Aceclofenac and Paracetamol Tablets B.P. 100mg/325mg (Acetaj P)

Aceclofenac and Paracetamol Tablets 100mg/325mg (Acetaj P)
Aceclofenac and Paracetamol Tablets 100mg/500mg (Acetaj P)

1. Name of the medicinal product

Aceclofenac and Paracetamol Tablets BP 100mg/325mg (Acetaj P)
Aceclofenac and Paracetamol Tablets 100mg/500mg (Acetaj P)

2. Qualitative and quantitative composition

a) Aceclofenac and Paracetamol Tablets BP 100mg/325mg (Acetaj P)
Each film coated tablets contains
Aceclofenac BP 100mg
Paracetamol BP 325mg
Excipients: Q.S.
Colours: Titanium Dioxide USP

b) Aceclofenac and Paracetamol Tablets 100mg/500mg (Acetaj P)
Each film coated tablets contains
Aceclofenac BP 100mg
Paracetamol BP 500mg
Excipients: Q.S.
Colours: Titanium Dioxide B.P.

For a full list of excipients, see section 6.1.

6. Pharmaceutical form

Film-coated tablet

4. Clinical particulars

• Therapeutic indications

Acetaj- P film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

• Posology and method of administration

Acetaj- P film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.

To be taken preferably with or after food. When Acetaj- P was administered to fasting and fed healthy volunteers only the rate and not the extent of Acetaj- P absorption was affected.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

Adults

The recommended dose is 200mg daily, taken as two separate 100mg doses, one tablet in the morning and one in the evening.

Paediatric population

There are no clinical data on the use of Acetaj- P in children and therefore it is not recommended for use in children under 18 years of age.

Elderly

The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, 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.

The pharmacokinetics of Acetaj- P are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Renal insufficiency

There is no evidence that the dosage of Acetaj- P needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see Section 4.4).

Hepatic insufficiency

There is some evidence that the dose of Acetaj- P should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100mg be used.

Method of administration

Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.

• Contraindications

Hypersensitivity to Acetaj- P or to any of the excipients listed in section 6.1 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 (eg. Asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

Hepatic failure and renal failure (see section 4.4).

Patients with established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy. Active bleedings or bleeding disorders. Acetaj- P should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used (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).

The use of Acetaj- P 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 or recovering from major surgery, and the elderly. The importance of prostaglandins in maintaining renal blood flow should be taken into account in these patients.

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

Renal:

Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of Acetaj P.

Hepatic:

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Acetaj- P Tablets should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms.

Use of Acetaj- P in patients with hepatic porphyria may trigger an attack.

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. Patients with congestive heart failure ( NYHA-I) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Acetaj- P after careful consideration. As the cardiovascular risks of Acetaj- P may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re- evaluated periodically.

Acetaj- P should also be administered with caution and under close medical surveillance to patients with a history of cerebrovascular bleeding.

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.

Close medical surveillance is imperative in patients with symptoms indicative of gastro-intestinal disorders involving either the upper or lower gastrointestinal tract, with a history suggestive of gastro-intestinal ulceration, bleeding or perforation, with ulcerative colitis or with Crohn’s disease, or haematological abnormalities, as these conditions may be exacerbated (see section 4.8)

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 GI toxicity, particularly when 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 systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Acetaj P, the treatment should be withdrawn.

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

Exceptionally, varicella can trigger serious cutaneous and soft tissues infections complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Acetaj- P in case of varicella.

Hypersensitivity reactions:

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

Haematological:

Acetaj- P Tablets may reversibly inhibit platelet aggregation (see section 4.5 anticoagulants under ‘Interactions’).

Long-term treatment:

All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal, hepatic function (elevation of liver enzymes may occur) and blood counts.

• Interaction with other medicinal products and other forms of interaction

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

Anti-hypertensives: NSAIDs, may reduce the effect of activity antihypertensives. 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 ACE- inhibitors or 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: Acetaj P, like other NSAIDs, may inhibit the activity of diuretics. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored.

Cardiac glycosides like digoxin: NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and inhibit the renal clearance of glycosides, resulting in increased plasma glycoside levels. The combination should be avoided unless frequent monitoring of glycoside levels can be performed.

Lithium: Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of lithium. The combination should be avoided unless frequent monitoring of lithium can be performed.

Methotrexate: The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function. When combination therapy has to be used, the renal function should be monitored. Caution should be exercised if both an NSAID and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels, resulting in increased toxicity.

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). Close monitoring of patients on combined anti-coagulants and Acetaj- P Tablets therapy should be undertaken.

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 (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).

Ciclosporin, Tacrolimus: Administration of NSAID drugs together with ciclosporin or tacrolimus is thought to increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. During combination therapy it is therefore important to carefully monitor renal function.

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

Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents with influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Acetaj- P Tablets, consideration should be given to adjustment of the dosage of hypoglycaemic agents.

• Fertility,pregnancy and lactation

Pregnancy:

There is no information on the use of Acetaj- P during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of 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, Acetaj- P should not be given unless clearly necessary. If Acetaj- P is used by a women 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-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 uterine contractions resulting in delayed or prolonged labour Consequently, Acetaj- P is contraindicated during the third trimester of pregnancy (see section 4.3)

Lactation:

There is no information on the secretion of Acetaj- P to breast milk, there was however no notable transfer of radio labelled (14C) Acetaj- P to the milk of lactating rats.

The use of Acetaj- P Tablets should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus.

Fertility;

The use of Acetaj- P tablets 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 Acetaj- P tablets should be considered .

• Effects on ability to drive and use machines

Undesirable effects such as dizziness, vertigo, drowsiness, fatigue, visual disturbances or other central nervous system disorders are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

• Undesirable effects

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. Pancreatitis has been reported very rarely.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions 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, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and cerebrovascular:

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

Acetaj- P is both structurally related and metabolised to diclofenac for which a greater amount of clinical trial and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (for example myocardial infarction or stroke , particularly at high doses or in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of Acetaj- P (see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).

Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment

Other adverse reactions reported less commonly include:

Renal: interstitial nephritis

Neurological and special senses:

optic neuritis, reports of aseptic meningitis (especially in patients with existing auto-immune 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) , confusion, hallucinations, malaise, and drowsiness.

Haematological:

agranulocytosis, aplastic anaemia

Dermatological:

Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

If serious adverse reactions occur, Acetaj- P tablets should be withdrawn.

The following is a table of adverse reactions reported during clinical studies and after authorisation, grouped by System OrganClass and estimated frequencies. 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).

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.

4.9 Overdose

a) Symptoms

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

b) Therapeutic measure:

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Specific therapies such as, dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. 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. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Management of acute poisoning with oral Acetaj- P essentially consists of supportive and symptomatic measuresfor complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression.

5. Pharmacological properties

• Pharmacodynamic properties

Acetaj- P is a non-steroidal agent with marked anti-inflammatory and analgesic properties.

The mode of action of Acetaj- P is largely based on the inhibition to prostaglandin synthesis. Acetaj- P is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.

• Pharmacokinetic properties

After oral administration, Acetaj- P is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Acetaj- P penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L.

The mean plasma elimination half-life is around 4 hours. Acetaj- P is highly protein- bound (>99%). Acetaj- P circulates mainly as unchanged drug. 4′- hydroxyAcetaj- P is the main metabolite detected in plasma. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.

No changes in the pharmacokinetics of Acetaj- P have been detected in the elderly.

• Preclinical safety data

The results from preclinical studies conducted with Acetaj- P are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract.

No unexpected findings were recorded.
Acetaj- P was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.
Acetaj- P was not found to be carcinogenic in either the mouse or rat.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with Acetaj- P (10mg/kg/day) resulted in a series of morphological changes in some fetuses.

6. Pharmaceutical particulars
   • List of excipients

Core Tablet:

Cellulose microcrystalline, Croscarmellose sodium, Povidone K-30, Glyceryl palmitostearate

Tablet coating:

Hypromellose 15 cps, Macrogol 400, Titanium dioxide

• Incompatibilities

Not applicable

• Shelf life

4 years.

• Special precautions for storage

“Store below 25°C”.

• Nature and contents of container

Acetaj- P Tablets are 100mg/325mg and 100mg/500mg are packed in aluminium -aluminium PVC packs.

Pack size: 10X10 Tablets

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local 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

Aceclofenac and Paracetamol Tablets B.P. 100/325mg (Acetaj P) Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Acetaj P

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 , pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Acetaj P Tablets is and what it is used for

Acetaj P Tablets belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

They have anti-inflammatory and painkiller properties causing a lowering of swelling, redness (inflammation) and pain. The medicine/active ingredient of Acetaj P Tablets is Acetaj P.

Acetaj P Tablets works by blocking the production of hormone-like substances called prostaglandins.

Prostaglandins have many functions in the body including an important role in both the way the body responds to inflammation and also the reabsorption of calcium in some diseases of the bone. Acetaj P Tablets is used to relieve pain and reduce redness and swelling (inflammation) in patients suffering from:

• Arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
• Autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
• Arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).

2. What you need to know before you take Acetaj P Tablets

Do not take Acetaj P Tablets:

• If you are allergic to Acetaj P or any of the other ingredients of this medicine (listed in section 6). if you are allergic to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac).
• if you have taken aspirin or any other NSAIDs and experienced one of the following:
  • Asthma attack causing tightness in the chest wheezing and difficulty breathing.
  • Runny nose, itching and/or sneezing (irritation of the nose).
  • Raised red circular patchy rash on the skin which may have felt itchy or like a sting or burn .
  • A severe allergic reaction known as anaphylactic shock. The symptoms may be life threatening and include difficulty breathing, wheezing, abdominal pain and vomiting.
• If you have a history of, suffer from, or suspect that you have a stomach ulcer or have vomited blood or passed blood in your faeces (black tarry stools).
• If you have severe kidney disease.
• If you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.
• If you have or have had problems with your blood circulation (peripheral arterial disease).
• If you suffer from, or suspect that you have severe liver failure.
• If you suffer from bleeding or any type of blood clotting disorders.
• If you are pregnant (unless your doctor considers it essential for you to continue to take this medicine) Acetaj P Tablets is not recommended for use in children.

Warnings and precautions:

Before you start taking Acetaj P Tablets, tell your doctor:

• if you suffer from any other form of kidney or liver disease.
• if you have any of the following disorders, as they may worsen:
  • Disorders of the stomach or gut/bowel
  • inflammatory bowel disease (ulcerative colitis)
  • chronic inflammatory bowel disease (Crohn’s disease)
  • ulceration, bleeding or perforation of the stomach or bowel
• if you have, or have ever had problems with the circulation of the blood to your brain.
• if you suffer from asthma or any other breathing problems.
• if you suffer from a rare inherited disorder known as porphyria.
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised cholesterol or other raised body fats such as triglycerides
• if you suffer from an autoimmune condition known as systemic lupus erythematosus or other connective tissue disorders.
• if you are infected with chicken pox, the use of this medicine should be avoided because a rare serious infection of the skin may develop.
• if you are recovering from major surgery.
• if you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration).

Hypersensitivity reactions can occur and very rarely, very serious allergic reactions are appearing (see section 4. Possible side effects). The risk is higher in the first month of treatment. Acetaj P Tablets should be stopped immediately at the first onset of symptoms such as tightness of the chest, breathing difficulties, fever, skin rashes , soreness of the skin lining the mouth and other mucous membranes causing ulcers, or any signs of hypersensitivity.

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

Other medicines and Acetaj P Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Please tell your doctor if you are taking:

• medicines used to treat mental health problems like depression (selective serotonin-reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or manic depression (lithium)
• medicines used to treat heart failure and irregular heart beats (cardiac glycosides such as digoxin)
• medicines used to treat high blood pressure (antihypertensives: ACE inhibitors such as enalopril, lisinopril; angiotensin II receptor antagonists such as losartan, candesartan; also hydralazine, methyldopa, clonidine, moxonidine, propranalol)
• medicines to treat infection (quinolone antibiotics such as ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
• drugs used to increase the rate of urine excretion (diuretics such as thiazides,furosemide amiloride hydrochloride)
• medicines that stop blood clotting (anticoagulants) such as warfarin, heparin
• methotrexate which is used to treat cancer and autoimmune disorders such as arthritis and skin conditions
• mifepristone
• any steroids for the treatment of swelling and inflammation (glucocorticoids such as hydrocortisone, prednisolone,)
• medicines used to suppress the immune system after organ transplant (ciclosporin or tacrolimus)
• medicines used to treat HIV (zidovudine)
• medicines used to lower blood sugar levels in diabetes (antidiabetics such as glibenclamide, glicazide, tolbutamide)
• any other painkiller NSAID drugs (aspirin, ibuprofen, naproxen, COX-2 inhibitors such as celecoxib and etoricoxib)
• Antiplatelet drugs such as clopidogrel.

Acetaj P Tablets with food and drink

Acetaj P Tablets must be taken preferably with or after food.

Pregnancy,breast-feeding and fertility

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.

You should inform your doctor if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.

Do not take Acetaj P Tablets if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy is not known. It is not recommended for use in pregnancy unless considered essential by your doctor. (it must not be used during the last three months of pregnancy). Acetaj P Tablets should not be used if you are breast-feeding. It is not known if this medicine passes into breast milk. It is not recommended for use during breast-feeding unless considered essential by your doctor.

Driving and using machines:

If you are taking Acetaj P Tablets and you experience dizziness, drowsiness, vertigo, tiredness or any difficulty with your eyesight, you must not drive or use machinery.

3. How to take Acetaj P Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults is 200mg a day. One 100mg tablet should be taken in the morning and one in the evening.

Children:

Acetaj P Tablet is not recommended for use in children under the age of 18.
Tablets should be swallowed whole with plenty of water and should be taken with or after food.
Do not crush or chew the tablets.
Do not exceed the stated daily dose.

Elderly

If you are elderly, you are more likely to experience serious side effects (listed in section 4 ‘Possible Side Effects). If your doctor prescribes Acetaj P Tablets for you, you will be given the lowest effective dose over the shortest duration of treatment.

Method and route of administration:

Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.

If you take more Acetaj P Tablets than you should

If you accidentally take too many Acetaj P Tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Acetaj P Tablets came in, with you to the hospital so that they will know what you have taken.

If you forget to take Acetaj P Tablets

If you miss a dose, do not worry, just take the next dose at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Acetaj P Tablets

Do not stop taking Acetaj P Tablets unless your doctor advise you.
If you have any further questions on the use of this medicine, ask your doctor ,pharmacist or nurse.

4. Possible side effects

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

Stop taking the medicine and seek medical advice IMMEDIATELY, If you experience any of the following side effects,

• Severe allergic reaction (anaphylactic shock). Symptoms may develop quickly and can be lifethreatening if not immediately treated and include fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat.
• Severe skin rashes such as Stevens-Johnnson Syndrome and Toxic Epidermal Necrolysis. These are potentially life-threatening and develop quickly forming large blisters and the skin to peel away. The rash can also appear in the mouth, throat or eyes. Fever, headache and aching of the joints usually occur at the same time.
• The symptoms include high fever, headache, vomiting, blotchy red rashes, neck
• Stiffness, sensitivity and intolerance to light.
• Passing blood in your faeces (stools/motions).
• Passing black tarry stools. Vomit any blood or dark particles that look like coffee grounds.
• Kidney failure.

Stop taking the medicine and seek medical advice if you experience:

• indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
• blood disorders such as reduced production of blood cells, abnormal breakdown of red blood cells known as haemolytic anaemia, low content of iron in the blood, low level of white blood cells, low number of platelet cells, increased blood potassium levels which can irritate the blood vessels causing inflammation known as vasculitis. These disorders can cause you to feel extremely tired, breathless, aching of the joints and be prone to repeated infections and bruising.

If any of the below side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common (may affect up to 1 in 10 people):

• dizziness
• nausea (feeling sick)
• diarrhoea
• increased liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people):

• wind
• inflammation or irritation of the lining of the stomach
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• inflammation of the skin
• raised circular red itchy, stinging or burning patches on the skin (hives)
• increase in blood urea levels
• increase in blood creatinine levels

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

• hypersensitivity (allergic reaction)
• problems with eyesight
• heart failure
• high blood pressure shortness of breath
• bleeding from the stomach or bowel
• stomach or bowel ulceration

Very Rare ( may affect up to 1 in 10,000 people ):

• depression
• strange dreams
• inability to sleep
• tingling, pricking or numbness of skin
• uncontrollable shaking
• drowsiness
• headaches
• abnormal taste in the mouth
• sensation of spinning when standing still
• ringing in the ears
• heart pounding or racing hot flushes
• difficulty breathing
• high pitched noise when breathing
• inflammation of the mouth
• perforation of either the stomach, large intestine or bowel wall
• worsening of colitis and Crohn’s disease
• inflammation of the pancreas injury of the liver (including hepatitis)
• yellowing of the skin (jaundice)
• spontaneous bleeding into the skin (appears as a rash)
• nephrotic syndrome: a condition which indicates kidney damage and includes large amounts of protein in the urine, low blood albumin levels, high blood cholesterol levels and swelling of the legs, feet or ankles
• water retention and swelling
• tiredness
• leg cramps
• increased blood alkaline phosphatase levels
• weight gain
• Other side effects that have been reported with this type of drug (NSAIDs) are:
• hallucinations
• confusion
• blurred, partial or complete loss of vision
• painful movement of the eye
• worsening of asthma
• skin reaction to sunlight
• inflammation of the kidneys
• generally feeling unwell

Serious skin infections may occur in association with chickenpox.

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.

5. How to store Acetaj P Tablets

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the carton after (EXP). The expiry date refers to the last day of that month.
• Store below 25°C
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longeruse. These measures will help protect the environment.

6. Contents of the pack and other information

What Acetaj P Tablets contains The active substance is Aceclofenac and Paracetamol. Each tablet contains 100mg of Aceclofenac and paracetamol 500mg

The other ingredients (excipients) are:
Core tablet: Cellulose microcrystalline, Croscarmellose sodium, Povidone K-30, Glyceryl palmitostearate.
Film-coating: Hypromellose 15 cps, macrogol 400 and titanium dioxide
Pack size: 10X10  and packing type is Aluminium -Aluminium
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