Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
doxylamine succinate, Quantity: 5 mg; codeine phosphate hemihydrate, Quantity: 9.75 mg; paracetamol, Quantity: 450 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: quinoline yellow; sodium starch glycollate; sunset yellow FCF; purified talc; magnesium stearate; microcrystalline cellulose; stearic acid; povidone; pregelatinised maize starch; crospovidone
Oral
40 tablets, 20 tablets, 10
(S4) Prescription Only Medicine
For the relief of acute moderate pain and fever
Visual Identification: Yellow, round, scored tablet marked "MERSYNDOL" "008" with "M" inside two concentric circles on the non-scored side.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-07-08
MERSYNDOL ® M e r s y n d o l ® 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 MERSYNDOL? Mersyndol contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Mersyndol is used for short term use to relieve moderate pain and fever. For more information, see Section 1. Why am I using Mersyndol? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MERSYNDOL? Do not use if you have ever had an allergic reaction to Mersyndol 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 Mersyndol? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Mersyndol 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 MERSYNDOL? • The standard dose of this medicine for adults and children 12 years or over is one or two tablets/caplets every 4-6 hours as needed for pain relief. More instructions can be found in Section 4. How do I use Mersyndol? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MERSYNDOL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Mersyndol. • If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Mersyndol. • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine. THINGS YOU SHOULD NOT DO • Do not take more than 8 tablets in a 24-hour period. • Do not give Mersyndol to anyone else, even if Διαβάστε το πλήρες έγγραφο
mer-ccdsv2-piv19-19nov21 Page 1 AUSTRALIAN PRODUCT INFORMATION – MERSYNDOL (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, AND DOXYLAMINE SUCCINATE) WARNINGS LIMITATIONS OF USE BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, MERSYNDOL 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 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. 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. mer-ccdsv2-piv19-19nov21 Page 2 1 NAME OF THE MEDICINE Paracetamol, codeine phosphate hemihydrate and doxylamine succinate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mersyndol contains paracetamol 450 mg, codeine phosphate hemihydrate 9.75 mg, doxylamine succinate 5 mg. Mersyn Διαβάστε το πλήρες έγγραφο