Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 9.6 mg; paracetamol, Quantity: 500 mg
Sanofi-Aventis Australia Pty Ltd
codeine phosphate hemihydrate,Paracetamol
Tablet, uncoated
Excipient Ingredients: sodium starch glycollate; magnesium stearate; purified talc; stearic acid; povidone; pregelatinised maize starch; crospovidone
Oral
36, 40, 2, 12, 24, 12 caplets purse pack
(S4) Prescription Only Medicine
For the relief of acute moderate pain and fever
Visual Identification: A white capsule shaped tablet plain on one side and breakline on the other.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2012-09-04
PRODEINE ® P R O D E I N E 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 PRODEINE? Prodeine contains the active ingredients paracetamol and codeine phosphate hemihydrate. Prodeine is used to relieve acute moderate pain and fever. For more information, see Section 1. Why am I using Prodeine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PRODEINE? Do not use if you have ever had an allergic reaction to Prodeine 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. For more information, see Section 2. What should I know before I use Prodeine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Prodeine 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 PRODEINE? Adults and children 12 years or over: One or two tablets every 3 to 4 hours as needed for relief. Do not take more than 8 caplets in 24 hour period More instructions can be found in Section 4. How do I use Prodeine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PRODEINE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Prodeine. • Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain. THINGS YOU SHOULD NOT DO • Do not take more than the recommended dose unless your doctor tells you to. • Do not give this medicine to children under 12 years of age. • Do not take Prodeine during the third trimester of pregnancy or if you are in la Citiți documentul complet
prodeine-ccdsv5-piv18-03dec21 Page 1 AUSTRALIAN PRODUCT INFORMATION – PRODEINE (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE) UNCOATED TABLET WARNINGS LIMITATIONS OF USE BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, PRODEINE 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 PRODEINE 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 PRODEINE. 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 PRODEINE. prodeine-ccdsv5-piv18-03dec21 Page 2 1 NAME OF THE MEDICINE Paracetamol, codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prodeine contains paracetamol 500 mg and codeine phosphate hemihydrate 9.6 mg. Prodeine is aspirin-free. For the full list of excipients, see Citiți documentul complet