Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400
Oral
15, 24, 20, 30, 12, 10
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain and inflammation
Visual Identification: White to off-white capsule-shaped biconvex, film coated tablet.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2018-03-28
BRUFEN ® PLUS 200/12.8 _ibuprofen and codeine phosphate hemihydrate_ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE BRUFEN PLUS 200/12.8 should only be used when your doctor decides that other treatment options are not able to effec- tively manage your pain or you cannot tolerate them. HAZARDOUS AND HARMFUL USE BRUFEN PLUS 200/12.8 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 BRUFEN PLUS 200/12.8 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 BRUFEN PLUS 200/12.8 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 BRUFEN PLUS 200/12.8 USING BRUFEN PLUS 200/12.8 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. GABAPEN- TIN 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 BRUFEN PLUS 200/12.8. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BRUFEN PLUS 200/12.8. 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 BRUFEN PLUS 200/12.8 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 Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION BRUFEN ® PLUS 200/12.8 _Ibuprofen 200 mg/codeine phosphate hemihydrate 12.8 mg tablet _ _ _ 1 NAME OF THE MEDICINE ibuprofen and codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Brufen Plus 200/12.8 tablet contains 200 mg of ibuprofen and 12.8 mg of codeine phosphate hemihydrate as the active ingredients. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Brufen Plus 200/12.8: white to off-white capsule-shaped, biconvex, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of acute moderate pain and inflammation. 4.2 DOSE AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ). WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Brufen Plus 200/12.8 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 _ Brufen Plus 200/12.8 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 Brufen Plus 200/12.8. 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 NERVO Lees het volledige document