Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 30 mg
Sanofi-Aventis Australia Pty Ltd
codeine phosphate hemihydrate,Paracetamol
Tablet, uncoated
Excipient Ingredients: potassium sorbate; maize starch; povidone; purified talc; stearic acid; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch
Oral
10 tablets, 20 tablets, 4 tablets, 50 tablets, 2 tablets
(S4) Prescription Only Medicine
Paracetamol/Codeine GH 500/30 is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
Visual Identification: White to off-white, capsule shaped tablets, marked "P" and "F" either side of a scoreline on one side and plain on the other. Dimensions: 17.46 x 7.14 x 6.05mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-10-22
PARACETAMOL/CODEINE GH 500/30 ® P a r a c e t a m o l / C o d e i n e G H 5 0 0 / 3 0 ® 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 TAKING PARACETAMOL/CODEINE GH 500/30? Paracetamol/Codeine GH 500/30 contains the active ingredients paracetamol and codeine phosphate hemihydrate. Paracetamol/ Codeine GH 500/30 is used to relieve severe pain. For more information, see Section 1. Why am I taking Paracetamol/Codeine GH 500/30? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE PARACETAMOL/CODEINE GH 500/30? Do not use if you have ever had an allergic reaction to Paracetamol/Codeine GH 500/30 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 Paracetamol/Codeine GH 500/30? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Paracetamol/Codeine GH 500/30 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 TAKE PARACETAMOL/CODEINE GH 500/30? The standard dose for adults is 1 or 2 tablets for severe pain, taken every 4 to 6 hours if necessary. More instructions can be found in Section 4. How do I use Paracetamol/Codeine GH 500/30? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PARACETAMOL/CODEINE GH 500/30? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Paracetamol/Codeine GH 500/30. • Talk to your doctor about pain control if the medicine is not helping. • Tell your doctor if you become pregnant while taking Para সম্পূর্ণ নথি পড়ুন
Paracetamol-codeine-gh-ccdsv5-piv12-03dec21 1 AUSTRALIAN PRODUCT INFORMATION – PARACETAMOL/CODEINE GH 500/30 (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE) WARNINGS LIMITATIONS OF USE BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, PARACETAMOL/CODEINE GH 500/30 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 PARACETAMOL/CODEINE GH 500/30 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 PARACETAMOL/CODEINE GH 500/30. 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 PARACETAMOL/CODEINE GH 500/30. Paracetamol-codeine-gh-ccdsv5-piv12-03dec21 2 1 NAME OF THE MEDICINE Paracetamol and codeine phosphate hemihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule-shaped tablet cont সম্পূর্ণ নথি পড়ুন