Hedenza

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEDENZA (HAEDENSA)

Composition:

Active substances: monochlorocarvacrol, ichthammol, levomenthol;

1 g of ointment contains: monochlorocarvacrol 0.5 mg, ichthammol 5 mg, levomenthol 25 mg;

Excipients: peanut oil, sunflower oil, polyethylene glycol (macrogol) cetylstearyl ether, octyldodecanol, lanolin, linseed oil, purified water.

Pharmaceutical form. Rectal ointment.

Main physicochemical properties: homogeneous light beige-colored ointment (water-in-oil emulsion) with a menthol odor.

Pharmacotherapeutic group. Agents for the treatment of hemorrhoids and anal fissures for topical use. Other preparations, combinations.

ATC code C05AX03.

Pharmacological Properties

Pharmacodynamics

Monochlorocarvacrol has anti-inflammatory, antibacterial, and antifungal properties. Ichthammol exhibits not only anti-inflammatory but also antiseptic effects. Levomenthol produces a cooling, analgesic effect and reduces itching. Antiseptic effect of levomenthol has also been demonstrated. The ointment base contains vegetable fat and lanolin.

Pharmacokinetics

The drug acts locally at the site of application. There are no pharmacokinetic data regarding the effect of ichthammol in humans.

Active substances penetrate into the tissue, are partially absorbed, metabolized, and excreted with urine and feces.

Clinical characteristics.

Indications.

External and internal hemorrhoids, anal fissures, anal itching.

Contraindications.

Hypersensitivity to the active substances, peanuts, soy, or to any other components of the medicinal product.

Children under 12 years of age (due to lack of experience in use).

Interaction with other medicinal products and other types of interactions.

Studies on interactions have not been conducted.

Special precautions for use

The medicinal product contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

The product should not be used in cases of significant skin damage in the anal area.

Use during pregnancy or breastfeeding.

Fertility

Available preclinical studies do not indicate any effect on fertility.

Pregnancy

There are no clinical data on the use of Xyloproct ointment in pregnant women.

Animal studies have not shown any direct or indirect adverse effects on pregnancy, embryonic/fetal development, parturition, or postnatal development. The medicinal product should be used with caution during pregnancy.

Breastfeeding

The product may be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery

Has no effect.

Method of Administration and Dosage.

Hedenza ointment should be applied 3 times daily and additionally after each bowel movement.

For administration into the anal canal in cases of internal hemorrhoids and fissures, the provided applicator can be used.

Before use, a small amount of ointment should be applied to the applicator to facilitate insertion. The applicator must be thoroughly washed after use.

Local treatment of hemorrhoids is usually long-term. If symptoms do not improve within 5 days, alternative treatment options should be considered.

Children.

The drug is contraindicated in children under 12 years of age.

Overdose.

Not reported.

Side effects.

The following classification is used to assess the frequency of adverse reactions:

very common: ≥ 1/10
common: ≥ 1/100 to < 1/10
uncommon: ≥ 1/1000 to < 1/100
rare: ≥ 1/10000 to < 1/1000
very rare, including isolated cases: < 1/10000

Local reactions:

Common:
Transient burning sensation.

Very rare:
Allergic reactions, local skin irritation.

Shelf life. 5 years.
Shelf life after first opening of the tube – 6 months.

Storage conditions.
Store at a temperature not exceeding 25 ºC.
Keep out of reach of children.

Packaging.
20 g in a tube; 1 tube with an applicator in a cardboard box.

Availability. Over-the-counter.

Manufacturer.
Merz Pharma GmbH & Co. KGaA.

Manufacturer's address and place of business.
Ludwigstrasse 22, 64354 Reinheim, Germany.