Levomepromazine Hydrochloride 25mg/ml Solution for Injection

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Levomepromazine Injection is and what it is used for
2. What you need to know before Levomepromazine Injection is given
3. How Levomepromazine Injection is given
4. Possible side effects
5. How to store Levomepromazine Injection
6. Contents of the pack and other information

• you are allergic (hypersensitivity) to levomepromazine hydrochloride or any of the other ingredients of Levomepromazine Injection (listed in section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• you are taking any of the following medicines:
  • citalopram and escitalopram
  • hydroxyzine
  • piperaquine
  • domperidone

Talk to your doctor or nurse before Levomepromazine Injection is given if:

• you have liver or kidney problems
• you are an elderly patient with dementia
• you are elderly, frail, have heart disease or you have had problems with dizziness or feeling faint when going from a lying or sitting to a standing position due to low blood pressure, as you may feel faint or light-headed when you are given the injection. If you receive a large initial dose, you will have to stay in bed. You should not get up quickly and you should obtain assistance when necessary
• you suffer from slow or irregular heartbeats/ palpitations (Torsades de Pointes) or have a family history of heart problems
• you or someone else in your family have a history of blood clots, as medicines like these (antipsychotics) have been associated with formation of blood clots
• you have been told by your doctor that you might have a stroke or you have risk factors (e.g. if you smoke or have high blood pressure, or have an excessive amount of sugar, cholesterol or fat in the blood). This medicine should be used in caution as the risk of a stroke (cerebrovascular accident) may be increased
• you are diabetic or have been told that you have an increased risk of diabetes. You will need to monitor your blood sugar levels very carefully
• you already know you have low levels of potassium, calcium or magnesium in your blood
• you have constipation
• you find it difficult, or are unable, to eat
• you are an alcoholic
• you have ever had convulsions or epilepsy
• your prostate (sperm producing gland) has increased in size (prostate hypertrophy)
• you have an adrenal gland tumour (phaeochromocytoma)
• you have decreased thyroid hormone secretion condition (hyperthyroidism)
• you have a muscle disease causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs (myasthenia gravis).

You must tell your doctor or nurse immediately if:

• you experience stiffness in your muscles, impaired consciousness and fever (see section 4)
• you have a fever, pallor, heavy sweating or any other sign of infection. In very rare cases, this medicine can cause a drop in your white blood cells which predisposes you to infection (see section 4)
• you have long-term constipation, as well as bloating and stomach pain, or a blocked intestine (Paralytic ileus) (see section 4).

Additional tests will be done by your doctor before and during treatment. This includes if you are being given Levomepromazine Injection for a long period of time, or if you are taking other medicines at the same time such as heart drugs, anti-depressants or drugs for mental health disorders. Your doctor may carry out:

• blood tests to monitor your liver function
• blood tests to check your white blood cells due to a potential side effect, a significant decrease in the number of certain white blood cells in the blood (agranulocytosis)
• an ECG (electrocardiogram) to check your heart is working normally, as certain medicines in the same family as Levomepromazine (antipsychotics) can, in very rare cases, cause heart rhythm disorders (see section 4).

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, as they may change the way Levomepromazine Injection works. Do not use Levomepromazine Injection and tell your doctor if you are taking any of the following medicines (see section 2 ‘Do not use Levomepromazine Injection if’):

• Citalopram and escitalopram – used to treat anxiety and depression
• Hydroxyzine – used to treat the minor symptoms of anxiety, as premedication before general anaesthesia, in nettle rash and in the treatment of some kinds of insomnia
• Piperaquine – used to treat malaria, an illness caused by a parasite
• Domperidone – used to treat nausea and vomiting.

Before using Levomepromazine Injection, tell your doctor if you are taking any of the following medicines:

• medicines for the treatment of Parkinson’s disease
• cabergoline, quinagolide – used to treat the production of excessive or abnormal amounts of milk
• medicines containing alcohol
• desferrioxamine – used to treat iron poisoning
• adrenaline (epinephrine) – used to treat patients overdosed with antipsychotic drugs
• medicines that can cause severe heart rhythm disorders (torsades de pointes):
  • antiarrhythmics used to treat irregular heartbeats (e.g. amiodarone, dronedarone, disopyramide, hydroquinidine, quinidine and sotalol)
  • medicines used to treat mental health disorders such as anti-depressants (e.g. amitriptyline, amitriptylinoxide and nortriptyline) and antipsychotics (e.g. other neuroleptics or lithium-containing medicines)
  • sedatives and medicines used to treat anxiety (e.g. barbiturates)
  • anti-parasitics used to treat diseases caused by parasites (e.g. chloroquine, halofantrine, hydroxychloroquine, lumefantrine and pentamidine)
  • antibiotics used to treat infections (e.g. erythromycin and spiramycin administered into a vein, moxifloxacin)
  • mizolastine – used to treat an allergy
  • anti-cancer medicines used to treat cancer (e.g. toremifene, arsenic trioxide and vandetanib)
  • dolasetron administered into a vein – used in adults to treat or prevent nausea and vomiting induced by some treatments or surgery
  • vincamine administered into a vein – used to treat some minor neurological disorders related to ageing
  • diphemanil – used to treat gastric secretion disorders and excessive perspiration
  • prucalopride – used to treat constipation
  • mequitazine – used to treat allergic rhinitis or hives
  • methadone – used to treat addiction.

Avoid alcohol while you are having these injections.

Pregnancy

Talk to your doctor or nurse before using this medicine:

• if you are woman of childbearing potential and are not using effective contraception
• if you are pregnant, think you may be pregnant or are planning a pregnancy.

This medicine will only be used during pregnancy on the advice of your doctor.

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

Breast-feeding

This medicine is excreted into breast milk. Breast-feeding is not recommended for the duration of treatment with this medicine.

Fertility

The use of this medicine can result in an excessive amount of prolactin (the hormone which causes milk to be produced) in the blood. This may be associated with a lowering of fertility.

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

Do not drive or operate machinery whilst receiving Levomepromazine Injections as it may make you feel drowsy, confused, disorientated, dizzy or lightheaded.

• Sodium: This medicine contains less than 1mmol sodium (23mg) per millilitre, that is to say essentially ‘sodium-free’
• Sulphites: May rarely cause hypersensitivity reactions and bronchospasm.

• The usual dose is half to one vial by injection, although up to two vials may be used. This dose may be repeated every 6 to 8 hours if required.

Alternatively a dose of up to 8 vials diluted with saline may be infused over 24 hours.

Levomepromazine Tablets 25mg may be given instead of Levomepromazine Injection if oral therapy is more convenient.

• If the injection is given to children, the dose will be calculated according to their weight; usually 0.35mg – 3.0mg/kg/day.

As this product will be given to you under medical supervision, it is unlikely that you will be given too much. However, speak to your doctor or nurse if you are worried. Symptoms of overdose include: drowsiness or loss of consciousness, convulsions, low blood pressure, irregular heartbeats and hypothermia (abnormally low body temperature) and severe extrapyramidal dyskinesias (involuntary movements).

Contact your doctor or nurse as soon as you remember to arrange another appointment for your next injection.

• you have an allergic reaction. Signs include: severe itching of the skin, with a red rash or raised lumps (hives), difficulty breathing or swallowing, swelling of the face, lips, tongue or throat. This may be an indication that you are sensitive to the medicine and should not be given a repeat dose.

Common: may affect up to 1 in 10 people:

• low blood pressure, especially in elderly patients or when you move suddenly from lying or sitting to a standing position
• heat stroke.

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
• a significant decrease in the number of white blood cells, sometimes revealed by fever and breathing difficulties (agranulocytosis).

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

• heart palpitations (usually rapid or irregular heartbeats)
• alteration of heart rhythm (called prologation of ‘QT interval’ seen on ECG, electrical activity of the heart), which may, in exceptional cases, be life-threatening
• 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
• Neuroleptic malignant syndrome. Signs include: a high fever, sweating, pale complexion, stiff muscles, fast heart rate, fast breathing, difficulty passing urine 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. See also Section 2
• very severe inflammation of the intestine, which may cause localised destruction (necrosis), colicky abdominal pain with bloody diarrhoea
• skin irritation or burning due to sensitivity to sunlight
• unwanted, painful 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)
• disease of the brain (Parkinson’s disease) affecting movement (trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk)
• uncontrollable twitching or jerking movements of the arms and legs (dyskinesia)
• decreased number of white blood cells (leukocytopenia), which may lead to serious infections.

Very common: may affect more than 1 in 10 people

• sleepiness
• dry mouth.

Common: may affect up to 1 in 10 people

• weakness.

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

• lack of periods in women, increased breast size or breast growth in men, impotence, abnormal milk production
• high blood sugar (hyperglycaemia)
• a change in body temperature
• mood disorders, feeling anxious or confused
• weight gain
• vision problems including disorders affecting the ability of your eyes to adapt to see close up or far away (accommodation disorders), or brownish deposits in the eye that do not generally affect vision.

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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for the 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 ingredient is levomepromazine hydrochloride (25mg/ml) per 1 ml ampoule.

The other ingredients are ascorbic acid, sodium sulfite, sodium chloride and water for injections (see end of Section 2 for further, important information on sodium).

Levomepromazine Injection is a clear, colourless solution for injection. It is supplied in packs of 10 colourless neutral Type I glass ampoules per pack.

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Manufacturer