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PROMETHAZINE HYDROCHLORIDE 50 MG FILM-COATED TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE / PROMETHAZINE HYDROCHLORIDE / PROMETHAZINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Promethazine Hydrochloride 50mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
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.
The full name of this medicine is Promethazine Hydrochloride 50mg Film-coated Tablets but within
the leaflet it will be referred to as Promethazine Tablets.
What is in this leaflet
1. What Promethazine Tablets are and what they are used for
2. What you need to know before you take Promethazine Tablets
3. How to take Promethazine Tablets
4. Possible side effects
5. How to store Promethazine Tablets
6. Contents of the pack and other information

1.

What Promethazine Tablets are and what they are used for

Promethazine Tablets contain a medicine called promethazine hydrochloride. This belongs to a group of
medicines called phenothiazines. It works directly on the brain to help you feel more relaxed.
Promethazine Tablets may be used in the following situations:
To treat adults with difficulty sleeping (insomnia).
As a sedative for children over 10 years. This is a medicine given to reduce awareness or make you
feel relaxed and at ease.

2.

What you need to know before you take Promethazine Tablets

Do not take this medicine and tell your doctor if:
 You are allergic to promethazine hydrochloride or any of the other ingredients of this medicine (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). Also, do not
take Promethazine 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 “Other medicines and Promethazine
Tablets” section below)
 The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache
Do not give Promethazine Tablets to children younger than 10 years.
Warnings and precautions
Talk to your doctor or pharmacist before taking Promethazine Tablets if
 you have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs
(bronchitis)
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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 Tablets.
Promethazine Tablets may occasionally cause a condition called neuroleptic malignant syndrome which is
potentially life-threatening. If you notice symptoms such as high temperature, pale complexion, muscle
stiffness or tremor, and changes in your mental state (such as confusion, irritability and extreme agitation),
you should stop taking these tablets and immediately inform your doctor. See also section 4 ‘Possible
side effects’.
Other medicines and Promethazine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 Tablets may hide the side
effects of these medicines.
Promethazine Tablets with alcohol
Do not drink alcohol while you are taking Promethazine Tablets. This is because it can affect the way the
medicine works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Promethazine Tablets should not be taken 2 weeks before birth.
You should not take Promethazine 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. If this happens, do not drive or use any tools or
machines.

3.

How to take Promethazine Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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Taking this medicine
Take this medicine by mouth.
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask
your doctor.
The recommended dose is:
For treatment of adults with difficulty sleeping (insomnia)
Adults (including the elderly):
- 25 mg or 50 mg taken at night.
As a sedative for children
Children over 10 years:
- 25 mg or 50 mg taken at night.
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 Tablets 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 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 Tablets
Do not take a double dose to make up for a forgotten dose
 If you are taking Promethazine Tablets for sedation or sleeping problems - miss that dose and take the
next evening’s dose as usual.
Tests
Taking Promethazine Tablets may affect the results of certain tests. These include some pregnancy tests and
skin tests. Promethazine Tablets should not be taken for at least 3 days before the start of a skin test.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Promethazine 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)
 Tiredness which lasts for a long time. This may be due to a blood problem called anaemia
 Over-active behaviour in children

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A combination of symptoms (known as ‘neuroleptic malignant syndrome’) including high temperature,
pale complexion, muscle stiffness or tremor, and changes in your mental state (such as confusion,
irritability and extreme agitation). See also section 2 ‘Warnings and precautions’.

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
Website: 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 Tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
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 protect the environment.

6.

Contents of the pack and other information

What Promethazine Tablets contain
- The active substance is promethazine hydrochloride
- The other ingredient(s) are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch
glycolate (Type A), stearic acid, magnesium stearate.
Tablet coating: hypromellose (E464), macrogol 8000 (E1521), titanium dioxide (E171), talc.
What Promethazine Tablets look like and contents of the pack
Promethazine 50mg Film-coated Tablets are white oval shaped, 12.3 x 7.8mm biconvex with “C50” on one
side and plain on the other side.
Pack sizes:
Blisters: 56 film-coated tablets.
Marketing Authorisation Holder
Caduceus Pharma Ltd.
2 Martin House
179-181 North End Road
London
W14 9NL
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Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546, Kraków, Poland
This leaflet was last revised in March 2017
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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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