Patient leaflet - Promazine 50 mg / 5 ml oral syrup
1. What Promazine Syrup is and what it is used for
The name of your medicine is Promazine Hydrochloride 50mg/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)
Promazine Hydrochloride 50mg/5ml Oral Syrup
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Important information about what is in this medicine:
Promazine Syrup contains:
n Methyl hydroxybenzoate (E218), Ethyl hydroxybenzoate (E214) and Propyl hydroxybenzoate (E216). May cause allergic reactions (possibly delayed).
n Propylene glycol (E1520). This medicine contains 78.2mg propylene glycol in each 5ml.
n Liquid glucose. This medicine contains 1.3g glucose in each 5ml. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
n Sucrose. This medicine contains 1.8g sucrose in each 5ml.
This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the 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 50mg 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. 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
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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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Promazine Syrup
n Keep this medicine out of the sight and reach of children
n Store below 25°C. Protect from light
n Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year) n The expiry date refers to the last day of that month
n 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 50mg/5ml Oral Syrup contains
n The active ingredient is promazine hydrochloride.
n The other ingredients are methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214), propyl hydroxybenzoate (E216),
propylene glycol (E1520), sucrose, liquid glucose, ascorbic acid (E330), lime flavour (containing propylene glycol and glycerol) and purified water.
What Promazine Hydrochloride 50mg/5ml Oral Syrup looks like and contents of the pack
A colourless to orange-brown coloured syrup with an odour of lime.
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 10/2020