Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Pholcodine 3 mg/mL; ; ; ; Pholcodine 3 mg/mL
iNova Pharmaceuticals (New Zealand) Limited
Pholcodine 3 mg/mL
3 mg/mL
Oral solution
Active: Pholcodine 3 mg/mL Excipient: Apricot flavour 012500 Citric acid Hyetellose Methyl hydroxybenzoate Purified water Saccharin sodium Sorbitol Sunset yellow FCF Active: Pholcodine 3 mg/mL Excipient: Apricot flavour 012500 Citric acid Disodium edetate Hyetellose Purified water Saccharin sodium Sodium benzoate Sodium citrate Sorbitol Sunset yellow FCF
Bottle, plastic, PET sample, with pp CRC tamper evident wadded cap, 30 mL
Pharmacy only
Restricted
PCAS
Package - Contents - Shelf Life: Bottle, plastic, PET sample, with pp CRC tamper evident wadded cap - 30 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET, with pp CRC tamper evident wadded cap - 100 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET, with pp CRC tamper evident wadded cap - 200 mL - 24 months from date of manufacture stored at or below 30°C
1994-11-14
Duro-Tuss Dry Cough Forte_Sep 2010 final_NZ.doc Page 1 of 3 pages DURO-TUSS TM DRY COUGH LIQUID FORTE _PHOLCODINE _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about these medicines. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking these medicines 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. You may need to read it again. WHAT DURO-TUSS DRY COUGH LIQUID FORTE IS USED FOR Pholcodine is used to relieve dry coughs. Pholcodine works on the cough centre in the brain to control and help stop coughing. ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. Your pharmacist or doctor may have given it for another reason. BEFORE YOU TAKE DURO- TUSS DRY COUGH LIQUID FORTE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing Pholcodine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath_ _ • wheezing or difficulty breathing_ _ • swelling of the face, lips, tongue or other parts of the body_ _ • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU HAVE: • severe asthma, bronchitis or other serious respiratory conditions DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS DAMAGED OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it Прочитать полный документ
NEW ZEALAND DATA SHEET Page 1 of 5 1 PRODUCT NAME Duro-Tuss Dry Cough Liquid Forte 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of the medicine contains 15 mg pholcodine. Excipients with known effect: Sodium benzoate, saccharin sodium and sorbitol. For full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Oral solution. A clear yellow-orange, slightly viscous solution with an odour of apricot. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Temporary relief of stubborn dry coughs. 4.2 Dose and method of administration For oral administration. AGE DOSAGE HOW OFTEN Adults & children 12 years & over 5 mL Every 6 hours as required (Maximum 4 times a day) Children under 12 years Do not use 4.3 Contraindications • Children under the age of 12 years. • Hypersensitivity to pholcodine or any of the excipients listed in section 6.1 . • Patients in, or at risk of, developing respiratory failure or during acute asthma attacks (may depress respiration). • Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention. • Patients with renal or hepatic failure. • Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5 ). 4.4 Special warnings and precautions for use Use with caution in patients with liver or renal disease. Pholcodine should be used with caution in patients with chronic or persistent cough, asthma, including an acute asthma attack, or where cough is accompanied by excessive secretions. Severe cutaneous adverse reactions (SCARs) including acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine-containing products, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Duro-Tuss Dry Cough Liquid Forte should be withdrawn immediately. NEW ZEALAND DATA SHEET Page 2 of 5 C Прочитать полный документ