PROMAZINE 50 MG / 5ML ORAL SYRUP - patient leaflet, side effects, dosage

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 B7TD1RBJ1

Package leaflet: Information for the user

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

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) Continued overleaf

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n you have epilepsy

n 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.

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.

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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.