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
Immune system disorders
Very rare:                               Hypersensitivity (including urticaria), angioneurotic oedema.
Infections and infestations
Very rare:                               Rash pustular.
Respiratory, thoracic and mediastinal disorders
Very rare:                               Asthma.
Skin and subcutaneous tissue disorders
Common:                                  Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus.
Rare:                                    Dermatitis bullous.
Very rare:                               Photosensitivity reaction.

General: Systemic absorption of this medicine is low compared with plasma levels obtained following administration of oral forms of Voltaren Emulgel and the likelihood of systemic side- effects occurring with topical diclofenac is small compared with the frequency of side-effects associated with oral diclofenac. However, where Voltaren Emulgel is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on Voltaren oral dosage forms should be consulted.

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
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@mo h.gov.il).
Additionaly, please also report to GSK Israel (il.safety@gsk.com)