Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
promethazine hydrochloride, Quantity: 25 mg
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Tablet, film coated
Excipient Ingredients: lactose monohydrate; hypromellose; magnesium stearate; maize starch; povidone; macrogol 200; titanium dioxide; indigo carmine; purified water; industrial methylated spirit
Oral
50's
(S3) Pharmacist Only Medicine
ALLERGIES: Treatment of allergic conditions including some allergic reactions to drugs, urticaria, contact dermatitis, and allergic reactions to insect bites and stings. UPPER RESPIRATORY TRACT: Relief of excesive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis. NAUSEA AND VOMITING: Antiemetic in vomiting of various causes, including post-operative vomiting, irradiation sickness, drug induced nausea, and motion sickness. SEDATION: For short term use on the advice of a doctor or pharmacist.
Visual Identification: Circular, film-coated biconvex tablets with bevelled edges, pale blue in colour, one face impressed 'PN' above '25', the reverse face plain.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2001-09-17
PHENERGAN ® (fen-er-gan) P H E N E R G A N ® ACTIVE INGREDIENT: _Promethazine hydrochloride_ (PRO-meth-ar-zine HIGH-dro (h)-CLOR-ride) CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using Phenergan. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING PHENERGAN. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using Phenergan? 2. What should I know before I use Phenergan? 3. What if I am taking other medicines? 4. How do I use Phenergan? 5. What should I know while using Phenergan? 6. Are there any side effects? 7. Product details 1. WHY AM I USING PHENERGAN? PHENERGAN CONTAINS THE ACTIVE INGREDIENT PROMETHAZINE HYDROCHLORIDE. PHENERGAN IS AN ANTIHISTAMINE USED TO TREAT A NUMBER OF CONDITIONS: • ALLERGIES - ALLERGIC CONTACT DERMATITIS, HIVES, HAYFEVER, BITES AND STINGS • RESPIRATORY SYMPTOMS DUE TO ALLERGIES - RUNNY NOSE • NAUSEA AND VOMITING - MOTION SICKNESS • ASSISTS IN THE MANAGEMENT OF THE SYMPTOMS OF CHICKEN POX AND MEASLES BY ACTING AS A SEDATIVE • FOR SHORT-TERM USE FOR SEDATION ON THE ADVICE OF A PHARMACIST OR DOCTOR - DO NOT USE FOR MORE THAN 7-10 DAYS Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances that the body is allergic to. Your pharmacist or doctor may have recommended Phenergan for another reason. Ask your pharmacist or doctor if you have any questions about this medicine. 2. WHAT SHOULD I KNOW BEFORE I USE PHENERGAN? WARNINGS PHENERGAN MUST NOT BE USED IN CHILDREN UNDER 2 YEARS OF AGE, DUE TO THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. DO NOT USE PHENERGAN IF: • you are allergic to promethazine hydrochloride, medicines of similar properties or belonging to the specific family of chemicals called phenothiazines, other phenothiazines, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to Lesen Sie das vollständige Dokument
phenergan-ccdsv5-piv10-27may22 Page 1 AUSTRALIAN PRODUCT INFORMATION – PHENERGAN ® (PROMETHAZINE HYDROCHLORIDE) TABLET AND ELIXIR 1 NAME OF THE MEDICINE Promethazine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phenergan Elixir contains promethazine hydrochloride 5 mg / 5 mL. Excipients with known effect: maltitol solution, sodium benzoate, sodium sulfite, sodium metabisulfite. Phenergan tablets contain 10 mg or 25 mg of promethazine hydrochloride. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ELIXIR : 5 MG/5 ML Sugar free, alcohol free, orange flavoured, clear, bright, golden syrupy liquid. TABLETS : 10 MG Circular, film-coated biconvex tablets with bevelled edges, pale blue in colour, one face impressed 'PN' above '10', the reverse face plain. 25 MG Circular, film-coated biconvex tablets with bevelled edges, pale blue in colour, one face impressed 'PN' above '25', the reverse face plain. phenergan-ccdsv5-piv10-27may22 Page 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Allergies: _ Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings. _Upper respiratory tract: _ Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis. _Nausea and vomiting: _ Antiemetic for vomiting from various causes, including postoperative vomiting, irradiation sickness, drug induced nausea and motion sickness. _Sedation: _ For short term use under the advice of a doctor or pharmacist. Do not use for more than 7 to 10 consecutive days. _Other: _ Promethazine has sedative effects and can be used in the symptomatic management of measles and chicken pox. Promethazine can be used as a preanaesthetic medication for the prevention and control of post operative vomiting. 4.2 DOSE AND METHOD OF ADMINISTRATION This product must not be used in children under 2 years of a Lesen Sie das vollständige Dokument