Nabumetone Tablets USP 500mg Taj Pharma

  1. Name of the medicinal product

Nabumetone Tablets USP 500mg Taj Pharma
Nabumetone Tablets USP 750mg Taj Pharma
Nabumetone Tablets USP 1g Taj Pharma

  1. Qualitative and quantitative composition

a) Nabumetone Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Nabumetone USP 500mg.
Excipients: Q.S.

b) Nabumetone Tablets USP 750mg Taj Pharma
Each film-coated tablet contains:
Nabumetone USP 750mg.
Excipients: Q.S.

c) Nabumetone Tablets USP 1g Taj Pharma
Each film-coated tablet contains:
Nabumetone USP 1g.
Excipients: Q.S.

For a full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablets

  1. Clinical particulars
  • Therapeutic indications

Nabumetone Taj Pharma is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. However, following absorption from the gastrointestinal tract it is rapidly metabolised in the liver to the principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA), a potent inhibitor of prostaglandin synthesis.

It is indicated for the treatment of osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment.

  • Posology and method of administration

For oral administration.

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

Nabumetone Taj Pharma 500mg film-coated tablets should be taken preferably with or after food.

Adults

The recommended daily dose is two tablets (1g) taken as a single dose at bedtime.

For severe or persistent symptoms, or during acute exacerbations, an additional one or two tablets (500mg-1g) may be given as a morning dose.

Elderly

In common with many drugs, blood levels may be higher in elderly patients. The recommended daily dose of two tablets (1g) should not be exceeded in this age group and in some cases one tablet (500mg) may give satisfactory relief.

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 patients should be monitored for gastrointestinal bleeding during NSAID therapy.

Children

There are no clinical data to recommend use of Nabumetone Taj Pharma in children.

  • Contraindications

Hypersensitivity to Nabumetone Taj Pharma or to any of the excipients (see section 6.1).

Active, or history of recurrent peptic ulcer/ GI haemorrhage, perforation or peptic disease (two or more distinct episodes).

NSAID’s are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Severe heart failure, hepatic failure and renal failure (see section 4.4).

During the last trimester of pregnancy and in nursing mothers (see section 4.6).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Patients with severe heart failure and in patients with current cerebrovascular or other haemorrhage.

  • 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 gastrointestinal and cardiovascular risks below).

The use of Nabumetone Taj Pharma with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).

Respiratory Disorders:

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. In patients with severe renal impairment (creatinine clearance less than 30 ml/minute): laboratory tests should be performed at baseline and within some weeks of starting therapy. Further tests should be carried out as necessary; if the impairment worsens, discontinuation of therapy may be warranted. In moderate renal impairment (creatinine clearance 30 to 49 ml/min) there is a 50 % increase in unbound plasma 6-MNA and dose reduction may be warranted (see section 4.5).

As with other NSAIDs, abnormalities of liver function tests, rare cases of jaundice and hepatic failure (some of them with fatal outcomes), have been reported. A patient with signs/symptoms suggesting liver dysfunction or who has experienced an abnormal liver function test while on Nabumetone Taj Pharma therapy should be evaluated for evidence of development of a more serious hepatic reaction. Nabumetone Taj Pharma should be discontinued if such a reaction occurs.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and therapy should be instigated if warranted 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.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Nabumetone Taj Pharma.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Nabumetone Taj Pharma after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, 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.

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 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 required concomitant low dose acetylsalicylic acid, aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

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

Caution should be advised in patients received concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anti-coagulants such as warfarin, NSAIDs, selective serotonin re-uptake inhibitors or anti-platelet agents such as aspirin, acetylsalicylic acid and clopidogrel (see section 4.5).

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

NSAIDS should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (see section 4.8). In patients with active peptic ulcer, physicians must wheigh the benefits of therapy with Nabumetone Taj Pharma against possible hazards, institute an appropriate ulcer treatment regimen and monitor the patients’ progress carefully.

Nabumetone Taj Pharma is better tolerated than most other NSAIDs, primarily because it results in fewer effects on the gastrointestinal (GI) system. In a review of both pre- and post-registration data from clinical trials with Nabumetone Taj Pharma, the mean cumulative frequencies of GI perforations, ulcers or bleeds (PUBs) in patients treated from 3 to 6 months, 1 year and 2 years were respectively 0.3 %, 0.5 % and 0.8 %; although these figures are lower than those ascribed to other NSAIDs, the prescribing physician should be aware that these ADR can occur even in the absence of previous peptic disease.

Despite the relative gastrointestinal and renal safety of Nabumetone Taj Pharma, caution should be used when administering to patients with:

  • active upper GI ulceration. Appropriate treatment should be instigated prior to initiating Nabumetone Taj Pharma therapy.
  • Previous acetylsalicylic acid, aspirin- or other NSAID-induced asthma, urticaria or other allergic type reactions. Since fatal asthma attacks have been reported in such patients receiving other NSAIDs, the first administration of Nabumetone Taj Pharma should be medically supervised.

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).

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. Nabumetone 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 Nabumetone Taj Pharma 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 Nabumetone Taj Pharma should be considered.

NSAIDs could hide signs of infectious disease.

Cases of blurred vision or reduced visual activity have been reported with NSAID use, including Nabumetone Taj Pharma. Patients presenting with these events must be submitted to ophtalmological examination.

  • Interaction with other medicinal products and other forms of interaction

Other analgesics including cyclooxygenase-2 selective inhibitors: avoid the concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.4).

Diuretics and other antihypertensives drugs such as angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor antagonists (ARA) may present with decreased effect when concomitantly administered with NSAID; in some persons (such as elderly or dehydrated patients) this could lead to a further decrease in renal function and eventually to ARF.

Consequently, hydration and frequent monitoring of these patients is warranted.

Hyperkalaemia might develop, particularly with concomitant potassium-sparing diuretics administration.

The following commonly available drugs do not affect Nabumetone Taj Pharma metabolism and bioavailability: paracetamol, ASA, cimetidine, aluminium hydroxide antacids.

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

Use of more than one NSAID is not recommended.

Lithium: Decreased elimination of lithium.

Methotrexate: Decreased elimination of methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

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

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4); its concomitant administration with Nabumetone Taj Pharma should be undertaken with caution and overdose signals carefully monitored.

Probenecid: Reduction in the metabolism of Nabumetone Taj Pharma and a reduction in the elimination of Nabumetone Taj Pharma and metabolites.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Alcohol, bisphosphonates, oxpentifylline (pentoxyfilline) and sulfinpyrazone, may potentiate the GI side-effects and the risk of bleeding or ulceration.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRI’s): Increased risk of gastrointestinal bleeding (see section 4.4).

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

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

Concomitant administration of Nabumetone Taj Pharma with other protein-bound drugs, e.g. sulphonamides, sulphonilureas or hydantoin should be undertaken with caution and overdose signals carefully monitored.

No specific interaction studies between Nabumetone Taj Pharma and the above have been performed. Caution is therefore recommended for concomitant therapy with the drugs listed above.

  • Fertility, pregnancy and lactation

Pregnancy:

There is no clinical trial experience with the use of Nabumetone Taj Pharma during human pregnancy.

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the emryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of 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 been 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 the organogentic period. During the first and second trimester of pregnancy, Nabumetone Taj Pharma should not be given unless clearly necessary. If Nabumetone Taj Pharma is used by a woman attempting to conceive, or during the first and second 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 prostaglandid 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 pregnancy, to;
  • Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
  • Inhibition of unterine contractions resulting in delayed or prolonged labour.

Consequently, Nabumetone Taj Pharma is contraindicated during the third trimester of pregnancy.

Breast feeding

There is no clinical trial experience with the use of Nabumetone Taj Pharma during lactation.

It is not known whether Nabumetone Taj Pharma is excreted in human milk; however, 6MNA is excreted in the milk of lactating rats. With the potential for serious adverse reactions in breast fed infants from Nabumetone Taj Pharma, a decision should be made whether to discontinue breast feeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Fertility

See section 4.4 Special warnings and precautions for use, regarding female fertility.

  • Effects on ability to drive and use machines

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

  • Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo and comparator groups has not been taken into account in estimation of these frequencies. Rare and very rare events were generally determined from spontaneous data.

Blood and lymphatic system disorders
Very Rare: Thrombocytopenia
Not known: Neutropenia, agranulocytosis, leucopenia, aplastic anaemia and haemolytic anaemia.
Immune system disorders
Very rare: Anaphylaxis, anaphylactoid reaction
Psychiatric disorders
Uncommon: Confusion, nervousness, insomnia
Not known: Depression, hallucinations
Nervous system disorders
Uncommon: Somnolence, dizziness, headache, paraesthesia, anxiety
Not known: Aseptic meningitis (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 (see section 4.4)), vertigo, drowsiness
Eye disorders
Uncommon: Abnormal vision, eye disorder
Not known: Optic neuritis
Ear and labyrinth disorders
Common: Tinnitus, ear disorder
Vascular disorders
Common: Increases in blood pressure
Respiratory, thoracic and mediastinal disorders
Uncommon: Dyspnoea, respiratory disorder, epistaxis
Very rare: Interstitial pneumonitis
Not known: Asthma, aggravated asthma, bronchospasm
Gastrointestinal disorders
Common: Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence
Uncommon: Duodenal ulcer, Gl bleeding, gastric ulcer, Gl disorder, melena, vomiting, stomatitis, dry mouth
Very rare: Pancreatitis
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature.

Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed.

Hepatobiliary disorders
Very rare: Hepatic failure, jaundice
Skin and subcutaneous tissue disorders
Common: Rash, pruritus
Uncommon: Photosensitivity, urticaria, sweating
Very rare: Bullous reactions induding toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, angioedema, pseudoporphyria, alopecia
Not known: Purpura
Musculoskeletal and connective tissue disorders
Uncommon: Myopathy
Renal and urinary disorders
Uncommon: Urinary tract disorder
Very rare: Renal failure, nephrotic syndrome
Not known: Interstitial nephritis
Reproductive system and breast disorders
Very rare: Menorrhagia
General disorders and administration site conditions
Common: Oedema
Uncommon: Asthenia, fatigue
Not known: Malaise
Investigations
Uncommon: Elevated liver function tests

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Reporting of suspected adverse reactions

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

4.9 Overdose

a) Symptoms: Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

b) Therapeutic measure: There is no specific antidote and the active metabolite 6-MNA is not dialyzable. 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. 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. Other measures may be indicated by the patients’ clinical condition.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids.

Nabumetone Taj Pharma contains as active substance 4-(6´-methoxy-2´-naphthyl)-2-butanone

Nabumetone Taj Pharma is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. A notable feature of the animal pharmacology is the lack of effect on the gastric mucosa. Nabumetone Taj Pharma has a weak effect on platelet aggregation caused by collagen and no effect on bleeding time

In humans, lower frequency of peptic ulcers, bleeding or perforation has been reported in comparison with other NSAIDs. Following absorption from the gastrointestinal tract Nabumetone Taj Pharma is rapidly metabolised in the liver to the principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA) a potent inhibitor of prostaglandin synthesis.

  • Pharmacokinetic properties

Nabumetone Taj Pharma is absorbed almost entirely (>80%) from the gastrointestinal tract, but the first-pass metabolism is extensive, and no unchanged Nabumetone Taj Pharma is found in the plasma. The absorption rate is increased by concurrent ingestion of food or milk. However, the total quantity of the active metabolite in plasma is unchanged. In-vivo studies suggest that 6-MNA does not undergo any enterohepatic circulation. The bioavailability of 6-MNA in administration of Nabumetone Taj Pharma is approximately 35% (23-52%). The maximum plasma level of 6-MNA is reached at around 3 (1-12) hours after dosing. 6-MNA binds strongly to plasma proteins (>99%). The free fraction is dependent on the total concentration of 6-MNA and is proportional to dose in the range 1-2 g. The free fraction is 0.2-0.3% for 1g daily dosing and approximately 0.6-0.8% with 2 g daily dosing. Because of its strong binding to proteins, 6-MNA cannot be dialysed.

Following intravenous administration, the distribution volume has been measured as 7.5 (6.8-8.4) l and clearance as 4.4 (1.0-6.9) ml/min.

Intravenous studies in rats with Nabumetone Taj Pharma indicate it to be rapidly distributed throughout the body, in keeping with its highly lipophilic character. The active metabolite, 6-MNA is distributed into inflamed tissue and crosses the placenta into foetal tissue. It is found in the milk of lactating females. 6-MNA is eliminated by metabolism, principally conjugation with glucuronic acid, and o-demethylation followed by conjugation, the main route of excretion being the urine. The plasma elimination half-life is about 1 day in man.

Elderly

The steady-state plasma concentration in the elderly is usually higher and the half-life longer (29.8±8.1 hours) than in young healthy individuals, but the different intervals overlap to a great extent.

Renal Impairment

In patients with severely impaired renal function (creatinine clearance <30 ml/min), the mean value of the half-life of 6-MNA increased to around 40 hours and the plasma levels are 30% higher than in other patients. In patients who underwent dialysis, the steady-state plasma concentration of the active metabolite was equivalent to the values observed in healthy individuals.

  • Preclinical safety data

Not applicable.

  1. Pharmaceutical particulars

List of excipients

  • Sodium starch glycolate type A
  • Sodium lauryl sulfate
  • Hypromellose
  • Magnesium stearate
  • Microcrystalline cellulose
  • Red carmine
  • Yellow iron oxide
  • Titanium dioxide
  • Talc
  • Polyethylene glycol
  • Saccharin sodium
  • Liquid caramel flavour
  • Purified water
  • Carnauba wax

Incompatibilities

Not applicable.

  • Shelf life

36 months.

  • Special precautions for storage

Keep the tablets in the original carton in order to protect from light.

  • Nature and contents of container

Each tablet containing active substances Nabumetone Taj Pharma 50mg, 750mg and 1g film coated tablets.

High density polyethylene (HDPE) rectangular bottles with white, opaque high density polyethylene (HDPE) caps each containing following pack size.

Pack Size:

Each pack contains 5, 10, 14, 15, 20, 25, 28, 30, 40, 50, 56, 60 or 80 tablets.

Each box contains 10, 20, 40, 60, 80, 100, 120, 240, 360 and 500 tablets.

56 tablets or blister packs comprising clear PVC/PVdC and aluminium containing 60 tablets. The underside of the foil is coated with a heat seal lacquer and print primer on the other side.

Not all pack size may be marketed.

  • Special precautions for disposal and other handling

None.

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

Nabumetone Tablets USP 500mg Taj Pharma

Patient Information Leaflet

Nabumetone Tablets USP 500mg Taj Pharma

Nabumetone Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • In this leaflet, Nabumetone Taj Pharma 500mg & 1g Film-coated Tablets will be called Nabumetone Taj Pharma.

What is in this leaflet:

  1. What Nabumetone Taj Pharma is and what it is used for
  2. What you need to know before you take Nabumetone Taj Pharma
  3. How to take Nabumetone Taj Pharma
  4. Possible side effects
  5. How to store Nabumetone Taj Pharma
  6. Contents of the pack and other information

1. What Nabumetone Taj Pharma is and what it is used for

Nabumetone Taj Pharma belongs to a group of medicines called non-steroidal anti-inflammatory drugs (known as NSAIDs).

It works by reducing the production of some natural

chemicals found in the body. These chemicals (prostaglandins) cause the symptoms of inflammation such as pain and swelling.

Nabumetone Taj Pharma is used to treat the pain, stiffness and swelling of joints which are affected by osteoarthritis or rheumatoid arthritis.

  1. What you need to know before you take Nabumetone Taj Pharma

Do not take Nabumetone Taj Pharma if:

  • You are allergic to Nabumetone Taj Pharma
  • You are allergic to any of the other ingredients of Nabumetone Taj Pharma (see section 6)
  • You have ever had an allergic reaction like a rash, itchy, runny or bleeding nose, or become short of breath when you have taken aspirin or other NSAID medicines. Such medicines include ibuprofen, acetylsalicylic acid, diclofenac or naproxen. Some people who have had previous allergic reactions to NSAID medicines have very serious, sometimes fatal reactions if they take this kind of medicine again.
  • You have, or have ever had a stomach (peptic) ulcer or any perforation or bleeding (haemorrhage) in your digestive system or if you have or have ever had peptic disease
  • You have serious problems with your heart (severe heart failure)
  • You are currently receiving treatment for a stroke or other internal bleed
  • You have serious problems with your liver (liver cirrhosis)
  • You have serious problems with your kidneys (kidney failure)
  • You are in the last three months of pregnancy.
  • You are breast-feeding

If any of the above applies to you, talk to your doctor or pharmacist.

Check with your doctor before taking Nabumetone Taj Pharma if:

  • You have, or have ever had asthma
  • You have, or have ever had stomach problems. This includes Crohn’s disease or ulcerative colitis
  • You have kidney problems
  • You have liver problems
  • You have heart problems
  • You have or have ever had high blood pressure (hypertension)
  • You have ever had a stroke
  • You have any signs of water building up in your body, such as swollen ankles
  • You have a condition called systemic lupus erythematosus (SLE or Lupus for short) or any other autoimmune disease
  • You are in the first six months of pregnancy
  • You are trying to, or planning to become pregnant
  • You have diabetes
  • You have high cholesterol
  • You are a smoker
  • You are over 65 years of age
  • You have an infection. NSAID medicines such as

Nabumetone Taj Pharma may hide the symptoms of infections such as fever and inflammation

Children

Do not give Nabumetone Taj Pharma to children.

Warnings

Medicines such as Nabumetone Taj Pharma 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.

Tell your doctor if you are taking any of the following medicines:

  • Anticoagulants such as warfarin (to thin your blood)
  • Anticonvulsants such as phenytoin (to prevent fits)
  • Antidepressants such as selective serotoninreuptake inhibitors (SSRI’s) (to treat depression)
  • Antidiabetics (taken by mouth to control blood sugar levels)
  • Antihypertensives such as ACE inhibitors or angiotensin receptor agonists (to control high blood pressure)
  • Cardiac glycosides such as digoxin (to manage certain heart conditions)
  • Ciclosporin and tacrolimus (to prevent transplanted organs being rejected)
  • Corticosteroids (to treat skin conditions)
  • Diuretics or ‘water tablets’ (to make you pass more water)
  • Lithium (to treat mental problems)
  • Methotrexate (to treat arthritis)
  • Mifepristone (used by doctors to terminate pregnancies).

If you have taken mifepristone within the last two weeks you should not take Nabumetone Taj Pharma

  • Non steroidal anti-inflammatory drugs (NSAIDs or COX-2).

These include ibuprofen acetylsalicylic acid, diclofenac, naproxen, clopidogrel or aspirin

  • Quinolone antibiotics (to treat infections)
  • Zidovudine (to treat HIV)
  • Protein bound drugs such as sulphonamides, sulphonylureas, probenecid, sulfinpyrazone or hydantoin (used in medicines to treat bacterial infections, diabetes, oedema, hypertension and gout)
  • Bisphosphonates (used in medicines to treat conditions that effect your bones)
  • Oxpentifylline (pentoxyfilline) (used in medicines to treat the symptoms of intermittent claudication)
  • Any other medicine, including medicines obtained without a prescription.

Taking Nabumetone Taj Pharma with food

You must take this medicine with or after a meal.

Taking Nabumetone Taj Pharma with alcohol

No alcohol should be consumed during treatment with Nabumetone Taj Pharma.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding.

Your doctor will decide if taking this medicine at this time is right for you and/or your baby.

Remember: Taking this medicine may make it harder for you to become pregnant. Ask your doctor for advice

Driving and using machines

Whilst taking Nabumetone Taj Pharma you may feel dizzy, tired, drowsy, confused or notice problems with your eye sight. If this happens, do not drive or operate machinery. Your doctor may arrange for you for have an eye examination if your eyesight is affected whilst you are taking this medicine.

  1. How to take Nabumetone Taj Pharma

Important:

  • Only take the amount of this medicine your doctor has prescribed
  • Only take this medicine for the treatment time your doctor has prescribed.

This will stop you getting so many side-effects. This will reduce any chance of you having a stroke or heart attack.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Remember: Always take this medicine with or after a meal.

Swallow the tablets whole with water. Do not chew the tablets. Some patients may need to take another medicine at the same time as taking Nabumetone Taj Pharma. Your doctor will prescribe this if you need it.

Nabumetone Taj Pharma tablets come in two strengths – 500mg and 1g.

The number of tablets you take will therefore depend on which strength of tablet the doctor has prescribed for you.

Adults

  • The usual dose is 1g taken once a day at bedtime (as either two 500mg tablets or one 1g tablet).
  • The label your pharmacist puts on your medicine will tell you exactly how many tablets to take.
  • If you need to take more, your doctor will explain how much to take and when to take it.

Elderly (65 years and over)

  • The usual starting dose is 500mg taken once a day at bedtime (as either one 500mg tablet or half a 1g tablet).
  • The label your pharmacist puts on your medicine will tell you exactly how many tablets to take.
  • If you need to take more, your doctor will explain how much to take and when to take it.
  • Never take more than 1g of Nabumetone Taj Pharma each day (either two 500mg tablets or one 1g tablet per day).

Medical check-ups

When you are taking this medicine, your doctor may ask you to come for check-ups which may include:

  • Checking your kidneys to make sure they are working properly. Your doctor may want to do some tests before you start taking Nabumetone Taj Pharma and then re-check your kidney function once you have been taking the medicine for a few weeks.
  • Checking your liver is working properly
  • Checking you are not getting any problems with swelling of any part of your body. Your doctor may want to give you some medicine to help with these symptoms.
  • If you are elderly you will need to go for check-ups during the first four weeks of taking the medicine. This is to make sure that the medicine is working properly and that the dose you are taking is right for you.

If you take more Nabumetone Taj Pharma than you should

Do not take more Nabumetone Taj Pharma than you should. If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.

Taking too much Nabumetone Taj Pharma may make you feel or be sick, be dizzy or faint, develop a headache or have fits (convulsions).

If you forget to take Nabumetone Taj Pharma

Do not take a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any questions about the use of this medicine ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines Nabumetone Taj Pharma can cause side effects, although not everybody gets them.

Stop taking this medicine and seek immediate medical help if you have any of the following symptoms:

  • You have difficulty breathing
  • Your face or throat swells
  • You have a severe rash which may blister
  • You have chest pains or sudden numbness and confusion
  • You have blood in your stools. They may look black and tarry
  • You vomit blood or dark particles that look like coffee granules.

Stop taking this medicine and tell your doctor if you have any of the following symptoms:

This is especially important if you are elderly.

  • You have indigestion or heart burn
  • You have severe pains in your stomach
  • You have any other abnormal stomach symptoms

The following side effects are common and may affect up to one in 10 people taking Nabumetone Taj Pharma:

  • Ringing in your ears or problems with the ears
  • Increase in blood pressure (you may feel dizzy and have a headache)
  • Diarrhoea, constipation, feeling sick, inflammation of the stomach lining, stomach ache, wind
  • Rash, itchy skin
  • Fluid retention which causes swelling e.g. swollen ankles

The following side effects are uncommon and may affect up to one in 100 people:

  • Confusion, nervousness, problems sleeping
  • Tiredness, dizziness, headache, “pins and needles” or tingling feelings, anxiety
  • Problems with your sight or with your eyes
  • Breathing difficulties, nose bleeds
  • Upset stomach, being sick,
  • Mouth ulcers, dry mouth
  • Increased skin sensitivity to sunlight or artificial light, red, raised patches on the skin, sweating
  • Problems with your muscles
  • Problems with your urinary tract
  • Loss of strength or energy, fatigue
  • Abnormal liver enzymes

The following side effects are very rare and may affect up to one in 10,000 people:

  • Low numbers of blood platelets
  • Inflammation of the lungs causing shortness of breath and a dry cough
  • Yellowing of your skin and the whites of your eyes (jaundice), liver failure
  • Severe skin eruptions where the skin reddens, peels and swells and looks severely burnt, or a severe skin rash with flushing, fever, blisters and ulcers or a widespread skin rash with circular irregular red patches on the hands and feet
  • Skin hives, loss of hair
  • A disorder called pseudoporphyria which causes skin blisters, stomach pains and nervous system problems
  • Kidney problems such as blood in the urine, kidney failure
  • Heavy or unusually prolonged periods

The following side effects have also been reported by people taking Nabumetone Taj Pharma although it is not known how many people have these side effects:

  • Depression, hallucinations
  • Aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially in patients who already have an autoimmune disorder such as systemic lupus erythematosus or mixed connective tissue disorder
  • Vertigo, drowsiness
  • Inflammation of the optic nerve
  • Asthma or worsening of existing asthma
  • Red or purple skin patches
  • A problem with the kidneys known as interstitial nephritis.

The symptoms include fever, rash, enlarged kidneys, lower back pain, problems when passing water

  • A general feeling of being unwell or “out of sorts”
  • Changes in the numbers and types of blood cells. You may get ill more often with a sore throat, fever, chills, anaemia or abnormal bruising
  • Worsening of existing stomach conditions such as Crohn’s disease or ulcerative colitis

Important: Medicines such as Nabumetone Taj Pharma may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of 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 Nabumetone Taj Pharma

Keep out of the reach and sight of children.

Do not use Nabumetone Taj Pharma after the expiry date on the label or carton. The expiry date refers to the last day of that month. Keep the tablets in their original bottle in order to protect from light.

The blister strips do not require any special storage conditions.

Medicines should not be disposed of via wastewater or in household waste. Return any medicine you no longer need to your pharmacist.

  1. Contents of the pack and other Information

What Nabumetone Taj Pharma contains

The active substance in Nabumetone Taj Pharma is Nabumetone Taj Pharma.

  • Nabumetone Taj Pharma 500mg Film-coated Tablets Each 500mg tablet contains 500mg Nabumetone Taj Pharma. The other ingredients are sodium starch glycolate, sodium lauryl sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, red carmine, yellow iron oxide, titanium dioxide, talc, polyethylene glycol 400, saccharin sodium, liquid caramel flavour, purified water and carnauba wax.
  • Nabumetone Taj Pharma 1g Film-coated Tablets Each 1g tablet contains 1g Nabumetone Taj Pharma. The other ingredients are hydroxyl-propyl-methylcellulose, macrogol 6000, sodium lauryl sulphate, sodium starch glycollate, Type A, microcrystalline cellulose and titanium dioxide.

What Nabumetone Taj Pharma looks like

Nabumetone Taj Pharma 500mg/750mg and 1g  Film-coated Tablets are white to off white or red, oblong shaped film coated tablets and marked ‘Nabumetone Taj Pharma’ on one side and ‘500’ on the other. The tablets come in plastic bottles containing 56 tablets or in blister strips containing 60 tablets. Nabumetone Taj Pharma 1g Film-coated Tablets are white, with a break-line on one side. The tablets come in plastic bottles containing 100 or 200 tablets

Pack Size:

Each pack contains 5, 10, 14, 15, 20, 25, 28, 30, 40, 50, 56, 60 or 80 tablets.

Each box contains 10, 20, 40, 60, 80, 100, 120, 240, 360 and 500 tablets.

Not all pack size may be marketed.

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