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Therapeutic Category
- Muscle Relaxants & Cholinesterase Inhibitors
- Pharmaceutical Form : Tablets
- Composition : Paracetamol 450 mg + Orphenadrine citrate 35 mg / Tab
- Active Substance : Orphenadrine citrat+Paracetamol
Actions :
Medagesic is an analgesic and muscle relaxant .
Pharmacokinetics :
Orphenadrine is readily absorbed from the gastrointestinal tract and is almost completely metabolised to at least eight metabolites .
Orphenadrine and its metabolites are excreted from the body in the urine , with a half of 14 hours .
Paracetamol is also readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration.
Paracetamol is distributed into most body tissues . It has a halfe life of between 1 to 3 hours.
Indications :
Medagesic tablets are indicated for use as an analgesic/muscle relaxant for the treatment of mild to moderate pain and musculoskeletal spasm of voluntary muscle .
Appropriate use of Medagesic is for painful conditions , musculoskeletal spasm, sports muscle injuries and muscle contraction headaches .
Contraindications :
Bladder neck or prostate obstruction or hypertrophy , glaucoma , myasthenia , oesophageal spasm and pyloric or duodenal obstruction .
Hypersensitivity to paracetamol or orphenadrine citrate .
Warnings and Precautions :
Consult a doctor should pain persist or worsen or treatment with Medagesic exceeds more than 10 days
continuously .
Concomitant treatment with other medicines that contain Orphenadrine or Paracetamol is not recommended .
Caution is advised for patients with impaired kidney or liver function , or in patients with cardiac failure , coronary insufficiency , cardiac arrhythmias and tachycardia .
Effects on ability to drive and operate machinery
Caution should be advised if blurred vision , drowsiness or dizziness occurs as this may affect ability to drive or use machinery .
Pregnancy and lactation
Use in Pregnancy
Medagesic is not recommended for use during pregnancy .
Use in Lactation :
It is unknown whether Orphenadrine is excreted during lactation .
However it is established that Paracetamol is excreted into the breast milk , one to two hours after oral
administration .
Adverse Effects :
Adverse effects are mainly due to the mild anti-cholinergic action of Orphenadrine and are usually associated with higher doses .
The known adverse effects include; dryness of the mouth, tachycardia , palpitation , urinary Hesitancy or retention, blurred vision, dilation of the pupils , increased ocular tension, Weakness, nausea, headache, dizziness, constipation
and drowsiness. These effects can usually be eliminated by reducing the dose .
Drug interactions :
Patients taking tricyclic antidepressants and alcohol may have diminished ability to metabolise large doses of Paracetamol .
Dosage and Administration :
Adults : Two tablets , three or four times daily .
Children :Medagesic is not recommended for children under 12 years of age .
Elderly :The elderly should be advised to take a reduced dosage as they may be more susceptible to anti-cholinergic side effects at regular doses .
Storage :
Store in a dry pleace at temperature below 25ºC
Packing :
Box containg 20 Tablet