Ibuprofen Tablets USP 600mg Taj Pharma

  1. Name of the medicinal product

Ibuprofen Tablets USP 200mg Taj Pharma
Ibuprofen Tablets USP 400mg Taj Pharma
Ibuprofen Tablets USP 600mg Taj Pharma
Ibuprofen Tablets USP 800mg Taj Pharma

2. Qualitative and quantitative composition

a) Ibuprofen Tablets USP 200mg Taj Pharma
Each film coated tablet contains:
Ibuprofen USP 200mg
Excipients: Q.S.

b) Ibuprofen Tablets USP 400mg Taj Pharma
Each film coated tablet contains:
Ibuprofen USP 400mg
Excipients: Q.S.

c) Ibuprofen Tablets USP 600mg Taj Pharma
Each film coated tablet contains:
Ibuprofen USP 600mg
Excipients: Q.S.

d) Ibuprofen Tablets USP 800mg Taj Pharma
Each film coated tablet contains:
Ibuprofen USP 800mg
Excipients: Q.S.

Excipient with known effect: 26.67mg Lactose monohydrate

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film coated tablets

  1. Clinical particulars
    • Therapeutic indications

Ibuprofen is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.

In the treatment of non-articular rheumatic conditions, Ibuprofen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Ibuprofen can also be used in soft tissue injuries such as sprains and strains.

Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine headache.

  • Posology and method of administration

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

Adults and children over 12 years of age: The recommended dosage of Ibuprofen is 1200-1800mg daily in divided doses. Some patients can be maintained on 600-1200mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400mg in divided doses.

Children: The daily dosage of Ibuprofen is 20mg/kg of body weight in divided doses.

For young children, more suitable formulations are available.

In Juvenile Rheumatoid Arthritis, up to 40mg/kg of body weight daily in divided doses may be taken.

Not recommended for children weighing less than 7 kg.

Elderly: The elderly are at increased risk of 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. If renal or hepatic function is impaired, dosage should be assessed individually.

For oral administration. It is recommended that patients with sensitive stomachs take Ibuprofen with food. If taken shortly after eating, the onset of action of Ibuprofen may be delayed. To be taken preferably with or after food, with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

  • Contraindications

Ibuprofen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking Ibuprofen, aspirin or other NSAIDs.

Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.

Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4).

Ibuprofen is contraindicated during the last trimester of pregnancy (see section 4.6).

  • 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).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medication.

As with other NSAIDs, Ibuprofen may mask the signs of infection.

The use of Ibuprofen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding (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).

Paediatric population

There is a risk of renal impairment in dehydrated children and adolescents.

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime 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 requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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 Ibuprofen, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohn’s disease as these conditions may be exacerbated (see section 4.8).

Respiratory disorders and hypersensitivity reactions

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

Cardiac, renal and hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. For these patients, use the lowest effective dose, for the shortest possible duration and monitor renal function especially in long-term treated patients (see also section 4.3).

Ibuprofen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with Ibuprofen administration.

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 studies suggest that use of Ibuprofen, particularly at a high dose (2400mg/ day) may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke. Overall, epidemiological studies do not suggest that low dose Ibuprofen (e.g. ≤ 1200mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Ibuprofen after careful consideration and high doses (2400mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of Ibuprofen (2400mg/day) are required.

Renal effects

Caution should be used when initiating treatment with Ibuprofen in patients with considerable dehydration.

As with other NSAIDs, long-term administration of Ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependant reduction in prostaglandin formation and, secondarily, in renal blood flow, which may cause renal failure. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.

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 below and section 4.8).

Dermatological effects

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 of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Haematological effects

Ibuprofen, like other NSAIDs, can interfere with platelet aggregationand prolong bleeding time in normal subjects.

Aseptic meningitis

Aseptic meningitis has been observed on rare occasions in patients on Ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.

Impaired female fertility

The use of Ibuprofen 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 Ibuprofen should be considered.

  • Interaction with other medicinal products and other forms of interaction

Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients.

Antihypertensives, beta-blockers and diuretics: NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors, angiotensin-II receptor antagonists, beta-blockers and diuretics. Diuretics can also increase the risk of nephrotoxicity of NSAIDs.

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

Cholestyramine; The concomitant administration of Ibuprofen and cholestyramine may reduce the absorption of Ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.

Lithium: Decreased elimination of lithium.

Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: A decrease in the efficacy of the medicinal product can theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that coadministration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medicinal termination of pregnancy.

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

Aspirin (Acetylsalicylic acid): As with other products containing NSAIDs, concomitant administration of Ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that Ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of Ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional use (see section 5.1).

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

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, 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.

Sulfonylureas: NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare reports of hypoglycaemia in patients on sulfonylurea medications receiving Ibuprofen.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding with NSAIDs (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 haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and Ibuprofen.

Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.

Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.

CYP2C9 Inhibitors: Concomitant administration of Ibuprofen with CYP2C9 inhibitors may increase the exposure to Ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-Ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the Ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose Ibuprofen is administered with either voriconazole or fluconazole.

  • Pregnancy and lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses 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, Ibuprofen should not be given unless clearly necessary. If Ibuprofen is used by a woman attempting to conceive, or during the first or 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 the following:

  • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
  • Renal dysfunction, which may progress to renal failure with oligohydramnios.

At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to the following:

  • Possible prolongation of bleeding time
  • Inhibition of uterine contractions, which may result in delayed or prolonged labour.

Consequently, Ibuprofen is contraindicated during the third trimester of pregnancy.

Lactation

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

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, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

  • Undesirable effects

Gastrointestinal disorders: 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, gastrointestinal haemorrhage and exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following Ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.

Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens- Johnson syndrome and toxic epidermal necrolysis).

Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical studies suggest that use of Ibuprofen, particularly at high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4).

Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).

Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay.

Skin and subcutaneous tissue disorders: In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also “Infections and infestations”)

The following adverse reactions possibly related to Ibuprofen and displayed by MedDRA frequency convention and system organ classification. Frequency groupings are classified according to the subsequent conventions: very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

System organ class Frequency Adverse reaction
Infections and infestations Uncommon Rhinitis
Rare Meningitis aseptic (see section 4.4)
Blood and lymphatic system disorders Rare Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia , haemolytic anaemia
Immune system disorders Rare Anaphylactic reaction
Psychiatric disorders Uncommon Insomnia, anxiety
Rare Depression, confusional state
Nervous system disorders Common Headache, dizziness
Uncommon Paraesthesia, somnolence
Rare Optic neuritis
Eye disorders Uncommon Visual impairment
Rare Toxic optic neuropathy
Ear and labyrinth disorders Uncommon Hearing impaired , tinnitus, vertigo
Respiratory, thoracic and mediastinal disorders Uncommon Asthma, bronchospasm, dyspnoea
Gastrointestinal disorders Common Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage
Uncommon Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation
Very rare Pancreatitis
Not known Exacerbation of Colitis and Crohn´s disease
Hepatobiliary disorders Uncommon Hepatitis, jaundice, hepatic function abnormal
Very Rare Hepatic failure
Skin and subcutaneous tissue disorders Common Rash
Uncommon Urticaria, pruritus, purpura, angioedema, photosensitivity reaction
Very rare Severe forms of skin reactions ( e.g. Erythema multiforme, bullous reactions, including Stevens-Johnson syndrome,and toxic epidermal necrolysis)
Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Renal and urinary disorders Uncommon Nephrotoxity in various forms e.g.Tubulointerstitial nephritis, nephrotic syndrome and renal failure
General disorders and administration site conditions Common Fatigue
Rare Oedema
Cardiac disorders Very rare Cardiac failure, myocardial infarction (also see section 4.4)
Vascular disorders Very rare Hypertension

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

Toxicity

Signs and symptoms of toxicity have generally not been observed at doses below 100mg/kg in children or adults. However, supportive care may be needed in some cases. Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400mg/kg or greater.

Symptoms

Most patients who have ingested significant amounts of Ibuprofen will manifest symptoms within 4 to 6 hours. The most frequently reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsion, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been rarely reported. In serious poisoning metabolic acidosis may occur. Disorientation, excitation, fainting and cardiovascular toxicity, including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Large overdoses are generally well tolerated when no other drugs are being taken.

Therapeutic measures

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 classification: Anti-inflammatory and antirheumatic products, nonsteroidal; propionic acid derivatives.

Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activity. The drug’s therapeutic effects as an NSAID is thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis.

Experimental data suggest that Ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of Ibuprofen 400mg were taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of Ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional Ibuprofen use. (see section 4.5)

  • Pharmacokinetic properties

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hours after administration. The elimination half-life is approximately 2 hours.

Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged Ibuprofen, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete.

Ibuprofen is extensively bound to plasma proteins.

  • Preclinical safety data

Not applicable.

  1. Pharmaceutical particulars
    • List of excipients

Microcrystalline cellulose

Croscarmellose sodium

Lactose monohydrate

Colloidal anhydrous silica

Sodium laurilsulfate

Magnesium stearate

Extragranular excipients:

Opaspray white M-1-7111B*

Dry colour dispersion, white 06A28611**

*Opaspray white M-1-7111B comprises industrial methylated spirit, purified water, hypromellose 2910 and titanium dioxide

** or combination of Opaspray white M-1-7111B, hypromellose and talc

NB industrial methylated spirit and purified water are removed during the drying process

  • Incompatibilities

Not applicable.

  • Shelf life

PVC or PVC/PVDC blister packs: 36 months

  • Special precautions for storage

PVC or PVC/PVDC blister packs: Do not store above 25°C, store in the original package.

  • Nature and contents of container

Blister pack comprising of transparent polyvinyl chloride (PVC) with aluminium foil backing – pack size 60 or 100 tablets.

Blister pack comprising of transparent polyvinyl chloride (PVC) film coated on one face with polyvinylidene chloride (PVDC) with aluminium foil backing – pack size 60 or 100 tablets.

Not all pack sizes are 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

Ibuprofen Tablets USP 600mg Taj Pharma

PACKAGE LEAFLET IMPORTANT INFORMATION

Ibuprofen

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

  • Keep this leaflet as you may need to read it again
  • This leaflet provides a summary of the information currently available about Ibuprofen Tablets
  • For further information or advice ask your doctor or pharmacist
  • This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you
  • Tell your doctor or pharmacist if you experience any side effects

Leaflet Contents

  1. What are Ibuprofen Tablets & what are they used for?
  2. What should you know before taking Ibuprofen Tablets?
  3. How should you take Ibuprofen Tablets?
  4. Possible side effects of Ibuprofen Tablets.
  5. How should you store Ibuprofen Tablets?
  6. Further information about Ibuprofen Tablets.

1.      What are Ibuprofen Tablets & what are they used for?

Ibuprofen Tablets belongs to a group of medicines called anti-inflammatory pain killers. They can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine, ankylosing spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains. Ibuprofen Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

The active ingredient in Ibuprofen Tablets is Ibuprofen and each tablet contains either 400 or 600mg.

  1. What should you know before taking Ibuprofen Tablets?

If the answer to any of the following questions is ‘YES’ please tell your doctor or pharmacist

BEFORE taking any Ibuprofen Tablets:

  • Are you pregnant or planning to become pregnant, or are you breast-feeding? Ibuprofen tablets 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.
  • Are you sensitive (allergic) to any of the ingredients in the tablets? These are listed in Section 6.
  • Do you have, or have you previously had, a stomach ulcer or other gastric complaint?
  • Do not take Ibuprofen Tablets if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.
  • Do you have a condition which increases your tendency to bleeding?
  • Do you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking Ibuprofen, aspirin or other anti-inflammatory pain killers?
  • Do you suffer from swelling and irritation inside the nose?
  • Do you suffer from liver or kidney disease?
  • Do you suffer from heart disease?

Medicines such as Ibuprofen Tablets 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. You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Tablets if you:

  • have heart problems including heart failure , angina (chest pain) or you have had a heart attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries).
  • have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke , high blood pressure, diabetes, high cholesterol or are a smoker).
  • Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)?
  • Do you have chicken pox or shingles?
  • Have you been told by your doctor that you have an intolerance to some sugars?
  • Is your child dehydrated? As there is a risk of kidney damage in dehydrated children and adolescents.

Can you take Ibuprofen with other medicines? Some medicines that are anti-coagulants (i.e. thin

blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or

angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

  • diuretics (water tablets)
  • cardiac glycosides, such as digoxin, used to treat heart conditions
  • lithium
  • zidovudine (an anti-viral drug)
  • steroids (used in the treatment of inflammatory conditions)
  • methotrexate (used to treat certain cancers and rheumatoid arthritis)
  • medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen
  • down your immune response)
  • medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
  • antibiotics called quinolones such as ciprofloxacin
  • aminoglycosides (a type of antibiotic)
  • mifepristone
  • any other Ibuprofen, such as those you can buy without a prescription
  • any other anti-inflammatory pain killer, including aspirin
  • cholestyramine (a drug used to lower cholesterol)
  • medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
  • voriconazole or fluconazole (type of anti-fungal drugs)
  • gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with Ibuprofen).

Pregnancy and breast-feeding: The use of Ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in late (the last three months of) pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and Using Machines: Ibuprofen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

  1. How should you take Ibuprofen Tablets?

ALWAYS take Ibuprofen exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.

Take your Ibuprofen Tablets with or after food, with a glass of water. Ibuprofen Tablets should be swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in the mouth or irritation in the throat.

DOSAGE:

Adults and children over 12 years – The usual dosage is 600 to 1800mg spread throughout the day.

Your doctor may choose to increase this depending on what you are being treated for; but no more than 2400mg should be taken in one day.

Children – The usual daily dose is 20mg per kg of bodyweight each day, given in divided doses. Ibuprofen Tablets should NOT be taken by children weighing less than 7 kg. The 600mg tablets should not be given to children under the age of 12 years.

In cases of severe juvenile arthritis your doctor my increase the dosage up to 40mg/kg in divided doses.

You should avoid excessive use of painkillers. If you usually take painkillers , especially combinations of different painkillers , you may damage your kidneys, tell your doctor if you are already taking another painkiller before taking this medicine and your doctor will decide whether you should take this medicine. This risk may be increased if you are dehydrated.

If you take more Ibuprofen than you should

If you have taken more Ibuprofen than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

IF YOU FORGET TO TAKE YOUR IBUPROFEN TABLETS take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

  1. Possible side effects of Ibuprofen Tablets

As with all medicines, Ibuprofen Tablets may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.

STOP TAKING Ibuprofen Tablets and seek immediate medical help if you experience:

  • Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or intolerance to bright light.
  • Signs of intestinal bleeding such as
  • Passing blood in your faeces (stools/motions)
  • Passing black tarry stools
  • Vomiting any blood or dark particles that look like coffee grounds

TELL YOUR DOCTOR AND STOP TAKING IBUPROFEN TABLETS IF YOU EXPERIENCE:

  • Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
  • Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms of an allergic reaction).
  • Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
  • Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’ and ‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness)
  • A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Medicines such as Ibuprofen Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.

Medicines such as Ibuprofen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles

Blood disorders such as reduction in blood cells and platelet counts – the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with Ibuprofen. Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

Other side effects

Common (affects up to 1 in 10 people):

  • feeling dizzy or tired
  • diarrhoea, wind, constipation
  • Headache – if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

Uncommon (affects up to 1 in a 100 people):

  • feeling drowsy
  • feeling anxious
  • feeling a tingling sensation or ‘pins and needles’
  • difficulty sleeping
  • hives
  • skin becomes sensitive to light
  • hearing problems
  • sneezing, blocked, itchy or runny nose (rhinitis)
  • stomach or gut ulcer, hole in the wall of the digestive tract
  • inflammation of your stomach lining
  • ringing in ears (tinnitus)
  • sensation of spinning (vertigo)
  • mouth ulcers
  • Rare (affects up to 1 in a 1000 people):
  • feeling depressed or confused

Very rare (affects up to 1 in 10,000 people):

  • inflammation of the pancreas

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.

  1. How should you store Ibuprofen Tablets?

Your tablets should not be stored above 25° C. They should be kept in a safe place out of the reach and sight of children as your medicine could harm them.

They should be kept in their original packaging. Do NOT take Ibuprofen Tablets after the ‘use by’ date shown on the carton. If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist.

Only keep the tablets if your doctor tells you to.

  1. Further information about Ibuprofen Tablets

The active substance in Ibuprofen Tablets is Ibuprofen available as either a 400 or 600mg tablet. They are supplied in blister packs containing 60 tablets. Ibuprofen Tablets inactive ingredients: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, colloidal anhydrous, silica, sodium laurilsulfate, magnesium stearate, Opaspray white M-1-7111B (comprising hypromellose 2910 and titanium dioxide), dry colour dispersion, white 06A28611 (or a combination of Opaspray white M-1-7111B, hypromellose and talc).

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.