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PROMETHAZINE HYDROCHLORIDE 10MG TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PROMETHAZINE HYDROCHLORIDE
10 MG TABLETS
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.

What is in this leaflet
1. What Promethazine is and what it is used for
2. What you need to know before you take
Promethazine
3. How to take Promethazine
4. Possible side effects
5. How to store Promethazine
6. Contents of the pack and other information

1. WHAT PROMETHAZINE IS AND
WHAT IT IS USED FOR
The name of your medicine is Promethazine
Hydrochloride 10 mg Tablets, (referred to as
Promethazine in this leaflet). It belongs to a group of
medicines known as phenothiazines, and works by
blocking a substance called histamine that your body
makes during an allergic reaction. It also works directly on
the brain to help you feel more relaxed.
Promethazine is used to treat the following conditions:
 to treat allergic conditions, such as hay fever or
rashes (like nettle rash or hives)
 for short term use: to treat adults with difficulty
sleeping (insomnia)
 to treat or prevent you feeling sick (nausea) or being
sick (vomiting), such as in travel sickness.
 for short term use: as a sedative for children

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE PROMETHAZINE
Do not take Promethazine if:
 you are allergic (hypersensitive) to promethazine
hydrochloride or any of the other ingredients in the
tablets (listed in section 6). 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) or you have
stopped taking one of these MAOI medicines within
the last 14 days (See “Taking other medicines” section
below).
 the person taking this medicine is under 2 years of
age.
 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 apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Promethazine.
Warnings and precautions
Tell your doctor or pharmacist before you take this
medicine if you:
 have difficulty in breathing, wheezing, tightness in the
chest (asthma) or an infection in your lungs (bronchitis)
 have epilepsy
 have any serious heart problems
 have liver or kidney problems
 have a stomach blockage or difficulty passing water
(urine)
 have hearing problems
 have increased pressure in the eye (narrow angle
glaucoma)
 have suffered from Reye’s Syndrome or you have
signs of Reye’s Syndrome, such as being sick and
confused after 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.

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.
This risk of abuse is greater in those with a history of drug
abuse.
Other medicines and Promethazine Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
even medicines you can buy without a prescription,
including herbal medicines. This is because
Promethazine can affect the way some medicines work,
and 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, this includes some
medicines used for irritable bowel syndrome, asthma
or a weak bladder. These can increase the risk of
dizziness, dry mouth, blurred vision.
 other medicines for depression called tricyclic
antidepressants, such as amitriptyline or dosulepin
 medicines to help you to sleep or feel more relaxed,
such as diazepam or zolpidem
 medicines to relieve pain (for arthritis and pain in your
joints), such as aspirin. Promethazine may hide the
side effects of these medicines.
Tests
Taking Promethazine may affect the results of certain
tests. These include some pregnancy tests based on
urine samples and skin tests. Promethazine should not be
taken at least 3 days before the start of a skin test.
Promethazine tablets with food and drink
Do not drink alcohol while you are taking Promethazine.
Alcohol may increase the sedative effects of
Promethazine and make you feel very drowsy.
Pregnancy and breast-feeding
Talk to your doctor before taking Promethazine if you are
pregnant or planning to become pregnant. Promethazine
should not be taken 2 weeks before birth.
You should not take Promethazine if you are
breastfeeding. This is because small amounts may pass
into the mothers’ milk. This could 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 day after you have taken this medicine. If this
happens, do not drive or operate any machines.
Promethazine Tablet contains lactose and sucrose
This medicine contains lactose and sucrose (types of
sugars). If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor
or pharmacist before taking Promethazine.

3. HOW TO TAKE PROMETHAZINE
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 Promethazine. The following information will
help you to decide how much you need to take.
Taking this medicine
 Swallow the tablets whole with a glass of water
 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, ask your
doctor.
How much to take
The usual doses are:
For allergies (such as hay fever, rashes and hives)
Children 2-5 years: A liquid form of this medicine should
be used in this age group.

Children 5-10 years: A single dose of either one or two
tablets (10 mg or 20 mg) given at night or one tablet (10
mg) given twice a day. DO NOT give more than two
tablets (20 mg) each day.
Children over 10 years and adults (including the
elderly): Start with one tablet (10 mg) twice a day. This
may be increased to a maximum of two tablets (20 mg)
three times a day.
For treatment and prevention of feeling sick or being
sick (such as in travel sickness)
Children 2-5 years: A liquid form of this medicine should
be used in this age group.
Children 5-10 years: A single tablet to be taken the night
before the journey. This may be repeated after 6-8 hours
if necessary.
Children over 10 years and adults (including the
elderly): Two tablets (20 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: A liquid form of this medicine should
be used in this age group.
Children 5-10 years: Two tablets (20 mg) given as a
single dose at night time.
Children over 10 years and adults (including the
elderly): Two to five tablets (20 mg to 50 mg) as a single
dose at night time.
Children under 2 years
DO NOT give this medicine to children under 2 years of
age.
Use this medicine only as recommended. Do not exceed
the recommended dose.
Exposure to sunlight
Promethazine Tablets 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 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 occur:
 In children: excitation, moving unsteadily or
stumbling, uncontrolled writhing movements
especially of the hands or feet, hearing or seeing
things that are not there (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
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Promethazine can cause side effects,
although not everybody gets them.
STOP TAKING this medicine 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 of which may include a
rash, swelling of the face, lips, tongue or throat,
difficulty in breathing or swallowing
 liver problems which may cause yellowing of the skin
or whites of the eyes (jaundice)
 muscle stiffness or shaking
 being unable to control some muscles in the head or
face
 unusual movements of the tongue, facial muscle
spasms, rolling eyes, trembling
 very fast, uneven or forceful heart beat (palpitations)
 irregular heartbeat

 changes in the numbers and types of your blood cells.
If you notice increased bruising, nosebleeds, sore
throats, infections, excessive tiredness,
breathlessness or abnormal paleness of the skin, you
should tell your doctor who may want you to have a
blood test.
 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 become serious or last longer than a few
days. Also tell them if you notice any side effects not
listed in this leaflet:
 dry mouth, blurred vision, constipation, difficulty
passing urine
 feeling drowsy or sleepy, tired, disorientated or
restless
 feeling confused, especially in the elderly
 having nightmares or headaches
 loss of appetite (anorexia), indigestion
 feeling dizzy, lightheaded or faint (hypotension)
 being more sensitive to the sun than usual. If this
happens keep out of direct sunlight and do not use
sun beds.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any 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.
Store below 25°C. Store in the original packaging and
keep the blister packs in the outer carton.
Do not use the tablets after the expiry date, which is
stated on the carton and blister packs. The expiry date
refers to the last day of that month.
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 to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Promethazine Hydrochloride 10 mg Tablets
contain
The active substance is promethazine hydrochloride.
Each tablet contains 10 mg of the active substance.
The other ingredients in the tablets are lactose, maize
starch, pregelatinised maize starch, magnesium stearate,
bleached shellac, talc, titanium dioxide (E171), povidone,
sucrose, beeswax, carnauba wax and Opalux blue which
also contains patent blue (E131), indigo carmine (E132)
and sodium benzoate (E211).
What Promethazine Hydrochloride 10 mg Tablets look
like and contents of the pack
Promethazine Hydrochloride 10 mg Tablets are blue,
sugar-coated tablets, which are available in blister packs
of 16 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia,
P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 03/2016

CL0134/P/PIL/CL2

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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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