PHENERGAN ELIXIR 5MG/5ML ORAL SOLUTION

Active substance: PROMETHAZINE HYDROCHLORIDE

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LIQUID MANUFACTURIN

G

Packaging code : 301817
Old packaging code : 301467

Format : 157x210-DCRL
Plant barcode : 817

Update : 29/11/2013 - V2

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 : JL
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 because it
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.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your
symptomsworsen or do not improve after 7 days.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
See section 4
In this leaflet :
1. What Phenergan Elixir is and what it is used for
2. Before you take Phenergan Elixir
3. How to take Phenergan Elixir
4. Possible side effects
5. How to store Phenergan Elixir
6. Further 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 can be given to you either by a
doctor or directly by a pharmacist depending on
the condition you are being treated 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 treat adults with difficulty sleeping (insomnia)
• 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)
✕ 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.
Take special care with Phenergan Elixir
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 increased pressure in the eye (narrow
angle glaucoma)
301817 - 817

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1

LIQUID MANUFACTURIN

G

Packaging code : 301817
Old packaging code : 301467

Format : 157x210-DCRL
Plant barcode : 817

Update : 29/11/2013 - V2

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 : JL
Plant : Colomiers

Logo version :

If you feel the effect of your medecine is too weak
or too strong, do not change the dose yourself, but
ask your doctor
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:
• Either a single dose of one to five 5ml
spoonfuls OR one or two 5ml spoonfuls twice
a day
• DO NOT give more than 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 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:
• 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
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.
▲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.
2

LIQUID MANUFACTURIN

G

Packaging code : 301817
Old packaging code : 301467

Format : 157x210-DCRL
Plant barcode : 817

Update : 29/11/2013 - V2

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 : JL
Plant : Colomiers

Logo version :

Important information about some of the
ingredients of Phenergan Elixir
Taking other medicines
This medicine contains:
Please tell your doctor or pharmacist if you are
• Hydrogenated glucose syrup (maltitol liquid).
taking or have recently taken any other medicines.
This is a type of carbohydrate which the body
This includes medicines you can buy without
will convert into small amounts of sugar. The
prescription, including herbal medicines. This is
maximum 25ml single dose of Phenergan Elixir
because Phenergan Elixir can affect the way some
is equivalent to approximately 5 grams of sugar,
medicines works. Also some medicines can affect
or one teaspoon of sugar/ sugar lump. Taking this
the way Phenergan Elixir works.
amount of Phenergan Elixir is unlikely to affect
the control of your diabetes or require you to
Do not take this medicine, and tell your
increase your diabetes medication. If you have
doctor, if you are taking or have taken the
been told by your doctor that you cannot tolerate
following in the last 2 weeks:
or digest some sugars (have an intolerance to
• Some medicines for depression called
some sugars), talk to your doctor before taking
monoamine oxidase inhibitors (MAOIs). If you
this medicine. Hydrogenated glucose syrup may
are not sure ask your doctor or pharmacist
have a mild laxative effect. The calorific value
Tell your doctor or pharmacist if you are
of hydrogenated glucose syrup is 2.3kcal/g. A
taking any of the following:
5ml dose (one teaspoon) contains approximately
• Anticholinergic medicines - includes some
10kcal.
medicines used for irritable bowel syndrome,
• Sodium sulphite and sodium metabisulphite.
asthma or weak bladder. These can increase the
These may rarely cause severe allergic
risk of dizziness, dry mouth and blurred eyesight (hypersensitivity) reactions and difficulty
• Medicines for depression (such as amitriptyline)
breathing, wheezing and tightness in the chest
• Medicines to help you to sleep or feel more
(bronchospasm)
relaxed (such as diazepam or zolpidem)
• Sodium. It contains 37mg sodium per dose (5ml).
• Medicines such as aspirin (for arthritis and pain
Take this into account if you are on a controlled
in your joints). Phenergan Elixir may hide the
sodium diet
side effects of these medicines
3. How to take Phenergan Elixir
Taking 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. You should check with
Pregnancy and breast-feeding
your doctor or pharmacist if you are not sure.
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant, or think Taking this medicine
you may be pregnant. Phenergan Elixir should not • Take this medicine by mouth
• Do not take for longer than 7 days. If your
be taken in the 2 weeks before birth.
symptoms worsen or do not improve after 7 days
You should not take Phenergan Elixir if you are
talk to your doctor or pharmacist
breast-feeding. This is because small amounts may
• After use, wipe the neck of the bottle with a
pass into mothers’ milk. This can be harmful to
clean damp cloth. This will remove any liquid
your baby.
that is left, before putting the cap back on
If you are breast-feeding or planning to breast-feed,
talk to your doctor or pharmacist before taking any 4. Possible effects
medicine.
Like all medicines, Phenergan Elixir can cause side
effects, although not everybody gets them.
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.

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 : 301817
Old packaging code : 301467

Format : 157x210-DCRL
Plant barcode : 817

Update : 29/11/2013 - V2

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 : JL
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
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 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
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 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

• 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 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
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
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 November 2013
© Sanofi, 1973 - 2013

6. Further Information
What Phenergan Elixir contains.
• Each 5ml of solution contains 5mg of the active
substance, promethazine hydrochloride.

301817 - 817

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.

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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