General: Cataflam tablets contain sucrose and therefore are not recommended for patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving Cataflam, the treatment should be discontinued.
As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing Cataflam in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see ADVERSE REACTIONS). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation and in the elderly.
To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.
Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of low-dose acetylsalicylic acid (ASA) or other drugs likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see INTERACTIONS and INCOMPATIBILITIES under Cautions for Usage).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see ADVERSE REACTIONS).
NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak. Close medical surveillance and caution are recommended when using Cataflam after gastro-intestinal surgery.
Risk of cardiovascular thrombosis: Non-steroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, with systemic use may increase the risk of cardiovascular thrombosis, including heart attack and stroke, may lead to death. This risk may occur early at the first weeks of using drug and may increase with duration of exposure. The risk of cardiovascular is recorded almost with high dose.
Doctors need to evaluate periodically the occurrence of cardiovascular events, even if patients do not have cardiovascular symptoms previously. Patients need to be warned about symptoms of serious cardiovascular events and need to consult doctor immediately when having these symptoms.
To minimize the risk of adverse events, it is needed to use Cataflam at the daily lowest effective dose for the shortest duration as possible.
It is needed to consider carefully when using diclofenac for patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes, tobacco addiction).
Patients with congestive heart failure (NYHA-I), uncontrolled hypertension or significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration and only at doses ≤100 mg daily when treatment continues for more than 4 weeks.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for more than 4 weeks.
Hematologic effects: Use of Cataflam is recommended only for short-term treatment. If, however, Cataflam is used for a prolonged period, monitoring of the blood count is recommended, as with other NSAIDs.
Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of hemostasis should be carefully monitored.
Respiratory effects (Pre-existing asthma): In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke's edema or urticaria are more frequent than in other patients. Therefore, special caution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.
Hepatobiliary effects: Close medical surveillance is required when prescribing Cataflam to patients with impaired hepatic function, as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Cataflam, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), Cataflam should be discontinued. Hepatitis may occur with use of diclofenac without prodromal symptoms.
Caution is called for when using Cataflam in patients with hepatic porphyria, since it may trigger an attack.
Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Cataflam (see ADVERSE REACTIONS). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Cataflam should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug.
Renal effects: As fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see CONTRAINDICATIONS). Monitoring of renal function is recommended as a precautionary measure when using Cataflam in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.
Interactions with NSAIDs: The concomitant use of Cataflam with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to no evidence of beneficially synergistic effects and the potential for additive undesirable effects (see INTERACTIONS and INCOMPATIBILITIES under Cautions for Usage).
Masking signs of infections: Like other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Fertility: As with other NSAIDs, the use of Cataflam may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Cataflam should be considered (see USE IN PREGNANCY & LACTATION).
Effects on the Ability to Drive and Use Machines: Patients with visual disturbances, vertigo, dizziness, drowsiness or confusion of other central nervous system when using Cataflam should not be driving and using machines.
Use in the Elderly: Caution is indicated in the elderly on basic medical grounds, especially in frail elderly patients or those with a low body weight.