PROMAZINE 25MG/5ML ORAL SYRUP

Active substance: PROMAZINE HYDROCHLORIDE

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If you get any of the following side effects, see your doctor as soon as possible:
n blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which
may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of
these symptoms seek medical advice immediately
n lack of emotion
n fits
n blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or
throat and unusual tiredness, yellowing of the skin, weakness or breathlessness
n heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms
of a heart attack are chest pain which may spread to the
shoulders, neck or arms and shortness of breath. If you get
these see a doctor straight away. Unexplained deaths have
been reported but it is not proven that they were caused by
promazine
n fever
n low body temperature
n low blood pressure. You may feel dizzy when standing up
n unusual movements, often of the mouth, lips, eyes and tongue. These movements can also include trembling
and shaking of the hands and feet, twisting of the body, shuffling walk and stiffness of the arms and legs and
unable to sit still
n eye changes such as blurred vision, clouding of the lens or purple colouring of the eye
n feeling confused, agitated or over-excited
n eye changes such as pain in the eye, blurred vision or loss of vision, seeing halos around lights, clouding of the
lens or purple colouring of the eye.
Tell your doctor if you get any of these side effects:
n unable to sleep, feeling sleepy, drowsy or dizzy
n dry mouth, blocked nose
n constipation, difficulty in passing water particularly if you have an enlarged prostate
n skin rash caused by medicine spilt on your skin, skin rashes, skin reaction to direct sunlight
n swelling of the breasts (particularly in men) and breast milk production
n sexual impotence
n headache, upset stomach
n light periods or absence of periods
n weight gain.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking
antipsychotics compared with those not receiving antipsychotics.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Promazine Syrup
n
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Keep this medicine out of the sight and reach of children
Store below 25°C. Protect from light
Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year)
The expiry date refers to the last day of that month
Do not use this medicine if you notice that the appearance or smell of your medicine has changed.
Talk to your pharmacist
n 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 Promazine Hydrochloride 25mg/5ml Oral Syrup contains
n The active ingredient is promazine hydrochloride.
n The other ingredients are propylene glycol (E1520), methyl hydroxybenzoate (E218), ethyl hydroxybenzoate
(E214), propyl hydroxybenzoate (E216), sucrose, syrup liquid glucose, ascorbic acid (E330), lemon flavour
(containing propylene glycol) and purified water
What Promazine Hydrochloride 25mg/5ml Oral Syrup looks like and contents of the pack
A colourless to orange-brown coloured syrup with an odour of lemon.
It comes in a brown glass bottle holding 150ml of syrup.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 02/2012. P0587

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Promazine Hydrochloride 25mg/5ml
Oral Syrup

Date:

Strength:

25mg/5ml

Proof Number:

New Item Code:

P0587

Page:

Previous Item Code:

P0518

New Pharmacode:

Design Icon:

-

Sugar-Free

NO

Cutter Ref:

-

Pack Size

150ml

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

Black

02.3.12
THREE(a)
1 of: 2

108
Barcode:

Keyline

Package leaflet: Information for the user
Promazine Hydrochloride 25mg/5ml Oral Syrup
Read all of this leaflet carefully before you start taking this medicine
- because it contains important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or your pharmacist.
n 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.
n If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
What is in this leaflet:
1. What Promazine Syrup is and what it is used for
2. What you need to know before you take Promazine Syrup
3. How to take Promazine Syrup
4. Possible side effects
5. How to store Promazine Syrup
6. Contents of the pack and other information

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108

1. What Promazine Syrup is and what it is used for
The name of your medicine is Promazine Hydrochloride 25mg/5ml Oral Syrup (referred to as Promazine Syrup in this
leaflet). It contains promazine hydrochloride. This belongs to a group of medicines called phenothiazines.
Promazine can be used to calm your emotions particularly if you feel restless and agitated, particularly if you are an
older person.

2. What you need to know before you take Promazine Syrup
Do not take Promazine Syrup and tell your doctor if:
n

you are allergic (hypersensitive) to promazine or medicines like promazine or any other ingredients in this
liquid (listed in section 6). The signs of allergic reaction can include a rash, itching or shortness of breath
n you are pregnant or breast-feeding
n you have bone marrow depression. This means that your immune system is not working as well as usual. Your
body will find it harder to fight infection
n you have a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)
n you have dulled senses such as feeling sleepy or uncoordinated, having blurred vision, slurred speech or being
less aware of your surroundings (CNS depression).
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 Promazine Syrup.
Warnings and precautions
Talk to your doctor before taking Promazine Syrup, if:
n you have liver problems or a history of jaundice (yellowing of the skin and whites of the eyes)
n you have a history of blood problems including low levels of potassium or magnesium
n you or someone else in your family has a history of blood clots, as medicines like these have been associated
with formation of blood clots
n you have heart problems including unusual heart beats, heart disease or heart failure
n you have lung and breathing problems
n you have kidney problems
n you have Parkinson’s Disease
n you have had a stroke or you have any of the following that can increase your risk of having a stroke
-
a heart attack
-
a TIA (transient ischaemic attack). This is a type of stroke where symptoms last less than 24 hours
-
an artificial heart valve
-
uncontrolled high blood pressure
- diabetes
-
high cholesterol
-
a family history of strokes
-
you smoke
-
you drink excess alcohol (this tends to weaken blood vessels and can raise blood pressure)
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you have epilepsy
you have or have had in the past narrow angle glaucoma (this is abnormal pressure in the eye accompanied by
pain and blurred vision)
n you have an underactive thyroid
n you have a condition that causes muscle weakness with tiredness, called myasthenia gravis
n you have an enlarged prostate gland
n older people should take promazine with caution in very hot or cold weather. This is because there is a risk of
having a higher body temperature than usual in hot weather (hyperthermia) and a lower body temperature in
cold weather (hypothermia) if you take this medicine
n if you are going to have an anaesthetic, tell your doctor or dentist that you are taking promazine.
Other important information to take into account before you take
this medicine:
n if you or members of your family have heart problems
(including heart failure, heart attack or uneven heart beats) or
you have low potassium or magnesium in your blood,
your doctor may do some tests on your heart and blood
before giving you this medicine
n your doctor may also want to give you regular blood and eye tests during your
treatment
n do not go into direct sunlight if you are taking high doses of this medicine. This is
because you may become more sensitive to strong sunlight while taking this medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Promazine Syrup.
Other medicines and Promazine Syrup:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes
medicines you buy without a prescription, including herbal medicines. This is because promazine can affect the way
some other medicines work. Also some medicines can affect the way promazine works.
Tell your doctor if you are taking any of these medicines:
n heart medicines such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, bretylium
n medicines to treat high blood pressure
n medicines that control your emotions such as chlorpromazine, trifluoperazine, antidepressants such as
amitriptyline and maprolitine, pimozide, sertindole, haloperidol, lithium, MAOIs (Monoamine Oxidase
Inhibitors), reboxetine
n medicines that dull the senses such as sleeping tablets
n medicines to treat epilepsy
n medicines used to treat malaria such as quinine and mefloquine
n antibiotics such as sparfloxacin, moxifloxacin and intravenous erythromycin
n medicines used to treat Parkinson’s Disease such as levodopa
n medicines to treat allergies such as hayfever (antihistamines) for example terfenadine
n medicines used to treat stomach problems such as cimetidine and cisapride
n medicines to treat diabetes, for example, chlorpropamide, glibenclamide, gliclazide or tolbutamide
n strong painkillers such as codeine
n medicines used to stop the body producing red blood cells such as carbamazepine, co-trimoxazole,
chloramphenicol, sulphonamides, pyralizone, azapropazone, penicillamine and cytotoxics (used in cancer
treatment)
n medicines that help the body get rid of water and affect electrolyte balance (diuretics) such as furosemide or
indapamide
n metoclopramide, used to treat nausea (feeling sick) and vomiting
n tetrabenazine, used to treat disorders that cause unnatural movements
n ritonavir, used to treat HIV and AIDS
n tramadol, used to treat pain
n sympathomimetics, medicines that copy the effects of substances such as adrenaline that naturally occur in the
body, for example, salbutamol or pseudoephedrine.
n memantine, used to treat Alzheimer’s disease
n kaolin, used to treat diarrhoea.
Promazine Syrup with food, drink and alcohol
You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy
and drinking alcohol will make you even more drowsy. Drinking alcohol may also affect the condition you are
suffering from.
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. You should not use this medicine if you are pregnant or breast-feeding unless
your doctor feels it is absolutely necessary.
P0587

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Promazine Hydrochloride 25mg/5ml
Oral Syrup

Date:

Strength:

25mg/5ml

Proof Number:

New Item Code:

P0587

Page:

Previous Item Code:

P0518

New Pharmacode:

Design Icon:

-

Sugar-Free

NO

Cutter Ref:

-

Pack Size

150ml

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

Black

02.03.12
THREE(a)
2 of: 2

108
Barcode:

Keyline

The following symptoms may occur in newborn babies, of mothers that have used promazine in the last trimester
(last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing
problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your
doctor.
Driving and using machines
Do not drive or use tools or machines if this medicine makes you drowsy or gives you blurred vision.
When using this medicine, alcohol and some other medicines may make you feel more drowsy than usual.
Important information about what is in this medicine:
Promazine Syrup contains:
n methyl, ethyl and propyl parahydroxybenzoates. These may
cause an allergic reaction. This allergy may happen
some time after starting the medicine
n sucrose and liquid glucose. If your doctor has told you that you
cannot tolerate some sugars, see your doctor before taking this
medicine. It may also be harmful to your teeth.

3. How to take Promazine Syrup
Always take this medicine exactly as your doctor or pharmacist has told you. Look on the label and check with your
doctor or pharmacist if you are not sure.
Taking this medicine
n this medicine contains 25mg of promazine hydrochloride in each 5ml
n take this medicine by mouth
n if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to
your doctor or pharmacist.
Adults
n The usual dose for adults is 100mg to 200mg four times a day
n The dose prescribed and how often you should take the doses will depend upon the condition being treated and
on your response. You will start treatment on a low dose which will be increased as necessary by your doctor
n Older people will be given a lower dose. Your doctor will gradually increase this dose.
Children
This product should not be given to children.
If you take more Promazine Syrup than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you
have taken. Signs of an overdose may include deep sleep, feeling agitated, feeling excited, fits and coma.
If you forget to take Promazine Syrup
n Do not take a double dose (two doses at the same time) to make up for forgotten doses
n Skip the missed dose then go on as before.
If you stop taking Promazine Syrup
Keep taking Promazine Syrup until your doctor tells you to stop. The doctor will lower your dose gradually.
If you stop taking the medicine suddenly you may get withdrawal symptoms. Signs include:
n feeling or being sick, sweating and difficulty sleeping (insomnia)
n your original symptoms becoming worse
n movements that you can’t control.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, promazine can cause side effects, although not everybody gets them.
Stop taking the medicine straight away and see your doctor if:
n you have an allergic reaction to promazine syrup
An allergic reaction may include any kind of skin rash, flaking skin, boils or sore lips and mouth, sudden
wheezing, fluttering or tightness of the chest or collapse.
n you have any of the following symptoms:
- unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint) and sweating.
These are early warning signs of a disorder caused by the type of medicine you are taking
- very high body temperature, muscle stiffness or a change in consciousness leading to coma
- yellowing of the skin and whites of your eyes (jaundice) with fever and possible liver damage.

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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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