Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
orphenadrine citrate, Quantity: 35 mg; paracetamol, Quantity: 450 mg
iNova Pharmaceuticals (Australia) Pty Ltd
Orphenadrine citrate,Paracetamol
Tablet, uncoated
Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; Gelatin
Oral
8 (sample pack), 100, 24
Medicine Registered
(S4) Prescription Only Medicine
Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.
Visual Identification: white scored biconvex tablet marked "N/C" on one side and no markings on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2009-01-14
NORGESIC ® N O R G E S I C ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING NORGESIC? NORGESIC contains the active ingredients orphenadrine citrate and paracetamol. NORGESIC is used to treat tension headache and headaches caused by muscle spasms in the back of your head and neck. It also helps relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injury to your muscles. For more information, see Section 1. Why am I using NORGESIC? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NORGESIC? Do not use if you have ever had an allergic reaction to NORGESIC or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use NORGESIC? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NORGESIC and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE NORGESIC? The usual dose of NORGESIC in adults is two tablets three times a day. Your doctor will prescribe the correct dose for you. Follow instructions provided on the pack. More instructions can be found in Section 4. How do I use NORGESIC? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NORGESIC? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using NORGESIC. • Contact your doctor if you become pregnant while using NORGESIC. THINGS YOU SHOULD NOT DO • Do not give NORGESIC to anyone else even if they have the same condition as you. • Do not take NORGESIC to treat any other complaints unless your doctor tells you to. DRIVING OR USING MACHINES • Be careful driving or operating machinery until yo Les hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION – NORGESIC (ORPHENADRINE AND PARACETAMOL) TABLETS 1 NAME OF THE MEDICINE Orphenadrine and paracetamol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Orphenadrine citrate 35 mg and paracetamol 450 mg tablets. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet, uncoated White, scored, immediate release tablets marked N/C on one side and no markings on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc. 4.2 D OSE AND METHOD OF ADMINISTRATION 2 tablets three times daily. 4.3 C ONTRAINDICATIONS • Glaucoma • Prostatic hypertrophy or obstruction at the bladder neck, • Myasthenia gravis • Oesophageal spasm and pyloric or duodenal obstruction. • Hypersensitivity to paracetamol or orphenadrine citrate. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS Orphenadrine citrate should be used 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. 2 Concomitant treatment with other medicines that contain orphenadrine or paracetamol is not recommended. 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 The elderly should be advised to take a reduced dosage as they may be more susceptible to anti- cholinergic side effects at regular doses. PAEDIATRIC USE NORGESIC is not recommended for children under 12 years of age. EFFECTS ON LABORATORY TESTS 4.5 I NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS Interactions have been Les hele dokumentet