Contractubex Gel

Each 100 g contains: Extract cepae 10 g, Heparin sodium 5,000 IU, Allantoin 1 g.
Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel exerts a softening and smoothing effect on indurated, hypertrophic, painful and cosmetically disfiguring scar tissue. Heparin promotes the hydration (water-binding capacity) of the hardened tissue thus effecting the swelling and, therefore, a relaxation of the scars. Extract cepae and Allantoin support this softening effect. The water-soluble Serol base mediates the deep penetration of the active ingredients into the skin and therefore affords an intensive treatment.
Excipients/Inactive Ingredients: Sorbic acid, Methyl-4-hydroxybenzoate, Macrogol 200, Xanthan gum, Purified water, Fragrance.

Pharmacotherapeutic category: Anti-cicatricial/Anti-inflammatory. ATC code: D03AX.
Pharmacology: Pharmacodynamics: Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel has an antiproliferative, antiphlogistic, loosening and smoothing effect on scar tissue. Extract cepae acts as an antiphlogistic by inhibiting the release of inflammation mediators and has an antiallergic effect. Extract cepae inhibits the growth of fibroblasts of various origins and of keloid fibroblasts in particular. In addition to a mitogenic inhibitory effect, the drug has been shown to diminish the formation of extracellular matrix constituents from fibroblasts (e.g. proteoglycans). Extract Cepae has a bactericidal action. These properties stimulate primary wound healing and counteract unphysiological scar formation. Heparin is antiphlogistic, antiallergic, antiproliferative and increases tissue hydration. It also has a loosening effect on collagen structure. For the treatment of scars, the anti-inflammatory effect of heparin and its effect on the constituents of the connective tissue matrix are more important than its known antithrombotic action. Allantoin promotes wound healing; it has an epithelialising effect and increases the tissue's water-binding capacity. In addition, its keratolytic and penetration-promoting properties improve the efficacy of the other active ingredients of Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel. Allantoin has a soothing effect, which relieves the pruritus often associated with scar formation. The synergistic effect of this combination of active ingredients lies in the super additive inhibition of fibroblast proliferation and especially of pathologically increased collagen synthesis.
Toxicology: Preclinical Safety Data: According to present knowledge, there is no toxicological risk, especially with regard to mutagenic, teratogenic and carcinogenic effects.

Hypertrophic and keloidal scars, movement restricting and cosmetically disfiguring scars after operations, amputations, burns and accidents, contractures such as Dupuytren's contracture and traumatic tendon contracture, cicatricial strictures.

Unless otherwise prescribed by the physician, apply Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel to the skin or scar tissue several times daily and gently massage in until the gel has been completely absorbed. In the case of hard, old scars allow the gel to take effect overnight under a dressing. Depending to the extent and thickness of the scar or contracture treatment will be necessary for several weeks or months. Particularly when treating fresh scars, physical irritants such as extreme cold, UV light or heavy massaging should be avoided.
Paediatric population: In children from 1 year of age the gel can be applied once or twice daily to the scar tissue, according to the studies performed. The safety and efficacy of Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel in children under 1 year of age has not been established. No data are available.

No case of overdose has been reported.

Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel should not be used by patients with hypersensitivity to the active substances Extract cepae, Heparin sodium, or Allantoin, Sorbic Acid or methyl-4-hydroxybenzoate (parabens) or any of the other ingredients.

Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel contains methyl-4-hydroxybenzoate, which may cause allergic reactions (possibly delayed) and Sorbic acid, which may cause local skin reactions, e.g. contact dermatitis.

Risks during pregnancy and lactation are unknown to date. No data on fertility are available.

The frequencies of undesirable effects are based on the following categories: See table.

Click on icon to see table/diagram/image

The most commonly reported side effects were local reactions at the treatment site. The following undesirable effects were reported from a pharmaco-epidemiological retrospective cohort study in 592 patients treated with Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel (2005) which investigated efficacy and tolerability of Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel versus local corticoid treatment: Skin and subcutaneous tissue disorders: Common: pruritus, erythema, telangiectasis, scar atrophy.
Uncommon: hyperpigmentation of the skin, skin atrophy.
The undesirable effects listed as follows were reported spontaneously: Infections and infestations: Frequency unknown: pustular rash.
Immune system disorders: Frequency unknown: hypersensitivity (allergic reaction).
Nervous system disorders: Frequency unknown: paraesthesia.
Skin and subcutaneous tissue disorders: Frequency unknown: urticaria, rash, pruritus, erythema, skin irritation, papules, inflammation of the skin, burning sensation in the skin, feeling of tightness in the skin, contact dermatitis.
General disorders and administration site conditions: Frequency unknown: swelling, pain at the application site, application site exfoliation.
In general, Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel is very well tolerated, even in long-term use. The itching, which has uncommonly been observed during treatment with Extract Cepae + Heparin Sodium + Allantoin (Contractubex) Gel l, is the manifestation of the desired cicatricial change, and generally does not require discontinuation of treatment.

No studies of interactions have been performed. No evidence of interactions is known to date.

Store at temperatures not exceeding 25°C.

Other Dermatologicals

C05BA53 - heparin, combinations ; Belongs to the class of heparins or heparinoids used topically in antivaricose therapy.

Non-Rx