Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Most frequently reported reactions include skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, irritation, pain and blistering. In studies there appeared to be no age specific increase or pattern of reactions.
Adverse reactions are listed in Table 1 according to Medical Dictionary for Regulatory Activities (MedDRA) system organ class and in decreasing frequency defined as follows:: 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); Not known: frequency cannot be estimated from the available data.
Table 1: Treatment-related adverse reactions reported by body system and frequency
Infections and Infestations
Very rare (<1/10,000)                        Rash pustular
Immune System Disorders
Very rare (<1/10,000)                        Topical application of large amounts may result in systemic effects including all types of hypersensitivity (including urticaria,
angioneurotic oedema)
Nervous System disorders
Common (≥1/100, <1/10)                       Hyperesthesia, hypertonia, localised paraesthesia
Eye Disorders
Common (≥1/100, <1/10)                       Conjunctivitis Uncommon (≥1/1,000, <1/100)                  Eye pain, lacrimation disorder Vascular Disorders
Uncommon (≥1/1,000, <1/100)                  Haemorrhage
Respiratory, Thoracic and Mediastinal Disorders
Very rare (<1/10,000)                        Asthma
Gastrointestinal Disorders
Uncommon (≥1/1,000, <1/100)                  Abdominal pain, diarrhoea, nausea Very rare (<1/10,000)                        Gastrointestinal haemorrhage Skin and Subcutaneous Tissue Disorders
Common (≥1/100, <1/10)                       Dermatitis (including contact dermatitis), eczema, dry skin, erythema, oedema,
pruritus, rash, scaly rash, skin hypertrophy,
skin ulcer, vesiculobullous rash
Uncommon (≥1/1,000, <1/100)                  Alopecia, face oedema, maculopapular rash, seborrhoea
Rare (≥1/10,000, <1/1,000)                   Dermatitis bullous Very rare (<1/10,000)                        Photosensitivity reaction Renal and Urinary System Disorders
Very rare (<1/10,000)                        Renal failure
General Disorders and Administration Site Conditions
Common (≥1/100, <1/10)                       Application site reactions (including inflammation, irritation, pain and tingling or blistering at the treatment site)


Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping treatment.
Patch testing of previously treated patients indicate a 2.18% probability of allergic contact dermatitis sensitisation (type IV) to diclofenac with as yet unknown clinical relevance. Cross-reactivity to other NSAIDs is not likely. Serum testing more than 100 patients indicated no presence of type I anti-diclofenac antibodies.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.gov.il
Additionally, you can also report to Padagis.co.il.