PHENERGAN 2.5 %w/v Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Dosage:

2.5 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

IS THIS LEAFLET HARD TO SEE OR 
READ? PHONE [phone] FOR 
HELP
READ ALL OF THIS LEAFLET CAREFULLY 
BEFORE YOU START HAVING THIS MEDICINE
•  Keep this leaflet. You may need to 
read it again
•  If you have any further questions, 
ask your doctor or pharmacist
•  This medicine has been prescribed 
for you. Do not pass it on to others. 
It may harm them, even if their 
symptoms are the same as yours
•  If any of the side effects gets 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 Injection is and 
what it is used for
2. Before you are given Phenergan 
Injection
3. How Phenergan Injection is given
4. Possible side effects
5. How to store Phenergan Injection
6. Further Information
1. WHAT PHENERGAN 
INJECTION IS AND  
WHAT IT IS USED FOR
Phenergan Injection 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.
WHAT PHENERGAN INJECTION IS USED 
FOR
•  To treat allergic conditions such as 
hay fever or rashes (like nettle rash 
or hives).
•  As a sedative. This is a medicine 
given to reduce awareness or 
make you feel relaxed and at ease
•  To help you feel more relaxed 
before an operation
• To treat adults with difficulty 
sleeping (insomnia)
2.  BEFORE YOU ARE 
GIVEN PHENERGAN 
INJECTION
DO NOT HAVE 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 
Injection (listed in Section 6 below) 
The signs of an allergic reaction 
include: a rash, swallowing

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan 2.5% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains Promethazine Hydrochloride 25 mg.
Excipients: Contains Sodium Sulphite (E221) 0.5mg and Sodium Metabisulphite (E223) 0.7mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, bright, almost colourless, solution.
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: Intramuscular or Intravenous.
INTRAMUSCULAR:
ADULTS:
The usual daily dose is 25-50 mg by deep intramuscular injection. A maximum dose of 100mg parenterally should not
be exceeded.
CHILDREN:
Children 5-10 years only:
6.25 - 12.5 mg daily be deep intramuscular injection.
ELDERLY:
No specific dosage recommendations.
INTRAVENOUS:
ADULTS ONLY:
In an emergency, the usual dose is 25-50mg after dilution to 10 times the volume with water for injection. A maximum
dose of 100mg parenterally should not be exceeded.
ELDERLY:
No specific dosage recommendations.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/03/2014_
_CRN 2144304_
_page number: 1_
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.
Phenergan should be avoided in patients with blood dycrasias and in patients taking monoamine oxidase inhibitors up
to 14 days