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Novartis Pharma
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Diclofenac potassium.
The active substance is diclofenac potassium.
One Cataflam 25 sugar-coated tablet contains 25 mg of diclofenac potassium. One Cataflam 50 sugar-coated tablet contains 50 mg of diclofenac potassium.
In Cataflam the sodium ion of diclofenac sodium (Voltaren) has been replaced by a potassium ion.
Excipients/Inactive Ingredients: Core: Magnesium stearate; povidone; colloidal anhydrous silica; sodium starch glycollate; maize starch; calcium phosphate.
Sugar-coat: Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead); povidone; talc; sucrose.
Polish: polyethylene glycol 8000; sucrose.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances. ATC code: M01A B05.
Pharmacology: Pharmacodynamics: Mechanism of action (MOA): Cataflam contains potassium salt of diclofenac, a non-steroidal compound with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered fundamental to its mechanism of action. Prostaglandins play an important role in causing inflammation, pain and fever.
Cataflam tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.
Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in humans.
Cataflam has been found to exert a pronounced analgesic effect in moderate and severe pain. In the presence of inflammation, e.g. due to trauma or following surgical interventions, it rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and wound edema.
Clinical studies have also revealed that in primary dysmenorrhea the active substance is capable of relieving the pain and reducing the extent of bleeding.
In migraine attacks Cataflam has been shown to be effective in relieving the headache and in improving the accompanying symptoms nausea and vomiting.
Clinical Studies: Cataflam is a well established product.
Pharmacokinetics: Absorption: Diclofenac is rapidly and completely absorbed from diclofenac potassium tablets. The absorption sets in immediately after administration and the same amount is absorbed as from an equivalent dose of diclofenac sodium gastro-resistant tablets.
Mean peak plasma concentrations of 3.8 micro mol/L are attained after 20 to 60 minutes after ingestion of one tablet of 50 mg. Ingestion together with food has no influence on the amount of diclofenac absorbed although onset and rate of absorption may be slightly delayed.
Since about half of diclofenac is metabolized during its first passage through the liver ("first pass" effect), the area under the concentration curve (AUC) is about half as large following oral or rectal administration as it is following a parenteral dose of equal size.
Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.
Linearity/non-linearity: The amount absorbed is in linear proportion to the size of the dose.
Distribution: 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution calculated is 0.12 to 0.17 L/kg.
Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.
Diclofenac was detected in a low concentration (100 ng/mL) in breast milk in one nursing mother. The estimated amount ingested by an infant consuming breast milk is equivalent to a 0.03 mg/kg/day dose.
Metabolism: Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5-hydroxy-, 4',5-dihydroxy-, and 3'-hydroxy-4'-methoxy-diclofenac), most of which are converted to glucuronide conjugates.
Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
Elimination: Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min (mean value ± SD). The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. One metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. However, this metabolite is virtually inactive.
About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.
Special populations: Geriatric patients: No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.
Renal impairment: In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single-dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects.
However, the metabolites are ultimately cleared through the bile.
Hepatic impairment: In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.
Toxicology: Non-Clinical Safety Data: Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. In standard preclinical animal studies, there was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.
Diclofenac had no influence on the fertility of parent animals in rats. Except for minimal fetal effects at maternally toxic doses, the prenatal, perinatal and postnatal development of the offspring was not affected.
Administration of NSAIDs (including diclofenac) inhibited ovulation in the rabbit and implantation and placentation in the rat, and led to premature closure of the ductus arteriosus in the pregnant rat. Maternally toxic doses of diclofenac were associated with dystocia, prolonged gestation, decreased fetal survival, and intrauterine growth retardation in rats. The slight effects of diclofenac on reproduction parameters and delivery as well as constriction of the ductus arteriosus in utero are pharmacologic consequences of this class of prostaglandin synthesis inhibitors (see CONTRAINDICATIONS and also USE IN PREGNANCY & LACTATION).
Short-term treatment in the following acute conditions: Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
Post-operative pain, inflammation and swelling, e.g. following dental or orthopedic surgery.
Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis.
Migraine attacks.
Painful syndromes of the vertebral column.
Non-articular rheumatism.
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Dosage/Direction for Use
Dosage: As a general recommendation, the dose should be individually adjusted. 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 (see more in PRECAUTIONS).
General target population: adults: 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 or 3 separate doses, as applicable.
In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. An initial dose of 50 mg is usually sufficient. If necessary, an initial dose of 100 mg can be prescribed with a maximum of 200 mg/day reached over the course of several menstrual cycles. 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: Pediatric patients (below 18 years of age): Cataflam tablets are not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops or suppositories of diclofenac 12.5 mg and 25 mg could be used. For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient.
The maximum daily dose of 150 mg should not be exceeded. The total daily dose should generally be divided into 2 to 3 separate doses, as applicable.
The use of Cataflam (all forms) in migraine attacks has not been established in children and adolescents.
Geriatric patients (aged 65 years or above): Although the pharmacokinetics of Cataflam are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight and the patient should be monitored for GI bleeding during NSAID therapy (see PRECAUTIONS).
Congestive heart failure (NYHA-I) or significant cardiovascular risk factors: Patients with congestive heart failure (NYHA-I), uncontrolled hypertension or significant risk factors for cardiovascular disease should be treated with Cataflam only after careful consideration and only at doses ≤100 mg daily if treated for more than 4 weeks (see PRECAUTIONS).
Renal impairment: Cataflam is contraindicated in patients with severe renal failure (GFR <15 mL/min/1.73m2) (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with mild to moderate renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Cataflam to patients with renal impairment (see PRECAUTIONS).
Hepatic impairment: Cataflam is contraindicated in patients with severe hepatic failure (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with mild to moderate 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 (see PRECAUTIONS).
Method of administration: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
Symptoms: There is no typical clinical picture resulting from diclofenac overdosage. Overdosage 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.
Known hypersensitivity to the active substance or any of the other excipients.
Active gastric or intestinal ulcer, bleeding or perforation (see PRECAUTIONS and also ADVERSE REACTIONS).
Last trimester of pregnancy (see USE IN PREGNANCY & LACTATION).
Severe hepatic failure.
Severe renal failure (GFR <15 mL/min/1.73m2).
Patients with congestive heart failure (from level II to level IV according to functional heart failure classification of New York Heart Association-NYHA), ischemic heart disease, peripheral arterial disease, cerebrovascular disease.
Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam is also contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria, or acute rhinitis (i.e. NSAID-induced cross-reactivity reactions) (see PRECAUTIONS and also ADVERSE REACTIONS).
History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy.
Special Precautions
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.
Use In Pregnancy & Lactation
Women of child-bearing potential: There are no data to suggest any recommendations for women of child-bearing potential.
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and or cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% up to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has shown to result in increased pre-and post-implantation loss and embryo-foetal lethality.
In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during organogenetic period. If Cataflam is used by a woman attempting to conceive, or during the 1st trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
The mother and the neonate, at the end of the pregnancy, to: Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; Inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, Cataflam is contraindicated during the third trimester of pregnancy.
Breast-feeding: 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.
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.
Adverse Reactions
Tabulated summary of adverse drug reactions: Adverse drug reactions from clinical trials and/or spontaneous or literature reports (table) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
The following undesirable effects include those reported with Cataflam sugar-coated tablets and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use. (See table.)

Click on icon to see table/diagram/image

Description of selected adverse drug reactions: Risk of Cardiovascular thrombosis: Clinical trials and epidemiology show that the use of diclofenac is associated with increase of risk of cardiovascular thrombosis (such as heart attack and stroke), particularly while using high dose of diclofenac (150 mg/day) and during long term (see more in PRECAUTIONS).
Visual effects: Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.
Drug Interactions
The following interactions include those observed with Cataflam sugar-coated tablets and/or other pharmaceutical forms of diclofenac.
Observed interactions to be considered: CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with CYP2C9 inhibitors (such as voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac.
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 (see PRECAUTIONS).
Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin and tacrolimus due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.
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 (see PRECAUTIONS).
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 (see PRECAUTIONS).
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding (see PRECAUTIONS). Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are reports of an increased risk of hemorrhage 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 (see PRECAUTIONS).
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.
There have also been isolated reports of metabolic acidosis when diclofenac was co-administered with metformin, especially in patients with pre-existing renal impairment.
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.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. This might be mediated through renal antiprostaglandin effects of both NSAID and calcineurin inhibitor.
Colestipol and cholestyramine: These agents can induce a delay or decrease in absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4 to 6 hours after administration of colestipol/cholestyramine.
CYP2C9 inducers: Caution is recommended when co-prescribing diclofenac with CYP2C9 inducers (such as rifampicin), which could result in a significant decrease in plasma concentration and exposure to diclofenac.
Caution For Usage
Instructions for use, handling and disposal: No special requirements.
Incompatibilities: Not applicable.
Do not store above 30°C. Protect from moisture.
Shelf-Life: Cataflam 25mg: 24 months from manufacturing date.
Cataflam 50mg: 24 months from manufacturing date.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Sugar-coated tab 25 mg (pale red, round, biconvex, approximately 7.7 mm diameter, approximately 5.0 mm thickness, white core) x 10's. 50 mg (reddish-brown, round, biconvex, approximately 8.8 mm diameter, approximately 5.2 mm thickness, white core) x 10's.
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