Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
ibuprofen, Quantity: 200 mg; codeine phosphate hemihydrate, Quantity: 12.8 mg
Cipla Australia Pty Ltd
codeine phosphate hemihydrate,Ibuprofen
Tablet, film coated
Excipient Ingredients: lactose monohydrate; purified water; maize starch; glyceryl behenate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000
Oral
30
(S4) Prescription Only Medicine
AMCAL IBUPROFEN PLUS CODEINE is used for temporary relief of acute moderate pain and inflammation in patients over the age of 12 years.
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
2014-09-01
AMCAL IBUPROFEN PLUS CODEINE 1 AMCAL IBUPROFEN PLUS CODEINE 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 AMCAL IBUPROFEN PLUS CODEINE? AMCAL IBUPROFEN PLUS CODEINE contains the active ingredients Ibuprofen and Codeine phosphate. AMCAL IBUPROFEN PLUS CODEINE is used to relieve pain, inflammation (swelling, redness, soreness) and fever when other analgesics have proven not to be effective. For more information, see Section 1. Why am I using AMCAL IBUPROFEN PLUS CODEINE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AMCAL IBUPROFEN PLUS CODEINE? Do not use if you have ever had an allergic reaction to AMCAL 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. Do not use at all during the last three months of pregnancy, For more information, see Section 2. What should I know before I use AMCAL IBUPROFEN PLUS CODEINE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with AMCAL 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 AMCAL IBUPROFEN PLUS CODEINE? The usual dose of AMCAL IBUPROFEN PLUS CODEINE for adults and children over 12 years of age is 2 tablets followed by, if necessary 1 or 2 tablets every 4 hours. Do not take more AMCAL IBUPROFEN PLUS CODEINE than 6 tablets in 24 hours. More instructions can be found in Section 4. How do I use AMCAL IBUPROFEN PLUS CODEINE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AMCAL IBUPROFEN PLUS CODEINE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION - AMCAL IBUPROFEN PLUS CODEINE (IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE) TABLET _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, AMCAL 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 _ AMCAL 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 AMCAL 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 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 AMCAL IBUPROFEN PLUS CODEINE. 1 NAME OF THE MEDICINE Ibuprofen and codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200 mg, codeine phosphate 12.8 mg. AMCAL IBUPROFEN PLUS CODEINE tablets do not Lees het volledige document