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PHENERGAN 25MG/ML SOLUTION FOR INJECTION

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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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

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Phenergan® 25mg/ml
Solution for Injection

2. What you need to know before you are given
Phenergan Injection

Promethazine hydrochloride

Is this leaflet hard to see or read?
Phone 0845 372 7101 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.
In this leaflet:
1. What Phenergan Injection is and what it is used for
2. What you need 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

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 last 14
days. If you are not sure ask your doctor or pharmacist (see “Taking
other medicines” section below)
X The person is unconscious (in a coma) or suffers from severe
dizziness, drowsiness or headache
You should not be given this medicine if any of the above applies to
you. If you are not sure, talk to your doctor or pharmacist before
having Phenergan Injection.

i

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.

Warnings and precautions
Do not have this medicine and tell your doctor if:
▲ You have difficulty breathing, wheezing, tightness in the chest
(asthma) or an infection in your lungs (bronchitis)
▲ You have epilepsy








You have any serious heart problems
You have liver or kidney problems
You have a stomach blockage or difficulty passing water
You have a headache due to dehydration or high blood pressure
You have increased pressure in the eye (narrow angle glaucoma)
You have had something called Reye’s Syndrome or possible Reye’s
Syndrome – signs include being sick and confused following a viral
illness
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before having Phenergan Injection.

Phenergan Injection with food and drink
Do not drink alcohol while you are having Phenergan Injection. This is
because it can affect the way the medicine works.

Other medicines and Phenergan Injection
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you can buy
without prescription, including herbal medicines. This is because
Phenergan Injection can affect the way some medicines work. Also
some medicines can affect the way Phenergan Injection works.
Do not take this medicine, and tell your doctor, if you are taking
or have taken the following in the last 2 weeks:
• Some medicines for depression called monoamine oxidase
inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist
Tell your doctor or pharmacist if you are taking any of the following:
• Anticholinergic medicines - includes some medicines used for
irritable bowel syndrome, asthma or weak bladder. These can
increase the risk of dizziness, dry mouth and blurred eyesight
• Medicines for depression (such as amitriptyline)
• Medicines to help you to sleep or feel more relaxed (such as
diazepam or zolpidem)
• Medicines such as aspirin (for arthritis and pain in your joints).
Phenergan Injection may hide the side effects of these medicines
• Medicines for high blood pressure
• Medicines for fits (epilepsy)
• Medicines for diabetes. Your doctor may need to change the dose of
your medicine

If you are breast-feeding or planning to breastfeed, talk to your doctor
or pharmacist before taking any medicine.

Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant,
might become pregnant, or think you may be pregnant. You should
not have Phenergan Injection 2 weeks before you give birth.
You should not have Phenergan Injection if you are breast-feeding.
This is because small amounts may pass into mothers’ milk. This can
be harmful to your baby.

Driving and using machines
You may feel drowsy, dizzy or confused while having this medicine or
in the morning after taking this medicine. If this happens, do not drive
or use any tools or machines.
Phenergan Injection contains:
• Sodium sulphite and sodium metabisulphite. These may rarely
cause severe allergic (hypersensitivity) reactions and difficulty
breathing, wheezing and
tightness in the chest (bronchospasm)
• Sodium. It contains 0.4mg sodium per ml and is essentially
‘sodium-free’.

3. How Phenergan Injection will be given
Your medicine will normally be given to you by a doctor or
nurse. This is because it needs to be given by a deep
injection into a muscle or by a slow injection into the vein.

Having this medicine
• This medicine is usually given by a deep injection into a muscle. It
can also be given by a slow injection into the vein after dilution using
water for injection
• If you feel the effect of your medicine is too weak or too strong, tell
your doctor
How much is given
The usual dose is:
Children 5-10 years:
• 6.25 to12.5mg given by deep injection into a muscle
Children over 10 years and adults (including the elderly):
• 25 to 50mg given by deep injection into a muscle. It can also be
given in an emergency by a slow injection into a vein after being
mixed with water for injections.
The maximum dose is 100mg.
If you are not sure why you are being given Phenergan Injection or
have any questions about how much Phenergan Injection is being
given to you, speak to your doctor or nurse.
Exposure to sunlight
Phenergan Injection can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.
If you have more Phernergan Injection than you should
It is unlikely that your doctor or nurse will give you too much
medicine. Your doctor and nurse will be monitoring your progress, and
checking the medicine that you are given. Always ask if you are not
sure why you are getting a dose of medicine.
The following effects may happen:
In children: Excitation, moving unsteadily or stumbling, uncontrolled
writhing movements especially of the hands or feet, hallucinations, fits
(seizures), loss of consciousness, uneven heart beat and breathing
difficulties.

In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven
heart beat and breathing difficulties.
If you miss a dose of Phenergan Injection
Your doctor or nurse will have instructions on when to give you this
medicine. It is unlikely that you will not be given the medicine as it has
been prescribed. However if you do think you have missed a dose, tell
your doctor or nurse.
If you have any further questions on the use of this product, ask your
doctor or nurse.
Tests
Having Phenergan Injection may affect the results of certain tests.
These include some pregnancy tests and skin tests. Phenergan
Injection should not be given at least 3 days before the start of a skin
test.

4. Possible side effects
Like all medicines, Phenergan Injection can cause side effects,
although not everybody gets them.
Tell a doctor or nurse straight away if you have:
• An allergic reaction. The signs may include: a rash, hives, itchiness
swallowing or breathing problems, swelling of your lips, face, throat
or tongue
• 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)
• Tiredness which lasts for a long time. This may be due to a blood
problem called anaemia
• Over-active behaviour in children

CROMinFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

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 eyesight or you can not pass water (urine)
• Feeling drowsy or sleepy, tiredness, disorientation, having
nightmares, headaches, feeling restless
• If you have a headache this may be as a result of high blood pressure
and/or dehydration and you are advised to see your doctor.
• Loss of appetite (anorexia), sore stomach
• 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 Injection
• This medicine will be kept by your doctor or pharmacist in a safe
place where children cannot see or reach it
• Do not have Phenergan Injection after the expiry date which is
stated on the carton and ampoule after EXP. The expiry date refers to
the last day of that month
• Store in the original carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines no longer use.
These measures will help protect the environment.

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(int. version 1)

6. Contents of the pack and other Information
What Phenergan Injection contains
• Each 1ml ampoule contains 25mg of the active substance,
promethazine hydrochloride
• The other ingredients are sodium sulphite anhydrous (E221), sodium
metabisulphite (E223) and water for injection
What Phenergan Injection looks like and contents of the pack
Phenergan Injection is a colourless or almost colourless solution. Your
solution for injection is available in cartons containing 10 x 1ml
ampoules or 10 x 2ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
SANOFI S.P.A.
Loc. Valcanello
03012 Anagni (FR)
ITALY
This leaflet does not contain all the information about your medicine.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
This leaflet was last revised in 07/2016
© Sanofi, 1991 - 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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