Contractubex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KONTRAKTUBEKS

Composition:

Active substances: liquid extract of onion (0.16:1) (Ext. Cepae), sodium heparin, allantoin;

100 g of gel contain liquid extract of onion (0.16:1) (Ext. Cepae) 10 g, sodium heparin 0.04 g (5000 IU), allantoin 1 g;

Excipients: methyl parahydroxybenzoate (E 218), sorbic acid, xanthan gum, polyethylene glycol 200, fragrance oil Fragrance 30263773, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: opaque gel ranging from light beige to light brown in color with a characteristic odor.

Pharmacotherapeutic group.
Agents for the treatment of wounds and ulcerative lesions. ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

The product exerts anti-proliferative, anti-inflammatory, softening, and smoothing effects on scar tissue.

Onion extract acts as an anti-inflammatory agent by inhibiting the release of inflammatory mediators and exerts an anti-allergic effect. It inhibits the growth of fibroblasts of various origins, particularly keloid fibroblasts. In addition, a suppressive effect on mitosis (cell division) and on reducing the production of extracellular matrix components by fibroblasts (e.g., proteoglycans) has been demonstrated. Onion extract also exhibits bactericidal activity. These properties promote primary wound healing and prevent non-physiological scar formation.

Heparin exerts anti-inflammatory, anti-allergic, anti-proliferative effects, enhances tissue hydration, and produces a softening effect on collagen structure. For scar treatment, the anti-inflammatory action of heparin and its influence on connective tissue matrix components are more relevant than its well-known antithrombotic effect.

Allantoin promotes wound healing, exerts epithelializing effects, and increases tissue capacity for water binding. In addition, its keratolytic properties and ability to enhance permeability improve the efficacy of other components of the product. Allantoin also exhibits a soothing effect, which reduces itching commonly associated with scar formation.

The synergistic effect of this combination of active substances consists in slowing fibroblast proliferation and, in particular, pathological overproduction of collagen.

Pharmacokinetics.

Not applicable.

Clinical characteristics.

Indications.

Hypertrophic, keloid scars limiting mobility and impairing appearance following surgery, amputations, burns, and other traumatic skin injuries; contractures, e.g. of the fingers (Dupuytren's contracture), as well as traumatic tendon contractures and cicatricial strictures (atrophic scars).

Contractubex is used for treatment of these types of scars after wound healing.

Contraindications.

Hypersensitivity to any component of the product.

Special precautions.

Contractubex contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Contractubex contains sorbic acid, which may cause local skin reactions, e.g. contact dermatitis.

Interaction with other medicinal products and other forms of interaction.

No cases of interaction have been reported.

Usage characteristics.

Use during pregnancy or breastfeeding.

The risk of using the drug during pregnancy or breastfeeding is currently unknown.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

For adults and children aged 2 years and older, apply an adequate amount of gel several times daily, depending on the size of the scar, and gently rub it into the scar until completely absorbed.

For hard, old scars, the gel may be left under a dressing overnight.

Depending on the extent and thickness of the scar or contracture, treatment should be continued for several weeks or months. In particular, when treating fresh scars, avoid physical irritants such as very low temperatures, ultraviolet light, or intensive massage.

Children

Do not use the product in children under 1 year of age.

Prior to use in children aged 1 to 2 years, consultation with a physician is recommended.

The product may be used in children aged 2 years and older.

Overdose

No cases of overdose have been reported.

Adverse reactions.

The frequency of adverse reactions is defined according to the following categories:

Very common (≥ 1 / 10)

Common (≥ 1 / 100, <1/10)

Uncommon (≥ 1 / 1,000, <1/100)

Rare (≥1 / 10,000, <1/1,000)

Very rare (<1/10,000)

Frequency not known (frequency cannot be estimated from the available data)

The most common adverse reactions were local reactions at the site of application.

The undesirable effects listed below were recorded in a retrospective cohort pharmacoe pidemiological study in 592 patients (2005) investigating the efficacy and tolerability of Contractubex compared with local corticosteroid treatment.

Skin and subcutaneous tissue disorders.

Common: pruritus, erythema, telangiectasia, scar atrophy.

Uncommon: hyperpigmentation of the skin, skin atrophy.

Frequency not known: urticaria, rash, pruritus, erythema, skin irritation, papules, skin inflammation, burning sensation on the skin, feeling of skin tightness, contact dermatitis.

The following adverse effects have been reported spontaneously.

Infections and infestations.

Frequency not known: pustular eruptions.

Immune system disorders.

Frequency not known: hypersensitivity (allergic reactions).

Nervous system disorders.

Frequency not known: paraesthesia.

General and administration site conditions.

Frequency not known: swelling, pain at application site, peeling at application site.

Overall, Contractubex is very well tolerated, even with prolonged use. Pruritus, which is usually observed during treatment with Contractubex, is a manifestation of expected scar changes and generally does not require discontinuation of treatment.

Shelf life. 2 years.

Shelf life after first opening: 6 months.

Storage conditions.

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

Do not use the medicinal product after the expiry date stated on the packaging.

Packaging.

10, 20 or 50 g of gel in tubes in a cardboard box.

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

Manufacturer.

Merz Pharma GmbH & Co. KGaA.

Manufacturer's address and place of business.

Ludwigstrasse 22, 64354 Reinheim, Germany.