Cataflam®
1-Disclaimer:-
Cataflam® (diclofenac potassium) is a non-steroidal anti-inflammatory drug (NSAID) with clinically important gastrointestinal, cardiovascular, renal, hepatic, hypersensitivity, and pregnancy-related risks. This information is intended for educational and general reference purposes and does not replace the product leaflet, a physician’s assessment, or a pharmacist’s advice. Dosing and product-specific instructions should always be verified against the exact strength, pharmaceutical form, country-specific labeling, and the patient’s clinical circumstances.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2-Summary
Cataflam® contains diclofenac potassium, an NSAID belonging to the acetic acid derivatives and related substances group (ATC M01AB05). Diclofenac produces analgesic, anti-inflammatory, and antipyretic effects primarily by inhibiting prostaglandin biosynthesis. The current Novartis product information that is publicly available describes Cataflam sugar-coated tablets containing 25 mg or 50 mg diclofenac potassium and recommends their use principally for short-term treatment of acute painful and inflammatory conditions.
The principal safety concerns are gastrointestinal ulceration and bleeding, cardiovascular thrombotic events, renal toxicity and fluid retention, hepatotoxicity, serious hypersensitivity and skin reactions, and important pregnancy-related fetal risks. Diclofenac should generally be used at the lowest effective dose for the shortest necessary duration.
3-Brand Name
Cataflam®
Cataflam is a registered Novartis brand containing diclofenac potassium. The current Novartis product information identifies Cataflam specifically as a diclofenac-potassium product. (Novartis)
4-Category
Therapeutic class:
Non-steroidal anti-inflammatory drug (NSAID); analgesic; anti-inflammatory; antipyretic.
Pharmacotherapeutic/ATC classification:
Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances — ATC M01AB05 (diclofenac).
5-Active Ingredient
Diclofenac potassium
The pharmacologically active moiety is diclofenac. Cataflam uses the potassium salt of diclofenac rather than the sodium salt used in diclofenac sodium formulations.
6-Pharmaceutical Form & Strength
The current publicly available Novartis Cataflam product information describes:
- Sugar-coated tablets — 25 mg diclofenac potassium
- Sugar-coated tablets — 50 mg diclofenac potassium
The current Novartis document explicitly notes that dosage strengths may vary by country and that pharmaceutical formulations may differ between countries.
Publicly indexed Egyptian pharmacy/medicine listings additionally show Cataflam presentations including 15 mg/mL oral drops (15 mL), 75 mg suppositories, and 75 mg/3 mL ampoules, alongside the 25-mg and 50-mg tablets. These Egyptian listings should be interpreted as market-availability evidence rather than a substitute for the official Egyptian regulatory record or the leaflet supplied with the individual pack. (Egypt Dwa)
Pack quantities may also vary. For example, current Egyptian listings identify 6 ampoules for the 75 mg/3 mL presentation. (Vezeeta)
7-Manufacturer & Marketing Authorization Holder
The current Novartis Cataflam product information identifies Novartis Pharma AG, Basel, Switzerland in connection with the product information and states that the exact manufacturer should be checked on the folding box.
In Egypt, Novartis Pharma S.A.E. is the local Novartis pharmaceutical entity identified on Novartis Egypt's professional portal. The exact Egyptian marketing-authorization/manufacturing details can be presentation-specific and should therefore be taken from the packaging and local regulatory documentation for the particular product. (Novartis Pro)
8-Mechanism of Action
Diclofenac is a non-steroidal compound that inhibits prostaglandin biosynthesis. Prostaglandins are important mediators of pain, inflammation, and fever; reducing their production accounts for much of diclofenac's analgesic, anti-inflammatory, and antipyretic activity. The current Novartis Cataflam information also describes a relatively rapid onset of action for the tablet formulation, making it suitable for acute painful and inflammatory conditions.
Diclofenac also acts on inflammatory pain associated with trauma, surgery, dysmenorrhoea, and migraine.
9-Spectrum of Activity
Not applicable in the antimicrobial sense.
Cataflam is not an antibiotic or antimicrobial drug and therefore does not have an antibacterial, antiviral, antifungal, or antiparasitic spectrum of activity.
Its pharmacological effects are instead directed toward pain, inflammation, and fever. In certain severe painful inflammatory infections of the ear, nose, or throat, diclofenac may be used as an adjunct to treatment of the underlying infection, but it does not eradicate the infection itself. Fever alone is not an indication for Cataflam according to the current Novartis product information.
10-Pharmacokinetics
For the oral diclofenac-potassium tablet formulation:
Absorption: Diclofenac is rapidly and completely absorbed. Absorption begins immediately after administration. Following a 50-mg tablet, the mean peak plasma concentration is reported at approximately 3.8 micromol/L within 20–60 minutes. Food does not materially change the amount absorbed, although it may slightly delay the onset and rate of absorption.
First-pass metabolism: Approximately half of diclofenac is metabolized during its first passage through the liver, contributing to an oral/rectal AUC approximately half that achieved following a parenteral dose of equivalent size.
Distribution: Approximately 99.7% of diclofenac is protein-bound, principally to albumin. The apparent volume of distribution is approximately 0.12–0.17 L/kg. Diclofenac enters synovial fluid; concentrations there may remain higher than plasma concentrations for a period after administration.
Metabolism: Diclofenac undergoes glucuronidation and extensive hydroxylation/methoxylation, producing several metabolites. Two phenolic metabolites retain biological activity, but considerably less than diclofenac itself.
Elimination: Plasma terminal half-life is approximately 1–2 hours. Around 60% of the administered dose is excreted in urine as the glucuronide conjugate and metabolites, with less than 1% excreted unchanged; the remainder is eliminated predominantly through the bile and feces.
Repeated administration: No clinically relevant accumulation is expected when the recommended dosage intervals are followed.
Renal impairment: In severe renal impairment, the parent drug does not necessarily accumulate based on single-dose pharmacokinetics, but hydroxy-metabolite exposure can increase substantially. The current Cataflam labeling nevertheless contraindicates use in renal failure with GFR <15 mL/min/1.73 m² and advises caution in renal impairment.
11-Indications
According to the current Novartis Cataflam product information, Cataflam tablets are intended mainly for short-term treatment of acute painful and inflammatory conditions, including:
- Post-traumatic pain, inflammation, and swelling, such as after sprains.
- Post-operative pain, inflammation, and swelling, including following dental or orthopedic surgery.
- Painful and/or inflammatory gynecological conditions, including primary dysmenorrhoea and adnexitis.
- Migraine attacks.
- Painful syndromes of the vertebral column.
- Non-articular rheumatism.
- As an adjunct in severe painful inflammatory infections of the ear, nose, or throat, such as pharyngotonsillitis or otitis, while the underlying condition receives appropriate treatment.
Fever alone is not an indication.
12-Administration
The dose should be individualized and treatment should use the lowest effective dose for the shortest duration necessary.
Adults — oral tablets
The current Novartis information states:
- Initial daily dose: generally 100–150 mg/day.
- In milder cases, 75–100 mg/day is usually sufficient.
- The total daily dose should generally be divided into 2 or 3 doses.
Primary dysmenorrhoea
The daily dose is individualized and generally 50–150 mg/day. An initial 50 mg dose is usually sufficient. When clinically necessary, an initial 100-mg dose may be used, with a maximum of 200 mg/day under the specific regimen described in the product information. Treatment should begin when symptoms first appear and generally continue for only a few days.
Migraine
An initial 50 mg dose is taken at the first signs of an impending attack. If adequate relief is not achieved within 2 hours, another 50 mg may be taken. Additional 50-mg doses may be taken at 4–6-hour intervals, without exceeding 200 mg/day.
Adolescents
Cataflam tablets are not recommended below 14 years of age in the current Novartis product information. For adolescents aged 14 years and over, 75–100 mg/day is usually sufficient. The current document does not establish Cataflam use for migraine attacks in children and adolescents.
Method of taking the tablets
The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
The 25-mg/50-mg tablet dosing described above should not automatically be applied to the oral drops, suppositories, or injection presentations, because formulation-specific labeling and routes of administration must be followed for those products.
13-Method of Preparation
Tablets: No preparation is required. Swallow the tablet whole with liquid; do not chew or divide it.
Oral drops: A ready-to-use liquid dosage form; measure and administer only according to the instructions supplied with the specific local product.
Suppositories: Ready-to-use rectal dosage form; no reconstitution is required.
Injection: A ready-to-use injectable presentation that requires appropriate professional administration according to the product-specific instructions. It should not be prepared, diluted, or administered by an untrained person.
Because these non-tablet formulations are country- and presentation-specific, their exact composition, dosing, dilution requirements, route, and administration limits should be verified from the leaflet/pack accompanying the Egyptian presentation.
14-Contraindications
The current Novartis Cataflam information identifies the following contraindications:
- Known hypersensitivity to diclofenac or any component of the formulation.
- Active gastric or intestinal ulcer, bleeding, or perforation.
- Third trimester of pregnancy.
- Hepatic failure.
- Renal failure, specifically GFR <15 mL/min/1.73 m² in the current document.
- Severe cardiac failure.
- A history of asthma, angioedema, urticaria, or acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs, i.e. NSAID-related cross-reactivity reactions.
- High-dose diclofenac (150 mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease or uncontrolled hypertension under the current labeling.
15-Warnings & Precautions
Gastrointestinal
NSAIDs including diclofenac can cause gastrointestinal ulceration, bleeding, and perforation, potentially fatal, at any time during treatment and sometimes without warning symptoms. Risk is increased with higher doses, previous ulcer disease, older age, and concomitant medicines that increase gastrointestinal bleeding risk. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued.
Particular caution is required with systemic corticosteroids, anticoagulants, antiplatelet drugs, and SSRIs. Patients with ulcerative colitis or Crohn's disease may experience worsening of their disease. The current label additionally warns of possible increased risk of gastrointestinal anastomotic leakage after gastrointestinal surgery.
Cardiovascular
Diclofenac is associated with a small increased risk of serious arterial thrombotic events, including myocardial infarction and stroke, particularly with higher doses and longer exposure. The lowest effective dose should be used for the shortest possible duration.
The current Novartis labeling specifically restricts prolonged high-dose treatment in patients with established cardiovascular disease or uncontrolled hypertension and recommends careful assessment in patients with cardiovascular risk factors such as hypertension, hyperlipidemia, diabetes, and smoking.
Renal
NSAIDs may cause fluid retention, edema, deterioration of renal function, and acute kidney injury. Particular caution is needed in patients with renal or cardiac impairment, hypertension, dehydration/volume depletion, older age, or concomitant use of diuretics or medicines that affect renal function. Renal-function monitoring may be appropriate in higher-risk patients.
Hepatic
Diclofenac can increase liver enzymes and can cause hepatitis, jaundice, hepatic necrosis, or hepatic failure. Patients with impaired liver function require caution and prolonged therapy may warrant liver-function monitoring. Diclofenac should be discontinued if abnormal liver tests persist or worsen or if clinical signs of liver disease occur.
Hypersensitivity and respiratory disease
Patients with asthma, allergic rhinitis, nasal polyps, chronic respiratory disease, or previous NSAID sensitivity may have an increased risk of NSAID-induced bronchospasm, urticaria, angioedema, or related reactions. Serious anaphylactic/anaphylactoid reactions can occur.
Skin reactions
Rare but potentially fatal reactions such as Stevens–Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and generalized bullous fixed drug eruption have been reported. Treatment should be stopped at the first appearance of rash, mucosal lesions, or other signs of hypersensitivity.
Hematologic
Diclofenac can temporarily inhibit platelet aggregation. Rare or very rare hematological abnormalities include thrombocytopenia, leukopenia, anemia, and agranulocytosis. Prolonged treatment may warrant blood-count monitoring.
Masking infection
Like other NSAIDs, diclofenac can mask signs and symptoms of infection because of its anti-inflammatory and antipyretic actions.
Elderly patients
Older and frail patients are more susceptible to NSAID-related adverse effects. The lowest effective dose should be used, especially in frail older adults or those with low body weight.
Sucrose-containing tablets
The sugar-coated tablet formulation contains sucrose and is not recommended for patients with certain rare hereditary disorders of carbohydrate handling specified in the product information.
16-Drug Interactions
Important interactions described in the current Novartis information include:
CYP2C9 inhibitors: Drugs such as voriconazole may substantially increase diclofenac exposure.
CYP2C9 inducers: Rifampicin may decrease diclofenac plasma exposure.
Lithium: Diclofenac may increase lithium concentrations; monitoring is recommended.
Digoxin: Diclofenac may increase digoxin concentrations.
Diuretics and antihypertensive agents: Diclofenac may reduce antihypertensive effectiveness and increase renal risk, particularly with diuretics and ACE inhibitors. Adequate hydration and appropriate renal-function/BP monitoring may be needed.
Ciclosporin and tacrolimus: Increased nephrotoxicity may occur.
Potassium-raising medicines: Potassium-sparing diuretics, ciclosporin, tacrolimus, and trimethoprim may increase serum potassium levels.
Quinolone antibiotics: Rare reports of convulsions have occurred with combined quinolone/NSAID therapy.
Other systemic NSAIDs and corticosteroids: Increased gastrointestinal toxicity.
Anticoagulants and antiplatelet agents: Increased bleeding risk.
SSRIs: Increased risk of gastrointestinal bleeding.
Antidiabetic agents: Occasional hypo- or hyperglycemic effects have been reported; blood-glucose monitoring may be appropriate. Metabolic acidosis has also been reported with concomitant metformin, particularly in patients with renal impairment.
Phenytoin: Diclofenac may increase phenytoin exposure.
Methotrexate: NSAIDs may increase methotrexate concentrations and toxicity, particularly when given less than 24 hours before or after methotrexate.
The concomitant use of diclofenac with another systemic NSAID should generally be avoided because adverse effects can be additive.
17-Side Effects
Adverse reactions reported with Cataflam/diclofenac include:
Common: headache, dizziness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite, increased transaminases, and rash.
Uncommon: myocardial infarction, cardiac failure, palpitations, and chest pain.
Rare: hypersensitivity reactions including anaphylactic/anaphylactoid reactions, somnolence, asthma including dyspnea, gastritis, gastrointestinal bleeding, hematemesis, melena, gastrointestinal ulceration, hepatitis, jaundice, liver disorder, urticaria, and edema.
Very rare: thrombocytopenia, leukopenia, various forms of anemia, agranulocytosis, angioedema, neuropsychiatric reactions, paresthesia, convulsions, aseptic meningitis, cerebrovascular accident, visual impairment, blurred vision, diplopia, tinnitus, impaired hearing, hypertension, vasculitis, pneumonitis, severe colitis, pancreatitis, fulminant hepatitis, hepatic necrosis, hepatic failure, severe cutaneous reactions including Stevens–Johnson syndrome and toxic epidermal necrolysis, acute kidney injury, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, and renal papillary necrosis.
The current Novartis information additionally recognizes Kounis syndrome and generalized bullous fixed drug eruption as adverse reactions with frequency not known.
Severe symptoms such as chest pain, shortness of breath, weakness, slurred speech, gastrointestinal bleeding, facial/throat swelling, severe rash, or marked reduction in urine output require urgent medical assessment.
18-Use in Special Populations
Pregnancy
Diclofenac should not be used in the third trimester because of risks including premature closure of the fetal ductus arteriosus and uterine effects.
Current safety information also emphasizes the risk beginning around 20 weeks of gestation, when NSAIDs may cause fetal renal dysfunction and oligohydramnios. If an NSAID is considered necessary between 20 and 30 weeks, the lowest effective dose and shortest duration should be used; ultrasound monitoring of amniotic fluid should be considered when treatment extends beyond 48 hours.
During the first two trimesters, Cataflam should only be considered when the expected maternal benefit outweighs potential fetal risk.
Breast-feeding
Diclofenac passes into breast milk in small amounts. The current Novartis Cataflam information states that Cataflam should not be administered during breast-feeding to avoid undesirable effects in the infant.
Female fertility
Diclofenac may impair female fertility and is not recommended for women attempting to conceive. Discontinuation should be considered in women experiencing difficulty conceiving or undergoing infertility evaluation.
Male fertility
The current Cataflam information states that there are no human data establishing an effect on male fertility.
Children and adolescents
Cataflam tablets are not recommended below 14 years of age. For younger patients, other appropriately formulated diclofenac products may be used only according to their own pediatric labeling and medical advice. Migraine use with Cataflam has not been established in children and adolescents.
Elderly
No routine starting-dose adjustment is required solely because of age, but elderly and particularly frail patients have a higher risk of adverse reactions and should generally receive the lowest effective dose.
Renal impairment
Cataflam is contraindicated in renal failure defined in the current labeling as GFR <15 mL/min/1.73 m². Other degrees of renal impairment require caution, and there is no universally applicable dosage-adjustment scheme in the current product information.
Hepatic impairment
Cataflam is contraindicated in hepatic failure. Mild-to-moderate hepatic impairment requires caution and clinical monitoring.
Cardiovascular disease
Patients with established cardiovascular disease or uncontrolled hypertension require particular caution. High-dose diclofenac (150 mg/day) for more than four weeks is contraindicated in the patient groups specified by the current Cataflam labeling; when prolonged treatment is considered necessary in higher-risk patients, the current label limits treatment to ≤100 mg/day after careful benefit-risk assessment.
19-Storage Conditions
According to the current Novartis information:
- Store according to the conditions stated on the folding box/package.
- Cataflam sugar-coated tablets should be protected from moisture.
- Do not use the medicine after the date marked EXP.
- Keep out of the reach and sight of children.
20-Additional Sections
Overdose
There is no single characteristic clinical picture of diclofenac overdose. Possible manifestations include vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, and convulsions. Severe poisoning may cause acute renal failure and liver injury.
Treatment is primarily supportive and symptomatic. Complications such as hypotension, renal failure, convulsions, gastrointestinal toxicity, and respiratory depression require appropriate medical management. Due to extensive protein binding and metabolism, forced diuresis, dialysis, and hemoperfusion are unlikely to substantially enhance elimination. Activated charcoal may be considered after a potentially toxic ingestion, with gastrointestinal decontamination considered in selected life-threatening overdoses under medical supervision.
Pharmacodynamics
Cataflam provides analgesic and anti-inflammatory effects in moderate and severe pain, particularly when inflammation is present. The product information describes rapid relief of spontaneous and movement-related pain and reduction of inflammatory swelling. It has also demonstrated benefit in primary dysmenorrhoea and migraine-associated symptoms such as nausea and vomiting.
Non-clinical safety
Preclinical investigations did not demonstrate a specific mutagenic or carcinogenic hazard at intended therapeutic exposure. However, animal reproductive studies have demonstrated pharmacological effects consistent with inhibition of prostaglandin synthesis, including effects on ovulation, implantation, gestation, fetal development, and the fetal ductus arteriosus.
Egyptian market presentations
Publicly indexed Egyptian market sources currently identify Cataflam presentations including:
- Cataflam 15 mg/mL oral drops — 15 mL
- Cataflam 25 mg sugar-coated tablets — pack of 20
- Cataflam 50 mg sugar-coated tablets — pack of 20
- Cataflam 75 mg suppositories — pack of 5
- Cataflam 75 mg/3 mL injection — listings for packs of 6 ampoules
These presentations are currently listed by Egyptian pharmacy/medicine sources, but availability and pack configuration can change. The exact local composition and instructions should be confirmed on the individual Egyptian package/leaflet, particularly for formulations other than the sugar-coated tablets covered by the current Novartis international product information. (Egypt Dwa)
21-Frequently Asked Questions (FAQ)
What is Cataflam?
Cataflam is a brand of diclofenac potassium, an NSAID used to reduce pain and inflammation and, as an antipyretic, fever.
Is Cataflam an antibiotic?
No. It does not kill bacteria or treat the underlying infection. It may occasionally be used as an adjunct for symptomatic relief in certain painful inflammatory ENT infections while the underlying disease receives appropriate treatment.
What is the usual adult dose?
For the oral tablet formulation, the current product information gives an initial adult daily dose of 100–150 mg, while 75–100 mg/day is usually adequate in milder cases. The daily dose is generally divided into two or three doses. Indication-specific regimens, such as migraine and dysmenorrhoea, have their own maximums.
Can Cataflam be taken with another NSAID such as ibuprofen or naproxen?
Concomitant use of systemic NSAIDs is generally discouraged because adverse effects, especially gastrointestinal toxicity, may be additive.
Can Cataflam be used during pregnancy?
It should not be used during the third trimester. NSAID use from around 20 weeks onward can also cause fetal renal dysfunction and oligohydramnios, so use during this period requires careful medical assessment and, where necessary, the lowest dose for the shortest duration.
What are the most important warning symptoms?
Urgent medical evaluation is warranted for signs of gastrointestinal bleeding, severe allergic reaction, severe skin reaction, chest pain, shortness of breath, neurological symptoms such as sudden weakness or speech difficulty, or significant reduction in urine output.
22-References
- Novartis Pharma AG — Cataflam® Product Information / Package Insert, August 2025. Current publicly accessible Novartis product information for Cataflam, including composition, indications, dosing, contraindications, precautions, interactions, adverse reactions, pregnancy information, pharmacology, pharmacokinetics, overdose, and storage.
Novartis Cataflam Product Information - Novartis Egypt — Healthcare Professional Portal. Egyptian Novartis pharmaceutical entity/contact information and professional product-information resources. (Novartis Pro)
Novartis Egypt Healthcare Professional Portal - U.S. Food and Drug Administration (FDA) — NSAID Pregnancy Safety Communication. Safety information concerning NSAID exposure at approximately 20 weeks of pregnancy or later, fetal renal dysfunction, oligohydramnios, and the recommendation to use the lowest dose for the shortest duration when treatment is unavoidable. (U.S. Food and Drug Administration)
FDA NSAID Pregnancy Safety Communication - European Medicines Agency (EMA) — Diclofenac cardiovascular safety. Regulatory safety information concerning cardiovascular thrombotic risk, especially at high doses and with prolonged treatment, and the importance of lowest effective dose/shortest duration. (European Medicines Agency (EMA))
EMA Diclofenac Safety Advice - Egyptian market/medicine listings for current Cataflam presentations in Egypt, including 25-mg and 50-mg tablets, 15-mg/mL oral drops, 75-mg suppositories, and 75-mg/3-mL ampoules. These sources are useful for market presentation/availability verification but do not replace the official local regulatory leaflet. (Egypt Dwa)
Current-source status: The most recent official Novartis Cataflam document I could verify publicly is the August 2025 product information, which remains available on the Novartis website in 2026. The Egyptian market section is based on currently indexed Egyptian medicine/pharmacy listings and is intentionally distinguished from the official Novartis tablet product information. (Novartis)