দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Promethazine hydrochloride
Opella Healthcare France SAS T/A Sanofi
R06AD; R06AD02
Promethazine hydrochloride
25 milligram(s)
Film-coated tablet
Phenothiazine derivatives; promethazine
Marketed
1979-04-01
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER PHENERGAN ® 25MG FILM-COATED TABLETS 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 Tablets • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. What Phenergan Tablets are and what it is used for 2. What you need to know before you take Phenergan Tablets 3. How to take Phenergan Tablets 4. Possible side effects 5. How to store Phenergan Tablets 6. Contents of the pack and other information 1. WHAT PHENERGAN TABLETS ARE AND WHAT IT IS USED FOR Phenergan Tablets contain 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. WHAT PHENERGAN TABLETS ARE USED FOR • To treat allergic conditions such as hay fever or rashes (like nettle rash or hives). • To treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness. • As a sedative. This is a medicine give to reduce awareness or make you feel relaxed and at ease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENERGAN TABLETS 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 Tablets (listed in Section 6 below). The signs of an allergic reaction include: a rash, swallowing or bre সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 15 November 2023 CRN00DRFC Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenergan 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Promethazine Hydrochloride 25 mg Excipients - Contains Lactose Monohydrate 173.52mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Pale blue, circular biconvex tablet with bevelled edges marked ‘PN25’ on one side and the other plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of allergic conditions and reactions. As an antiemetic. As a tranquilliser. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral. Adults including The Elderly: The usual daily dose is 25-75 mg (1 to 3 tablets) either as a single daily dose at bedtime or in 3 divided doses, starting with the lower dose. Children: Children below 2 years: Not recommended. Children 2-6 years: Use of Phenergan 5mg/5ml oral solution is recommened in this age group. As a tranquilliser: Children 6-12 years: 25mg (1 tablet) once daily at bedtime. 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. Phenergan should not be given to patients with a known hypersensitivity to promethazine or any of the excipients. 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 be used in patients with pre-existing coronary insufficiency. Adjustment of dosage may be necessary to avoid postural hypotension, especially in the elderly. Health Products Regulatory Authority 15 November 2023 CRN00DRFC Page 2 of 5 Since the drug is metabolized in the liver, promethazine s সম্পূর্ণ নথি পড়ুন