Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Tramadol hydrochloride 50mg; ;
AFT Pharmaceuticals Ltd
Tramadol hydrochloride 50 mg
50 mg
Capsule
Active: Tramadol hydrochloride 50mg Excipient: Croscarmellose sodium Erythrosine Gelatin Indigo carmine Iron oxide black Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode black S-1-27794 Titanium dioxide Water
Blister pack, PVC/PVdC/Al foil, 100 capsules
Prescription
Class C2 Controlled Drug
Perrigo API Ltd
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 100 capsules - 48 months unopened stored at or below 25°C
2001-12-06
1 New Zealand Consumer Medicine Information TRAMADOL HYDROCHLORIDE _TRAMADOL HYDROCHLORIDE 50 MG CAPSULES _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Tramadol Hydrochloride. This leaflet answers some common questions about Tramadol Hydrochloride. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Tramadol Hydrochloride against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT TRAMADOL HYDROCHLORIDE IS USED FOR Tramadol Hydrochloride is used to relieve moderate to severe pain and belongs to a group of medicines called analgesics (pain relievers). Your doctor may have prescribed Tramadol Hydrochloride for another reason. Ask your doctor if you have any questions about why Tramadol Hydrochloride has been prescribed for you. This medicine is available only with a doctor's prescription. Tramadol Hydrochloride is not normally addictive, although some cases have been reported. BEFORE YOU USE TRAMADOL HYDROCHLORIDE _ _ _WHEN YOU MUST NOT USE IT _ Do not use Tramadol Hydrochloride if you: are allergic to tramadol or other opioids or any of the other ingredients listed at the end of this leaflet; 2 have been drinking alcohol or taking other medicines that affect the nervous system such as hypnotics (used to relieve sleeplessness; e.g., nitrazepam), opioids (used to relieve moderate to severe pain; e.g., morphine and codeine) or psychotropic drugs (e.g., chlorpromazine; used to treat schizophrenia and severe anxiety); have had a head injury or feel faint from shock; have uncontrolled epilepsy or epilepsy not adequately controlled by treatment; are also taking drugs known as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), which are used to treat Lesen Sie das vollständige Dokument
1 of 14 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TRAMADOL 50MG CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg of tramadol hydrochloride. Chemical Structure: Chemical Name : (±) - cis-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)- cyclohexanol hydrochloride Molecular Formula : C 16 H 25 NO 2 .HCl Molecular Weight : 299.84 CAS Registry Number: 36282-47-0. Excipient with known effect: gelatin, methyl hydroxybenzoate, propyl hydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Green/Yellow coloured hard gelatin capsules, size 3 filled with homogeneous white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of moderate to severe pain. 2 of 14 4.2 DOSE AND METHOD OF ADMINISTRATION The dose of tramadol should be titrated to the severity of the pain and the clinical response of the individual patient. Tramadol is approved for use in adults, adolescents, and children over the age of 2 years. See the Paediatric Use section below for children aged between 2 and 12 years. For the treatment of moderate pain Tramadol 50 - 100 mg administered two or three times daily may be sufficient. Tramadol 50 mg may be adequate as the initial dose for moderate pain. For moderate to severe pain, 50 - 100 mg as needed for relief, every four to six hours may be administered. Tramadol 100mg is usually more effective as the initial dose for more severe pain. The maximum daily dose should not exceed 400mg per day. PAEDIATRIC USE - On account of their high dosage strengths, Tramadol capsules are not recommended for use in children below the age of 12 years. USE IN THE ELDERLY - In subjects over the age of 75 years, serum concentrations are slightly elevated and the elimination half-life is slightly prolonged. Subjects in this age group are also expected to vary more widely in their ability to tolerate adverse drug effects. Daily doses in excess of 300 mg are not recommended in patients over 75 years. RENAL INSUFFICIENCY - in patients with renal insuf Lesen Sie das vollständige Dokument