Levomepromazine Maleate 50mg Tablets

• 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 is and what it is 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 (hypersensitive) 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 nortriptyline 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.

Adults - the initial dose is usually 25mg to 50mg a day, divided into three doses. If you are confined to bed, the initial dose may be 100mg to 200mg a day, divided into three doses. These doses may be increased in small steps until a suitable dose is found for you.

Elderly - your doctor will decide whether these tablets are appropriate for you and will tell you how many to take.

Children - will normally be given no more than 37.5mg a day.

Adults and Elderly – 12.5mg to 50mg every four to eight hours; the dose may be varied until a suitable dose is found for you.

Children - these tablets are NOT recommended for children for treating pain.

If you, or a child, 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.

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps.

Very common: may affect more than 1 in 10 people:

• sleepiness
• dry mouth

Common: may affect up to 1 in 10 people:

• weakness

Common: may affect up to 1 in 10 people:

• low blood pressure, especially in elderly patients
• heat stroke
• alteration of heart rhythm (called ‘prolongation of QT interval’ seen on ECG, electrical activity of the heart)

Uncommon: may affect up to 1 in 100 people:

• stiffness, shaking (tremor) or slow movements
• you have a fit (seizure)
• blood abnormalities
• constipation, which may become severe and stop food moving through the bowel

Rare: may affect up to 1 in 1,000 people:

• heart palpitations (usually rapid or irregular heartbeats)
• jaundice (yellowing of the skin and eyes)

Not known: frequency cannot be estimated from the available data:

• dizziness, feeling faint or loss of alertness
• 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
• a serious but rare side effect is neuroleptic malignant syndrome. Signs of this include a high fever, sweating, stiff muscles, fast heart rate, fast breathing and drowsiness or confusion. There may also be difficulty in walking and shaking or involuntary muscle movements. Rarely there may be rolling of the eyes. If these symptoms develop please contact your doctor immediately.
• high temperature, sweating, pale complexion, difficulty passing urine
• colicky abdominal pain with bloody diarrhoea
• skin irritation or burning due to sensitivity to sunlight
• unwanted and persistent erections
• an illness where the removal of bile from the liver is blocked (cholestasis). Signs include jaundice, rash or fever, and the colour of your water (urine) becomes darker
• you have discolouration of the skin or eyes, pain in the abdomen (stomach) or a bloated feeling, severe itching, pale or bloody stools, extreme weakness, nausea or loss of appetite. This could be caused by an infection or injury to the liver
• tired, weak, confused, have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood
• feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate antidiuretic secretion (SIADH)

Other side effects include:

Not known: frequency cannot be estimated from the available data:

• high blood sugar (hyperglycaemia)
• feeling confused

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 any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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
  Each 25mg tablet contains 25mg Levomepromazine Maleate
  Each 50mg tablet contains 50mg Levomepromazine Maleate
  Each 100mg tablet contains 100mg Levomepromazine Maleate
• The other excipients are: lactose monohydrate, pregelatinized maize starch, povidone K-29/32, silica colloidal anhydrous, magnesium stearate.

Levomepromazine Maleate 25mg Tablets are white to off white round shaped tablet with break line on one side and ‘L3’ debossing on another side.

Levomepromazine Maleate 50mg Tablets are white to off white round shaped tablet with break line on one side and ‘L2’ debossing on another side.

Levomepromazine Maleate 100mg Tablets are white to off white round shaped tablet with break line on one side and ‘L1’ debossing on another side.

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.