Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: 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: cannot be estimated from the available data.
Table 1

Infections and infestations
Very rare              Rash pustular
Immune system disorder
Very rare              Hypersensitivity (including urticaria),
angioneurotic oedema, anaphylactic type reaction
Respiratory,
thoracic and mediastinal disorders
Very rare              Asthma
Skin and subcutaneous tissue disorders *
Common                 Rash, eczema, erythema *, dermatitis (including allergic and contact dermatitis*), pruritus*

Uncommon               petechiae *

Rare                   Dermatitis bullous (e.g. erythema bullosum), dry skin
Very rare
Photosensitivity reaction
General disorders and administration site conditions *
Common                 Application site reactions *

Uncommon               Feeling hot


*Adverse reactions have been reported in a clinical trial, where 1252 patients were treated with Dicloplast medicated patch and 734 with Placebo inclinical trials.
Systemic absorption of diclofenac is very low compared with plasma levels obtained following administration of oral forms of diclofenac and the likelihood of systemic side effects reactions (like gastric, hepatic and renal disorders) occurring with topical diclofenac is very small compared with the frequency of side effects associated with oral diclofenac. However, where Dicloplast is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side effects cannot be excluded.

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.health.gov.il