Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Promethazine hydrochloride
Opella Healthcare France SAS T/A Sanofi
R06AD; R06AD02
Promethazine hydrochloride
5 mg/5ml
Oral solution
Phenothiazine derivatives; promethazine
Marketed
1979-04-01
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER PHENERGAN 5MG/5ML ORAL SOLUTION promethazine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Phenergan Oral Solution. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 7 days. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Phenergan Oral Solution is and what it is used for 2. What you need to know before you take Phenergan Oral Solution 3. How to take Phenergan Oral Solution 4. Possible side effects 5. How to store Phenergan Oral Solution 6. Contents of the pack and other information 1. WHAT PHENERGAN ORAL SOLUTION IS AND WHAT IT IS USED FOR Phenergan Oral Solution contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. Phenergan 5mg/5ml oral solution also contains Sodium Metabisulphite (E223), this may rarely cause severe hypersensitivity reactions and bronchospasm. WHAT PHENERGAN ORAL SOLUTION IS USED FOR • To treat allergic conditions such as hay fever or rashes (like nettle rash or hives). • To prevent nausea or vomiting (e.g. travel sickness). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENERGAN ORAL SOLUTION Do not take this medicine and tell your doctor if: • The person taking the medicine is under 2 years of age. • You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Oral Solution (listed in Section 6 below). The signs of an allergic reaction include: a rash, swallowing or Perskaitykite visą dokumentą
Health Products Regulatory Authority 15 November 2023 CRN00DRFC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenergan 5 mg/5 ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml spoonful contains Promethazine Hydrochloride 5 mg Excipients - Contains Sodium Sulphite (E221) 5.0mg, Sodium Citrate 140.0mg, Sodium Metabisulphite (E223) 5.0mg, Sodium Benzoate (E211) 5.0mg and Maltitol Liquid 4.44g Sodium content is 37mg/5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution A clear bright golden oral solution with an odour of oranges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of allergic conditions and reactions. As an antiemetic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Not for use in children under the age of 2. Adults: The usual daily dose is 25-75mg as a single daily dose or in 3 divided doses, starting with the lower dose. Children: Children 2-5 years: 1-3 x 5ml spoonfuls (5-15mg) once daily at bedtime Or 5mg twice daily Maximum daily dose 15mg Children 5-10 years: 2-5 x 5ml spoonfuls (10-25mg) once daily at bedtime Or 5-10mg twice daily Maximum daily dose 25mg When two doses are required in 24 hours, the lower dose should be used. 4.3 CONTRAINDICATIONS Phenergan should not be used in patients in pre-coma states, in a coma or suffering from CNS depression of any cause. It must not be given to neonates, or premature infants. Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients. Health Products Regulatory Authority 15 November 2023 CRN00DRFC Page 2 of 6 Phenergan should be avoided in patients with blood dycrasias and in patients taking monoamine oxidase inhibitors up to 14 days previously. Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution should b Perskaitykite visą dokumentą