• 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.

1. What Levomepromazine Maleate Tablets are and what they are used for
2. What you need to know before you take Levomepromazine Maleate Tablets
3. How to take Levomepromazine Maleate Tablets
4. Possible side effects
5. How to store Levomepromazine Maleate Tablets
6. Contents of the pack and other information

• if you are allergic to levomepromazine maleate or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Levomepromazine Maleate Tablets if you:

• have liver problems
• are elderly, frail or have heart disease as you may feel faint or light-headed when you take the tablets (if you have a large initial dose, you will have to stay in bed)
• suffer from slow or irregular heartbeats/ palpitations (Torsades de Pointes), or have a family history of heart problems
• or someone else in your family have a history of blood clots, as medicines like these have been associated with formation of blood clots
• suffer from dementia and are elderly
• have been told by your doctor that you might have a stroke
• are diabetic or have been told you have an increased risk of having diabetes
• already know you have low levels of potassium, calcium or magnesium in your blood
• find it difficult, or are unable, to eat
• are an alcoholic
• have epilepsy

Additional tests will be done by your doctor at the start of treatment if you are taking Levomepromazine Maleate Tablets for a long period of time, or if you are taking other medicines at the same time such as heart drugs, antidepressants or drugs for mental health disorders.

These tests might include an ECG (electrocardiogram) to check your heart is working normally and/or blood tests. If you have to go to the dentist or hospital for any reason, tell them that you are taking Levomepromazine Maleate Tablets.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may change the way Levomepromazine Maleate Tablets work.

These include:

• medicines for the treatment of irregular heartbeats
• antidepressants such as amitriptyline and amitriptylinoxide and drugs for other mental health disorders (i.e. antipsychotics)
• desferrioxamine (for iron poisoning)
• adrenaline (epinephrine) in patients overdosed with antipsychotic drugs.

Avoid alcohol while you are taking these tablets.

If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist before taking Levomepromazine Maleate Tablets or any other medicine.

The following symptoms may occur in newborn babies, of mothers that have used Levomepromazine Maleate Tablets 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.

Do not drive or operate machinery if taking Levomepromazine Maleate Tablets as they may make you feel drowsy, confused, dizzy or lightheaded.

This medicine contains lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nausea in palliative care.

Your doctor will review your treatment on a daily basis.

Number of days of treatment Number of tablets

Initial (3 days) ½ to 1 tablet to be taken once at night for 3 days.

4 to 5 days Your dose may be increased up to maximum of 2 tablets on days 4-5. This may be achieved by taking 1 tablet twice a day.

6 to 14 days From day 6 the dose may then be switched to 2 tablets once daily at night, or as directed by your doctor. Your treatment may be extended to a maximum of 2 weeks, as needed.

No data are available. Levomepromazine tablets should not be used in children aged under 18 years.

For oral use only.

The tablet can be divided into equal doses.

If you accidentally swallow too many tablets, contact your doctor or nearest hospital casualty department immediately.

Symptoms of overdose include: drowsiness or loss of consciousness, convulsions, low blood pressure, irregular heartbeats, hypothermia (abnormally low body temperature) and severe extrapyramidal dyskinesias (involuntary movements).

If you miss a dose, just take your tablets as soon as you remember then carry on as before. Do not take a double dose to make up for the forgotten one. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Do not stop taking Levomepromazine Maleate Tablets unless your doctor tells you to.

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 via 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.

• The active substance is Levomepromazine Maleate, 6mg per tablet.
• The other excipients are: lactose monohydrate, pregelatinized maize starch, povidone K-29/32, silica colloidal anhydrous, magnesium stearate.

The tablets are white to off white round shaped tablet with break line on one side and ‘L4’ debossing on another side. The tablet can be divided into equal halves.

They are supplied in blister packs of 7, 10, 14, 20, 24, 28, 30, 56, 60, 84, 90, 100 and 112 tablets.

Not all pack sizes may be marketed.