoid possible scalp irritation, the patient must ensure that Carexidil has been completely washed from the hair and scalp before using these chemicals.

Instructions for use:

• Unscrew the white polypropylene cap;
• Insert the spray applicator onto the bottle and screw it tightly;
• Attach the extender to the stem, press to secure it firmly;
• Orient the extender towards the area to be treated, spray once and distribute Carexidil with the fingertips on the area to be treated;
• Repeat the operation a total of 10 times to reach the application of a dose of 1 ml of solution. 

Avoid inhaling vapors.
10 pulses are equivalent to 1 ml of delivered solution.

Warnings

Patients who are considering therapy with Carexidil should have a medical history and undergo physical examinations. The physician should ensure that the patient has a normal, healthy scalp, for example, 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 minoxidil, some patients have experienced changes in hair color and/or texture. Increased hair loss may occur due to minoxidil's effect on hair growth (the old hair falls out as new hair grows in its 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 Carexidil and consult a doctor. Use of topical products, especially if prolonged, may cause sensitization. If this occurs, discontinue treatment and consult a doctor for appropriate treatment. Although extensive clinical studies with minoxidil have not demonstrated sufficient absorption of this active ingredient 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. Careful medical evaluation is required in the presence of cardiovascular disorders, including hypertension. The patient should discontinue use of Carexidil 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, or if other new unexpected symptoms appear. Patients with a history of underlying cardiac disorders should be warned that Carexidil may worsen these conditions. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. Accidental ingestion can cause serious cardiac adverse events. Patients should avoid inhaling the product when using the spray applicator. If systemic side effects or dermatological reactions occur, discontinue use. Unwanted hair growth may result from product transfer to areas other than the scalp. Hypertrichosis in children following inadvertent topical exposure to minoxidil: Cases of hypertrichosis in young children have been reported following skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hypertrichosis is reversible within a few months when young children are no longer exposed to minoxidil. Therefore, contact between children and minoxidil application sites should be avoided. Important information about some of the excipients. Carexidil 2% cutaneous spray, solution contains: ethyl alcohol: may cause burning and irritation to the eyes. In case of accidental contact with sensitive surfaces (eyes, broken skin, and mucous membranes), the area should be moistened with large amounts of cool tap water; propylene glycol: may cause irritation. cause skin irritation.

Undesirable effects

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

• Very common (> 1/10)
• Common (> 1/100, <1/10)
• Uncommon (> 1/1,000, <1/100)
• Rare (> 1/10,000, <1/1,000)
• Very rare (<1/10,000)
• Not known (frequency cannot be estimated from the available data). (based on available data).

The safety of minoxidil for cutaneous use is based on data from seven randomized, placebo-controlled clinical studies evaluating the 2% and 5% solution, and two similar studies evaluating the 5% cutaneous foam. The most common adverse reactions, with a frequency of 1% or greater, reported during these clinical studies mainly concern peripheral edema (common) and headache (very common). Other common reactions include dyspnea and various skin disorders, such as dermatitis, dermatitis acneiform, hypertrichosis, pruritus, and rash.

With regard to the 5% foam, in addition to headache, pruritus and rash have also been reported. Weight gain has also been observed, which was common in subjects treated with the foam.

Adverse reactions reported during post-marketing experience are based on the incidence of spontaneous reports. Among these, nervous system disorders such as dizziness, vertigo, tingling, taste disturbances, and burning sensations have been reported (uncommon). Visual disturbances (uncommon) and eye irritation (rare) have been described among eye problems. Some subjects have also experienced ear infections (uncommon) and palpitations or tachycardia (rare). Among gastrointestinal disorders, nausea and vomiting are very rare.

More serious skin reactions, such as bleeding, ulcers, exacerbation of hair loss, or alopecia, have been reported rarely. Very rarely, temporary hair loss and changes in hair color or texture have occurred. Other skin disorders, such as irritation, pain, eczema, hives, and allergic reactions, have been reported uncommonly. In some cases, sexual dysfunction (rare) has been reported, as well as urinary incontinence (rare). such as hepatitis (rare) and kidney stones (rare).

The nature and severity of adverse reactions are similar with both 2% and 5% minoxidil, but the incidence is higher with the 5% treatment. It is important to report suspected adverse reactions that occur after authorization of the medicinal product, as this allows continuous monitoring of the benefit/risk balance of the product.

Pregnancy and breastfeeding

Minoxidil should not be used during pregnancy and breastfeeding and in women of childbearing potential who are not using contraceptives.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Animal studies have shown a risk to the fetus 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. The potential risk in humans is unknown.

Storage

No special storage precautions.

Format

4 bottles of 60 ml with polypropylene cap and dosing pump.