Freederm^® Zinc (Shampoo) Instructions for Use

Marketing Authorization Holder

Schering-Plough Farma, Lda. (Portugal)

ATC Code

D11AC30 (Other medicated shampoos)

Active Substance

Pyrithione zinc (Rec.INN registered by WHO)

Dosage Form

Freederm® Zinc

Shampoo 20 mg/1 ml: 150 ml bottle

Dosage Form, Packaging, and Composition

Excipients: triethanolamine lauryl sulfate, polyethylene glycol-8 distearate, monoethanolamine cocamide, diethanolamine cocamide, sodium chloride, gum, hydroxypropyl methylcellulose, distilled water.

150 ml – plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antifungal and antiproliferative action for external use

Pharmacotherapeutic Group

Dermatoprotective agent

Pharmacological Action

A topical agent. Activated zinc pyrithione possesses anti-inflammatory, antibacterial, and antifungal activity.

Antifungal activity is particularly pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which cause inflammation and excessive flaking in dandruff, seborrhea, psoriasis, and other skin diseases.

The antibacterial activity of zinc pyrithione is manifested against a number of pathogenic microorganisms (streptococcus, staphylococcus, Pseudomonas aeruginosa and Escherichia coli, Proteus, etc.).

Zinc pyrithione reduces the intracellular level of ATP, promotes depolarization of cell membranes, causing the death of fungi and bacteria.

Pharmacokinetics

With topical application, activated zinc pyrithione is deposited in the epidermis and superficial layers of the dermis.

Systemic absorption occurs slowly. It is detected in the blood in trace amounts.

Indications

Psoriasis, atopic dermatitis, eczema, neurodermatitis, seborrheic dermatitis in adults and children from 1 year of age.

ICD codes

Dosage Regimen

Apply a sufficient amount of shampoo to wet hair and scalp.

Massage thoroughly into the scalp until a rich lather forms.

Leave the lather on for 3-5 minutes to allow contact with the affected skin.

Rinse hair and scalp thoroughly with warm water.

Repeat this application process.

Use the shampoo twice weekly for the first 2 weeks to achieve initial control.

For maintenance therapy, reduce application frequency to once weekly or as needed.

Duration of treatment is determined by the clinical response for conditions such as dandruff, seborrheic dermatitis, and psoriasis.

Avoid contact with eyes. If contact occurs, rinse immediately with water.

Discontinue use and consult a physician if irritation persists or worsens.

Adverse Reactions

Rarely local allergic reactions. In the first days of treatment, a short-term burning sensation at the application site is possible, which, as a rule, does not require discontinuation of therapy.

Contraindications

Hypersensitivity to zinc pyrithione; children under 1 year of age.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, use is possible according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Special Precautions

Treatment with zinc pyrithione is not recommended to be combined with topical preparations containing corticosteroids.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.