Phenergan 25mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Promethazine hydrochloride

Available from:

Sanofi Consumer Healthcare

ATC code:

R06AD02

INN (International Name):

Promethazine hydrochloride

Dosage:

25mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5013011000629

Patient Information leaflet

_i_
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• If you get any side-effects, talk to your doctor, pharmacist or
nurse
(see section 4).
WHAT IS IN THIS LEAFLET:
1. What Phenergan Injection is and what it is used for
2. What you need to know before you are given Phenergan Injection
3. How Phenergan Injection will be given
4. Possible side effects
5. How to use Phenergan Injection
6. Contents of the pack and other 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 for both adults and children. This is a medicine
given
to reduce awareness or make you feel relaxed and at ease
• To treat adults with difficulty sleeping (insomnia)
• To help you feel more relaxed before an operation
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
PHENERGAN INJECTION
DO NOT USE THIS MEDICINE IF:
X The person taking the medicine is under 2 years of age
X 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
or breathing problems, swelling of your lips, face, throat or tongue
X You are taking a medicine for depression called a monoamine
oxidase inhibitor (MAOI). Also do not take Phenergan Injection if you
have stopped taking one of these MAOI medicines within the las

Summary of Product characteristics

OBJECT 1
PHENERGAN INJECTION
Summary of Product Characteristics Updated 26-Sep-2016 | SANOFI
1. Name of the medicinal product
Phenergan 25mg/ml Solution for Injection.
2. Qualitative and quantitative composition
Each ampoule contains 25mg/ml of the active substance Promethazine
hydrochloride.
Also contains 0.5mg of sodium sulphite anhydrous (E221) and 0.7mg of
sodium metabisulphite (E223).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Phenergan Injection is a clean, bright, colourless or almost
colourless solution.
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.
Sedation and treatment of insomnia in adults.
As an adjunct in preoperative sedation in surgery and obstetrics.
As a paediatric sedative.
4.2 Posology and method of administration
Route of administration: Intramuscular or intravenous (after dilution)
The usual dose is 25 - 50 mg by deep intramuscular injection, or, in
emergency, by slow intravenous
injection after dilution of the 2.5% solution to 10 times its volume
with water for injections immediately
before use.
Maximum parenteral dose 100 mg.
Elderly:No specific dosage recommendations.
Children:6.25 - 12.5 mg for children from 5 - 10 years by deep
intramuscular injection. Not for use in
children under 2 years of age (see section 4.3).
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 patients with a known
hypersensitivity to promethazine or to any of the
excipients.
Promethazine is contraindicated for use in children less than two
years of age because of the potential for
fatal respiratory depression..
Phenergan should be avoided in patients taking monoamine oxidase
inhibitors up to 14 days previously.
4.4 Special warnings and precautions for use
Phenergan may thicken