Patient leaflet - Promazine Hydrochloride 25 mg/5 ml oral syrup

1. What Promazine Syrup is and what it is used for

The name of your medicine is Promazine hydrochloride 25 mg/5 ml or 50 mg/5 ml 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.

2. What you need to know before you take Promazine Syrup

Do not take Promazine Syrup and tell your doctor if:

you are allergic (hypersensitive) to promazine or
medicines like promazine or any other ingredients in this liquid (listed in section 6). The signs of an allergic reaction can include a rash, itching or shortness of breath
you are pregnant or breastfeeding
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
you have a tumour of your adrenal gland that causes
high blood pressure (phaeochromocytoma)
you have dulled senses such as feeling sleepy
or uncoordinated, having blurred vision, slurred speech or being less aware of your surroundings (CNS depression).
you have moderate or severe liver problems
you have heart problems such as an unusually
fast heartbeat or unstable blood pressure, causing dizziness, light-headedness or fainting. 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, or pharmacist or nurse before taking Promazine Syrup, if:

you have liver problems or a history of jaundice
(yellowing of the skin and whites of the eyes)
you have a history of blood problems including
low levels of potassium or magnesium
you or someone else in your family has a history
of blood clots, as medicines like these have been associated with the formation of blood clots
you have heart problems including unusual
heartbeats, heart disease or heart failure
you have lung and breathing problems
you have kidney problems
you have Parkinson’s Disease
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)
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)
you have an underactive thyroid
you have a condition that causes muscle
weakness with tiredness, called myasthenia gravis
you have an enlarged prostate gland
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
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:

if you or members of your family have heart
problems (including heart failure, heart attack or uneven heartbeats) 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
your doctor may also want to give you regular
blood and eye tests during your treatment
- 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:

heart medicines such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, bretylium
medicines to treat high blood pressure
medicines that control your emotions such as chlorpromazine, trifluoperazine, antidepressants such as amitriptyline and maprolitine, pimozide, sertindole, haloperidol, lithium, MAOIs (Monoamine Oxidase Inhibitors), reboxetine
medicines that dull the senses such as sleeping tablets
medicines to treat epilepsy
medicines used to treat malaria such as quinine and mefloquine
antibiotics such as sparfloxacin, moxifloxacin and intravenous erythromycin
medicines used to treat Parkinson’s Disease such as levodopa
medicines to treat allergies such as hay fever
(antihistamines) for example terfenadine
medicines used to treat stomach problems such as cimetidine and cisapride
medicines to treat diabetes, for example, chlorpropamide, glibenclamide, gliclazide or tolbutamide
strong painkillers such as codeine
medicines used to stop the body from producing red blood cells such as carbamazepine, co-trimoxazole, chloramphenicol, sulphonamides, pyralizone, azapropazone, penicillamine and cytotoxics (used in cancer treatment)
medicines that help the body get rid of water and affect electrolyte balance (diuretics) such as furosemide or indapamide
metoclopramide, used to treat nausea (feeling sick) and vomiting
tetrabenazine, used to treat disorders that cause unnatural movements
ritonavir, used to treat HIV and AIDS
tramadol, used to treat pain
sympathomimetics, medicines that copy the effects of substances such as adrenaline that naturally occur in the body, for example, salbutamol or pseudoephedrine.
memantine, used to treat Alzheimer’s disease
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 breastfeeding, 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 breastfeeding unless your doctor feels it is absolutely necessary.

The following symptoms may occur in newborn babies, of mothers who 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.

Promazine Syrup contains:

Methyl hydroxybenzoate (E218), Ethyl hydroxybenzoate (E214) and Propyl hydroxybenzoate (E216). May cause allergic reactions (possibly delayed).
Propylene glycol (E1520). This medicine contains
100mg propylene glycol in each 5ml.
Liquid glucose. This medicine contains 250mg 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.

Sucrose. This medicine contains 2.38g sucrose in each 5ml.

160 mm

3. How to take Promazine Syrup:

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

This medicine contains either 25mg or 50mg of
promazine hydrochloride in each 5 ml.
Take this medicine by mouth
Use the dosing cup supplied in the pack
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
The recommended dose for adults is 100 mg to
200 mg up to four times a day
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.

Elderly

The recommended dose is 25 mg initially,
increasing to up to 50 mg, four times a day. You will receive the lowest effective dose for the shortest period possible.

Children

This product should not be given to children. Instructions for use: measuring cup

1. Shake the bottle well before use.
2.
Fill the measuring cup to the millilitre (ml) dose
marker prescribed by your doctor.
3. Swallow the dose of syrup.

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

Do not take a double dose (two doses at the
same time) to make up for forgotten doses
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:

feeling or being sick, sweating and difficulty
sleeping (insomnia)
your original symptoms becoming worse
movements that you can’t control.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Promazine can cause side effects, although not everybody gets them.

Stop taking Promazine Syrup straight away and see your doctor if:

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.
you have any of the following symptoms:
- unusually fast heartbeat, 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:

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
lack of emotion
fits
blood problems. You may notice signs such as
high temperature or chills, sore throat, ulcers in your mouth or throat, unusual tiredness, yellowing of the skin, weakness or breathlessness
heart changes including fast heartbeats, unusual
heartbeats, and 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
fever
low body temperature
low blood pressure. You may feel dizzy when
standing up
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
eye changes such as blurred vision, clouding of
the lens or purple colouring of the eye
feeling confused, agitated or over-excited
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:
- unable to sleep, feeling sleepy, drowsy
  or dizzy
- dry mouth, blocked nose
- constipation, difficulty in passing water
  particularly if you have an enlarged prostate
- skin rash caused by medicine spilt on
  your skin, skin rashes, skin reaction to direct sunlight
- swelling of the breasts (particularly in men) and breast milk production
- sexual impotence n headache, upset stomach
- light periods or absence of periods
- 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 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Promazine Syrup

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store below 25ºC. Store in the original bottle in order to protect from light.

After first opening, use within 15 days.

Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Promazine Syrup contains

The active substance is promazine hydrochloride. Each 5ml of the syrup contains 25 mg or 50 mg of promazine hydrochloride.

The other ingredients are propylene glycol (E1520), methyl para hydroxybenzoate (E218), ethyl para hydroxybenzoate (E214), propyl para hydroxybenzoate (E216), sucrose, liquid glucose, ascorbic acid (E300), tutti frutti flavour and purified water.

What Promazine Syrup looks like and contents of the pack

Promazine hydrochloride 25 mg/5 ml and 50 mg/5 ml oral syrup is a colourless to orange-brown colour syrup.

Each carton contains 1 amber glass bottle with a child-resistant cap and a 30 ml measuring cup (graduated at every 2.5 ml equivalent to either 12.5 mg or 25 mg promazine hydrochloride).

Marketing Authorisation Holder

Zydus Pharmaceuticals UK Ltd

Sandretto Building, Cavalry Hill Industrial Park, Weedon, Northampton, NN7 4PP, UK

Manufacturer:

LM Manufacturing Limited