Diclofenac sodium .......................  50 mg

Excipients.q.s ..............................1 tablet

(Aerosil, sucrose, avicel, gelatin, lactose, magnesium stearate, sodium starch glycolate, talc, tapioca starch, eudragit L100, PEG 6000, titanium dioxide, orange E110, red ferric oxide, black ferric oxide).

DOSAGE FORM: Enteric film coated tablet.

PRESENTATION: Box of 10 blisters x 10 tablets.

PHARMACODYNAMICS: Diclofenac, a phenylacetic acid derivative, is a nonsteroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory, analgesic, antipyretic properties. Diclofenac remarkedly reduces the synthesis of prostaglandin, prostacyclin, and thromboxane, which cause inflammations, pains, and fever by inhibiting cyclooxygenase.

PHARMACOKINETICS: Diclofenac is well dissolved in the intestinal juice, rapidly absorbed from the gastrointestinal tract after oral administration and obtains a plasma maximum concentration and high bioavailability. The drug is bound to a great deal of plasma-protein (over 99%), mainly to albumin.

Diclofenac easily penetrates into synovial fluid where the drug concentration is still maintained while plasma concentration decreased. The plasma half-life is about 1 to 2 hrs. The synovial fluid elimination half-life is from 3 to 6 hrs. Approximately 60% of the administered dose is excreted via the kidneys in form of metabolites (the glucuronide and the sulfate conjugates) and less than 1% in unchanged form. The remainder of the dose is excreted via the bile and faeces. The processes of absorption, metabolism, and excretion do not likely depend on age.

INDICATIONS: Treatment of inflammations, pains in the following cases:

Musculoskeletal disorders e.g., rheumatoid arthritis, osteoarthritis, inflammation forms and progressive degeneration of rheumatism, painful syndromes of backbone, vertebral degeneration, aches and pains caused by dislocation, ostalgia. Periarticular disorders e.g., bursitis, tendinitis, etc. Soft tissue disorders e.g., sprains, strains. 

Other pains and aches e.g., lumbago, scapulalgia, traumatic injuries, headache, acute gout, dysmenorrhea, appendage inflammations.

Postoperative pains, tooth extraction, tonsillectomy, etc.

Relief of painful, inflammatory conditions with or without fever due to viral and bacterial infections (in ears, nose-sinus, throat, gums).

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with a history of allergy (asthma, rash, acute rhinitis) to prostaglandin inhibitors or acetylsalicylic acid group. Patients with progressive peptic ulcer or a history of gastrointestinal bleeding. Patients with bleeding, stasis heart failure, severe renal or hepatic impairment, hypovolemia, collagenosis. Individuals receiving coumarin anticoagulant and wearing contact lenses. Pregnant women should not take NSAIDs in the last trimester of pregnancy. Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, cerebrovascular disease.

WARNINGS AND PRECAUTIONS: Patients with a history of gastrointestinal bleeding, ulceration and perforation. Patients with renal and hepatic failure, systemic lupus erythematosus. Renal, hepatic function should be monitored during long-term therapy with NSAIDs. Patients with hypertension or cardiopathy associated with fluid retention or oedema. Patients with infections. Patients with a history of hemophilia, bleeding.

Cardiovascular thrombotic events: Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

To minimize the potential risk for an adverse cardiovascular event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.

PREGNANCY AND LACTATION: The drug should only be used in these subjects if clearly needed. The drug is advised not to be taken during the last trimester of pregnancy. Diclofenac should not be given to the subjects who have planned to become pregnant.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Cautions should be taken when driving and operating machinery.


Diclofenac should not be used concomitantly with the following substances:

NSAIDs, salicylate derivatives, and glucocorticoids: Increased risk of gastrointestinal ulcer, bleeding.

Anticoagulants e.g., heparin, coumarin, ticlopidine: Increased risk of hemorrhage.

Quinolone antibiotics: Increased risk of adverse effects on CNS (e.g., seizures).

IUD: Decreased effect of contraception.

Lithium, digoxin: A rise in plasma concentrations of lithium, dixogin, leading to toxicity may be seen. Doses of lithium and diogxin should be adjusted in case of obligate concomitant administration with diclofenac; moreover, plasma lithium and digoxin concentrations should be carefully monitored.

Methotrexate: Toxicity has occurred following concomitant administration of diclofenac and methotrexate.

Diclofenac may be used concomitantly with the following substances but the patient should be monitored:

Ciclosporin: Renal function should be monitored.

Diuretics: Patients receiving diuretics may have an increased risk of developing renal failure secondary to decreased renal blood flow.

Anti-hypertensives (angiotensin converting enzyme inhibitors, beta-blockers, etc.).

Antacids: Antacids may reduce intestinal irritations by diclofenac, but decreasing plasma diclofenac concentrations.

Caution should be taken if diclofenac is concomitantly used the following substances:

Cimetidine mildly decreases plasma diclofenac concentration, but does not reduce diclofenac's effect and helps to protect the duodenum, stomach from the adverse effects of diclofenac.

Probenecid makes a double diclofenac concentrations. This is a good clinical effect on patients with arthropathy but poisoning of diclofenac may occur, particularly in patients with impaired renal function. The effect of uricaciduria excretion is not affected. The dose of diclofenac should be reduced if necessary.


Common: nausea, vomiting, diarrhea, constipation, epigastralgia.

Rare: gastrointestinal ulcer, bleeding (in long-term therapy), blood disorders (leucopenia, thrombocytopenia, anemia), headache, insomnia, irritability, urticaria, Quincke's oedema, asthma, bronchospasm, blurred vision, eye pain, diplopia, acute renal failure, interstitial nephritis, haematuria, increased transaminases, hepatitis.

Cardiovascular thrombotic events: Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see more Warnings and precautions).

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: Acute diclofenac overdosage produces manifestations that are mainly extensions of adverse effects of the drug. General measures should include immediately emptying the stomach by inducing emesis or by gastric lavage, followed by initiation of symptomatic and supportive treatment. Administration of activated charcoal after emesis or gastric lavage may be useful in minimizing absorption of diclofenac from the gastrointestinal tract and the enterohepatic cycle. Forced diuresis may not be beneficial because the drug is highly protein bound. If forced diuresis is used an attempt, fluid and electrolyte balance should be monitored carefully, since potentially serious electrolyte disturbances and fluid retention may occur.


Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Warnings and precautions)

The tablets should be swallowed whole.

Adults: 1 tablet x 2 - 3 times daily.

Note: The maximum dose is 150 mg of diclofenac sodium daily for any route.

Or as directed by the physician.

Read the directions carefully before use.         

Consult the physician for more information.   

The drug is for prescriptions only.        

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light

Specifications: Vietnamese Pharmacopoeia IV.


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