Pantexol jadran

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTHEXOL JADRAN (PANTEXOL JADRAN)

Composition:

Active substance: dexpanthenol;

1 g of cream contains 50 mg of dexpanthenol;

Excipients: polyethylene glycol (macrogol) cetostearyl ether (cremophor A 25), polyethylene glycol (macrogol) cetostearyl ether (cremophor A 6), dimethicone, glycerol monostearate, Luwitol ENO, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), propylene glycol, seaside 2026 flavoring, cetyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: homogeneous white cream with a specific odor.

Pharmacotherapeutic group. Agents promoting wound healing (scar formation).

ATC code D03A X03.

Pharmacological properties.

Pharmacodynamics.

Dexpanthenol, the active substance of Panteksol Jadran cream, is rapidly converted into pantothenic acid within cells and acts as a vitamin. Following topical application, dexpanthenol is absorbed more readily than pantothenic acid.

Pantothenic acid is a component of essential coenzyme A (CoA). In this form, acetyl-coenzyme A, CoA plays a central role in the metabolism of every cell. Thus, pantothenic acid is necessary for the restoration and regeneration of damaged skin and mucous membranes.

Pharmacokinetics.

Dexpanthenol is rapidly absorbed through the skin. It is then immediately converted into pantothenic acid and added to the body's internal pool of this vitamin.

In the blood, pantothenic acid binds to plasma proteins (primarily to ß-globulins and albumin). In healthy adults, the concentration is approximately 500–1000 µg/L and 100 µg/L in whole blood and blood serum, respectively.

Pantothenic acid is not metabolized in the body and is excreted unchanged.

After oral administration, 60–70% of the dose is excreted in the urine, the remainder in the feces.

In adults, 2–7 mg of pantothenic acid is excreted daily in the urine; in children, 2–3 mg.

Clinical characteristics.

Indications.

The cream is used in the following cases:

• prophylactic treatment of dry, reddened, or cracked skin;
• acceleration of healing and epithelialization of skin in minor injuries (mild burns and abrasions); in skin irritations (e.g., due to radiotherapy, phototherapy, or ultraviolet radiation); diaper dermatitis; chronic skin ulcers and pressure sores; anal fissures; cervical erosions; and after skin grafting;
• skin care in patients during and after topical application of corticosteroids;
• prophylactic care of mammary glands in breastfeeding women, treatment of irritations and fissures of nipples.

Contraindications.

Hypersensitivity to dexpanthenol or to any of the excipients of the product.

Interaction with other medicinal products and other forms of interaction.

Cases of interaction with other medicinal products are unknown.

Special precautions for use

When using the medicinal product, avoid contact with the eyes.

Methylparaben (E218) and propylparaben (E216) may cause allergic reactions (possibly delayed).

Propylene glycol may cause skin irritation.

Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy or breastfeeding

There are no grounds to consider the use of the medicinal product during pregnancy or breastfeeding as hazardous. During pregnancy, the product should be used only as prescribed by a physician.

When used for the treatment of cracked nipples during breastfeeding, the product should be washed off before nursing.

Ability to influence reaction rate when driving or operating machinery

No influence.

Method of Administration and Dosage.

Accelerating healing and epithelialization, regular skin care: apply the cream one or several times daily, depending on need.

Breast care in breastfeeding women: apply the cream to the nipples after each breastfeeding session.

Treatment of cervical mucosal defects: apply the cream once or several times daily under medical supervision.

Infant care: apply the cream after each diaper change.

Pantexol Jadran, cream, rapidly penetrates the skin; therefore, it is suitable for care of weeping wounds, exposed skin surfaces (face), and hairy skin. It spreads easily over the surface and is thus suitable for treatment of painful sunburns and other mild burns.

Children.

The product can be used in children of all age groups, including infants.

Overdose.

The active ingredient of the cream, dexpanthenol, is well tolerated and therefore considered non-toxic in scientific literature. Hypervitaminosis has not been described.

Side effects.

Immune system disorders, as well as skin and subcutaneous tissue disorders. Allergic reactions have been reported, including skin reactions: contact dermatitis, allergic dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and vesicles.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

25 g of cream in a tube; 1 tube in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Jadran-Galenski Laboratorij d.d.

Manufacturer's address and location of business operations.

Svilno 20, 51000 Rijeka, Croatia.