Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 30 mg; paracetamol, Quantity: 450 mg; doxylamine succinate, Quantity: 5 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: sodium starch glycollate; magnesium stearate; purified talc; stearic acid; povidone; pregelatinised maize starch; crospovidone
Oral
40 tablets, 2 tablets (sample pack), 20 tablets, 10
(S4) Prescription Only Medicine
INDICATIONS AS AT 9 JUNE 2020: Mersyndol Forte 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: round, flat faced bevelled edge white tablet embossed "M" on one side and on the other side "MERSYNDOL" and "FORTE" either side of a breakbar; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-07-08
MERSYNDOL FORTE ® M e r s y n d o l F o r t 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 TAKING MERSYNDOL FORTE? Mersyndol Forte contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Mersyndol Forte is for the short-term management of severe pain where your doctor decides other treatment options are ineffective, are not recommended, not tolerated, or otherwise inappropriate to manage your pain. For more information, see Section 1. Why am I taking Mersyndol Forte? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE MERSYNDOL FORTE? Do not take Mersyndol Forte if you have ever had an allergic reaction to Mersyndol Forte or any of the ingredients listed at the end of this CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT, ARE BREASTFEEDING OR PLANNING TO BREASTFEED. For more information, see Section 2. What should I know before I take Mersyndol Forte? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Mersyndol Forte 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 MERSYNDOL FORTE? • The usual dose for adults and children between 12 and 18 years is one or two tablets every 4-6 hours as needed for relief. More instructions can be found in Section 4. How do I take Mersyndol Forte? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING MERSYNDOL FORTE? THINGS YOU SHOULD DO • Remind any doctor, surgeon, dentist or pharmacist you visit that you are using Mersyndol Forte. • Keep all your appointments, including those for blood tests. • Call your doctor straight away if you feel you need to change Lesen Sie das vollständige Dokument
mer-for-ccdsv2-piv21-19nov21 1 AUSTRALIAN PRODUCT INFORMATION – MERSYNDOL FORTE (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, DOXYLAMINE SUCCINATE) 1 NAME OF THE MEDICINE Paracetamol, codeine phosphate hemihydrate and doxylamine succinate WARNINGS LIMITATIONS OF USE BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, MERSYNDOL FORTE 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 MERSYNDOL FORTE 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 MERSYNDOL FORTE. 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 MERSYNDOL FORTE. mer-for-ccdsv2-piv21-19nov21 2 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paracetamol 450 mg, codeine phosphate hemihydrate 30 mg, doxylamine Lesen Sie das vollständige Dokument