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PHENERGAN ELIXIR 5MG/5ML ORAL SOLUTION

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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LIQUID MANUFACTURIN

G

Packaging code : 302287
Old packaging code : 301817

Format : 157x210-DCRL
Plant barcode : 287

Update : 17/09/2015 - V7

Colors :
Pantone Reflex Blue

Product : PHENERGAN ELIXIR 100 ml
Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : CR - CD
Plant : Colomiers

Logo version :

Phenergan Elixir
5mg/5ml Oral
Solution
promethazine hydrochloride

Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor
or pharmacist. This included any possible side
effects not listed in this leaflet. See section 4
• You must talk to a doctor if you do not feel better
or if you feel worse after 7 days.
What is in this leaflet :
1. What Phenergan Elixir is and what it is used for
2. What you need to know before you take
Phenergan Elixir
3. How to take Phenergan Elixir
4. Possible side effects
5. How to store Phenergan Elixir
6. Contents of the pack and other information
1. What Phenergan Elixir is and what it is
used for
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.
What Phenergan Elixir is used for
Phenergan Elixir is used to treat the following
conditions:

• For short term use: to treat adults with difficulty
sleeping (insomnia)
• 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
• For short term use: as a sedative for children aged
2 years and above
2. What you need to know before you take
Phenergan Elixir
Do not take this medicine 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)
✕ The person is unconscious (in a coma) or suffers
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.
Warnings and precautions
Check with your doctor or pharmacist
before taking your medicine 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 hearing problems
▲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
▲You have diabetes. This medicine contains
hydrogenated glucose syrup (see ‘Important
information about some of the ingredients of
Phenergan Elixir’ below)
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302287 - 287

PACKAGE LEAFLET:
INFORMATION FOR THE USER

LIQUID MANUFACTURIN

G

Packaging code : 302287
Old packaging code : 301817

Format : 157x210-DCRL
Plant barcode : 287

Update : 17/09/2015 - V7

Colors :
Pantone Reflex Blue

Product : PHENERGAN ELIXIR 100 ml
Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : CR - CD
Plant : Colomiers

Logo version :

If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Phenergan Elixir.
You may get high fever, muscle cramps or stiffness,
dizziness, very bad headache, fast heartbeat,
confusion, agitation, hallucinations, or are
sweating a lot. This may be signs of a very serious
and sometimes deadly health problem called
neuroleptic malignant syndrome. Stop taking your
medicine and tell your doctor immediately.
There have been some cases of abuse with this
medicine. The risk of abuse is greater in those with
a history of drug abuse.

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.

Phenergan Elixir 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
Other medicines and Phenergan Elixir
is equivalent to approximately 5 grams of sugar,
Please tell your doctor or pharmacist if you are
or one teaspoon of sugar/ sugar lump. Taking this
taking or have recently taken any other medicines.
amount of Phenergan Elixir is unlikely to affect
This includes medicines you can buy without
the control of your diabetes or require you to
prescription, including herbal medicines. This is
increase your diabetes medication. If you have
because Phenergan Elixir can affect the way some
medicines work. Also some medicines can affect the been told by your doctor that you cannot tolerate
or digest some sugars (have an intolerance to
way Phenergan Elixir works.
some sugars), talk to your doctor before taking
Do not take this medicine, and tell your
this medicine. Hydrogenated glucose syrup may
doctor, if you are taking or have taken the
have a mild laxative effect. The calorific value
following in the last 2 weeks:
of hydrogenated glucose syrup is 2.3kcal/g. A
• Some medicines for depression called
5ml dose (one teaspoon) contains approximately
monoamine oxidase inhibitors (MAOIs). If you
10kcal.
are not sure ask your doctor or pharmacist
• Sodium sulphite and sodium metabisulphite.
Tell your doctor or pharmacist if you are
These may rarely cause severe allergic
taking any of the following:
(hypersensitivity) reactions and difficulty
• Anticholinergic medicines - includes some
breathing, wheezing and tightness in the chest
medicines used for irritable bowel syndrome,
(bronchospasm)
asthma or weak bladder. These can increase the • Sodium. It contains 37mg sodium per dose (5ml).
risk of dizziness, dry mouth and blurred eyesight Take this into account if you are on a controlled
• Medicines for depression (such as amitriptyline)
sodium diet
• Medicines to help you to sleep or feel more
3. How to take Phenergan Elixir
relaxed (such as diazepam or zolpidem)
• Medicines such as aspirin (for arthritis and pain
Always use this medicine exactly as described in this
in your joints). Phenergan Elixir may hide the
leaflet or as your doctor or pharmacist has told you.
side effects of these medicines
Check with your doctor or pharmacist if you are not
sure.
Phenergan Elixir with food and drink
The amount you need to take depends on the
Do not drink alcohol while you are taking
reason you are taking Phenergan Elixir. The
Phenergan Elixir. This is because it can affect the
following information will help you to decide how
way the medicine works.
much you need to take.
Pregnancy and breast-feeding
Taking this medicine
Talk to your doctor or pharmacist before taking
• Take this medicine by mouth
this medicine if you are pregnant, might become
pregnant, or think you may be pregnant. Phenergan • Do not take for longer than 7 days. If your
symptoms worsen or do not improve after 7 days
Elixir should not be taken in the 2 weeks before
talk to your doctor or pharmacist
birth.
• After use, wipe the neck of the bottle with a clean
You should not take Phenergan Elixir if you are
damp cloth. This will remove any liquid that is
breast-feeding. This is because small amounts may
left, before putting the cap back on
pass into mothers’ milk. This can be harmful to
• If you feel the effect of your medecine is too weak
your baby.
2

LIQUID MANUFACTURIN

G

Packaging code : 302287
Old packaging code : 301817

Format : 157x210-DCRL
Plant barcode : 287

Update : 17/09/2015 - V7

Colors :
Pantone Reflex Blue

Product : PHENERGAN ELIXIR 100 ml
Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : CR - CD
Plant : Colomiers

Logo version :

or too strong, do not change the dose yourself,
but ask your doctor
How much to take
The recommended 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:
• Either a single dose of one to five 5ml
spoonfuls OR one or two 5ml spoonfuls twice
a day
• DO NOT give more than five 5ml spoonfuls
a 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 treatment and prevention of feeling sick or
being sick (such as 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 short term paediatric sedative and for short
term treatment of insomnia in adults
Children 2-5 years:
• Three or four 5ml spoonfuls as a single dose
at night time
Children 5-10 years:
• Four or five 5ml spoonfuls as a single dose at
night time
Children over 10 years and adults (including
the elderly):
• Use of Phenergan Tablets is recommended

Use this medicine only as recommended. Do not
exceed the recommended dose.
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.
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 problems.
In adults: Feeling sleepy or drowsy, fits, very fast,
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
Taking Phenergan Elixir may affect the results of
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.
4. Possible effects
Like all medicines, Phenergan Elixir can cause side
effects, although not everybody gets them.
Stop taking Phenergan Elixir and see a doctor
or go to a hospital straight away if you notice
any of the following side effects:
• 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)
3

LIQUID MANUFACTURIN

G

Packaging code : 302287
Old packaging code : 301817

Format : 157x210-DCRL
Plant barcode : 287

Update : 17/09/2015 - V7

Colors :
Pantone Reflex Blue

Product : PHENERGAN ELIXIR 100 ml
Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : CR - CD
Plant : Colomiers

Logo version :

• 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 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
Not known: frequency cannot be estimated
from the available data
• You have high fever, muscle cramps or stiffness,
dizziness, very bad headache, fast heartbeat,
confusion, agitation, hallucinations, or are
sweating a lot. This may be signs of a very serious
and sometimes deadly health problem called
neuroleptic malignant syndrome

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Phenergan Elixir contains.
• Each 5ml of solution contains 5mg of the active
substance, promethazine hydrochloride.
• The other ingredients are hydrogenated glucose
syrup (maltitol liquid), orange juice flavour,
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 and smells like and
contents of the pack
A clear, golden, syrupy liquid with an odour of
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer oranges contained in an amber glass bottle. Your
than a few days. Also tell them if you notice any elixir is available in glass bottles of 100ml.
side effects not listed in this leaflet.
Marketing Authorisation Holder and
• Dry mouth, blurred vision or you cannot pass
Manufacturer
water (urine)
Marketing Authorisation Holder
• Feeling drowsy or sleepy, tiredness, disorientation, Sanofi
having nightmares, headaches, feeling restless
One Onslow Street
• Loss of appetite (anorexia), indigestion
Guildford
• Feeling dizzy, lightheaded, faint (hypotension)
Surrey
• Feeling confused, especially in elderly people
GU1 4YS
• Being more sensitive to the sun than usual.
UK
• If this happens keep out of direct sunlight and do Tel: 0845 372 7101
not use sun lamps
email: uk-medicalinformation@sanofi.com

5. How to store Phenergan Elixir
• Keep this medicine out of the sight and reach 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

Manufacturer
Unither Liquid Manufacturing
1-3 Allee de la Neste
Z.I. d’en Signal
31770 Colomiers
France
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 09/2015
© Sanofi, 1973 - 2015

302287 - 287

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.

4

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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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