Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg
Sandoz Pty Ltd
codeine phosphate hemihydrate,Ibuprofen
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400
Oral
10, 30
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also Contraindications and Paediatric Use)
Visual Identification: white to off white coloured, caplet shaped film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-06-27
Sandoz® Ibuprofen Plus Codeine 1 SANDOZ® IBUPROFEN PLUS CODEINE TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 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. 1. WHY AM I USING SANDOZ IBUPROFEN PLUS CODEINE? Sandoz Ibuprofen Plus Codeine contains the active ingredient ibuprofen and codeine phosphate. Sandoz Ibuprofen Plus Codeine is used to provide temporary relief of acute moderate pain and inflammation. For more information, see Section 1. Why am I using Sandoz Ibuprofen Plus Codeine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SANDOZ IBUPROFEN PLUS CODEINE? Do not use if you have ever had an allergic reaction to Sandoz Ibuprofen Plus Codeine 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 OR ARE BREASTFEEDING. You may develop addiction, dependence and tolerance. For more information, see Section 2. What should I know before I use Sandoz Ibuprofen Plus Codeine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sandoz Ibuprofen Plus Codeine 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 SANDOZ IBUPROFEN PLUS CODEINE? • The usual dose of Sandoz Ibuprofen Plus Codeine 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 Sandoz Ibuprofen Plus Codeine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SANDOZ IBUPROFEN PLUS CODEINE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Sandoz Ibuprofen Plus Codeine. • Talk to your doctor about pain control if Sandoz Ibuprofen Plus Codeine is not helping. • Tell your docto Read the complete document
210810-sandoz-ibuprofen-plus-codeine-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION SANDOZ ® IBUPROFEN PLUS CODEINE (IBUPROFEN/CODEINE PHOSPHATE HEMIIHYDRATE) FILM COATED TABLETS 1. NAME OF THE MEDICINE Ibuprofen and Codeine phosphate hemihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Sandoz ® Ibuprofen plus Codeine film coated tablet contains 200 mg ibuprofen and 12.8 mg codeine phosphate hemihydrate. For the full list of excipients, see Section 6.1 List of excipients. WARNINGS _LIMITATIONS OF USE_ Because of the risks associated with the use of opioids, Sandoz Ibuprofen plus Codeine 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_ Sandoz Ibuprofen plus Codeine 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 Sandoz Ibuprofen plus Codeine. 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 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 patien Read the complete document