Pilfood bosnalek®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PILFUDBOSNALIJEK® (PILFUDBOSNALIJEK®)

Composition:

Active substance: minoxidil (minoxidil);

1 ml of topical spray solution contains 20 mg of minoxidil;

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

Pharmaceutical form. Topical spray solution.

Main physicochemical properties: clear solution ranging from colorless to light yellow or light orange.

Pharmacotherapeutic group. Dermatologicals. ATC code D11AX01.

Pharmacological properties.

Pharmacodynamics.

The mechanism by which minoxidil stimulates hair growth is not fully understood. Possible mechanisms for preventing hair loss include increasing the diameter of the hair shaft, stimulating the anagen (growth) phase of hair, prolonging the anagen phase, and promoting the regeneration of anagen coverage following the telogen phase. Minoxidil is a peripheral vasodilator that improves microcirculation in hair follicles. It stimulates vascular endothelial growth factor, which enhances capillary development, resulting in significantly increased metabolic activity during the anagen phase of hair growth.

Pharmacokinetics.

Systemic absorption of minoxidil following topical application to intact normal scalp skin amounts to 1–2% of the total applied dose. Absorption of minoxidil through the skin is enhanced by increasing the dosage, frequency, or surface area of solution application. Metabolism of absorbed minoxidil occurs in the liver, and elimination of minoxidil and its metabolites occurs primarily via the kidneys. After discontinuation of topical application, approximately 95% of absorbed minoxidil is excreted from the body within 4 days.

Clinical characteristics.

Indications.

Androgenetic alopecia in men and women.

Contraindications.

Hypersensitivity to the components of the drug, scalp skin diseases (including psoriasis and sunburn), concomitant use of other topical agents or occlusive dressings on the scalp, arterial hypertension; patient age under 18 or over 65 years.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Pilfood Bosnalek® 2% and other topical agents containing corticosteroids, tretinoin, dithranol, or vaseline may enhance the absorption of minoxidil. There is a possibility of increased orthostatic hypotension due to systemic absorption of minoxidil in patients taking peripheral vasodilators, although this has not been clinically confirmed.

An interaction between guanethidine and oral minoxidil preparations has been reported, leading to rapid and pronounced reduction in arterial blood pressure. There is a theoretical possibility that topical minoxidil may also interact with guanethidine.

Special precautions for use

Before starting treatment with Pilfood Bosnaliek® 2%, ensure that the scalp skin is healthy and intact.

The product is indicated for the treatment of male-pattern alopecia in both 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 hair loss, or when the cause of hair loss is unknown.

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

Patients with ischemic heart disease, angina pectoris, arrhythmia, or arterial hypotension should consult a physician prior to starting treatment due to the potential systemic effects of minoxidil.

This product is intended for topical use only. It should not be applied to any areas of the body other than the scalp. Inhalation of the solution should be avoided.

Pilfood Bosnaliek® 2% spray for skin, solution contains alcohol, which may cause eye irritation, and propylene glycol, which may cause skin irritation. If the product comes into contact with mucous membranes, damaged skin, or eyes, the affected areas should be thoroughly rinsed with running water.

In some patients, increased hair loss may occur during the first 2–6 weeks of treatment. This is due to changes in the hair growth cycle and typically resolves within a few weeks. If hair loss persists beyond 2 weeks, treatment should be discontinued and a physician consulted.

The solution should not be applied to shaved areas of the scalp, and the recommended dose and frequency of application should not be exceeded, as this may increase minoxidil absorption and lead to adverse effects. Accidental ingestion of the solution may result in serious cardiovascular adverse effects; therefore, the product must be stored out of reach of children.

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

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

Use during pregnancy or breastfeeding

There are insufficient data from clinical studies on the use of the product in pregnant or breastfeeding women. Systemically absorbed minoxidil is excreted in breast milk. The use of this product is contraindicated in women who are pregnant or breastfeeding.

Ability to affect reaction speed when driving or operating machinery

Based on the pharmacodynamics and safety profile of minoxidil, the medicinal product is not expected to affect the ability to drive or operate machinery.

Method of Administration and Dosage

Pilfood Bosnaliek® 2%, topical spray solution, is intended for external use only in men and women aged 18 to 65 years.

Before application, the scalp and hair must be thoroughly dried.

Using the spray applicator, apply 1 mL of the solution twice daily onto the dry scalp in the affected area, gently massaging from the center outward. At each application, press the spray pump 8 times to deliver 1 mL of solution. The daily dose must not exceed 2 mL. Hands must be washed after each application.

To achieve therapeutic effect, the solution should be applied twice daily for at least 4 months. After clinical improvement is achieved, continue treatment to maintain hair growth. There have been reports of resumption of hair loss within 3–4 months after discontinuation of minoxidil therapy.

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

Before first use, the spray pump must be primed by pressing it several times until a consistent spray is achieved. After this, the device is ready for use.

Children. This product is not intended for use in children.

Overdose.

Increased systemic absorption of minoxidil may occur when the product is used on large skin areas or at doses exceeding the recommended amount. Accidental ingestion of the solution may cause systemic effects due to the vasodilatory action of minoxidil (5 mL of Pilfood Bosnaliek® 2% contains 100 mg of minoxidil, which is the maximum recommended dose for the treatment of arterial hypertension).

Symptoms of overdose include cardiovascular disturbances, arterial hypotension, and tachycardia, associated with sodium and fluid retention.

Treatment of overdose is symptomatic. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administration of beta-adrenergic blockers.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including facial swelling, generalized erythema, pruritus, swelling of the face and throat; angioedema (including lip swelling, lip edema, mouth swelling, oropharyngeal swelling, tongue swelling, and tongue edema).

Nervous system disorders: headache, dizziness, depressed mood.

Cardiovascular system disorders: arterial hypotension, palpitations, chest pain, tachycardia.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting.

Skin and subcutaneous tissue disorders: hypertrichosis (undesired hair growth in areas outside the scalp, including facial hair growth in women), pruritus (including pruritic rash at the application site, generalized pruritus, eye pruritus), changes in hair color and texture, cases of temporary alopecia, skin desquamation (including at the application site, exfoliative rash, exfoliative dermatitis), rash (including at the application site, pustular, papular, generalized, and macular rash), acne (acneiform eruptions), dermatitis (including contact dermatitis at the application site, allergic, atopic, and seborrheic dermatitis), skin dryness (including at the application site).

General disorders and administration site conditions: peripheral edema, application site irritation, including skin irritation (sometimes the rash may spread to the ears and face), erythema at the application site (including redness and erythematous rash). Sometimes rashes may be more severe and include skin exfoliation, blisters, ulcers.

Reporting of adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua

Shelf life.

3 years.

Storage conditions.

Store out of reach of children at a temperature not exceeding 30 °C.

Packaging.

60 ml in a bottle with a spray pump, 1 bottle in a cardboard box.

Availability category.

Over-the-counter.

Manufacturer/Marketing Authorization Holder. Bosnaliek d.d.

Manufacturer's address and location of business operations.

Yukicheva 53, 71000 Sarajevo, Bosnia and Herzegovina.