Aceclofenac (100 mg) and Paracetamol (500 mg) Tablets 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 & throat.
The recommended dose ofAceclofenac (100 mg) and Paracetamol (500 mg) Tablets is 1 tablet twice daily. Generally, no dose adjustment is necessary in elderly patients and those with mild renal impairment. Safety and efficacy has not been established in children.
Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets.
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:
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 occur.
Aceclofenac (100 mg) and Paracetamol (500 mg) Tablets 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.
Do not exceed the recommended dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
Store below 30°C temperature and protect from light.
Keep the medicine out of reach of children.
Alu/Alu-blister packs.
Zsac-P is available in a Alu/Alu-blister of 10 tablets. Such 10 blisters in a unit carton with package insert.
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Conical Pharmaceuticals is a professionally managed and dynamic organization with decades of experience in the pharmaceutical field. With a desire of providing opportunities for a better life, we work very hard to bring quality drugs to our customers. We have instilled a level of trust and confidence amongst our clients by supplying the best quality products.