Composition
Each film coated tablet contains:
Thiocolchicoside 4mg
Aceclofenac BP 100 mg
Paracetamol IP 500 mg

Dosage Form
Tablets for oral use.

Product Description
Thiocolchicoside, a semi-synthetic derivative of the naturally occurring compound colchicoside with a relaxant effect on skeletal muscle, has been found to displace both [3H]gamma-amino butyric acid ([3H]GABA) and [3H]strychnine binding, suggesting an interaction with both GABA and strychnine-sensitive glycine receptors.
Aceclofenac is an orally administered phenylacetic acid derivative with effects on a variety of inflammatory mediators. It is from the class of non-steroidal anti-inflammatory drug (NSAID), related to diclofenac. Through its analgesic and anti-inflammatory properties, aceclofenac provides symptomatic relief in a variety of painful conditions.
Paracetamol is a nonopiate, non-salicylate analgesic and antipyretic.

Pharmacology
Thiocolchicoside
Potent competitive antagonist of GABA function.
A muscle relaxant and displays anti-inflammatory and analgesic properties
Following oral administration, thiocolchicoside is well absorbed from the gastrointestinal tract.
It shows its effect in 1-2 hours after oral administration and peak plazma level is achieved in about 0.7 hours
Elimination half-life is about 2.5-5 hours. Its effect is continued for 24 hours.
Aceclofenac
Aceclofenac belongs to a group of Non Steroidal Anti-inflammatory Drugs (NSAIDs) used to treat various painful inflammatory conditions. Aceclofenac has an outstanding anti-inflammatory profile mediated primarily through inhibition of cyclooxygenase (COX) activity and suppression of PGE2 synthesis.

Paracetamol
Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center.
Paracetamol is equal to aspirin in analgesic and antipyretic effectiveness.

Indications
Painful spasm of
Musculoskelatal & Neuromuscular
Acute Low back pain, Post-operative, Sciatica and Neck & Shoulder Pain

Dosage
One Tablet Twice Daily

Contra Indications
• Hypersensitivity to Thiocolchicoside, Aceclofenac or Paracetamol or any component of the tablet.
• In patients in whom substances with a similar action (e.g. aspirin, or other NSAIDs), precipitate attacks of asthma, bronchospasm, acute rhinitis or urticaria or patients are hypersensitive to these drugs.
• Severe heart failure or severely impaired hepatic or renal organ function and during the last three months of pregnancy.

Warnings and Precautions
Drug Interactions
Drug interactions associated with Acepol T are similar to those observed with other NSAIDs.
Aceclofenac may increase plasma concentrations of lithium, digoxin and methotrexate, increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporin nephrotoxicity and precipitate convulsions when co-administered with quinolone antibiotics.
When concomitant administration with potassium sparing diuretics is employed, serum potassium should be monitored.
Furthermore, hypo or hyperglycaemia may result from the concomitant administration of aceclofenac and antidiabetic drugs, although this is rare. The co-administration of aceclofenac with other NSAIDs or corticosteroids may result in increased frequency of side effects.
Caution should be exercised if NSAIDs and methotrexate are administered within 2-4 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity.
Potential hepatotoxicity of Paracetamol may be increased by large doses or long-term administration of barbiturates, carbamazepine, hydantoins, isoniazid, rifampin and sulfinpyrazone.

Renal Impairment
Patients with mild 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.

Hepatic impairment
The recommended initial dose of Acepol T should be reduced to one tablet daily in patients with impaired hepatic function.

Pregnancy
The drug in not recommended in pregnant women.

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

Paediatric use
The most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth and pharyngitis, and most were mild to moderate in intensity.

Storage and Handling Instructions
Store in a cool dry place. Protect from light.

Packaging Information
Acepol-T is available in a strip of 10 tablets.
In a box of 10 x 10 strips.