Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Orphenadrine citrate
iNova Pharmaceuticals Australia Pty Ltd
Medicine Registered
NORFLEX™ _Orphenadrine citrate 100mg tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NORFLEX tablets. However it does not contain all the available information. Your doctor and pharmacist have more information about this medicine. IF YOU HAVE ANY QUESTIONS ABOUT NORFLEX THAT ARE NOT ANSWERED BY THIS LEAFLET, PLEASE ASK YOUR DOCTOR OR PHARMACIST. All medicines have risks and benefits. Your doctor has weighed the risks of your taking NORFLEX against the benefits before prescribing it for you. IF YOU ARE WORRIED ABOUT TAKING THIS MEDICINE PLEASE TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE AS YOU MAY WANT TO READ IT AGAIN. WHAT NORFLEX IS USED FOR The name of your medicine is NORFLEX. It contains orphenadrine citrate. Orphenadrine citrate is a skeletal muscle relaxant. It acts in the central nervous system to produce its muscle relaxant effects. NORFLEX is used to help relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injury to your muscles. Your doctor may have prescribed NORFLEX for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE NORFLEX _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NORFLEX IF: • YOU HAVE HAD AN ALLERGIC REACTION TO ORPHENADRINE CITRATE OR OTHER SIMILAR MEDICINES, OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. • YOU HAVE ANY OF THE FOLLOWING: - GLAUCOMA (high pressure in the eye); - INTESTINAL BLOCKAGE, STOMACH ULCER OR OESOPHAGEAL DISEASE; - ENLARGED PROSTATE OR BLADDER OBSTRUCTION; - MYASTHENIA GRAVIS (a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing, and sometimes muscle weakness in the arms or legs). • AFTER THE EXPIRY DATE ON THE BOTTLE • IF THE PACKAGING SHOWS SIGNS OF TAMPERING DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF 12 YEARS. Safety and effectiveness in c Soma hati kamili
iapnorfx11108.doc PRODUCT INFORMATION NORFLEX COMPOSITION Each tablet contains orphenadrine citrate 100 mg. ACTIONS Skeletal muscle relaxant. INDICATIONS Relief of painful muscle spasm associated with fibrositis, whiplash injuries, torticollis, prolapsed intervertebral disc, strains, sprains and similar conditions. Has also been shown to be of value in tension headache and persistent hiccup. CONTRAINDICATIONS Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis. PRECAUTIONS Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias. Safety of continuous long-term therapy with orphenadrine has not been established. Therefore if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended. Use in Pregnancy: Category B2 ADVERSE REACTIONS Side effects rarely occur at the recommended dosage. Those encountered are associated with anticholinergic activity and may include nausea, dry mouth, blurring of vision. Rarely, rash or drowsiness may occur. These symptoms disappear rapidly with a reduction in dosage or cessation of medication. No toxic effects have been observed. iapnorfx11108.doc OVERDOSAGE Symptoms: Symptoms of orphenadrine overdosage are excitement, confusion, delirium leading to coma. Convulsions and tachycardia with dilated pupils and urinary retention may occur. Treatment: Gastric lavage should Soma hati kamili