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PHENERGAN 25 MG FILM COATED TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Phenergan® 25 mg Film coated Tablets
promethazine hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Phenergan is available in other strengths and formats
Your medicine is called Phenergan 25 mg Film coated Tablets but
throughout this leaflet will be referred to as Phenergan Tablets






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.

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
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.
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
2. What you need to know before you take Phenergan
Tablets
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.
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
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Phenergan Tablets.
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.
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.
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 Tablets may hide the side effects of these
medicines
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.
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.
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.
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 or the
morning after taking this medicine. If this happens, do not drive or
use any tools or machines.
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
3. How to take Phenergan Tablets
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

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
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 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
Use this medicine only as recommended.
Do not exceed the recommended dose.
Exposure to sunlight
Phenergan Tablets can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.
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.
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.
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.
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

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
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 Tablets
• Keep 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
• Do not store above 30°C
• Store in the original carton in order to protect from light
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. 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 monohydrate, maize starch,
povidone K30, magnesium stearate, macrogol 200, indigo carmine
(E132), titanium dioxide (E171) and hypromellose.
What Phenergan Tablets look like and contents of the pack
A pale blue film coated tablet marked PN 25 on one side and plain
on the reverse.
The tablets are available in blister packs of 56.
Manufacturer:
Famar Health Care Services Madrid S.A.U.,
Avenida de Leganes 62,
28923 Alcorcon
Spain.
Procured from within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD
PL 19065/0390
This leaflet was last revised 08/12/2015
E0390/4
Phenergan® is a registered trade mark

P

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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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