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PHENERGAN NIGHT TIME 25MG FILM-COATED TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

What Phenergan Night Time is used for

Phenergan Night Time is used to treat
the following conditions:
• For short term use: to treat adults
with difficulty sleeping (insomnia)
• For short term use: as a sedative for
children aged 16 years and above

Phenergan Night Time
25mg Film-coated Tablets
promethazine hydrochloride

2. What you need to know before you
take Phenergan Night Time

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

Do not take this medicine if:
 The person taking the medicine is
under 16 years of age
 You are allergic (hypersensitive) to
promethazine hydrochloride or any of
the other ingredients of Phenergan
Night Time (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 Night Time 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 “Other medicines and
Phenergan Night Time” 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 Night Time.

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 the 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 includes any
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 Night Time is and
what it is used for
2. What you need to know before you
take Phenergan Night Time
3. How to take Phenergan Night Time
4. Possible side effects
5. How to store Phenergan Night Time
6. Contents of the pack and other
information

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

1. What Phenergan Night Time
is and what it is used for
Phenergan Night Time 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.

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 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

Phenergan Night Time with food and
drink
Do not drink alcohol while you are taking
Phenergan Night Time. This is because it
can affect the way the medicine works.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before
taking this medicine if you are pregnant,
might become pregnant, or think you may
be pregnant. Phenergan Night Time
should not be taken 2 weeks before birth.
You should not take Phenergan Night Time
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.

This medicine is for short term sleeping
problems. It should not be used for more
than 7 days without talking to your doctor.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Phenergan Night Time.
Other medicines and Phenergan
Night Time
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 Night
Time can affect the way some medicines
work. Also some medicines can affect the
way Phenergan Night Time works.

Driving and using machines
You may feel drowsy or sleepy after taking
this medicine or the morning after taking
this medicine. If this happens, do not
drive or use any tools or machines.
Phenergan Night Time contains
lactose:
• This is a type of sugar. 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 or pharmacist before taking this
medicine.

Do not take this medicine, and tell
your doctor or pharmcist, 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

3. How to take Phenergan Night Time

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
Night Time may hide the side effects of
these medicines

Always take this medicine exactly as
described in the leaflet or as your doctor or
pharmacist has told you. 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
• If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor
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How much to take
The recommended dose is:

4. Possible side effects
Like all medicines, Phenergan Night Time
can cause side effects, although not
everybody gets them.
Stop taking Phenergan Night Time 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)
• 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)
• Irregular heartbeat
• Tiredness which lasts for a long time.
This may be due to a blood problem
called anaemia

Adults (including the elderly) and
children over 16 years of age:
• One or two tablets (25mg-50mg)
taken at night
Use this medicine only as recommended.
Do not exceed the recommended dose.
Exposure to sunlight
Phenergan Night Time can make your skin
more sensitive to sunlight. Keep out of
direct sunlight while taking this medicine.
If you take more Phenergan Night Time
than you should
If you or your child takes more Phenergan
Night Time 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.
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 heartbeat and
breathing difficulties.

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
cannot 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

In adults: Feeling sleepy or drowsy, fits,
loss of consciousness, uneven heart beat
and breathing difficulties
If you forget to take Phenergan Night
Time
Do not take a double dose to make up for
a forgotten dose, 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 Night Time may affect
the results of certain tests. These include
some pregnancy tests and skin tests.
Phenergan Night Time should not be
taken at least 3 days before the start of a
skin test.

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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

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 Night Time

Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganes, 62,
Alcorcon 28923 (Madrid) Spain

• Keep this medicine out of the sight and
reach of children
• Do not take Phenergan Night Time
after the expiry date which is stated on
the carton and blister pack after EXP.
The expiry date refers to the last day of
that month
• Store below 30°C
• 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
you no longer use. These measures will
help protect the environment.

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: 01/2017
© Sanofi, 2003 – 2017
SIX HELPFUL STEPS FOR A GOOD
NIGHT’S SLEEP
• Go to bed when you feel tired and
avoid sleep during the day.
• Get up at the same time every
morning.
• Make time for some gentle exercise
during the day, preferably in the
afternoon or early evening but not
just before going to bed.
• Sleep in a dark, well ventilated
room on a comfortable bed.
• Every night, before bedtime, do
something to help you relax and
take your mind off the stresses of
the day.
• A small warm milky drink may help
you sleep, but avoid alcohol, tea,
coffee and cocoa since these may
keep you awake, as can late night
eating.

6. Contents of the pack and other
information
What Phenergan Night Time contains.
• Each tablet contains 25mg of the active
substance, promethazine
hydrochloride
• The other ingredients are lactose,
maize starch, povidone, magnesium
stearate, polyethylene glycol, Opaspray
(contains titanium dioxide-E171,
hypromellose-E464 and indigo carmine
aluminium lake blue-E132) and
hypromellose
What Phenergan Night Time looks like
and contents of the pack
A pale blue film coated tablet marked PN
25 on one side. The tablets are available
in blister packs of 14.
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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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