Round, white uncoated tablet, bevel-edged, flat faces, 'HD' embossed and
scored on the same face.
Per tablet : Paracetamol 450 mg, Orphenadrine citrate 35 mg
Actions and Pharmacology
Paracetamol has analgesic and antipyretic actions. It may act by inhibiting
prostaglandin synthesis in the central nervous system and through a
peripheral action by blocking pain-impulse generation. The peripheral action
may also be due to inhibition of the synthesis or actions of other
substances which sensitize pain receptors to mechanical or chemical
stimulation. Its antipyretic property may be due to its action on the
hypothalamic heat-regulating center to produce peripheral vasodilation
resulting in increased blood flow through the skin, sweating and heat loss.
Orphenadrine may act on the central nervous system to depress
polysynaptic reflexes. Its skeletal muscle relaxant properties may be
related to its CNS depressant (sedative) or to its analgesic effects.
This medication is well absorbed after oral administration, metabolized
in the liver and excreted in the urine.
For the relief of mild to moderate pain of acute musculoskeletal disorders
and tension headache.
This medication should not be used in the following conditions :
• Patients with acute porphyria-aspirin-sensitive asthmatics
• Patients with conditions in which anticholinergic effects are undesirable
• This medication should be given with care to patients with hepatic or
renal function impairment, glaucoma, cardiac arrhythmias, coronary
insufficiency or peptic ulceration.
• Chronic use should be avoided, unless otherwise directed by physician.
• Safety for use during pregnancy and lactation has not been established.
• The usual precautions and contraindications associated with
antimuscarinics should be observed with orphenadrine.
Main Side/Adverse Effect
• Side-effects of this medication include dry mouth, mydriasis, cyclopegia,
urinary urgency, constipation and mental confusion.
• Other side-effects which occur rarely include blood dyscrasias, hepatitis,
hypersensitivity reactions such as skin rash, hives or
itching, increased intraocular pressure, tachycardia, CNS stimulation
usually manifested by restlessness, insomnia and
hallucinations, transient episodes of lightheadedness, dizziness or syncope.
This medication should not be used with the following drugs :
Hepatic enzyme-inducing agents such as barbiturates or other
anticonvulsants, general anaesthetics, CNS depressants, monoamine oxidase
(MAO) inhibitors, tricyclic antidepressants.
Clinical features : Nausea, vomiting or epigastric discomfort for the first
two days. Hepatic and renal failure may occur after 3 - 5 days. Other
symptoms include metabolic acidosis in severe poisoning, hypoglycaemia,
hypotension, sinus tachycardia, cardiac arrhythmias, coma, dry mouth,
disturbance of visual accomodation and micturition, tachycardia,
hyperthermia, dizziness, confusion, hallucinations, excitement, ataxia and
Treatment includes emesis or gastric lavage if appropriate. Activated
charcoal may interfere with absorption of the antidote, N-acetylcysteine. If
the 4 hour plasma paracetamol level exceeds 150 ug/ml, administer N-acetylcysteine
orally, 140 mg of 20 solution per kg as a loading dose, followed by 70 mg/kg
every 4 hours for 3 days (best given within 10 hours after ingestion).
Others include symptomatic and supportive treatment.
Dosage and Administration
Adult : Oral, 1 to 2 tablets three to four times daily up to a maximum of 8
tablets per day.
Children : Not recommended in children.
Note : The information given here is limited. For further information
consult your doctor or pharmacist.
Shelf-life : 3 years from the
date of manufacture.
Storage : Store below 25°C. Protect from light and moisture.
Presentation/Packing : Tablet x