מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Promethazine hydrochloride
Pilsco Ltd
R06AD02
Promethazine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 05060669871095
• Liver problems that may cause the eyes or skin to go yellow (jaundice) • Muscle stiffness or shaking • Being unable to control some muscles in your head or face • You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling • Very fast, uneven or forceful heartbeat (palpitations) • Irregular heartbeat • Tiredness which lasts for a long time. This may be due to a blood problem called anaemia • Over-active behaviour in children TELL YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING SIDE EFFECTS GET SERIOUS OR LASTS LONGER THAN A FEW DAYS. ALSO TELL THEM IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET. • Dry mouth, blurred vision or you cannot pass water (urine) • Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless • Loss of appetite (anorexia), indigestion • Feeling dizzy, lightheaded, faint (hypotension) • Feeling confused, especially in elderly people • Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE PHENERGAN TABLETS • Keep out of the sight and reach of children • Do not take Phenergan Tablets after the expiry date which is stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month • Do not store above 30°C • Store in the original package in order to protect from light Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT PHENER קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenergan 25 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg of the active substance Promethazine hydrochloride. Also contains 173.52mg of lactose monohydrate. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Pale blue film coated tablets marked PN 25 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins. As an antiemetic. For short term use: Treatment of insomnia in adults. As a paediatric sedative. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Not for use in children under the age of 2 years (see section 4.3). _AS AN ANTIHISTAMINE IN ALLERGY: _ Children 2-5 years The use of Phenergan Elixir is recommended for this age group. Children 5-10 years 25 mg as a single dose*. Maximum daily dose 25 mg. Children over 10 years and adults (including elderly) 25 mg as a single dose*. Increasing to a maximum of 25 mg bd as required. *Single doses are best taken at night. _AS AN ANTIEMETIC: _ Children 2-5 years The use of Phenergan Elixir is recommended for this age group. Children 5-10 years The use of Phenergan Elixir or Phenergan 10 mg Tablets is recommended. Children over 10 years and adults (including elderly) 25 mg to be taken the night before the journey. To be repeated after 6–8 hours as required. _AS A PAEDIATRIC SEDATIVE FOR SHORT TERM USE AND FOR SHORT TERM TREATMENT OF _ _INSOMNIA IN ADULTS: _ Children 2-5 years The use of Phenergan Elixir is recommended for this age group. Children 5-10 years 25 mg as a single night time dose. Children over 10 years and adults (including elderly) 25 or 50 mg as a single night time dose. 4.3 CONTRAINDICATIONS Phenergan should not be used in patients in coma or suffering from CNS depression of any cause. Phenergan should not be given to p קרא את המסמך השלם