Minoxidil intelі

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MINOXIDIL INTELI

Composition:

Active substance: minoxidil;

1 ml of solution contains 20 mg or 50 mg of minoxidil;

Excipients: ethanol 96 %, propylene glycol, purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties:

2 % solution: aqueous-alcoholic, clear, colorless solution with an alcoholic odor;

5 % solution: aqueous-alcoholic, clear, colorless solution with possible yellowish-brown tint and with an alcoholic odor.

Pharmacotherapeutic group. Medicinal products used in dermatology. Other dermatological preparations. Minoxidil. ATC code D11AX01.

Pharmacological properties.

Pharmacodynamics.

Minoxidil is a potent peripheral vasodilator affecting the smooth muscle of blood vessels. When applied to the scalp skin, minoxidil stimulates the restoration of hair growth in patients with androgenetic alopecia (male-pattern baldness). The mechanism of enhanced hair growth involves improved blood circulation in the scalp following topical application of minoxidil, thereby enhancing nutrient supply and leading to the revival of atrophied hair follicles.

Hair growth is usually observed after 2–4 months of therapy and varies individually for each patient.

Pharmacokinetics.

Following topical application of the solution to intact scalp skin, only a small amount of minoxidil is absorbed (up to 4.5%). Absorption of minoxidil through the skin increases with higher doses, increased frequency, or larger application area of the lotion. Absorbed minoxidil is metabolized in the liver, and elimination of minoxidil and its metabolites occurs primarily via the kidneys. After discontinuation of topical treatment, 95% of minoxidil is excreted within 4 days.

Clinical characteristics.

Indications.

MINOXIDIL INTELI 2 %

Androgenetic alopecia in men and women.

MINOXIDIL INTELI 5 %

Androgenetic alopecia in men.

Contraindications.

Hypersensitivity to the components of the drug; scalp skin disorders (including psoriasis and sunburn); concurrent application of other topical products on the scalp; pheochromocytoma; treated and untreated arterial hypertension; pregnancy or breastfeeding period; patient age under 18 or over 65 years. Do not use after shaving the head.

MINOXIDIL INTELI 5 % is contraindicated for use in women.

Special precautions.

Do not exceed the recommended dose or frequency of solution application, as this may lead to adverse effects.

Hands must be washed after each application. Inhalation of solution vapors should be avoided.

In case of contact with mucous membranes, damaged skin, or eyes, these areas should be thoroughly rinsed with running water.

Use of a hair dryer is not recommended during treatment, as it may cause accelerated evaporation of the active substance.

The product is highly flammable; therefore, after opening the original packaging, it should be protected from open flame and high temperatures.

Interaction with other medicinal products and other types of interactions.

Minoxidil should not be used concurrently with other topical products applied to the scalp.

Concomitant use of MINOXIDIL INTELI and other topical agents containing corticosteroids, tretinoin, dithranol, or vaseline may enhance the absorption of minoxidil. There is a potential for increased orthostatic arterial hypotension upon systemic absorption of minoxidil in patients taking peripheral vasodilators, although this has not been clinically confirmed.

It has been reported that guanethidine interacts with oral minoxidil preparations, resulting in rapid and pronounced reduction in blood pressure. There is a theoretical possibility of interaction between topical minoxidil and guanethidine.

Special precautions for use

Before starting treatment with MINOXIDIL INTELI, ensure that the scalp skin is healthy and intact.

Do not use minoxidil if there is inflammation, infection, irritation, or pain of the scalp skin.

MINOXIDIL INTELI 2%, topical solution, is indicated for the treatment of male-pattern alopecia in women and men. It should not be used for other causes of hair loss, such as when there is no family history of hair loss, sudden and/or patchy hair loss, postpartum-related hair loss, or when the cause of hair loss is unknown.

MINOXIDIL INTELI 5%, topical solution, is indicated for the treatment of male-pattern alopecia in men. It should not be used for other causes of hair loss, such as when there is no family history of hair loss, sudden and/or patchy hair loss, or when the cause of hair loss is unknown.

Discontinue use of the product and consult a physician if you experience low blood pressure, chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of hands and feet, persistent redness, irritation of the scalp, or the appearance of any other unexpected new symptoms.

If you have cardiovascular diseases or arrhythmia, consult your doctor before starting treatment with MINOXIDIL INTELI.

MINOXIDIL INTELI, topical solution, is intended for external use only. It should not be applied to any areas of the body other than the scalp.

Increasing the dose of the product or applying it more frequently than recommended will not improve treatment outcomes.

Excessive growth of unwanted hair may occur if the product is applied to areas other than the scalp.

In some patients, changes in hair color and/or texture may occur.

Some patients have reported increased hair loss after initiating treatment with minoxidil topical solution. This is most likely due to the transition from the resting phase (telogen phase) to the growth phase (anagen phase) of hair follicles. During this process, old hair sheds and is replaced by new hair. This temporary increase in hair shedding usually occurs 2–6 weeks after starting treatment and resolves within several weeks. If hair loss persists for more than 2 weeks, discontinue use of minoxidil topical solution and consult a physician.

Use with caution in patients with ischemic heart disease, angina pectoris, arrhythmia, or arterial hypotension due to the potential for systemic effects of minoxidil.

The product should also be used with caution in patients with individual variability, unusual sensitivity, or impaired skin integrity due to inflammatory or skin disease processes (e.g., scalp skin injury or scalp psoriasis).

Hypertrichosis in children following accidental topical exposure to minoxidil:

Cases of hypertrichosis in infants have been reported following skin contact with sites where minoxidil was applied in patients (or caregivers) using topical minoxidil. Hypertrichosis in infants was reversible within several months after discontinuation of minoxidil exposure. Therefore, contact between children and minoxidil application sites should be avoided.

Accidental ingestion of the solution may cause serious cardiovascular adverse effects; therefore, the product must be stored out of reach of children.

MINOXIDIL INTELI, topical solution, contains ethanol, which may cause eye irritation. If the product comes into contact with mucous membranes, damaged skin, or eyes, these areas should be thoroughly rinsed with running water.

The medicinal product contains propylene glycol, which may cause skin irritation.

If no satisfactory results are observed after 4 months of treatment, a dermatologist consultation is required. Continuing or repeating treatment is recommended only after consultation with a dermatologist.

Use during pregnancy or breastfeeding.

The use of this product is contraindicated in women who are pregnant or breastfeeding.

Effect on the ability to drive or operate machinery.

Due to the possible development of dizziness or low blood pressure, caution should be exercised when driving or operating machinery. If the aforementioned adverse effects occur, refrain from engaging in such activities.

Method of Administration and Dosage

Medical consultation is required before use.

The product is intended for topical use only in adults aged 18 to 65 years.

The recommended daily dose is 1 ml every 12 hours, corresponding to 10 actuations of the dosing pump provided with the bottle. It should be applied to dry scalp skin in the area of alopecia, starting from the center and moving toward the periphery. The recommended daily dose should be strictly followed regardless of the degree of alopecia.

The maximum recommended daily dose is 2 ml.

Do not exceed the recommended dosage.

The duration of therapy depends on treatment outcomes; typically, the course lasts 4 months.

There have been reports of hair loss resuming within 3–4 months after discontinuation of minoxidil treatment.

Treatment should be discontinued if no effect is observed after 1 year of use.

Elderly patients

The use of this product is not recommended in elderly patients. The safety and efficacy of minoxidil in patients aged 65 years and older have not been established.

Special populations

There are no specific recommendations regarding the use of minoxidil in patients with renal or hepatic impairment.

Children

The product is contraindicated in children under 18 years of age.

Overdose

Accidental or intentional overdose following topical application of minoxidil may lead to an increased intensity of adverse dermatological reactions, particularly itching, dryness, irritation, and eczema. Enhanced systemic absorption of minoxidil is possible when applied over large body surface areas or to areas other than the scalp, especially when doses exceed those recommended.

Accidental ingestion of minoxidil solution may cause systemic effects due to the vasodilatory action of minoxidil (5 ml of Minoxidil Inteli 2% contains 100 mg of minoxidil, which is the maximum recommended dose for hypertension treatment; 2 ml of Minoxidil Inteli 5% contains 100 mg of minoxidil, which is the maximum recommended dose for hypertension treatment).

Symptoms of minoxidil overdose primarily include cardiovascular disturbances associated with sodium and fluid retention. Tachycardia, arterial hypotension, dizziness, and somnolence may also occur.

Treatment

Treatment of minoxidil overdose should be symptomatic and supportive.

Beta-blockers are indicated for tachycardia. Diuretics may be used to manage fluid retention. Arterial hypotension may be treated with intravenous administration of physiological saline.

Adverse Reactions

Data indicate that the overall frequency of adverse reactions by organ system classes is approximately five times higher in women than in men.

Dermatological reactions such as irritation and itching after application have been reported in patients using both minoxidil topical solution and the vehicle solution without active ingredient, which is attributed to the presence of propylene glycol in both formulations.

Adverse reactions have been reported in men and women using minoxidil topical solution (20 mg/mL and 50 mg/mL in combination). Additionally, adverse reactions have been documented during the post-marketing period of use of this medicinal product.

The adverse reactions listed below are categorized according to the following frequency classification: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000); frequency not known (cannot be estimated based on available data).

Immune system disorders

Common – hypersensitivity reactions (including facial swelling, generalized erythema, generalized pruritus, facial swelling, and throat tightness).

Frequency not known – angioneurotic edema (including lip swelling, lip edema, oral cavity swelling, oropharyngeal swelling, pharyngeal swelling, tongue swelling, and tongue edema).

Psychiatric disorders

Frequency not known – depressed mood.

Nervous system disorders

Very common – headache.

Uncommon – dizziness.

Eye disorders

Frequency not known – eye irritation.

Cardiac disorders

Common – chest pain.

Uncommon – tachycardia.

Frequency not known – increased heart rate.

Vascular disorders

Frequency not known – decreased blood pressure.

Respiratory, thoracic and mediastinal disorders

Uncommon – dyspnea.

Gastrointestinal disorders

Uncommon – nausea.

Frequency not known – vomiting.

Skin and subcutaneous tissue disorders

Common – hypertrichosis (unwanted hair growth in areas other than the scalp, including facial hair growth in women), pruritus (including generalized rash with itching and eye pruritus), rash (including pustular, papular, generalized, vestibular, and macular rash), dermatitis (including contact dermatitis at the site of application, allergic, atopic, and seborrheic dermatitis).

Rare – change in hair texture.

Frequency not known – dry skin, skin desquamation (including exfoliative rash and exfoliative dermatitis), acne (acneiform rash), temporary hair loss, change in hair color.

General disorders and administration site conditions

Common – peripheral edema.

Frequency not known – application site reactions (which may sometimes spread to adjacent areas of the body, including ears and face), namely: pruritus, irritation, pain, rash, swelling, dry skin, erythema, and erythematous rash, which may occasionally be more severe and include desquamation, dermatitis, blistering, bleeding, and ulceration.

Investigations

Common – weight gain.

The drug should be discontinued and a physician consulted if chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of hands or feet, or persistent redness or irritation of the scalp occurs.

Shelf life.

3 years.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging.

60 mL in a bottle with a metering pump, in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Industrial Farmaceutica Cantabria, S.A.

Manufacturer's address.

Barrio Solía No. 30 – La Concha – Villaescusa, Santander, Cantabria, 39690, Spain.

Marketing authorization holder.

JSC "Intelie Generiks Nord".

Address of the marketing authorization holder.

Šeimininkų St. 3, 09312, Vilnius, Lithuania.