Freederm^® TAR (Shampoo) Instructions for Use

Marketing Authorization Holder

Schering-Plough Farma, Lda. (Portugal)

ATC Code

D11AC30 (Other medicated shampoos)

Active Substance

Tar (BP British Pharmacopoeia)

Dosage Form

Freederm® Tar

Shampoo 5 mg/1 ml: 150 ml bottle

Dosage Form, Packaging, and Composition

Excipients: triethanolamine lauryl sulfate, polyethylene glycol-8 distearate, cocamide monoethanolamide, cocamide diethanolamide, sodium chloride, distilled water.

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

Clinical-Pharmacological Group

A drug with antifungal and antiproliferative action for external use

Pharmacotherapeutic Group

Antiseborrheic agent

Pharmacological Action

An agent of plant origin, which is obtained by dry distillation of wood from trees of the pine family or from birch bark.

It has keratoplastic, antiseptic, antiparasitic, drying, anti-inflammatory, vasoconstrictive, and anesthetic action; reduces erythema, soothes itching. In infiltrative processes in the skin, it has a resolving effect.

Indications

As part of combination therapy: psoriasis in the stationary and regressing stages, eczema (including microbial and seborrheic), neurodermatitis outside of exacerbation, prurigo, seborrhea, skin itching; treatment of wounds, ulcers, bedsores, burns.

ICD codes

Dosage Regimen

Apply externally only. Use as a shampoo for scalp conditions or as a topical application for body skin lesions.

For scalp psoriasis, seborrheic dermatitis, and seborrhea: wet hair thoroughly. Apply a sufficient amount of shampoo to create a rich lather. Massage into the scalp for several minutes. Rinse thoroughly with warm water. Repeat application. Leave the second lather on the scalp for 3-5 minutes before rinsing completely.

Use this shampoo 2-3 times per week or as directed by a physician. Frequency may be reduced to once weekly or every other week for maintenance therapy after initial control is achieved.

For body skin conditions such as psoriasis, eczema, or neurodermatitis on non-hairy areas: apply a thin layer to affected skin. Leave on for 10-20 minutes. Rinse thoroughly with water. Apply once daily or as directed.

For wound care, ulcers, or burns: apply to the affected area as a compress or wet dressing according to medical supervision.

Avoid contact with eyes. If contact occurs, rinse immediately with plenty of water. Discontinue use and consult a physician if signs of irritation or sensitization develop.

Do not apply to acute, exudative, or inflamed skin. Limit application to large body surface areas. Duration of continuous use should be determined by a healthcare professional.

Adverse Reactions

With prolonged use, skin burning and irritation at the application site are possible.

When applied to areas of skin with increased hairiness or to the scalp, the development of folliculitis is possible.

Application to open areas of the skin (face, neck, hands) may provoke the appearance of sunburns.

Contraindications

Hypersensitivity to tar; acute skin inflammation, exacerbation of chronic skin diseases, especially with pronounced exudation (acute eczema, dermatitis, exudative psoriasis), damage to the sebaceous-hair follicles (folliculitis, furunculosis, acne, sycosis), diseases of the kidneys, liver, pancreas, myocardium.

Use in Pregnancy and Lactation

It is not recommended for use during pregnancy, during breastfeeding, and for women planning pregnancy.

Use in Hepatic Impairment

Contraindicated in liver diseases.

Use in Renal Impairment

Contraindicated in kidney diseases.

Pediatric Use

Used in children with caution, according to indications, in appropriate dosage forms.

Special Precautions

Before starting treatment, it is recommended to test tolerance to tar on a limited area of the skin.

Use with caution on the face, in areas of skin folds, and in the genital area.

During the use of tar, urine should be periodically examined (1-2 times a month). Tar should not be used for a long time on large areas of the skin (more than 1/10 of the surface).

Use Tar with caution in children and persons with sensitive skin, with a tendency to folliculitis, on areas with increased hairiness.

Drug Interactions

It should not be prescribed simultaneously with sulfonamide drugs, phenothiazine derivatives and other agents that have properties to increase skin photosensitivity.

Simultaneous use of tar with preparations containing sulfur and salicylic acid enhances its action.

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.