Naproxen Tablets BP 250mg Taj Pharma

  1. Name of the medicinal product

Naproxen Tablets BP 250mg Taj Pharma
Naproxen Tablets BP 375mg Taj Pharma
Naproxen Tablets BP 500mg Taj Pharma

  1. Qualitative and quantitative composition

a) Naproxen Tablets BP 250mg Taj Pharma
Each uncoated tablet contains:
Naproxen BP 250mg
Excipients: Q.S.

b) Naproxen Tablets BP 375mg Taj Pharma
Each uncoated tablet contains:
Naproxen BP 375mg
Excipients: Q.S.

c) Naproxen Tablets BP 500mg Taj Pharma
Each uncoated tablet contains:
Naproxen BP 500mg
Excipients: Q.S.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Uncoated tablets

  1. Clinical particulars
  • Therapeutic indications

Naproxen is indicated for the treatment of:

  • Rheumatoid arthritis.
  • Osteoarthritis (degenerative arthritis).
  • Ankylosing spondylitis.
  • Juvenile rheumatoid arthritis.
  • Acute gout.
  • Acute musculoskeletal disorders Dysmenorrhoea.
  • Posology and method of administration

Posology

Adults

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

500mg-1g daily in two doses at twelve hour intervals, or alternatively, if 1g daily is needed this can be administered as two 500mg doses or as a single dose. The size of the morning and evening doses can be adjusted on the basis of the predominant symptoms (ie night time pain or morning stiffness)

Acute gout

Initially 750mg followed by 250mg every 8 hours until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea

Initially 500mg followed by 250mg every 6-8 hours as necessary to a maximum of 1250mg daily after the first day.

Loading Dose

As a single administration of two tablets, morning or evening, a loading dose of 750mg-1g daily for the acute phase is recommended in the following cases:

  1. a) Patients reporting severe night time pain and/or morning stiffness.
  2. b) Patients commencing naproxen therapy following a switch from a high dose of another antirheumatic compound.
  3. c) Osteoarthritis where pain is the predominant symptom.

Paediatric population

For juvenile rheumatoid arthritis in children over 5 years old, 10mg/kg a day taken in two doses every 12 hours.

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. Studies indicate that although total plasma concentration of naproxen is unchanged, unbound plasma fraction of naproxen is increased in the elderly. The implication of this finding for naproxen dosing is unknown. As with other drugs used in the elderly it is prudent to use the lowest effective dose. Dosage should be reduced in the elderly where there is an impairment of renal function. (See other special warnings and precautions).

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

Method of administration

For oral administration preferably with or after food.

  • Contraindications
  • Hypersensitivity to naproxen, naproxen sodium or any of the excipients listed in section 6.1.
  • Patients with active gastrointestinal bleeding or peptic ulceration.
  • 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.
  • Severe heart failure, hepatic failure and renal failure (see section 4.4).
  • During the third trimester of pregnancy (see section 4.6).
  • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
  • 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 cardiovascular risks below).

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.

Clinical trial and epidemiological data suggest that use of coxibs and 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). Although data suggest that the use of naproxen (1000mg daily) may be associated with a lower risk, some risk cannot be excluded.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen 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 ot 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)
  • in the elderly
  • when used with alcohol
  • in smoking

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

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

Caution should be advised in patients receiving concomitant medications which could 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 naproxen, 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).

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. Renal function should be monitored in these patients (see also section 4.3).

Impaired renal function:

Naproxen should be used with great caution where there is impairment of renal function as it is eliminated to a large extent (95%) via glomerular filtration; the monitoring of serum creatinine and/or creatinine clearance should be conducted in these patients.

Naproxen is not recommended in patients having baseline creatinine clearance less than 20ml/minute.

Certain patients, specifically those whose renal blood flow is compromised, because of extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure, and pre-existing renal disease, should have renal function assessed before and during naproxen therapy. Some elderly patients in whom impaired renal function may be expected, as well as patients using diuretics, may also fall within this category. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.

Impaired liver function

Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown but it is prudent to use the lowest effective dose. The product should be used with caution in patients with a history of, or in those with impaired liver function.

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.

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. Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility

The use of naproxen 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 fertility, withdrawal of naproxen should be considered.

Anaphylactic (anaphylactoid) reactions

Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products. They may also occur in individuals with a history of angioedema, bronchospastic reactivity (eg asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.

Naproxen, in common with other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Patients who have coagulation disorders or who are receiving drug therapy that affects haemostasis should be carefully observed when given naproxen (see section 4.5).

Patients on full anticoagulant therapy (eg heparin or warfarin) may be at an increased risk of bleeding if given naproxen concurrently. Therefore, the benefits should be weighed against these risks.

Mild peripheral oedema has been observed in a few patients receiving naproxen. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised function may be at a greater risk when taking naproxen.

Steroids

If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

Ocular effects

Studies have not shown changes in the eye attributable to naproxen administration. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilledema, have been reported in users of NSAIDs including naproxen, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with naproxen-containing products should have an ophthalmological examination.

Combination with other NSAIDs

The combination of naproxen-containing products and others NSAIDs is not recommended, because of the cummulative risks of inducing serious NSAID-related adverse events.

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

The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation thereby diminishing their utility as diagnostic signs.

Interference in tests:

Naproxen therapy should be temporarily withdrawn 48 hours before adrenal function tests are performed as it may artifactually interfere with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with some assays of urinary 5-hydroxyindoleacetic acid.

Sporadic abnormalities in laboratory tests (e.g. liver function test) have occurred in patients on naproxen therapy, but no definite trend was seen in any test indicating toxicity.

Medication Overuse Headache (MOH)

After long term treatment with analgesics, headache may develop or aggravate. Headache caused by overuse of analgesics (MOH – medication-overuse headache) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of analgesics. Patients with medication overuse headache should not be treated by increasing the dose. In such cases the use of analgesics should be discontinued in consultation with a doctor.

Contains Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

  • Interaction with other medicinal products and other forms of interaction
  • Naproxen is highly protein-bound hence patients receiving hydantoins, anticoagulants or a highly protein-bound sulfonamide should be closely monitored for signs of overdosage of these drugs. No interactions have beern observed in clinical studies with naproxen or sulfonylureas, but caution is nevertheless advised since interaction has been seen with other non-steroidal agents of this class.
  • NSAIDs, including naproxen, have been reported to increase steady state plasma lithium levels by inhibition of renal lithium clearance. Decreased elimination of lithium. It is recommended that these levels are monitored whenever initiating, adjusting or discontinuing naproxen.
  • Anti-hypertensives: Reduced anti-hypertensive effect. Concomitant administration of naproxen with beta blockers may reduce their antihypertensive effect and may increase the risk of renal impairment associated with the use of ACE inhibitors or angiotensin II receptor antagonists.
  • Probenecid given concurrently increases naproxen plasma levels and extends its half-life considerably.
  • Decreased elimination of methotrexate. Caution is advised when methotrexate is administered concurrently, due to the possible enhancement of its toxicity as naproxen, like other NSAIDs, has been reported to reduce tubular secretion of methotrexate in an animal model.
  • The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class.
  • NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels when co-administered with cardiac glycosides..
  • As with all NSAIDs, caution is advised when ciclosporin is co-administered because of the increased risk of nephrotoxicity.
  • NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
  • As with all NSAIDs, caution should be taken when co-administering with corticosteroids because of the increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
  • Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).
  • Acetylsalicylic acid: Clinical pharmacodynamic data suggest that concomitant naproxen usage for more than one day consecutively may inhibit the effect of low-dose acetylsalicylic acid on platelet activity and this inhibition may persist for up to several days after stopping naproxen therapy. The clinical relevance of this interaction is not known.
  • Diuretics: NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
  • Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4).
  • 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.
  • Anti-platelet agents and selective serotonin reuptake inhibitors (SSRls): 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
  • There is evidence of an increased risk of haem arthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen
  • Bisphosphonates: concomitant use of bisphosphonates and NSAIDs may increase the risk of gastric mucosal damage.
  • Colestyramine: colestyramine delays the absorption of naproxen. Naproxen should be taken at least one hour before or four to six hours after colestyramine.
  • Fertility, 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 of cardiac malformation 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 organogenetic period. During the first and second trimester of pregnancy, naproxen should not be given unless clearly necessary. If naproxen 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 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-hydramniosis; 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 uterine contractions resulting in delayed or prolonged labour. Consequently naproxen is contraindicated during the last trimester of pregnancy.

Lactation

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

Fertility

See section 4.4 for use 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
System Organ Class Common

(≥ 1/100 < 1/10)

Uncommon

(≥ 1/1000 < 1/100)

Rare

(≥ 1/10,000 < 1/1000)

Very Rare

(< 1/10,00)

Frequency not known (cannot be estimated from the available data)
Blood and lymphatic system disorders haemolytic anaemia granulo-cyctopenia, thrombo-cytopenia, agranulocytosis aplastic anaemia, neutropenia
Immune system disorders allergic and hyper-sensitivity reactions, anaphylaxis
Endocrine disorders
Metabolism and nutrition disorders hyperkalaemia
Psychiatric disorders depression, cognitive dysfunction, insomnia, loss of concentration, abnormal dreams hallucinations
Nervous system disorders confusion, dizziness, drowsiness, headache convulsions, aseptic meningitis* vertigo, paraesthesia, malaise, exacerbation of Parkinson’s disease
Eye disorders visual disturbances optic neuritis, papilloedema
Ear and labyrinth disorders tinnitus hearing impairment
Cardiac disorders palpitations cardiac failure
Vascular disorders vasculitis arterial thrombotic events e.g. myocardial infarction or stroke(see 4.4) hypertension
Respiratory, thoracic and mediastinal disorders aggravated asthma, eosinophilic pneumontitis bronchospasm, dyspnoea, rhinitis, pulmonary oedema
Gastro-intestinal disorders pancreatitis thirst, peptic ulcers, perforation or GI bleeding**, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4), gastritis
Hepatobiliary hepatitis (sometimes fatal), jaundice abnormal liver function,
Skin and subcutaneous tissue disorders rash, pruritis, purpura urticaria, photo- sensitivity alopecia, pseudo-porphyria erythema multiforme, Stevens Johnsons syndrome, toxic epidermal necrosis, epidermolysis bullosa angio-oedema, epidermal necrosis, exfoliative and bullous dermatoses, lichen planus
Musculo-skeletal and connective tissue disorders myalgia, muscle weakness
Renal and urinary disorders glomerular nephritis, haematuria, interstitial nephritis, nephritic syndrome, renal papillary necrosis renal failure, nephropathy, increase in serum creatinine
Reproductive system and breast disorders impaired female fertility (see 4.4)
General disorders and administration site complications fatigue mild peripheral oedema, pyrexia

*especially in patients with existing auto-immune disorders, such as system lupus erythematosus, mixed connective tissue disease, with symptoms such as stiff neck headache, nausea, vomiting, fever and disorientation.

** sometimes fatal, particularly in the elderly, may occur (See section 4.4).

Clinical trial and epidemiological data suggests 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 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

Symptoms

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

Treatment

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 patient’s clinical condition.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, nonsteroids.Propionic acid derivatives.

Naproxen is a non-steroidal anti-inflammatory agent.

Mechanism of action

Naproxen reduces the synthesis of prostaglandins primarily by inhibiting the enzyme cyclo-oxygenase. Naproxen has been shown to have anti-inflammatory activity in a number of experimental models. Naproxen inhibits prostaglandin E2 synthesis in vitro by human rheumatoid synovial microsomes. It also inhibits prostaglandin E2 production by phytohaemagglutin-stimulated peripheral blood mononuclear cells. At 10-4 M (23mg.1-1) naproxen inhibits neutral protease activity derived from human polymorphonuclear leucocytes. Naproxen also inhibits in vitro the activity of cathepsin-β and other hydrolytic enzymes derived from lysosomes. Naproxen is a potent in inhibitor of leucocyte migration and produces effects comparable to those of colchicine.

  • Pharmacokinetic properties

Absorption

Naproxen is readily absorbed from the gastrointestinal tract.

Distribution

Peak plasma concentrations are attained 2-4 hours after ingestion. Plasma concentrations of naproxen increase proportionally with dose up to about 500mg daily; at higher doses there is an increase in clearance caused by saturation of plasma proteins. At therapeutic concentrations naproxen is more than 99% bound to plasma proteins and has a plasma half-life of about 13 hours.

Elimination

Approximately 95% of a dose is excreted in urine as naproxen and 6-O-desmethylnaproxen and their conjugates. Less than 3% of a dose has been recovered in the faeces. Naproxen crosses the placenta and is excreted in breast milk.

  • Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

  1. Pharmaceutical particulars
  • List of excipients

Also contains: lactose, magnesium stearate, maize starch, polyvidone,

  • Incompatibilities

Not applicable.

  • Shelf life

Shelf-life

3 years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

  • Special precautions for storage

Store below 25°C in a dry place. Protect from light.

  • Nature and contents of container

The product may also be supplied in blister packs and cartons:

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

No special requirements.

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

Naproxen Tablets BP 250mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 only. 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 or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Naproxen Tablets are and what they are used for
  2. What you need to know before you take Naproxen Tablets
  3. How to take Naproxen Tablets
  4. Possible side effects
  5. How to store Naproxen Tablets
  6. Contents of the pack and other information
  7. What Naproxen Tablets are and what they are used for

Naproxen Tablets contain a medicine called naproxen. This is a ‘Non Steroidal Anti Inflammatory Drug’ or NSAID.

Naproxen Tablets can lessen pain, swelling, redness and heat (inflammation) and is used to treat adults for:

  • Problems with your muscles, joints and tendons, like strains, gout, ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis.
  • Women, while having period pain. It can also be used in children over 5 years with rheumatoid arthritis.
  1. What you need to know before you take Naproxen Tablets

DO NOT take Naproxen Tablets

  • if you are allergic (hypersensitive) to naproxen or any of the other ingredients of Naproxen Tablets (listed in section 6)
  • if you are allergic to or have ever had a reaction to aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen, diclofenac or meloxicam
  • if you have a stomach ulcer or if you often get stomach ulcers
  • if you have a duodenal ulcer (in the first part of the small intestine) or if you often get duodenal ulcers
  • if you have serious liver or kidney disease
  • if you are suffering or have ever suffered from bleeding in the stomach or intestines while taking NSAIDs
  • if you are more than 6 months pregnant or if you are breast-feeding (see section 2
  • “Pregnancy and breast-feeding”)
  • if you have severe heart failure.

Do not take Naproxen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Naproxen Tablets if you:

  • have heart problems, have previously had a stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker)
  • have problems with how your blood clots
  • have ever had asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.
  • A feeling of weakness (perhaps because of an illness) or you are an older person.
  • Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis).
  • Problems with the blood vessels (arteries) anywhere in your body. suffer from localized swelling, high blood pressure or heart failure
  • have too much fat (lipid) in your blood (hyperlipidaemia)
  • have problems with your kidneys or liver
  • have an autoimmune condition, such as
  • ‘systemic lupus erythematosus’ that causes joint pain, skin rashes and fever
  • have colitis or Crohn’s disease, the symptoms are inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss.

Naproxen may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems getting pregnant. Tell your doctor, who will decide what to do (see section 2 “Pregnancy and breast-feeding”).

If you are elderly you may have an increased risk of side effects. Tell your doctor immediately if you suffer with any unusual symptoms of the stomach or bowel.

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen Tablets.

Other medicines and Naproxen Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

  • other pain killers, like aspirin, ibuprofen, diclofenac and paracetamol
  • medicines that prevent blood clotting such as aspirin/acetylsalicylic acid, warfarin, heparin, clopidogrel or ticlopidine.
  • diuretics (water tablets) such as furosemide
  • medicines to treat high blood pressure such as propranolol, enalapril, cilazapril
  • a ‘cardiac glycoside’ used to treat heart problems, such as digoxin
  • a steroid used to treat swelling and inflammation, like hydrocortisone,
  • prednisolone and dexamethasone
  • probenecid, a medicine to treat gout
  • certain medicines used to treat mental illness, such as lithium
  • selective serotonin reuptake inhibitors such as Fluoxetine or Citalopram
  • medicines used to treat epilepsy, such as phenytoin and hydantoin
  • sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and sulfonamide antibiotics used to treat infections
  • a ‘quinolone antibiotic’ used to treat infections, such as ciprofloxacin or moxifloxacin
  • A sulfonylurea (for diabetes), like glimepiride or glipizide
  • An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan.
  • ciclosporin or tacrolimus, medicines used to prevent transplant rejection after surgery
  • methotrexate, a medicine used to treat skin conditions, rheumatoid arthritis and cancer
  • colestyramine, a medicine used to reduce cholesterol
  • zidovudine, a medicine used to treat AIDS and HIV infections
  • mifepristone, a medicine used to end pregnancy or to bring on labour if the baby has died.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen Tablets. Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.

It may still be all right for you to take Naproxen tablets and your doctor will be able to decide what is suitable for you.

Pregnancy, breast-feeding and fertility

  • Do not take Naproxen if you are in the last three months of pregnancy, as it can harm your baby.
  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Naproxen may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Naproxen may make you tired, drowsy, dizzy, have problems with your eyesight and balance, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Naproxen Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. How to take Naproxen Tablets

Always take Naproxen Tablets exactly as your doctor has told you. Medicines such as Naproxen Tablets may be linked with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses and long term treatment. Do not take more than the recommended dose or exceed the length of the treatment. Check with your doctor or pharmacist if you are not sure.

Method of administration:

Naproxen Tablets should be swallowed whole with a glass of water, with or after food. Take your tablets at the same time each day.

You should make sure that you have enough to drink (stay well hydrated) when you are taking Naproxen.

This is particularly important for people who have problems with their kidneys.

While you are taking Naproxen Tablets your doctor will want to see you to check you are on the right dose for you and look for any side effects. This is particularly important if you are elderly.

Arthritis and ankylosing spondylitis

The usual dose is between 500mg and 1000mg.

The dose can be taken all at once, or half the dose may be taken twice a day. Gout The usual starting dose is 750mg, followed by one 250mg tablet every 8 hours as needed.

Elderly and patients with liver and kidney problems

The doctor will decide the right dose for you; it will usually be lower than for other adults.

Children over 5 years, rheumatoid arthritis

The usual dose is 10mg per kilogram of body weight each day.

The total daily dose is split into two doses, to be given 12 hours apart.

If you take more Naproxen Tablets than you should

If you take too many Naproxen Tablets, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Naproxen Tablets

If you have missed a dose, continue in accordance with your doctor’s prescription. Never take a double dose of Naproxen Tablets to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, Naproxen Tablets can cause side effects, although not everybody gets them.

Medicines such as Naproxen may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke

Serious side effects:

Stop taking Naproxen and tell your doctor straight away if any of the following side effects happen. You may need urgent medical treatment:

Allergic reactions, signs include:

  • sudden swelling of your throat, face, hands or feet
  • difficulty breathing, tightness in your chest
  • rashes, blisters or itching.
  • Serious stomach or gut problems, signs include:
  • bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds
  • bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea
  • ulcers or holes forming in your stomach or gut, seen as upset stomach, stomach pain, fever, feeling or being sick
  • problems with your pancreas, seen as severe stomach pain which spreads to your back
  • worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea, vomiting and weight loss.
  • Severe skin rashes, signs include:
  • a severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes. Fever, headache, cough and aching body may happen at the same time
  • blistering of skin when exposed to sunlight (porphyria cutanea tarda) seen most on arms, face and hands.

Liver problems, signs include:

  • yellowing of your skin or the whites of your eyes (jaundice)
  • feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems, shown in blood tests.

Heart attack, signs include:

  • chest pain which may spread to your neck and shoulders and down your left arm.
  • Stroke, signs include:
  • muscle weakness and numbness, which may only be on one side of your body
  • a sudden altered sense of smell, taste, hearing, vision or confusion.

Meningitis, signs include:

  • fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion. Most likely in people with autoimmune conditions such as ‘systemic lupus erythematosus.’

If you notice any of the serious side effects mentioned above, stop taking Naproxen and tell your doctor straight away.

Other possible side effects:

  • heartburn, indigestion, constipation, gaseous bowels
  • blood problems, like anaemia or changes to the numbers of white blood cells
  • high levels of blood potassium which can cause abnormal heart rhythm
  • difficulty sleeping or changes in your patterns of dreaming
  • depression
  • confusion or seeing and possibly hearing things that are not there (hallucinations)
  • headache
  • fits or seizures, feeling dizzy, light-headed or sleepy
  • pins and needles or numbness of your hands and feet
  • difficulty with your memory or concentration
  • changes to your eyesight, eye pain
  • changes to your hearing, including ringing in the ears (tinnitus) and hearing loss
  • dizziness that causes problems with your balance
  • Swelling of your hands, feet or legs (oedema), this may be with chest pains, tiredness, shortness of breath (cardiac failure).
  • a fluttering feeling in your heart (palpitations), slow heart beat or high blood pressure
  • problems with the way your heart pumps blood around the body or
  • damage to your blood vessels. Signs may include tiredness, shortness of
  • breath, feeling faint, general pain
  • pneumonia or swelling of your lungs bruising, itching, sweating, skin being more sensitive to the sun or hair loss
  • blood in your urine or kidney problems
  • thirst, fever, feeling tired or generally unwell
  • a sore mouth or mouth ulcers
  • muscle pain or weakness
  • problems for women in getting pregnant
  • ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, problems with your kidneys and joint pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. How to store Naproxen Tablets

Keep this medicine out of the sight and reach of children

Do not use Naproxen Tablets after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last date of that month.

This medicinal product does not require any special storage conditions.

Do not use Naproxen Tablets if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.      Contents of the pack and other information

What Naproxen Tablets contain

  • The active substance in Naproxen 250mg and Naproxen 500mg Tablets is naproxen. Each Naproxen 250mg tablet contains 250mg (milligrams) of naproxen. Each Naproxen 500mg tablet contains 500 mg (milligrams) of naproxen.
  • The other ingredients are lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate and quinolone yellow

What Naproxen Tablets look like and contents of the pack

Naproxen Tablets are available in packs of 28, 30, 56, 60, 84, 100, 250, 500 tablets.

Not all pack sizes 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

 

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.