Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
orphenadrine citrate, Quantity: 100 mg
iNova Pharmaceuticals (Australia) Pty Ltd
Tablet, modified release
Excipient Ingredients: ethylcellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica
Oral
100 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: White, round biconvex tablet. Markings N/X on one side and no markings on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-07-04
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 children younger than Pročitajte cijeli dokument
1 AUSTRALIAN PRODUCT INFORMATION – NORFLEX (ORPHENADRINE CITRATE) SLOW RELEASE TABLETS 1 NAME OF THE MEDICINE Orphenadrine citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NORFLEX slow release (modified release) tablets contain orphenadrine citrate 100 mg. Excipients with known effect: • Sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Slow release (modified release) tablet, 100 mg: White, round, biconvex tablet. Markings N/X on one side and no markings on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Relief of painful muscle spasm associated with fibrositis, whiplash injuries, torticollis, prolapsed intervertebral disc, strains, sprains and similar conditions. Norflex has also been shown to be of value in tension headache and persistent hiccup. 4.2 D OSE AND METHOD OF ADMINISTRATION 100mg twice daily. In severe cases, dosage may be increased to 300mg in any 24 hour period. 4.3 C ONTRAINDICATIONS 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. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE 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 THE ELDERLY No data available. 2 PAEDIATRIC USE No data available. EFFECTS ON LABORATORY TESTS No data available. 4.5 I NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS Interactions have been reported between orphenadrine and phenothiazines and other drugs with anti-muscarinic properties. Concomitant use with alcohol or other CNS depressants should be avoided. 4.6 F ERTILITY , PREGNANCY AND LACTATION EFFECTS ON FERTILITY No data availa Pročitajte cijeli dokument