Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Tramadol hydrochloride
Capsule
Excipient Ingredients: Gelatin; indigo carmine aluminium lake; magnesium stearate; colloidal anhydrous silica; propyl hydroxybenzoate; methyl hydroxybenzoate; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; sodium starch glycollate; microcrystalline cellulose
Oral
6, 8, 10 and 20
(S4) Prescription Only Medicine
For the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
Visual Identification: hard gelatin capsules, size 3, having green cap and yellow body filled with a homogeneous white to off-white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-04-09
APO-TRAMADOL 1 APO-TRAMADOL _Contains the active ingredient tramadol hydrochloride _ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE TRAMADOL should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. HAZARDOUS AND HARMFUL USE TRAMADOL poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION TRAMADOL can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting TRAMADOL and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING TRAMADOL USING TRAMADOL WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS SLEEPING TABLETS (E.G. BENZODIAZEPINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES, ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND PREGABALIN), CANNABIS AND ALCOHOL MAY RESULT IN SEVERE DROWSINESS, DECREASED AWARENESS, BREATHING PROBLEMS, COMA AND DEATH. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using TRAMADOL. _ _ _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it a Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION APO-TRAMADOL (TRAMADOL HYDROCHLORIDE) CAPSULES WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, APO-Tramadol should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). HAZARDOUS AND HARMFUL USE APO-Tramadol poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see section 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE). LIFE THREATENING RESPIRATORY DEPRESSION Serious, life-threatening or fatal respiratory depression may occur with the use of APO- Tramadol. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking APO-Tramadol. 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 Hydroxybenzoates and sulfites 2 For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Hard gelatin ca Lire le document complet