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PHENERGAN 25MG TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

What Phenergan Tablets are used for
Phenergan Tablets are 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 treat or stop you feeling sick
(nausea) or being sick (vomiting) such
as travel sickness
• For short term use: as a sedative for
children aged 5 years and above

Phenergan 25 mg
Tablets

promethazine hydrochloride
Is this leaflet hard to see or read?

2. What you need to know before you
take Phenergan Tablets

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 includes 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.

Do not take this medicine if:
 The person taking the medicine is
under 5 years of age
 You are allergic (hypersensitive) to
promethazine hydrochloride or any of
the other ingredients of Phenergan
Tablets (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
Tablets 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 Tablets.

What is in this leaflet:
1. What Phenergan Tablets are and what
they are used for
2. What you need to know before you
take Phenergan Tablets
3. How to take Phenergan Tablets
4. Possible side effects
5. How to store Phenergan Tablets
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
 You have a stomach blockage or
difficulty passing water

1. What Phenergan Tablets are
and what they are used for
Phenergan Tablets contain 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 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
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Phenergan Tablets.

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 Tablets should
not be taken 2 weeks before birth.

Other medicines and Phenergan
Tablets
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
Tablets can affect the way some medicines
work. Also some medicines can affect the
way Phenergan Tablets work.

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

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

Phenergan Tablets 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 before taking this medicine

You should not take Phenergan Tablets 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 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.

3. How to take Phenergan Tablets

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
Tablets may hide the side effects of
these medicines

Always use this medicine exactly as
described in this leaflet or as your doctor or
pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The amount you need to take depends on
the reason you are taking Phenergan
Tablets. The following information will help
you to decide how much you need to take.
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

Phenergan Tablets with food and drink
Do not drink alcohol while you are taking
Phenergan Tablets. This is because it can
affect the way the medicine works.
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Exposure to sunlight
Phenergan Tablets can make your skin
more sensitive to sunlight. Keep out of
direct sunlight while taking this medicine.

How much to take
The recommended dose is:
For allergies (such as hay fever, rashes
and hives)
Children 2-5 years:
• Phenergan Elixir should be given in
this age group
Children 5-10 years:
• A single tablet (25mg) given at night
• DO NOT give more than 25mg each
day
Children over 10 years and adults
(including the elderly):
• Start with one tablet (25mg) taken at
night
• This may be increased to a maximum
of one tablet (25mg) twice a day if
necessary

If you take more Phenergan Tablets
than you should
If you or your child takes more Phenergan
Tablets 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 or
your child has 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 heart beat and
breathing difficulties.
In adults: Feeling sleepy or drowsy, fits,
loss of consciousness, uneven heart beat
and breathing difficulties.

For treatment and prevention of feeling
sick or being sick (such as travel sickness)
Children 2-5 years:
• Phenergan Elixir should be given in
this age group
Children 5-10 years:
• Phenergan Elixir or Phenergan 10mg
Tablets should be given in this age
group
Children over 10 years and adults
(including the elderly):
• A single tablet (25 mg) to be taken the
night before the journey
• This may be repeated after 6-8 hours
if necessary

If you forget to take Phenergan Tablets
Do not take a double dose to make up for
a forgotten dose
• If you are taking Phenergan Tablets for
an allergic condition - take your
medicine as soon as you remember,
then carry on as before
• If you are taking Phenergan Tablets 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.

As a short term paediatric sedative and
for short term treatment of insomnia in
adults
Children 2-5 years:
• Phenergan Elixir should be given in
this age group
Children 5-10 years:
• A single tablet (25mg) given at night
Children over 10 years and adults
(including the elderly):
• One or two tablets (25mg-50mg)
taken at night

Tests
Taking Phenergan Tablets may affect the
results of certain tests. These include some
pregnancy tests and skin tests. Phenergan
Tablets should not be taken at least 3 days
before the start of a skin test.
4. Possible side effects
Like all medicines, Phenergan Tablets
can cause side effects, although not
everybody gets them.

Use this medicine only as recommended.
Do not exceed the recommended dose.
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Stop taking Phenergan Tablets 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
• Over-active behaviour in children

5. How to store Phenergan Tablets
• Keep this medicine out of the sight and
reach of children
• Do not take Phenergan Tablets 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.
6. Contents of the pack and other
Information
What Phenergan Tablets 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, hypromelloseE464 and indigo carmine aluminium
lake blue-E132) and hypromellose

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
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.

What Phenergan Tablets look 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 56.
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
FAMAR HEALTH CARE SERVICES MADRID
S.A.U. Avda. Leganés, 62, Alcorcón 28923
Madrid, Spain
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, 2003 - 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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