PROMETHAZINE HYDROCHLORIDE 25MG TABLETS

Active substance: PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR
THE USER

Phenergan 25mg Tablets
(promethazine hydrochloride)
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 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
symptoms worsen 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.
The name of your medicine is Phenergan
25mg Tablets but will be referred as
Phenergan throughout this leaflet.
In this leaflet:
1. What Phenergan is and what it is used for
2. Before you take Phenergan
3. How to take Phenergan
4. Possible side effects
5. How to store Phenergan
6. Further Information

1. What Phenergan is and what it
is used for
Phenergan 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 is used for
Phenergan can be given to you either by a
doctor or directly by a pharmacist depending
on the condition you are being treated for.
Phenergan 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 treat or stop you feeling sick (nausea)
or being sick (vomiting) such as travel
sickness
Phenergan 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
If you are having difficulty sleeping
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
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 (listed in
Section 6 overleaf) 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 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.

Take special care with Phenergan
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
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Phenergan.
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 because Phenergan can
affect the way some medicines work. Also
some medicines can affect the way
Phenergan 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
may hide the side effects of these
medicines
Taking Phenergan with food and drink
Do not drink alcohol while you are taking
Phenergan. This is because it can affect the
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 should not be taken 2 weeks
before birth.
You should not take Phenergan 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 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
This medicine contains:
Lactose monohydrate. 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

3. How to take Phenergan
The amount you need to take depends on
the reason you are taking Phenergan. 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
If you feel the effect of your medicine 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:
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
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
As a sedative (under the advice of a
doctor only)
Phenergan 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:
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
Exposure to sunlight
Phenergan can make your skin more
sensitive to sunlight. Keep out of direct
sunlight while taking this medicine.
If you take more Phenergan than you
should
If you or your child takes more Phenergan
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.
If you forget to take Phenergan
Do not take a double dose to make up for a
forgotten dose
If you are taking Phenergan for an allergic
condition - take your medicine as soon as
you remember, then carry on as before
If you are taking Phenergan 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 may affect the results of
certain tests. These include some pregnancy
tests and skin tests. Phenergan should not
be taken at least 3 days before the start of a
skin test.

4. Possible side effects
Like all medicines, Phenergan can cause
side effects, although not everybody gets
them.
Stop taking Phenergan 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)
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 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.

5. How to store Phenergan
.
Keep out of the sight and reach of children
Do not take your tablets after the expiry date
which is stated on the carton/blister after
„Exp‟. The expiry date refers to the last day
of that month.
Do not store above 30°C. Store in the
original package in order to protect from
light.
If the tablets become discoloured or show
any visible signs f deterioration, seek the
advice of your pharmacist.
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.
6. Further Information
What Phenergan contains.
Each film-coated tablet contains 25mg
promethazine hydrochloride. The other
ingredients are lactose monohydrate, maize
starch, povidone K30, magnesium stearate,
macrogol 200, indigo carmine (E132),
titanium dioxide (E171) and hypromellose.
What Phenergan looks like and contents
of the pack
Phenergan are pale blue, film-coated,
circular biconvex tablets marked „PN 25‟ on
one side and plain on the other.
Phenergan is available in blister pack of 56
tablets.
Manufactured by: Famar Healthcare
Services Madrid, S.A.U., Avenida de
Leganes 62, 28923 Alcoron, Spain.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Phenergan 25mg Tablets,
P
PL No: 18799/2345
Leaflet date: 20.10.2014
Phenergan is a registered trademark of
Sanofi.

PACKAGE LEAFLET: INFORMATION FOR
THE USER

Promethazine hydrochloride 25mg
Tablets
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
Promethazine 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
symptoms worsen 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.
The name of your medicine is Promethazine
hydrochloride 25mg Tablets but will be
referred as Promethazine throughout this
leaflet.
In this leaflet:
1. What Promethazine is and what it is used
for
2. Before you take Promethazine
3. How to take Promethazine
4. Possible side effects
5. How to store Promethazine
6. Further Information
1. What Promethazine is and
what it is used for
Promethazine 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 Promethazine is used for
Promethazine can be given to you either by
a doctor or directly by a pharmacist
depending on the condition you are being
treated for.
Promethazine 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 treat or stop you feeling sick (nausea)
or being sick (vomiting) such as travel
sickness
Promethazine 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
If you are having difficulty sleeping
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 Promethazine
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 Promethazine (listed
in Section 6 overleaf) 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 Promethazine 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
Promethazine.

Take special care with Promethazine
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
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Promethazine.
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 because Promethazine
can affect the way some medicines work.
Also some medicines can affect the way
Promethazine 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). Promethazine
may hide the side effects of these
medicines
Taking Promethazine with food and drink
Do not drink alcohol while you are taking
Promethazine. This is because it can affect
the 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.
Promethazine should not be taken 2 weeks
before birth.
You should not take Promethazine 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 after taking
this medicine. If this happens, do not drive or
use any tools or machines.
Important information about some of the
ingredients of Promethazine
This medicine contains:
Lactose monohydrate. 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

3. How to take Promethazine
The amount you need to take depends on
the reason you are taking Promethazine.
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
If you feel the effect of your medicine 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:
Promethazine 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
For treatment and prevention of feeling
sick or being sick (such as travel
sickness)
Children 2-5 years:
Promethazine Elixir should be given in
this age group
Children 5-10 years:
Promethazine Elixir or Promethazine
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
As a sedative (under the advice of a
doctor only)
Promethazine 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:
Promethazine 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
Exposure to sunlight
Promethazine can make your skin more
sensitive to sunlight. Keep out of direct
sunlight while taking this medicine.
If you take more Promethazine than you
should
If you or your child takes more Promethazine
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.
If you forget to take Promethazine
Do not take a double dose to make up for a
forgotten dose
If you are taking Promethazine for an
allergic condition - take your medicine as
soon as you remember, then carry on as
before
If you are taking Promethazine 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 Promethazine may affect the results
of certain tests. These include some
pregnancy tests and skin tests.
Promethazine should not be taken at least 3
days before the start of a skin test.

4. Possible side effects
Like all medicines, Promethazine can cause
side effects, although not everybody gets
them.
Stop taking Promethazine 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)
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 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.
5. How to store Promethazine
.
Keep out of the sight and reach of children
Do not take your tablets after the expiry date
which is stated on the carton/blister after
„Exp‟. The expiry date refers to the last day
of that month.
Do not store above 30°C. Store in the
original package in order to protect from
light.
If the tablets become discoloured or show
any visible signs f deterioration, seek the
advice of your pharmacist.
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.
6. Further Information
What Promethazine contains.
Each film-coated tablet contains 25mg
promethazine hydrochloride. The other
ingredients are lactose monohydrate, maize
starch, povidone K30, magnesium stearate,
macrogol 200, indigo carmine (E132),
titanium dioxide (E171) and hypromellose.
What Promethazine looks like and
contents of the pack
Promethazine are pale blue, film-coated,
circular biconvex tablets marked „PN 25‟ on
one side and plain on the other.
Promethazine is available in blister pack of
56 tablets.
Manufactured by: Famar Healthcare
Services Madrid, S.A.U., Avenida de
Leganes 62, 28923 Alcoron, Spain.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Promethazine 25mg Tablets,
P
PL No: 18799/2345
Leaflet date: 20.10.2014

Expand view ⇕

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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