Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Codeine phosphate hemihydrate 9.75mg; ; Doxylamine succinate 5mg; ; ; Paracetamol 450mg (As Compap L 500mg);
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Codeine phosphate hemihydrate 9.75 mg
Tablet
Active: Codeine phosphate hemihydrate 9.75mg Doxylamine succinate 5mg Paracetamol 450mg (As Compap L 500mg) Excipient: Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Quinoline yellow Sodium starch glycolate Sunset yellow FCF
Blister pack, Sample, 2 tablets
Restricted
Prescription
GlaxoSmithKline Australia Pty Ltd
For patients over the age of 12 for the symptomatic relief of acute moderate to severe pain including headache, toothache, backache or pain associated with trauma or surgery. The calmative properties may be especially useful in the treatment of tension headache, migraine and period pain and the antipyretic properties may be useful in controlling fever. Mersyndol is a suitable alternative for those individuals who cannot tolerate aspirin.
Package - Contents - Shelf Life: Blister pack, Sample - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, Al/PVC/PVDC or Al/PVC - 20 tablets - 24 months from date of manufacture stored at or below 30°C
1993-01-13
MERSYNDOL ® 1 MERSYNDOL ® _Paracetamol, codeine phosphate hemihydrate, doxylamine succinate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mersyndol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MERSYNDOL IS USED FOR Mersyndol is a type of analgesic used to relieve pain and tension. It is used for the relief of moderate to severe pain including toothache or pain from injury or surgery, and for the temporary relief of headache. In addition, the calmative properties of Mersyndol may be especially useful in the treatment of tension headache, migraine and period pain. Paracetamol and codeine work together to stop the pain messages from getting through to the brain. Doxylamine is an antihistamine with calmative effects. Your doctor, however, may prescribe Mersyndol for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine may be habit-forming if taken frequently or over long periods. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE MERSYNDOL IF YOU HAVE: • AN ALLERGIC REACTION TO PARACETAMOL, CODEINE OR DOXYLAMINE • A COUGH AND COLD AND IF YOU ARE UNDER 18 YEARS OF AGE. • RESPIRATORY DEPRESSION (SHALLOW BREATHING) OR RESPIRATORY INSUFFICIENCY (DIFFICULTY BREATHING) • COMPROMISED RESPIRATORY FUNCTION (RESPIRATORY ILLNESS) • SEVERE LIVER FAILURE OR IMPAIRED LIVER FUNCTION • G6PD DEFICIENCY, A HUMAN ENZYME DEFICIENCY • ULTRA-RAPID METABOLISER OF CYP 2D6 • HAD YOUR TONSILS OR ADENOIDS REMOVED AND ARE UNDER 18 YEARS OF AGE • USING ANTIDEPRESSANT MEDICATION (MONOAMINE I Прочитайте повний документ
mersyndol-reg-ccdsv2-dsv18-02feb22 Property of the Sanofi group - strictly confidential Page 1 NEW ZEALAND DATA SHEET 1 MERSYNDOL Mersyndol, 450 mg/9.75 mg/5 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Mersyndol Tablets:_ Paracetamol 450mg per tablet; Codeine Phosphate Hemihydrate 9.75mg per tablet; Doxylamine Succinate 5mg per tablet. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Mersyndol Tablets are yellow, round, flat faced bevelled edged tablets with a diameter of 12.7mm. One face is marked "M" within two concentric circles, the other "MERSYNDOL 008" and has a breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For patients over the age of 12 for the symptomatic relief of acute moderate to severe pain including headache, toothache, backache or pain associated with trauma or surgery. The calmative properties may be especially useful in the treatment of tension headache, migraine and period pain and the antipyretic properties may be useful in controlling fever. Mersyndol is a suitable alternative for those individuals who cannot tolerate aspirin. 4.2 DOSE AND METHOD OF ADMINISTRATION _Mersyndol Tablets_ Adults, children 12 years and older: 1 or 2 tablets every four to six hours as needed for relief. Do not exceed 8 tablets in a 24 hour period. Not recommended for children under 12 years. mersyndol-reg-ccdsv2-dsv18-02feb22 Property of the Sanofi group - strictly confidential Page 2 4.3 CONTRAINDICATION • Known hypersensitivity to paracetamol, codeine, doxylamine succinate, other opioids or any excipients of Mersyndol Tablets • Concomitant treatment with Monoamine inhibitors (MAOIs) or treatment within 14 days of stopping MAOIs (see Section 4.5 Interaction with other medicines and other forms of interaction) • Severe hepatocellular insufficiency • Pre-existing or acute respiratory depression • Respiratory insufficiency • Obstructive airways disease • Acute asthma attack • Patients with known glucose-6-phosphate-dehydrogenase deficiency • Patients with k Прочитайте повний документ