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Acycor Plus

Reals Pharmaceuticals Limited
Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Email: reals@realsgroup.com
Tel: + 234-1-774-1205
Fax: +234-1-263-0919
Website: http://realsgroup.com

Brand Name

Acycor Plus

Manufacturer

Stallion LABORATORIES PVT. LTD. C-1B, 30512 & 3, G.I.D.C., Kerala (Bavla), Dist.: Ahmedabad

Therapeutic Class

Analgesics/Anti-inflammatory combinations, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: A4-9021): Each film coated tablet contains: Aceclofenac BP 100 mg, Paracetamol BP 500 mg Excipients Q.S.

Acycor Plus

Pack size: 10 X 1 X 10 Tablets in Alu Alu blister pack

Pharmacology

Analgesic (Non-opoid), antipyretic and non-steroidal anti-inflammatory drug

Indications

ACYCOR 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 & throat.

Contra-indications

ACYCOR PLUS is contraindicated in the following situations:

- 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

Precautions/Warnings

ACYCOR PLUS may cause dizziness. Driving or operating machineries 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 n 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.

Interactions

Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase the plasma concentrations of lithium, digoxin and methotrexate. It may increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nehrotoxicity 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 heatotoxic drugs or drugs that induce hepatic microsomal enzymes.

Coadministration 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 coadministered with probenecid. Cholestyramine also reduces the absorption of Paracetamol.

PREGNANCY & LACTATION

Pregnancy: The drug in not recommended in pregnant women.

Lactation: The drug in not recommended in breast-feeding women.

Adverse Effects

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 diarrheal, 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 ACYCOR PLUS.

Dosage & Administration

ACYCOR PLUS tablets are supplied for oral administration in adults. The maximum recommended dose of ACYCOR PLUS is two tablets daily, taken as one tablet in the morning and one in the evening.

SYMPTOMS OF OVERDOSE & ANTIDOTE

Overdosage may cause nausea, vomiting, pain abdomen, 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.

Storage/Handling Recommendations

Store below 25oC

Review Date

2016-02-16 10:36:12