
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.
View ADR Reporting Link