Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Orphenadrine hydrochloride
Teva UK Ltd
N04AB02
Orphenadrine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090200; GTIN: 5017007599364
If you have any further questions on the use of this product, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital: • an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported: Not Known: frequency cannot be estimated from the available data • dry mouth • blurred vision • difficulty in passing water • stomach problems • dizziness. • fast heart rate • nervousness • an abnormal feeling of well-being • difficulty sleeping. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. HOW TO STORE ORPHENADRINE KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Store away from moisture and heat. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. FURTHER INFORMATION WHAT ORPHENADRINE TABLETS CONTAIN: • The active substance is orphenadrine hydrochloride 50 mg. • The other ingredients are lactose, maize starch, talc (E553b), light kaolin (E559) and stearic acid (E570). The tablet coating contains: sucrose, opadry-oy-28-0200, quinoline yellow (E104), sunset yellow (E110), titanium dioxide (E171), sodium benz Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Orphenadrine Hydrochloride 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of orphenadrine hydrochloride. Excipients with known effect This product contains lactose, sucrose, and sunset yellow (E110) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellow, sugar-coated, round tablet with convex faces, coded 5X1 on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anticholinergic agent used to treat all forms of Parkinsonism including drug- induced (neuroleptic syndrome) extrapyramidal symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS and ELDERLY_: Initially 150mg per day in divided doses, if necessary increasing by 50mg every two or three days until maximal benefit is obtained. Optimal doses are usually as follows: Idiopathic and post encephalitic Parkinsonism - 250 to 300 mg daily in divided doses. Neuroleptic syndrome - 100 to 300 mg daily in divided doses. Maximal dose is 400mg daily in divided doses. The elderly may be more susceptible to side effect at doses which are clinically optimal. _Paediatric population _ A suitable dose has not been established. Method of administration To be taken orally. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with glaucoma, prostatic hypertrophy and tardive dyskinesia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use with caution in patients with micturition difficulties, in pregnancy, in the presence of cardiovascular disease and hepatic or renal impairment. Do not discontinue treatment abruptly. It is potentially liable to abuse because of its mood altering effects e.g. euphoria. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with rare hereditary problems of fructose intolerance or sucrase- isomaltase in Soma hati kamili