PACKAGE LEAFLET: • For short term use: to treat adults with

INFORMATION FOR THE USER difficulty sleeping (insomnia)

• For short term use: as a sedative for children
25 mg aged 6 years and above

Tablets 2. What you need to know before you take

Phenergan Tablets
promethazine hydrochloride
Do not take Phenergan Tablets if:
 The person taking the medicine is under
6 years of age.
Is this leaflet hard to see or read?  You are allergic (hypersensitive) to
Phone 0800 035 2525 for help promethazine hydrochloride or any of the
other ingredients of this medicine (listed in
Read all of this leaflet carefully before you section 6). The signs of an allergic reaction
start taking this medicine because it contains include: a rash, swallowing or breathing
important information for you. problems, swelling of your lips, face, throat
Always take this medicine exactly as described in or tongue.
this leaflet or as your doctor or pharmacist has  You are taking a medicine for depression
told you. called a monoamine oxidase inhibitor (MAOI).
• Keep this leaflet. You may need to read it again
Also do not take Phenergan Tablets if you
• Ask your pharmacist if you need more
have stopped taking one of these MAOI
information or advice
medicines within the last 14 days.
• If you get any side effects, talk to your doctor
If you are not sure ask your doctor or
or pharmacist. This includes any possible side
pharmacist (see ’Other medicines and
effects not listed in this leaflet (see section 4).
Phenergan Tablets’)
• You must talk to a doctor if you do not feel
 The person is unconscious (in a coma) or
better or if you feel worse after 7 days.
suffers from severe dizziness, drowsiness or
What is in this leaflet: headache
1. What Phenergan Tablets are and what they are Do not take this medicine if any of the above
used for applies to you. If you are not sure, talk to your
2. What you need to know before you take doctor or pharmacist before taking Phenergan
Phenergan Tablets Tablets.
3. How to take Phenergan Tablets
4. Possible side effects
5. How to store Phenergan Tablets Warnings and precautions
6. Contents of the pack and other Information Check with your doctor or pharmacist before
1. What Phenergan Tablets are and taking Phenergan Tablets if:
what they are used for  You have difficulty breathing, wheezing,
tightness in the chest (asthma) or an infection
Phenergan Tablets contain a medicine called in your lungs (bronchitis).
promethazine hydrochloride.  You have seizure disorders such as epilepsy.
This belongs to a group of medicines called  You experience an allergic reaction (see section
phenothiazines. It works by blocking a natural Side Effects), seek medical help right away.
substance (histamine) that your body makes  You have any serious heart problems.
during an allergic reaction. It also works directly  You have any personal or family history of
on the brain to help you feel more relaxed. heart disease
What Phenergan Tablets are used for  You have an irregular heartbeat
Phenergan Tablets are used to treat the following  You develop a fever or an infection. Talk to
conditions: your doctor immediately as laboratory tests to
• To treat allergic conditions such as hay fever or check your blood count may be required.
rashes (like nettle rash or hives)  You have liver or kidney problems.
• To treat or stop you feeling sick (nausea) or  You have a stomach blockage or
being sick (vomiting) such as travel sickness difficulty passing water.
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 You have hearing problems. • Medicines for mental health problems
 You have increased pressure in the eye (antipsychotics such as haloperidol and
(narrow angle glaucoma). quetiapine) or depression (antidepressants
 You have had something called Reye's such as amitriptyline and citalopram).
Syndrome or possible Reye's Syndrome signs • Medicines to help you to sleep or feel more
include being sick and confused following a relaxed (such as diazepam or zolpidem)
viral illness. • Medicines such as aspirin (for arthritis and
pain in your joints). Phenergan Tablets may
Exposure to sunlight
hide the side effects of these medicines
Phenergan Tablets can make your skin more
• Medicines for the treatment of irregular
sensitive to sunlight. Keep out of direct sunlight
heartbeats (antiarrhythmics such as quinidine
while taking this medicine.
and amiodarone).
Tests • Medicines for the treatment of epilepsy or
Taking Phenergan Tablets may affect the results of seizures
certain tests. These include some pregnancy tests • Antimicrobials (such as erythromycin and
and skin tests. Phenergan Tablets should not be levofloxacin) for the treatment of infections.
taken at least 3 days before the start of a skin test.
Phenergan Tablets with alcohol
If you are not sure if any of the above apply to Do not drink alcohol while you are taking
you, talk to your doctor or pharmacist before Phenergan Tablets. This is because it can affect
taking Phenergan Tablets. the way the medicine works.
Children and adolescents Pregnancy and breastfeeding
Do not use in children less than 6 years of age. Use of Phenergan Tablets is not recommended
Because of the risk of choking, the tablets should during pregnancy. Talk to your doctor or
be avoided in children who have difficulty pharmacist before taking this medicine if you are
swallowing tablets. a woman of childbearing age and not using
effective contraception, or if you are pregnant,
Other medicines and Phenergan might become pregnant, or think you may be
Tablets pregnant. Phenergan Tablets should not be taken
Tell your doctor or pharmacist if you are taking, 2 weeks before birth.
have recently taken or might take any other You should not take Phenergan Tablets if you are
medicines. This includes medicines you can buy breastfeeding. This is because small amounts may
without prescription, including herbal medicines. pass into mothers’ milk. This can be harmful to
This is because Phenergan Tablets can affect the your baby.
way some medicines work. Also some medicines
can affect the way Phenergan Tablets work. If you are breastfeeding or planning to breastfeed,
talk to your doctor or pharmacist before taking
In particular, do not take this medicine, and any medicine.
tell your doctor, if you are taking or have
taken the following in the last 2 weeks:
• Some medicines for depression called Driving and using machines
monoamine oxidase inhibitors (MAOIs). You may feel drowsy, dizzy or sleepy or have
If you are not sure ask your doctor or blurred vision after taking this medicine or the
pharmacist morning after taking this medicine. If this
happens, do not drive or use any tools or
Also tell your doctor or pharmacist if you are machines. You should not drive a vehicle or
taking, have recently taken or might take any operate machinery until you know how
of the following: Phenergan Tablets affect you.
• Anticholinergic medicines – includes some
medicines used for irritable bowel syndrome, Phenergan Tablets contains lactose:
asthma or weak bladder. These can increase If you have been told by your doctor that you have
the risk of dizziness, dry mouth and blurred an intolerance to some sugars, contact your doctor
eyesight before taking this medicinal product

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 If you take more Phenergan Tablets than you
3. How to take Phenergan Tablets
should
Always use this medicine exactly as described in If you or your child takes more Phenergan Tablets
this leaflet or as your doctor or pharmacist has than you should, tell a doctor or go to a hospital
told you. Check with your doctor or pharmacist if casualty department straight away. Take the
you are not sure. medicine pack with you. This is so the doctor
knows what you or your child has taken.
The amount you need to take depends on the The following symptoms of an overdose may
reason you are taking Phenergan Tablets. The occur: fits (seizures), impaired consciousness,
following information will help you to decide coma, uneven heart beat and depressed breathing.
how much you need to take. Children may experience excitation, unsteady or
Taking this medicine uncontrollable movements especially of the hands
• Take this medicine by mouth or feet, hallucinations, limited ability to learn and
• Do not take for longer than 7 days. impairments in thinking, learning, or memory.
If your symptoms worsen or do not improve If you forget to take Phenergan Tablets
after 7 days talk to your doctor or pharmacist Do not take a double dose to make up for a
• Use this medicine only as recommended. Do forgotten dose
not exceed the recommended dose. • If you are taking Phenergan Tablets for an
• If you feel the effect of your medicine is too allergic condition - take your medicine as soon
weak or too strong, do not change the dose as you remember, then carry on as before
yourself, but ask your doctor • If you are taking Phenergan Tablets for
How much to take sedation or sleeping problems - miss that
dose and take the next evening’s dose as usual
The recommended dose is:
If you have any further questions on the use of
For allergies (such as hay fever, rashes and
this product, ask your doctor or pharmacist.
hives)
Children 6-10 years: 4. Possible side effects
• A single tablet (25mg) given at night
• DO NOT give more than 25mg each day Like all medicines, Phenergan Tablets can cause
Children over 10 years and adults (including side effects, although not everybody gets them.
the elderly):
Stop taking Phenergan Tablets and see a
• Start with one tablet (25mg) taken at night
doctor or go to a hospital straight away if
• This may be increased to a maximum of one
you notice any of the following side effects:
tablet (25mg) twice a day if necessary
• Allergic reactions (that can occur either
For treatment and prevention of feeling sick immediately or within several days of drug
or being sick (such as travel sickness) administration) that may be life-threatening.
Children 6-10 years: Symptoms may include rash, itching, difficulty
• Phenergan Elixir should be given in this age breathing, shortness of breath, swelling of the
group face, lips, throat, or tongue, cold, clammy skin,
Children over 10 years and adults (including palpitations, dizziness, weakness or fainting
the elderly): • Liver problems that may cause the eyes or skin
• A single tablet (25 mg) to be taken the night to go yellow (jaundice) and darkening of urine
before the journey • Muscle stiffness or shaking
• This may be repeated after 6-8 hours if • Unusual movements of the tongue, facial
necessary muscle spasms or being unable to control
some muscles in your face, rolling eyes and
As a short term paediatric sedative and for trembling
short term treatment of insomnia in adults • Very fast, irregular, uneven or forceful
Children 6-10 years: heartbeat (palpitations)
• A single tablet (25mg) given at night • General weakness, more frequent
Children over 10 years and adults (including infections (particularly throat infection)
the elderly): and fever due to changes in the blood
• One or two tablets (25-50mg) taken at night (agranulocytosis)
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• Eosinophilia which is an increase in the number Do not throw away any medicines via wastewater
of eosinophils (a type of white blood cell). or household waste. Ask your pharmacist how to
Eosinophilia will be detected by a blood test. throw away medicines you no longer use. These
• Thrombocytopenia which is a decrease in the measures will help protect the environment.
number of platelets (cells in the blood that
6. Contents of the pack and other
help with clotting) found in a blood test,
Information
which can lead to bleeding and bruising
(thrombocytopenic purpura). What Phenergan Tablets contain.
• Tiredness which lasts for a long time. This may • Each tablet contains 25mg of the active
be due to a blood problem called anaemia. substance, promethazine hydrochloride
• A feeling of aggression, hallucinations and • The other ingredients are lactose, maize
hyperactivity in children starch, povidone, magnesium stearate,
polyethylene glycol, Opaspray (contains
Tell your doctor or pharmacist if any of the
titanium dioxide-E171, hypromellose- E464
following side effects get serious or lasts and indigo carmine aluminium lake
longer than a few days. blue-E132) and hypromellose
• Dry mouth, blurred vision or you cannot pass
water (urine) What Phenergan Tablets look like and contents
• Feeling drowsy or sleepy, tiredness, of the pack
disorientation, having nightmares, headaches, A pale blue film coated tablet marked PN 25 on
feeling restless one side. The tablets are available in blister packs
• Loss of appetite (anorexia), indigestion or of 56.
irritated stomach Marketing Authorisation Holder and
• Feeling dizzy, lightheaded, faint (hypotension) Manufacturer
• Feeling confused, especially in elderly people Marketing Authorisation Holder
• Being more sensitive to the sun than usual. If Sanofi
this happens keep out of direct sunlight and 410 Thames Valley Park Drive
do not use sun lamps Reading
• Unpleasant sensation or an overwhelming Berkshire
urge to move the legs (also called Restless RG6 1PT
Legs Syndrome). UK
Tel: 0800 035 2525
Reporting of Side Effects
email:uk-medicalinformation@[Link]
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible Manufacturer
side effects not listed in this leaflet. You can also FAMAR HEALTH CARE SERVICES MADRID S.A.U.
report side effects directly via the Yellow Card Avda. Leganés, 62, Alcorcón 28923
Scheme at: [Link]. [Link]/yellowcard or Madrid, Spain
search for MHRA Yellow Card in the Google Play This leaflet does not contain all the information
or Apple App Store. about your medicine. If you have any questions
By reporting side effects you can help provide or are not sure about anything, ask your doctor
more information on the safety of this medicine. or pharmacist.
5. How to store Phenergan Tablets This leaflet was last revised in May 2024
©Sanofi, 1993-2024
Keep this medicine out of the sight and reach of
children For electronic version of this
Do not take Phenergan Tablets after the expiry leaflet scan the QR code.
date which is stated on the carton and blister pack This paper leaflet might
after EXP. The expiry date refers to the last day of not be the latest version
that month and thus different to the
Store below 30°C electronic leaflet which
Store in the original carton in order to protect is the last updated
from light version available.

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