ACENOL Plus Tablet
197, Muyibi Street, Olodi-Apapa, Lagos. 57B, Coker Road, Ilupeju, Lagos
Tel: 234-80-34731163, 234-1-7765232
Saga Laboratories Ltd. Survey No. 198/2 & 198/3, Chachrawadi Vasna., Ta. Sanand, Dist. Ahmedabad 382210, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Caplet (NRN: ) Aceclofenac BP 100 mg, Paracetamol BP 500 mg.
How to identify the product: ACENOL PLUS is a white oblong shaped caplets with a break-line on one side of the caplets.
Pack size: Blister Strips of 10x10 caplets; Blister Strips of 1x10 caplets
Aceclofenac: Aceclofenac relieve pain and inflammation through a variety of mechanism and in addition exerts stimulatory effects on cartilage matrix synthesis.
Paracetamol: Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandi synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
Aceclofenac: Aceclofenac is well absorbed from gastrointestinal tract and peak plasma concentrations (Cmax) are reached 1-3 hours after an oral dose. The drug is more than 99% bounds to plasma proteins and the volume of distribution (Vd) is approximately 25 liters. The presence of food reduces rate of absorption (increased Tmax) but not the extent of absorption (Cmax or AUC). In patients with knee pain and synovial fluid effusion, the plasma concentration of Aceclofenac was twice that in synovial fluid after multiple doses of the drug. Aceclofenac is metabolized mainly to 4’hydroxy-aceclofenac.
The drug is eliminated primarily through renal excretion with 70-80% of administered dose found in urine as glucoronides and rest being excreted in faeces. The plasma elimination half-life of Aceclofenac is approximately 4 hours.
Paracetamol: Paracetamol is readily absorbed from the gastro intestinal tract after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Paracetamol is metabolized predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.
Therapeutic indications ACENOL PLUS is indicated 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 and throat.
ACENOL PLUS is contraindicated in the following situation:
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 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.
Third trimester of pregnancy.
ACENOL PLUS may cause dizziness. Driving or operating machinery are 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.
Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase plasma concentration of lithium, digoxin and methotrexate. It may increase the activity of anticoagulants, inhibit activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when co-administered with quinolone antibiotics.
Co-administration 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 heatotoxic drugs or drugs that induce hepatic microsomal enzymes.
Co-administration of Paracetamol with rifampicin, isoniazid, chloramphenicol, antiepileptic drugs and antiviral drugs is to be avoided. Metoclopromide may increase the absorption of Paracetamol whereas excretion and plasma concentration may be altered when co-administered with probenecid. Cholestyramine also reduces the absorption of Paracetamol.
PREGNANCY AND LACTATION
Pregnancy The drug in not recommended for pregnant women
The drug in not recommended for breast-feeding women
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 diarrhoea), 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, agranulocytopenia, 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 ACENOL PLUS.
Dosage & Administration
ACENOL PLUS caplets are supplies for oral administration in adults.
The maximum recommended dose of ACENOL PLUS is two caplets daily, taken as one caplets in the morning and one in the evening.
Overdosage may cause nausea, vomiting, abdomen pain, dizziness, somnolence, headache, sweating, pancreatitis, hepatic failure and acute renal failure.
Treatment, if required includes gastric lavage, activated charcoal and other symptomatic measures as per medical advice.
Do not store above 25°C. Keep medicine out of reach of children