FLECTOR TISSUGEL

Cutaneous use only Posology One medicated plaster should be applied to the painful area twice daily, in the morning and in the evening. The maximum daily dose is 2 medicated plasters, even if there is more than one injured area to be treated.

Therefore, only one painful area can be treated at a time. Duration of administration The duration of use should not exceed 7 days. The therapeutic benefit of longer use has not been established. If there is no improvement, during the recommended duration of treatment or symptoms worsen, a doctor should be consulted.

Flector Tissugel is to be used for the shortest duration necessary to control symptoms depending on the indication. Elderly This medication should be used with caution in elderly patients who are more prone to adverse events. See also Section

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.

g. erythema bullosum), dry skin Photosensitivity reaction General disorders and administration site conditions * Common Uncommon Application site reactions * Feeling hot *Adverse reactions have been reported in a clinical trial, where 1252 patients were treated with Flector Tissugel medicated plaster and 734 with Placebo in clinical 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 Flector Tissugel 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. uk/yellowcard.

4. 3). In children aged 16 years and over, if the symptoms worsen, the patient/parents of the adolescents is/are advised to consult a doctor. 4. Method of administration Cut the envelope containing the medicated plaster as indicated. Remove one medicated plaster, remove the plastic film used to protect the adhesive surface and apply it to painful joint or region.

If necessary it can be held in place with an elastic net. Carefully reseal the envelope with the sliding closure. The plaster should be used whole. 1. - Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDS) - damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound.

- from the beginning of the 6th month of pregnancy (see

1. - Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDS) - damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound.

6 Pregnancy and lactation). - Patients with active peptic ulceration. - Children and adolescents aged less than 16 years.