PHENERGAN ELIXIR 5MG/5ML ORAL SOLUTION

Active substance: PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Phenergan Elixir
5mg/5ml Oral
Solution
promethazine hydrochloride

see or read?
Phone 01483 505515
for help
contains important information for you.
This medicine is available without prescription.
However, you still need to take Phenergan Elixir
carefully to get the best results from it.
• 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.
please tell your doctor or pharmacist.
1. What Phenergan Elixir is and what it is used for
2. Before you take Phenergan Elixir
3. How to take Phenergan Elixir
5. How to store Phenergan Elixir
6. Further Information
1. What Phenergan Elixir is and what it is
used for

Phenergan Elixir may be provided directly by a
pharmacist for use in the following situations:
• To treat allergic conditions such as hay fever or
rashes (like nettle rash or hives)
• To stop you feeling sick (nausea) or being sick
(vomiting) such as travel sickness
Phenergan Elixir may also be given to you by a
doctor. This can be for use in any of the above
situations or for use in the following additional
situations:
• To help you feel more relaxed before an
operation
• As a sedative for both adults and children. This
is a medicine given to reduce awareness or
make you feel relaxed and at ease
2. Before you take Phenergan Elixir
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 Elixir (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
You are taking a medicine for depression called
a monoamine oxidase inhibitor (MAOI). Also do
not take Phenergan Elixir 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)
from severe dizziness, drowsiness or headache
Do not take this medicine if any of the above
applies to you.
If you are not sure, talk to your doctor or
pharmacist before taking Phenergan Elixir.
Take special care with Phenergan Elixir
Check with your doctor or pharmacist
before taking your medicine if:

Phenergan Elixir 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.

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

What Phenergan Elixir is used for
Phenergan Elixir can be given to you either by a
doctor or directly by a pharmacist depending on
the condition you are being treated for.

passing water
You have increased pressure in the eye (narrow
angle glaucoma)
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How much to take
The usual dose is:
For allergies (such as hay fever, rashes and
hives)
Children 2-5 years:
• Either a single dose of one to three 5ml
spoonfuls OR one 5ml spoonful twice a day
• DO NOT give more than three 5ml spoonfuls
a day
Children 5-10 years:
spoonfuls OR one or two 5ml spoonfuls twice
a day
day
Children over 10 years and adults (including
the elderly):
• Start with two 5ml spoonfuls twice a day
• This may be increased to a maximum of four
5ml spoonfuls three times a day
For children over 10 years and adults,
Phenergan Tablets may be more convenient
For travel sickness
Children 2-5 years:
• One 5ml spoonful the night before the
journey
• This may be repeated after 6-8 hours if
necessary
Children 5-10 years:
• Two 5ml spoonfuls the night before the
journey
• This may be repeated after 6-8 hours if
necessary
Children over 10 years and adults (including
the elderly):
• Five 5ml spoonfuls the night before the
journey
• This may be repeated after 6-8 hours if
necessary
For children over 10 years and adults,
Phenergan Tablets may be more convenient
As a sedative
Phenergan Elixir may also be used as a short term
sedative. This will normally have been prescribed
by a doctor. The information below is a guide to
the doses recommended

Children 2-5 years:
• Three or four 5ml spoonfuls as a single dose
at night time
Children 5-10 years:
night time
Children over 10 years and adults (including
the elderly):
• Use of Phenergan Tablets is recommended
Exposure to sunlight
Phenergan Elixir can make your skin more
sensitive to sunlight. Keep out of direct sunlight
while taking this medicine.
If you take more Phenergan Elixir than you
should
If you take more Phenergan Elixir than you should,
tell a doctor or go to a hospital casualty
department straight away. Take the medicine pack
with you. This is so the doctor knows what you
have taken. Also do this if a child under 2 years of
age swallows some of this medicine.
In children: Excitation, moving unsteadily or
stumbling, uncontrolled writhing movements
(seizures) loss of consciousness, uneven heart beat
and breathing problems.
In adults:
uneven or forceful heartbeat (palpitations), loss of
consciousness, breathing problems.
If you forget to take Phenergan Elixir
Do not take a double dose to make up for a
forgotten dose
• If you are taking Phenergan Elixir for an allergic
condition - take your medicine as soon as you
remember, then carry on as before
• If you are taking Phenergan Elixir for sedation or
sleeping problems - miss that dose and take the
next evening’s dose as usual
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.
Tests
certain tests. These include some pregnancy tests
and skin tests. Phenergan Elixir should not
be taken at least 3 days before the start of a
skin test.

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467

weak or too strong, do not change the dose
yourself, but ask your doctor

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You have had something called Reye’s Syndrome
or possible Reye’s Syndrome – signs include
being sick and confused following a viral illness
You have diabetes. This medicine contains
hydrogenated glucose syrup (see ‘Important
information about some of the ingredients of
Phenergan Elixir’ below)
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Phenergan Elixir.
Taking other medicines
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

the way Phenergan Elixir 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 Elixir may hide the
Taking Phenergan Elixir with food and drink
Do not drink alcohol while you are taking
way the medicine works.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant, or
think you may be pregnant. Phenergan Elixir
should not be taken in the 2 weeks before birth.

You should not take Phenergan Elixir if you are
breast-feeding. This is because small amounts may
pass into mothers’ milk. This can be harmful to
your baby.
If you are breast-feeding or planning to
breast-feed, talk to your doctor or pharmacist
before taking any medicine.
Driving and using machines
You may feel drowsy or sleepy while taking this
medicine or in the morning after taking this
medicine. If this happens, do not drive or use any
tools or machines.
Important information about some of the
ingredients of Phenergan Elixir
This medicine contains:
• Hydrogenated glucose syrup (maltitol liquid). This is
a type of carbohydrate which the body will convert
into small amounts of sugar. The maximum 25ml
single dose of Phenergan Elixir is equivalent to
approximately 5 grams of sugar, or one teaspoon of
sugar/ sugar lump. Taking this amount of
your diabetes or require you to increase your
diabetes medication. If you have been told by your
doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to
your doctor before taking this medicine.
Hydrogenated glucose syrup may have a mild
glucose syrup is 2.3kcal/g. A 5ml dose (one
teaspoon) contains approximately 10kcal.
• Sodium sulphite and sodium metabisulphite.
These may rarely cause severe allergic
breathing, wheezing and tightness in the chest
(bronchospasm)
• Sodium. It contains 37mg sodium per dose
(5ml). Take this into account if you are on a
controlled sodium diet
3. How to take Phenergan Elixir
The amount you need to take depends on the
reason you are taking Phenergan Elixir. The
following information will help you to decide how
much you need to take. You should check with
your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Do not take for longer than 7 days. If your
symptoms worsen or do not improve after 7
days talk to your doctor or pharmacist
• After use, wipe the neck of the bottle with a
clean damp cloth. This will remove any liquid
that is left, before putting the cap back on

2

Stop taking Phenergan Elixir and see a doctor
or go to a hospital straight away if you notice
• An allergic reaction. The signs may include:
a rash, 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)
• 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 heartbeat or forceful
heartbeat (palpitations)
• Irregular heartbeat
• Tiredness which lasts for a long time. This may
be due to a blood problem called anaemia
• Over-active behaviour in children
Tell your doctor or pharmacist if any of the
than a few days. Also tell them if you notice
• Dry mouth, blurred vision or you can not pass
water (urine)
• Feeling drowsy or sleepy, tiredness,
disorientation, having nightmares,
headaches, feeling restless
• Loss of appetite (anorexia), indigestion
• 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
5. How to store Phenergan Elixir
• Keep out of the reach and sight of children
• Do not use Phenergan Elixir after the expiry date
which is stated on the carton and bottle label.
The expiry date refers to the last day of that
month
• Do not use Phenergan Elixir after the bottle has
been opened for more than a month
• Store below 25°C
• Keep the bottle in the outer carton in order to
protect from light

6. Further Information
What Phenergan Elixir contains.
• Each 5ml of solution contains 5mg of the
active substance, promethazine
hydrochloride.
• The other ingredients are hydrogenated glucose
caramel (E150), sodium benzoate (E211), sodium
sulphite anhydrous (E221), sodium
metabisulphite (E223), ascorbic acid (E300), citric
acid anhydrous (E330), sodium citrate (E331),
acesulphame potassium (E950) and water.
What Phenergan Elixir looks like and contents
of the pack
A clear, golden, syrupy liquid contained in an
amber glass bottle. Your elixir is available in glass
bottles of 100ml.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing
1-3 Allee de la Neste
Z.I. d’en Signal
31770 Colomiers
France
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 November 2012
© Sanofi, 1973 - 2012
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467

Like all medicines, Phenergan Elixir can cause side

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

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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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