HEDENZA

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

Composition:

Active substances: monochlorocarvacrol, ichthammol, levomenthol;

1 suppository contains: monochlorocarvacrol 1 mg, ichthammol 4 mg, levomenthol 50 mg;

Excipients: peanut oil; castor oil; chamomile oil; propyl gallate; citric acid monohydrate; flaxseed oil; hard fat; purified water.

Pharmaceutical form. Rectal suppositories.

Main physicochemical characteristics: light beige, torpedo-shaped suppositories with a smooth, homogeneous surface without dark spots, with a menthol odor.

Pharmacotherapeutic group. Medicinal products for the treatment of haemorrhoids and anal fissures for local use. Other preparations, combinations.

ATC Code C05AX03.

Pharmacological properties.

Pharmacodynamics.

Monochlorocarvacrol has anti-inflammatory, antibacterial, and antifungal properties. Ichthammol has antiseptic effects in addition to its anti-inflammatory action. Levomenthol exerts a cooling, analgesic, and antiseptic effect and reduces itching. Experimental studies have shown that menthol reduces the tendency to spasms, whereas other terpenes may lower the epileptic threshold.

The suppository base contains vegetable fat.

Pharmacokinetics.

The medicinal product acts locally. Pharmacokinetic data on the effects of ichthammol in humans are not available.

The active substances penetrate into tissues, are partially absorbed, metabolized, and excreted with urine and feces.

Clinical characteristics.

Indications.

Used for the treatment of external and internal hemorrhoids, anal fissures, and anal pruritus.

Contraindications.

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

Contraindicated in children under 12 years of age due to lack of application experience.

Interaction with other medicinal products and other forms of interaction.

Studies on interactions have not been conducted.

Special precautions for use.

The medicinal product contains castor oil, which may cause skin reactions.

Contains peanut oil. If you are allergic to peanuts or soy, do not use this medicinal product.

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

Do not exceed the recommended dose, as this increases the risk of adverse effects and overdose.

Use during pregnancy or breastfeeding.

Pregnancy.

Clinical data on the use of suppositories in pregnant women are lacking. Animal studies have not revealed any direct or indirect adverse effects on pregnancy, embryonic/fetal development, or postnatal development.

The medicinal product should be used with caution during pregnancy and breastfeeding, and only when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Fertility.

Animal studies do not indicate reproductive toxicity.

Ability to affect reaction speed when driving vehicles or operating machinery.

The medicinal product does not affect the ability to drive vehicles or operate machinery.

Method of administration and dosage.

Hedenza suppositories are administered rectally once or twice daily (e.g., in the morning and evening).

To achieve maximum effect, hold the suppository in the anal canal for 1–2 minutes before inserting it further.

Before use, it is recommended to cool the suppositories (in the refrigerator).

The duration of treatment depends on the severity and course of the disease and is determined individually by the physician, but should not exceed 5 days. If symptoms worsen or no improvement is observed after 5 days of treatment, treatment must be discontinued and medical advice should be sought.

Children. The medicinal product 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 – < 1/10
uncommon: ≥ 1/1000 – < 1/100
rare: ≥ 1/10000 – < 1/1000
very rare: < 1/10000

Local reactions:

Common:
Transient burning sensation.

Very rare:
Allergic reactions, local skin irritation.

Shelf life. 3 years.

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

Packaging.
5 suppositories per blister; 1 blister per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.
Dr. Gustav Klein GmbH & Co. KG.

Manufacturer's address.
Steinenfeld 3, 77736 Zell am Harmersbach, Germany.