1. Name of the medicinal product

Diclofenac Potassium Tablets USP 25mg Taj Pharma
Diclofenac Potassium Tablets USP 50mg Taj Pharma

  1. Qualitative and quantitative composition

a) Diclofenac Potassium Tablets USP 25mg Taj Pharma
Each film-coated tablet contains:
Diclofenac Potassium USP 25mg
Excipients: Q.S.

b) Diclofenac Potassium Tablets USP 50mg Taj Pharma
Each film-coated tablet contains:
Diclofenac Potassium USP 50mg
Excipients: Q.S.

For a full list of excipients, see section 6.1

  1. Pharmaceutical form

Film-coated tablets
Round film coated, biconvex tablets

  1. Clinical particulars
  • Therapeutic indications

Rheumatoid arthritis
Osteoarthrosis
Low back pain
Migraine attacks

Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures

Ankylosing spondylitis
Acute gout

Control of pain and inflammation in orthopaedic, dental and other minor surgery

Pyrophosphate arthropathy and associated disorders

  • Posology and method of administration

For oral administration.

To be taken preferably with or after food.

The tablets should be swallowed whole with liquid

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults

The recommended daily dose is 100 – 150mg in two or three divided doses. For milder cases, 75 – 100mg daily in two or three divided doses is usually sufficient.

In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4 – 6 hours, not exceeding a total dose of 200mg per day.

Paediatric population

For children over 14 years of age, the recommended daily dose is 75-100mg in two or three divided doses. Diclofenac Potassium Taj Pharma 25mg Tablets are not recommended for children under 14 years of age.

The use of Diclofenac Potassium Taj Pharma 50mg tablets in migraine attacks has not been established in children.

Elderly

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Renal impairment

No adjustment of the starting dose is required for renally impaired patients (see section 4.4).

Hepatic impairment

No adjustment of the starting dose is required for hepatically impaired patients (see section 4.4).

  • Contraindications
  • Hypersensitivity to the active substance or any of the excipients.
  • Active, gastric or intestinal ulcer, bleeding or perforation.
  • Active or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
  • NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
  • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
  • Severe heart failure, hepatic failure and renal failure (see section 4.4).
  • History of gastro-intestinal bleeding or perforation, relating to previous NSAID therapy.
  • During the last trimester of pregnancy (see section 4.6).
  • This product contains soya. If you are allergic to peanut or soya, do not use this medicinal product.
    • Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

The use of Diclofenac Potassium Taj Pharma with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see section 4.5).

Elderly

Caution is indicated in the elderly on basic medical grounds. The elderly have increased frequency of adverse reactions to NSAIDs especially gastro intestinal bleeding and perforation which may be fatal. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight (see section 4.2).

Gastrointestinal

Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastric or intestinal ulceration, bleeding or perforation, with ulcerative colitis, or with Crohn’s disease as these conditions may be exacerbated (see section 4.8).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

GI bleeding (haematemesis, melaena), ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence and maintain treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

Caution should be advised in patients receiving concomitant medications which increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Diclofenac Potassium Taj Pharma, the treatment should be withdrawn.

NSAID

Hypersensitivity reactions

As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without earlier exposure to the drug (see section 4.8).

Infection

Like other NSAIDs, Diclofenac Potassium Taj Pharma tablets may mask the signs and symptoms of infection due to their pharmacodynamic properties.

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 (see section 4.8).

Cardiovascular, Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.

As fluid retention and oedema have been reported in association with NSAIDs 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 those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.

Hepatic

Close medical surveillance is required when prescribing diclofenac to patients with impairment of 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 Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac Potassium Taj Pharma tablets should be discontinued.

Hepatitis may occur without prodromal symptoms.

Use of Diclofenac Potassium Taj Pharma tablets in patients with hepatic porphyria may trigger an attack.

Haematological

Diclofenac Potassium Taj Pharma tablets may reversibly inhibit platelet aggregation (see section 4.5). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

Long term treatment

All patients who are receiving long term treatment with non-steroidal, anti-inflammatory agents should be monitored as a precautionary measure eg renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. This is particularly important in the elderly.

Respiratory disorders

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 oedema 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.

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 and with significant risk factors for cardiovascular events (e.g.,, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.

As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically.

Dermatological

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 (see section 4.8). Patients appear to be at highest risk for 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. Diclofenac Potassium Taj Pharma should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility

The use of Diclofenac Potassium Taj Pharma tablets 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 Diclofenac Potassium Taj Pharma tablets should be considered (see section 4.6).

  • Interaction with other medicinal products and other forms of interaction

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids: Co-administration of diclofenac with other systemic NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4).

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors may cause a decrease in their antihypertensive effect via inhibition of vasodilatory prostaglandin synthesis.

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 periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.(see section 4.4)

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: If used concomitantly, diclofenac may increase plasma concentrations of lithium Monitoring of the serum lithium level is recommended.

Methotrexate: Diclofenac can inhibit the tubular renal clearance of methotrexate hereby increasing methotrexate levels. Caution is recommended when NSAIDs, including diclofenac, are administered less than 24 hours before treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increase. Cases of serious toxicity have been reported when methotrexate and NSAIDs including diclofenac are given within 24 hours of each other. This interaction is mediated through accumulation of methotrexate resulting from impairment of renal excretion in the presence of the NSAID.

Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin 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.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Anti-coagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding (see section 4.4). Although clinical investigations do not appear to indicate that diclofenac has an influence on the effect of anticoagulants, there are reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulant concomitantly (see section 4.4). Therefore, to be certain that no change in anticoagulant dosage is required, close monitoring of such patients is required. As with other nonsteroidal anti-inflammatory agents, diclofenac in a high dose can reversibly inhibit platelet aggregation.NSAID

Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin. Monitoring of the serum digoxin level is recommended.

Selective serotonin reuptake inhibitors (SSRls): lncreased risk of gastrointestinal bleeding (see section 4.4).

Tacrolimus: 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.

Quinolone antibacterials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving an NSAID.

Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.

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.

Zidovudine: lncreased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Antidiabetic agents: Clinical studies have shown that Diclofenac Potassium Taj Pharma tablets can be given together with oral antidiabetic agents without influencing their clinical effect. However there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustment to the dosage of hypoglycaemic agents. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

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 section 4.4).

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.

  • Pregnancy and lactation

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. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus. If diclofenac is used by a woman attempting to conceive, or during the 1st or 2nd trimesters 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, diclofenac is contra-indicated during the third trimester of pregnancy.

Lactation

Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore Diclofenac should not be administered during breast feeding in order to avoid undesirable effects in the infant (see section 5.2).

Female fertility

As with other NSAIDs, the use of diclofenac 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 diclofenac should be considered.

See section 4.4 regarding female fertility.

  • Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

  • Undesirable effects

Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1,000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); Unknown: cannot be estimated from available data.

The following undesirable effects include those reported with other short-term or long-term use. Blood and lymphatic system disorders
Very rareThrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
UnknownNeutropenia
Immune system disorders
RareHypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rareAngioneurotic oedema (including face oedema).
Psychiatric disorders
Very rareDisorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders
CommonHeadache, dizziness.
RareSomnolence, tiredness.
Very rareParaesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis*, taste disturbances, cerebrovascular accident.
UnknownConfusion, hallucinations, disturbances of sensation malaise
Eye disorders
Very rareVisual disturbance, vision blurred, diplopia.
UnknownOptic neuritis.
Ear and labyrinth disorders
CommonVertigo.
Very rareTinnitus, hearing impaired.
Cardiac disorders
Very rarePalpitations, chest pain, cardiac failure, myocardial infarction.
Vascular disorders
Very rareHypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders
RareAsthma (including dyspnoea).
Very rarePneumonitis.
Gastrointestinal disorders
CommonNausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
RareGastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).
Very rareColitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
UnknownIschaemic colitis
Hepatobiliary disorders
CommonTransaminases increased.
RareHepatitis, jaundice, liver disorder.
Very rareFulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
CommonRash.
RareUrticaria.
Very rareBullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Renal and urinary disorders
Very rareAcute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions
RareOedema
Reproductive system and breast disorders
Very rareImpotence

* especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease, with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.

Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment. (See section 4.3 and 4.4 for).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

  1. a) Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally convulsions. In rare cases of significant poisoning acute renal failure and liver damage are possible.

  1. b) Therapeutic measure

Patients should be treated symptomatically as required.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured. Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to high protein binding and extensive metabolism.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam. Supportive measures should be given for complications such as hypotension, renal failure, gastrointestinal disorder, and respiratory depression.

Other measures may be indicated by the patient’s clinical condition.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

Diclofenac Potassium Taj Pharma tablets contain the potassium salt of diclofenac, a non-steroidal compound with pronounced and clinically demonstrable analgesic, anti-inflammatory and anti-pyretic properties.

Diclofenac is a potent inhibitor of prostaglandin biosynthesis and a modulator of arachidonic acid release and uptake.

Diclofenac Potassium Taj Pharma tablets have a rapid onset of action and are therefore suitable for the treatment of acute episodes of pain and inflammation.

In migraine attacks Diclofenac Potassium Taj Pharma tablets have been shown to be effective in relieving the headache and in improving the accompanying symptom of nausea.

Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

  • Pharmacokinetic properties

Absorption

Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption.

Peak plasma concentration after one 50mg sugar-coated tablet was 3.9 µmol/l after 20-60 minutes. The plasma concentrations show a linear relationship to the size of the dose.

Diclofenac undergoes first-pass metabolism and is extensively metabolised.

Distribution

Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%)

Diclofenac was detected in a low concentration (100ng/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 (see section 4.6).

Elimination

The total systemic clearance of diclofenac in plasma is 263 ± 56 ml/min (mean ± SD).

The terminal half-life in plasma is 1 – 2 hours.

Repeated oral administration of Diclofenac Potassium Taj Pharma tablets for 8 days in daily doses of 50mg t.d.s does not lead to accumulation of diclofenac in the plasma.

Approx. 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Biotransformation

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

Characteristics in patients

The age of the patient has no influence on the absorption, metabolism, or excretion of diclofenac.

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 <10 ml/min the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis) the kinetics and metabolism are the same as for patients without liver disease.

  1. Pharmaceutical particulars
  • List of excipients

Silica colloidal anhydrous, Sodium starch glycollate, Povidone, Starch maize, Calcium hydrogen phosphate, Magnesium stearate,

Tablet Coating:

Polyvinyl alcohol partially hydrolysed, Titanium dioxide, Talc, Lecithin Soya, Iron Oxide red, Iron Oxide yellow, Xanthan gum

  • Incompatibilities

Not applicable

  • Shelf life

36 months

  • Special precautions for storage

Storage condition for Each Tablets at room temperature and do not store more than 250C.

  • Nature and contents of container

7,12,21,28,30,50,56,60,84,100 in Al/Al, PVC blister

Pack size: 14, 28, 56 and 100 or 500

*Not all pack sizes may be marketed*

  • Special precautions for disposal and other handling

Not applicable.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Diclofenac Potassium Tablets USP 50mg Taj Pharma

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you have any of the side effects, or if you notice any not listed, please tell your doctor or pharmacist.

In this leaflet:

  1. What Diclofenac Potassium Taj Pharma tablets are and what they are used for
  2. Before you take Diclofenac Potassium Taj Pharma tablets
  3. How to take Diclofenac Potassium Taj Pharma tablets
  4. Possible side effects
  5. How to store Diclofenac Potassium Taj Pharma tablets
  6. Further Information

1.What Diclofenac Potassium Taj Pharma tablets are and what they are used for

Diclofenac Potassium Taj Pharma belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation in the following conditions:

  • Sprains, strains and other injuries
  • Pain and inflammation following surgery
  • Gout
  • Other painful conditions affecting the joints and muscles such as backache, rheumatoid arthritis, osteoarthritis, ankylosing spondylytis and pyrophosphate arthropathy.

The tablets can also be used to relieve the symptoms associated with migraine attacks in adults.

  1. Before you take Diclofenac Potassium Taj Pharma tablets

Do not take Diclofenac Potassium Taj Pharma tablets if you:

  • are allergic (hypersensitive) to Diclofenac Potassium Taj Pharma or any of the other ingredients in the tablet (see section 6)
  • have a peptic ulcer, in your stomach (gastric) or small intestine (duodenal) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
  • have history of gastro-intestinal bleeding or perforation, relating to previous NSAID therapy
  • have previously had a reaction (asthma, hives or a cold) caused by an allergy to salicylates (e.g. aspirin) or other non-steroidal pain killers
  • suffer from severe kidney, heart or liver failure
  • have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
  • have or have had problems with your blood circulation (peripheral arterial disease)
  • are pregnant, and in the last three months (last trimester) of pregnancy.

Check with your doctor or pharmacist before taking Diclofenac Potassium Taj Pharma tablets if you:

  • have a history of gastrointestinal disease e.g. ulcerative colitis or Crohn’s disease
  • have reduced heart, kidney, or liver function
  • suffer from any blood clotting disorder
  • have or have had asthma
  • suffer from liver porphyria (disorder of the red blood pigment)
  • have had or need to have surgery
  • are elderly (over 65)
  • are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib
  • have Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease.

Make sure your doctor knows, before you are given diclofenac:

  • If you smoke
  • If you have diabetes
  • If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Medicines such as diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, have had a previous stroke or think that you might be at risk of these conditions you should discuss your treatment with your doctor or pharmacist.

Diclofenac may mask the signs and symptoms of infection.

Whilst you are taking these tablets, your doctor may want to give you a check-up from time to time.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially:

  • medicines to treat diabetes – a dose adjustment of these medicines may be necessary as blood sugar may drop too low
  • anticoagulants – (e.g. warfarin) – these may increase the risk of bleeding
  • diuretics (water tablets) – the effect of these may be decreased.
  • Potassium-sparing diuretics may increase the potassium levels in the blood
  • lithium (medicine to treat depression) the blood levels of these medicines may be increased if taken with Diclofenac
  • cytotoxic medicines (e.g. methotrexate to treat cancers) – should not be taken less than 24 hours before or after Diclofenac Potassium Taj Pharma tablets – the blood levels of these medicines may be increased if taken with Diclofenac
  • ciclosporin – this may harm kidney function
  • quinolones (to treat infections, e.g. ciprofloxacin and levofloxacin)
    • these may cause convulsions (fits)
  • steroid tablets – these may increase the risk of bleeding in the stomach
  • other NSAIDs (e.g. aspirin) – these may increase the risk of side effects
  • medicines to treat high blood pressure (ACE-inhibitors, beta blockers) – the blood pressure lowering effect may be reduced
  • mifepristone (used to induce abortion) – effect of mifepristone may be reduced by NSAIDs
  • cardiac glycosides (e.g. digoxin) used to treat heart failure. Use with Diclofenac may worsen heart failure or increase blood levels of these medicines
  • tacrolimus (an immunosuppressant) – these may increase the risk of kidney damage
  • zidovudine (an antiretroviral drug used to treat HIV) – combination with Diclofenac may increase the risk of blood disorders
  • phenytoin (a medicine used to treat seizures) – the blood level of this medicine may be increased if taken with Diclofenac
  • colestipol and cholestyramine – these may reduce the effect of Diclofenac
  • potent CYP2C9 Inhibitors (e.g. sulfinpyrazone and voriconazole)
    • the blood level of Diclofenac may be increased if taken with these medicines
  • selective serotonin reuptake inhibitors (SSRIs)
  • trimethoprim

Laboratory tests

Frequent liver and kidney function tests and monitoring of blood counts are necessary if taken for more than a few days.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

It is not recommended that you take Diclofenac during the first 6 months of pregnancy. However, your doctor may prescribe Diclofenac for you during the first six months of pregnancy if he/she feels the benefit to you outweighs the risk. You must not however take Diclofenac during the last 3 months of pregnancy as damage to the foetus and reduced labour may occur.

Breastfeeding

You should only use Diclofenac whilst breastfeeding if advised by your doctor.

Female fertility Diclofenac may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.

Important information about some of the ingredients

If you are allergic to peanut or soya do not take this medicine, as it contains soya. This medicine contains 0.075 mmol (2.92mg) potassium per 25mg tablet and 0.150 mmol (5.85mg) potassium per

50mg tablet. This should be taken into account if you have reduced kidney function or are on a controlled potassium diet.

  1. How To Take Diclofenac Potassium Taj Pharma tablets

Always take Diclofenac Potassium Taj Pharma tablets exactly as your doctor has told you. If you are unsure check with your doctor or pharmacist.

Diclofenac Potassium Taj Pharma tablets must not be taken long-term, blood tests should be carried out if taken for more than a few days. To minimise side-effects, you should take the lowest effective dose for the shortest time necessary to relieve your symptoms. The tablets must be swallowed whole with a glass of water, with or after food.

The usual dose is:

To treat pain and inflammation

  • Adults – 75mg to 150mg a day in two or three doses.
  • Elderly patients – a lower dose may be used. If you are frail or have a low body weight, your doctor may ask you to go back to see him regularly for the first 4 weeks of treatment, to make sure that you are not experiencing any side effects.
  • Children aged 14 years and over – 75mg to 100mg daily, in two or three doses.
  • Not recommended for children under 14 years old. To treat the symptoms of migraine in adults 50mg taken when the first signs of a migraine attack appear. Another 50mg taken 2 hours after the first dose if needed and then every 4 to 6 hourly. You should not take more than 200mg in 24 hours.

These tablets are not suitable for the treatment of migraine in children.

If you take more Diclofenac Potassium Taj Pharma tablets than you should:

Contact your doctor, emergency room or pharmacist if you have taken more Diclofenac Potassium Taj Pharma tablets than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell).

If you forget to take Diclofenac Potassium Taj Pharma tablets

Do not take a double dose to make up for a forgotten dose. Continue the treatment as advised by your doctor.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:

  • pass blood in your faeces (stools / motions)
  • pass black tarry stools
  • vomit any blood or dark particles that look like coffee grounds
  • an allergic reaction such as itching, low blood pressure, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing
  • a form of meningitis (aseptic) causing a combination of symptoms such as headache, fever, stiff neck, tiredness, muscle pain, sore throat and disorientation
  • yellowing of the skin or the whites of your eyes
  • stomach pain, indigestion, heartburn, wind, nausea (feeling sick), vomiting (being sick) or other abnormal stomach symptoms
  • any type of fit or seizure
  • an unexpected change in the amount of urine produced and/or its appearance
  • mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Potassium Taj Pharma tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).

Tell your doctor if you experience any of the following symptoms:

Common (affects up to 1 in 10 people):

headache, dizziness, ’spinning’ sensation, feeling or being sick, diarrhoea, pain or swelling of your stomach or abdomen, indigestion, heartburn, wind, loss of weight or poor appetite, abnormal liver function tests, skin rashes.

Rare (may affect up to 1 in 1,000 people):

allergic reactions, tiredness, difficulty breathing, inflammation of the stomach, stomach ulcers or bleeding, vomiting blood, blood in the faeces, hepatitis, yellowing of the skin or whites of eyes, rash or raised lumps on your skin, fluid retention (symptoms of which include swollen ankles), drowsiness.

Very rare (may affect up to 1 in 10,000 people): ‘pins and needles’, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), difficulty sleeping, nightmares, depression, irritability, anxiety, psychotic reactions, disorientation, loss of memory, seizures, aseptic meningitis, sensitivity to light, taste disturbance, constipation, inflammation of the tongue, mouth ulcers, ulcers of the gullet, lower gut disorders (including inflammation of the colon causing diarrhoea and stomach pains), palpitations (fast or irregular heart beat), chest pain, high or low blood pressure, inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia, making you tired and more prone to minor infections or bleeding), kidney or liver disorders or failure, presence of blood or protein in the urine, skin rash, itching, skin eruptions, eczema, dermatitis, Erythema Multiforme (round red patches on the skin),

Stevens-Johnson-Syndrome (severe skin rash with flushing, fever, blisters and ulcers), or Lyell’s Syndrome (severe rash with reddening, peeling and swelling of skin that looks like severe burns), hair loss, pancreatitis (inflammation of the pancreas), worsening of ulcerative colitis or Crohn’s disease, impotence (difficulty getting an erection), angioneurotic odema (swelling of the skin).

Unknown (frequency cannot be estimated from the data): neutropenia (can lead to low resistance to infections), confusion, hallucination, disturbances of sensation, generally feeling unwell, sudden loss of vision.

Medicines such as Diclofenac Potassium Taj Pharma tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (very rare).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Diclofenac Potassium Taj Pharma tablets

Keep out of the sight and reach of children.

This medicine has no special storage precautions. Do not use after the expiry date stated on the carton. Unused tablets should be taken back to the pharmacist for safe disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

  1. Further information

What Diclofenac Potassium Taj Pharma tablets contain

The active substance (the ingredient that makes the tablet work) is Diclofenac. Each tablet contains 25mg or 50mg Diclofenac Potassium Taj Pharma.

The tablets also contain silica colloidal anhydrous, sodium starch glycollate, povidone, maize starch, calcium hydrogen phosphate, magnesium stearate, polyvinyl alcohol partially hydrolysed, titanium dioxide, talc, lecithin soya, iron oxide red, iron oxide yellow and xanthan gum.

What Diclofenac Potassium Taj Pharma tablets look like and contents of the pack

The 25mg tablets are, round, unscored, biconvex  film coated tablets. The 50mg tablets are round, unscored, biconvex film coated tablets.

Pack sizes:

Blister packs: 14, 28 and 56 film-coated tablets.
Plastic bottles: 100 and 500 film-coated tablets

(Not all pack sizes may be available)

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com