Cataflam

/ Novartis

As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
General target population: The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient. The total daily dose should generally be divided into 2 to 3 separate doses. In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 to 150 mg. A dose of 50 to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days. In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 to 6 hours, not exceeding a total dose of 200 mg per day.
Special populations
Pediatrics: Cataflam tablets are not recommended for use in children and adolescents below 14 years of age; For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient. The total daily dose should generally be divided in 2 to 3 doses. The maximum daily dose of 150 mg should not be exceeded. The use of Cataflam in migraine attacks has not been established in children and adolescents.
Geriatrics (Patients aged 65 or above): No adjustment of the starting dose is required for elderly patients.
Established cardiovascular disease or significant cardiovascular risk factors: Cataflam is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. Patients with congestive heart failure (NYHA-1) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, 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.
Renal impairment: Cataflam is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Cataflam to patients with mild to moderate renal impairment.
Hepatic impairment: Cataflam is contraindicated in patients with hepatic failure. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Cataflam to patients with mild to moderate hepatic impairment.
Mode of administration: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.

Management of pain and primary dysmenorrhea, when prompt pain relief is desired.

Known hypersensitivity to the active substance or to any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Last trimester of pregnancy. Hepatic failure. Renal failure. Severe cardiac failure. Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs. The treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

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 medicinal product should be withdrawn. As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercized 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. The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with  haemorrhage or perforation and in the elderly. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include smoking and the use of alcohol. 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 medicinal products containing low-dose acetylsalicylic acid (ASA)/aspirin or other medicinal products 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. Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may be exacerbated.
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 precaution 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. Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.
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. 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.
Hepatobiliaryeffects: 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.
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. Monitoring of renal function is recommended as a precautionary measure when using Cataflam in such cases. Discontinuation of therapy is normally followed by recovery to the pre-treatment state.
Cardiovascular effects: Treatment with NSAIDs including diclofenac, particularly at high dose and in long term, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). To minimize the potential risk of an adverse cardiovascular event in patients taking a NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
Hematological 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, Cataflam may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.
Geriatrics: Caution is indicated in the elderly on basic medical grounds. In particular it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight. Interactions with NSAIDs The concomitant use of Cataflam with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive undesirable effects.
Interactions with NSAIDs: The concomitant use of Cataflam with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the potential for additive undesirable effects.
Special excipients: 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.
Masking signs of infections: Like other NSAIDs, Cataflam may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac. Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with diclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).
SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
Female fertility : The use of Cataflam may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Cataflam should be considered.
Effects on ability to drive and use machines: Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking Cataflam should refrain from driving or using machines.

Nervous system disorders: Common: Headache, dizziness.
Ear and labyrinth disorders: Common: Vertigo.
Gastrointestinal disorders: Common: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased apetite.
Hepatobiliary disorders: Common: Transaminases increased.
Skin and subcutaneous tissue disorders: Common: Rash.
For full details see prescribing information.

The following interactions include those observed with Cataflam sugar-coated tablets and/or other pharmaceutical forms of diclofenac.
Observed interactions to be considered
Potent CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.
Lithium: If used concomitantly, diclofenac may raise plasma concentrations of lithium. Monitoring of the serum lithium level is recommended.
Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin. Monitoring of the serum digoxin level is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.
Ciclosporin and Tacrolimus: Cases of nephrotoxicity have been reported in patients receiving concomitant ciclosporin and NSAIDs, including diclofenac sodium. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. This might be mediated through renal antiprostagladin effects of both NSAID and calcineurin inhibitor. Ciclosporin therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin.
Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently.
Quinolone antibacterials : There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
Anticipated interactions to be considered
Other NSAIDs and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects.
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding. Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are isolated reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding.
Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycemic and hyperglycemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.
Methotrexate : Caution is recommended when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.
Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs in patients may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
For full details see prescribing information.

Pregnancy:  There are insufficient data on the use of diclofenac in pregnant women. Therefore, Cataflam should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. As with other NSAIDs, use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.
Lactation:  Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Cataflam should not be administered during breast-feeding in order to avoid undesirable effects in the infant.

Symptoms:  There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures: Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism. Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g.vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.

Storage: Store below 30°C. Store in the original package. Protect from moisture.