Pilfud bosnalek®

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

Composition:

Active substance: minoxidil;

1 ml of topical spray solution contains 50 mg of minoxidil;

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

Pharmaceutical form. Topical spray solution.

Main physicochemical properties: clear solution ranging from light yellow to orange in color.

Pharmacotherapeutic group. Dermatologicals. ATC code D11AX01.

Pharmacological properties.

Pharmacodynamics.

The mechanism by which minoxidil stimulates hair growth is not fully understood. Possible mechanisms for halting 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, thereby enhancing capillary development, which manifests as significant metabolic activity during the anagen phase of hair growth.

Pharmacokinetics.

Systemic absorption of minoxidil following topical application to intact, normal scalp skin ranges from 1 to 2% of the total applied dose. Skin absorption of minoxidil increases with higher dosage, frequency, or application surface area. Absorbed minoxidil is metabolized in the liver, and excretion of minoxidil and its metabolites occurs primarily via the kidneys. After discontinuation of topical application, approximately 95% of absorbed minoxidil is eliminated from the body within 4 days.

Clinical characteristics.

Indications.

Male-pattern baldness in men.

Contraindications.

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

Pilfood Bosnalak® 5%, topical spray solution, is contraindicated for use in women.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Pilfood Bosnalak® 5% and other topical agents containing corticosteroids, tretinoin, dithranol, or vaseline may enhance the absorption of minoxidil. Potentiation of orthostatic hypotension is possible upon 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, resulting in rapid and pronounced reduction in arterial blood pressure. There is a theoretical possibility that topically applied minoxidil may also interact with guanethidine.

Special precautions for use.

Before starting treatment with Pilfood Bosnalac® 5%, ensure that the scalp skin is healthy and intact.

The product is indicated for the treatment of male pattern alopecia in men and 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.

Treatment must be discontinued and a physician should be consulted if chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of hands and 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 before 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 other areas of the body except the scalp. Inhalation of the solution should be avoided.

Pilfood Bosnalac® 5% spray for skin, solution contains alcohol, which may cause eye irritation, and propylene glycol, which may cause skin irritation. In case of 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 usually resolves within several weeks. If hair loss persists for more than 2 weeks, treatment should be discontinued and a physician should be consulted.

The solution should not be applied to shaved areas of the scalp, nor should the recommended dose or frequency of application be exceeded, as this may increase absorption of minoxidil and lead to adverse effects. Accidental ingestion of the solution may cause serious cardiovascular adverse effects; therefore, it 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 sites where minoxidil was applied by patients (caregivers) using topical minoxidil. Hypertrichosis in infants was reversible within several months after discontinuation of exposure to minoxidil. Therefore, contact between children and sites of minoxidil application should be avoided.

Use during pregnancy or breastfeeding.

Use in women is contraindicated.

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 Bosnalék® 5%, topical spray solution, is intended for external use only in men 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 area of alopecia, gently massaging it in a motion from the center toward the periphery. Each application requires 8 consecutive presses of the spray pump to deliver 1 mL of solution. The maximum daily dose should not exceed 2 mL. Hands must be washed after each application.

To achieve a therapeutic effect, the solution should be applied twice daily for at least 2 months. After achieving clinical improvement, treatment should be continued to maintain hair growth. There have been reports of resumption of hair loss within 3–4 months after discontinuation of minoxidil treatment.

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

Before first use, the spray applicator 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 applied to large body surface areas or when used in doses exceeding the recommended amount. Accidental ingestion of the solution may lead to systemic effects due to the vasodilatory action of minoxidil (2 mL of Pilfood Bosnalék® 5% 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 with beta-adrenergic blockers.

Adverse Reactions

Immune system disorders: hypersensitivity reactions, including facial swelling, generalized erythema, pruritus, swelling of the face and throat; angioneurotic edema (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 (unwanted 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 exfoliation (including at the application site, exfoliative rash, exfoliative dermatitis), rash (including at the application site, pustular, papular, generalized, and macular rash), acne (acneiform rash), dermatitis (including contact dermatitis at the application site, allergic, atopic, seborrheic dermatitis), dry skin (including at the application site).

General disorders and administration site conditions: peripheral edema, irritation at the application site, 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 desquamation, blisters, ulcers.

Reporting of adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System 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 per cardboard box.

Dispensing 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.