Nozinan (levomepromazine)

How do I take it?

• Nozinan tablets can be taken either with or without food.
• The dose of this medicine that is prescribed and how often it needs to be taken depends on the condition being treated. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the medicine.
• If you forget to take a dose take it as soon as you remember. If it is nearly time for your next dose leave it until then to take it. Don't take a double dose to make up for a missed dose.
• If you have been taking high doses of this medicine for a long time, for example to treat schizophrenia, you should not suddenly stop taking it unless your doctor tells you to, even if you feel better and think you don't need it any more. This is because the medicine controls the symptoms of the illness but doesn't actually cure it. This means that if you suddenly stop treatment your symptoms could come back. Stopping the medicine suddenly may also rarely cause withdrawal symptoms such as nausea, vomiting, difficulty sleeping or tremor. When long-term treatment with this medicine is stopped, it should be done gradually, following the instructions given by your doctor.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• Heart disease, such as heart failure, recent heart attack, very slow heart rate (bradycardia) or irregular heart beats (arrhythmias).
• People with a personal or family history of a type of abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• Elderly people with dementia. (Antipsychotic medicines have been shown to increase the risk of stroke in this group of patients. Levomepromazine is not licensed or recommended for treating behavioural disturbances in elderly people with dementia).
• People with risk factors for having a stroke, for example a history of stroke or mini-stroke (TIA), smoking, diabetes, high blood pressure, or a type of irregular heartbeat called atrial fibrillation.
• People with a personal or family history of blood clots (venous thromboembolism), for example in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• People with other risk factors for getting a blood clot, for example smoking, being overweight, taking the contraceptive pill, being over 40, recent major surgery or being immobile for prolonged periods.
• Epilepsy.
• People with conditions that increase the risk of epilepsy or convulsions, eg brain damage or withdrawal from alcohol.
• Diabetes. People with diabetes should monitor their blood sugar levels more closely whilst taking this medicine. This medicine may increase the blood sugar levels in the body.
• Parkinson's disease.
• Abnormal muscle weakness (myasthenia gravis).
• History of closed angle glaucoma.
• Enlarged prostate gland (prostatic hypertrophy).
• Tumour of the adrenal gland (phaeochromocytoma).
• Allergy to other phenothiazine medicines, such as prochlorperazine or trifluoperazine.
• People with low levels of potassium, magnesium or calcium in their blood (hypokalaemia, hypomagnesaemia or hypocalcaemia).
• People who are not eating properly or are dehydrated.
• People with low fluid volume in their body, eg due to diuretic therapy, kidney dialysis, diarrhoea, vomiting, dehydration.

Pregnancy and breastfeeding

• The safety of this medicine during pregnancy has not been established. It should not be used in pregnancy, particularly in the first and third trimesters, unless considered essential by your doctor. If the medicine is used during the third trimester it could cause side effects or withdrawal symptoms in the baby after birth and the baby may need extra monitoring because of this. Seek further medical advice from your doctor.
• If you do get pregnant while taking this medicine it is important to consult your doctor straight away for advice. If you have been taking the medicine for long periods of time, for instance to treat schizophrenia, you should not suddenly stop taking it unless your doctor tells you to, as this could cause your symptoms to come back.
• It is not known if this medicine passes into breast milk. It is recommended that women who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Label warnings

• This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Sleepiness.
• Weakness or loss of strength (asthenia).
• Dry mouth.
• A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
• Constipation.
• Skin rashes.
• Increased sensitivity of the skin to UV light.
• Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects). These Parkinson's-like side effects are more likely to happen in people who are taking high doses for long periods of time. Tell your doctor if you are affected in this way.
• Interference with the body's temperature regulation (this is more common in elderly people and may cause heat stroke in very hot weather or hypothermia in very cold weather).
• Increased blood glucose levels. Tell your doctor if you notice you feel unusually hungry or thirsty, or need to pass urine more often than usual. People with diabetes should monitor their blood sugar closely.
• Decrease in number of blood cells in the blood.
• Jaundice (tell your doctor straight away if you notice any yellowing of your eyes or skin while taking this medicine).
• Abnormal heart beats (arrhythmias).
• Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia). 
• High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There may be an increased risk of drowsiness and sedation if levomepromazine is used with any of the following, which can also cause drowsiness:

• alcohol
• barbiturates, eg amobarbital, phenobarbital
• benzodiazepines, eg diazepam, temazepam
• MAOI antidepressants, eg phenelzine
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• sleeping tablets, eg zopiclone
• strong opioid painkillers, eg morphine, codeine
• tricyclic antidepressants, eg amitriptyline.

There may be an increase in side effects such as dry mouth, constipation or heat stroke (in hot and humid conditions) if levomepromazine is used with other medicines that have anticholinergic effects, including the following:

• anticholinergic medicines for Parkinson's symptoms, eg procyclidine
• antihistamines, eg brompheniramine, chlorphenamine
• other antipsychotic medicines
• other antisickness medicines, eg promethazine, meclozine, cyclizine
• antispasmodic medicines, eg hyoscine
• MAOI antidepressants, eg phenelzine
• medicines for urinary incontinence, eg oxybutynin, flavoxate, tolterodine, propiverine, trospium
• muscle relaxants, eg baclofen
• tricyclic antidepressants, eg amitriptyline.

Levomepromazine may enhance the blood pressure-lowering effects of medicines that lower blood pressure, including medicines used to treat high blood pressure (antihypertensives) and medicines that lower blood pressure as a side effect, eg benzodiazepines. If you are taking medicines that lower blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your doses may need adjusting.

Medicines that increase the risk of a type of abnormal heart rhythm, seen as a 'prolonged QT interval' on an ECG, should be avoided in combination with levomepromazine. These medicines include the following:

• antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol
• the antihistamines astemizole, mizolastine or terfenadine
• arsenic trioxide
• atomoxetine
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
• certain antipsychotics, eg thioridazine, pimozide, sertindole , haloperidol
• cisapride
• dronedarone
• droperidol
• intravenous erythromycin or pentamidine
• methadone
• moxifloxacin
• saquinavir.

There may also be an increased risk of a prolonged QT interval if medicines that can alter the levels of salts such as potassium or magnesium in the blood, eg diuretics such as furosemide, are used in combination with levomepromazine.

There may be an increased risk of a drop in the number of white blood cells in the blood if levomepromazine is taken in combination with other medicines that can have this side effect, such as the following:

• anti-cancer chemotherapy medicines
• carbamazepine
• co-trimoxazole
• penicillamine
• phenylbutazone
• sulphonamides, eg sulfadiazine.

Levomepromazine may oppose the effect of anticonvulsant medicines used to treat epilepsy.

Levomepromazine may increase blood sugar levels and disturb the control of diabetes. People with diabetes may need an adjustment in the dose of their antidiabetic medication.

Levomepromazine may oppose the effects of dopamine agonists used to treat Parkinson's disease, eg levodopa, apomorphine, bromocriptine, cabergoline, pergolide, ropinirole, rotigotine.

Levomepromazine may oppose the effect of histamine (used to treat leukaemia) and is not recommended for people having this treatment.

Levomepromazine is not recommended for people receiving treatment with desferrioxamine.

References:

https://patient.info/medicine/levomepromazine-tablets-nozinan-levinan

https://www.netdoctor.co.uk/medicines/cancer-drugs/a7242/nozinan-levomepromazine/

https://www.medicines.org.uk/emc/product/1429/smpc

https://en.wikipedia.org/wiki/Levomepromazine

https://www.medicines.org.uk/emc/product/1429/pil

https://www.hpra.ie/HOMEPAGE/medicines/medicines-information/find-a-medicine/results/item?pano=PA0540/115/001&t=NOZINAN

http://products.sanofi.ca/en/nozinan.pdf