Product Name & Strength: Epigesic Tablets (Orphenadrine Citrate 35 mg, Paracetamol 450 mg).
Indications (Approved Uses): Used for the treatment of tension headaches and occipital headaches associated with spasms of skeletal muscles in the head and neck region. It is also indicated for acute and traumatic conditions of the limbs and trunk, such as sprains, strains, whiplash injuries, acute torticollis, and prolapsed intervertebral disc.
Contraindications (Safety Warnings): Contraindicated in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, myasthenia gravis, oesophageal spasm, and pyloric or duodenal obstruction. Do not use if there is a hypersensitivity to paracetamol or orphenadrine citrate. Use with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, or cardiac arrhythmias. Paracetamol should be used with caution in patients with hepatic or renal dysfunction. This medication is not recommended for children under 12 years of age. Concomitant treatment with other medicines containing orphenadrine or paracetamol is not recommended. Concomitant use with alcohol or other central nervous system depressants should be avoided.
Side Effects (Adverse Reactions): Adverse effects are mainly due to the anti-cholinergic action of orphenadrine and 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. Less common reactions include sedation, skin rashes, and other allergic reactions. Very rare cases of aplastic anaemia have been reported with the use of orphenadrine. Paracetamol-related reports of dyspepsia, nausea, and allergic or haematological reactions are rare.
Nutritional Information (per tablet): Orphenadrine citrate 35 mg, Paracetamol D.C. 450 mg, pregelatinized starch, magnesium stearate, purified talc, colloidal silicon dioxide (Aerosil 200), microcrystalline cellulose.
Instructions for Use / Dosage: For oral administration. Adults should take 2 tablets three times daily. The elderly should be advised to take a reduced dosage. This medication is not recommended for children under 12 years of age.
Regulatory Information: NAFDAC Registration Number: A4-0008. Manufactured by: Egyptian International Pharmaceutical Industries Co. (EIPICO), Egypt.
