Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride
Apotex Pty Ltd
Tramadol hydrochloride
Registered
CHEMMART TRAMADOL _Contains the active ingredient tramadol hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about tramadol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Chemmart Tramadol. It contains the active ingredient tramadol hydrochloride. It is used to treat: • moderate to severe pain Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. Tramadol is not normally addictive, although some cases have been reported. _USE IN CHILDREN_ This medicine should not be used in children. The safety and effectiveness of this medicine in children have not been established. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF: • You have or have had any of the following: - epilepsy which is not well controlled - known sensitivity to opioids (such as morphine or codeine). • You are taking a class of medicine known as 'monoamine oxidase inhibitors' (MAOIs) (often taken for depression), or you have taken such a medicine within the las Կարդացեք ամբողջական փաստաթուղթը
1 AUSTRALIAN PRODUCT INFORMATION CHEMMART TRAMADOL (TRAMADOL HYDROCHLORIDE) CAPSULES 1 NAME OF THE MEDICINE Tramadol Hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The capsules_ _contain 50 mg tramadol hydrochloride as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), gelatin For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Hard gelatin capsules having green cap and yellow body filled with a homogeneous white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of moderate to severe pain. 4.2 DOSE AND METHOD OF ADMINISTRATION The dose of tramadol should be titrated according to the severity of the pain and the clinical response of the individual patient. Tramadol is approved for use in adults and adolescents over the age of 12 years. The recommended dosage of Chemmart Tramadol capsules is as follows: For the treatment of moderate pain, 50 mg to 100 mg of tramadol administered orally, two or three times daily may be sufficient. An initial dose of 50 mg of tramadol may be sufficient for moderate pain. For moderate to severe pain, oral doses of 50 mg to 100 mg of tramadol, as needed for pain relief, every four to six hours may be administered. A 100 mg initial dose of tramadol is usually more effective for more severe pain. The maximum daily dose should not exceed 400 mg per day. 2 DOSAGE PAEDIATRIC USE Use of tramadol is not recommended as safety and efficacy in children have not been established. 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 IMPAIRMENT In patients with renal insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage i Կարդացեք ամբողջական փաստաթուղթը