AFLONEC-P Tablet

For relief from severe pain and inflammation in Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, Low back pain, Dental pain, Gynaecological pain and painful& Inflammatory conditions of ear, nose & throat.

Dosage and Method of administration

For oral administration in adults.

The maximum recommended dose is 2 tablets daily, taken a 1 tablet in the morning and 1 in the evening or as directed by the physician.

Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product.

Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm, acute rhinitis or urticaria or patients hypersensitive t to these drugs.

Patients with active or suspected peptic ulcer or gastrointestinal bleeding or bleeding disorders.

Patients with severe heart failure, hypertension, hepatic or renal insufficiency.

Most of the adverse events are minor and reversible with treatment discontinuation. The majority of side effects are related to gastrointestinal system (dyspepsia, abdominal pain, nausea and diarrhea), most frequent being dyspepsia, abdominal pain and rise in hepatic enzymes. Other rare side-effects include dizziness, constipation, vomiting, ulcerative stomatitis, rash, dermatitis, headache, fatigue, allergic reactions, anemia, granulocytopenia, thrombocytopenia, neutropenia, oedema, palpitation, leg cramps, flushing, purpura, paraesthesia, tremors, gastrointestinal bleeding, gastrointestinal ulceration, pancreatitis, interstitial nephritis, depression, abnormal dreaming, somnolence, insomnia, vasculitis, hypoglycemia, rise in blood urea, serum creatinine and serum potassium. As with other NSAIDs, severe mucocutaneous skin reactions may also occur with this medicine.

Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase the plasma concentrations of lithium, digoxin and methotrexate. If may increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when coadministered with quinolone antibiotics. Coadministration of Aceclofenac with other NSAIDs and corticosteroids are to be avoided due to increased incidence of side-effects.

The risk of Paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce hepatic microsomal enzymes.

Coadministration of Paracetamol with rifampicin, isoniazid, chloramphenicol, antiepileptic drugs and antiviral drugs is to be avoided. Metoclopramide may increase the absorption of Paracetamol whereas excretion and plasma concentration may be altered when coadministered with probenecid.

Cholestyramine also reduces the absorption of Paracetamol.

Pregnancy

Not recommended.

Lactation

Not recommended.

This medicine may cause dizziness. Driving or operating machinery is to be avoided.

Individuals receiving long-term treatment should be regularly monitored for renal function tests. Liver function tests and blood counts. It is to be used with caution in hepatic porphyria, coagulation disorders, history of peptic ulcers, ulcerative colitis, Crohn’s disease, SLE, cerebrovascular bleeding, pregnancy and lactation.

Caution should be exercised in patients with mild to moderate impairment of cardiac, hepatic or renal function and in elderly patients who are more likely to be suffering from these conditions.

Caution is also required in patients on diuretic therapy or otherwise at risk of hypovolemia.

Aceclofenac relieves pain and inflammation through a variety of mechanisms and in addition exerts stimulatory effects on cartilage matrix synthesis.

Anti-inflammatory activity: The anti-inflammatory effects on Aceclofenac have been shown in both acute and chronic inflammation. Stimulatory effects on cartilage matrix synthesis: Aceclofenac stimulates glycosaminoglycan synthesis in human osteoarthritic cartilage by inhibition of IL-1βand suppresses cartilage degeneration by inhibiting IL-1βmediated promatrix metalloproteinase production and proteoglycan release.

Paracetamol is a clinically proven analgesic and antipyretic agent with weak anti-inflammatory effect.

Analgesic action: The central analgesic action of Paracetamol resembles that of aspirin. It produces analgesia by raising pain threshold.

Antipyretic effect: The antipyretic effect of Paracetamol is attributed to its ability to inhibit COX in the brain where peroxide tone is low.

Recent evidence suggests inhibition of COX-3 (believed to be splice variant product of the COX-1 gene) could represent a primary central mechanism by which Paracetamol decreases pain and possibly fever.