61USE IN CLINICAL PRACTICE

8 USE IN CLINICAL PRACTICE

PLACE IN THERAPY

For patients Traumeel® is a first-line treatment for patients with musculoskeletal injuries and inflammation. While it is suitable for most patients, it may be particularly suitable for patients who are unable or unwilling to tolerate NSAIDs.

Contraindications to diclofenac[FDA MedWatch]

Hypersensitivity to the active substance or any of the excipients Patients who have previously shown hypersensitivity reactions (e.g.

asthma, angioedema, urticaria or acute rhinitis) to ibuprofen, aspirin or other NSAIDs

Patients with a history of, or active, gastrointestinal ulcers, bleeding or perforation (two or more distinct episodes of proven ulceration or bleeding)

Severe hepatic, renal and heart failure During the last trimester of pregnancy History of gastrointestinal bleeding or perforation, relating to previous

NSAID therapy Acute porphyria

Patient groups and conditions in which diclofenac should be used with caution[FDA MedWatch]

The elderly Gastrointestinal disorders including history of ulceration, or inflammatory

bowel disease Hepatic impairment* Respiratory conditions including asthma, seasonal allergic rhinitis, nasal

polyps, chronic obstructive pulmonary diseases or chronic infection of the respiratory tract

Renal impairment Cardiac impairment Hypertension Defects of hemostasis, bleeding diathesis or hematologic abnormalities Increased cardiovascular risk, including established ischemic heart disease,

peripheral arterial disease or cerebrovascular disease, also with risk factors including hypertension, hyperlipidemia, diabetes mellitus, smoking

Systemic lupus erythematosus and mixed connective tissue disorders Women attempting to conceive (may impair fertility)

The Food and Drug Administration (FDA) issued a warning concerning the potential for elevation in liver function tests during treatment with all products (including topical formulations) containing diclofenac sodium. In post-marketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment.[FDA MedWatch]