Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg
Arrotex Pharmaceuticals Pty Ltd
codeine phosphate hemihydrate,Ibuprofen
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; purified water; magnesium stearate; glyceryl behenate; maize starch; titanium dioxide; hypromellose; macrogol 6000
Oral
30, 24
(S4) Prescription Only Medicine
For temporary relief of acute moderate pain and inflammation
Visual Identification: White to off-white capsule shaped, biconvex, film coated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-12-23
Ibudeine 1 IBUDEINE TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY [OPTIONAL] The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. [Include if applicable] 1. WHY AM I USING IBUDEINE ? Ibudeine contains the active ingredients Ibuprofen and Codeine phosphate. Ibudeine is used to provide temporary relief of acute moderate pain and inflammation. For more information, see Section 1. Why am I using Ibudeine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IBUDEINE ? Do not use if you have ever had an allergic reaction to Ibudeine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT. You may develop addiction, dependence and tolerance. For more information, see Section 2. What should I know before I use Ibudeine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ibudeine and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE IBUDEINE? • The usual dose of Ibudeine is 2 tablets then, if necessary 1 or 2 tablets every 4 to 6 hours. More instructions can be found in Section 4. How do I use Ibudeine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IBUDEINE? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using Ibudeine. Talk to you doctor about pain control if Ibudeine is not helping. Tell your doctor if you become pregnant while taking Ibudeine. THINGS YOU SHOULD NOT DO • Do not take more than 6 tablets in 24 hours. • Do not give Ibudeine to children under the age of 12 years • Do not take Ibudeine for more than three days at a time DRIVING OR USING MACHINES Be careful before you drive or use any machines or tools until yo Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION – IBUDEINE (IBUPROFEN & CODEINE PHOSPHATE HEMIHYDRATE) TABLETS WARNINGS _LIMITATIONS OF USE _ BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, IBUDEINE 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 _ IBUDEINE 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 IBUDEINE. 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 IBUDEINE. 1 NAME OF THE MEDICINE Ibuprofen and codeine phosphate hemihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg. 2 LBUPROFEN: It is a white or almost white powder or crystals with a characteristic odour. Practically insoluble in water, solu Izlasiet visu dokumentu