How does it work?

Zyprexa tablets, velotabs and injection all contain the activeingredient olanzapine, which is a type of medicine known as an atypicalantipsychotic. Olanzapine tablets and orodispersible tablets are also available without a brand name, ie as the generic medicine.

Olanzapine works in the brain, where it affects variousneurotransmitters, in particular serotonin (5HT) and dopamine.Neurotransmitters are chemicals that are stored in nerve cells and are involvedin transmitting messages between the nerve cells.

Dopamine and serotonin are neurotransmitters known to beinvolved in regulating mood and behaviour, amongst other things. Psychoticillness is considered to be caused by disturbances in the activity ofneurotransmitters (mainly dopamine) in the brain. Schizophrenia is known to beassociated with an overactivity of dopamine in the brain, and this may beassociated with the delusions and hallucinations that are a feature of thisdisease.

Olanzapine works by blocking the receptors in the brain thatdopamine acts on. This prevents the excessive activity of dopamine and helps tocontrol schizophrenia.

Schizophrenic patients may experience 'positive symptoms' (suchas hallucinations, disturbances of thought, hostility) and/or 'negativesymptoms' (such as lack of emotion and social isolation). Olanzapine iseffective in relieving both positive and negative symptoms of schizophrenia,whereas the conventional antipsychotics are usually less effective against thenegative symptoms.

Olanzapine is also used to treat moderate to severe episodes ofmania in people with bipolar affective disorder (manic depression). In peoplewhose manic episode is controlled with olanzapine, the medicine may also beused long-term as a mood stabiliser to prevent further manic and depressiveepisodes of bipolar disorder.

What is it used for?

• Schizophrenia.
• Moderate to severe manic episodes of manic depression (bipolar affective disorder).
• Stabilising mood to prevent episodes of mania or depression in people with bipolar affective disorder whose manic episode has responded to olanzapine treatment.

Zyprexa injection is used when rapid control of agitation anddisturbed behaviours is needed for people with schizophrenia or a manicepisode. Once behaviour has been controlled, the treatment is usually switchedto oral treatment with Zyprexa tablets or Zyprexa velotabs. Zyprexa velotabsare tablets that are designed to dissolve on the tongue and be swallowed withthe saliva, without the need for water.

How do I take it?

• Olanzapine can be taken either with or without food. The tablets are usually taken once a day and you should try to take them at the same time each day.
• The dose prescribed 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 your pharmacist has put on the packet of medicine.
• Zyprexa tablets should be taken with a drink of water.
• Zyprexa velotabs should be placed in the mouth where they will rapidly dissolve in your saliva for easy swallowing. The velotabs are fragile, so should be taken as soon as you have opened the blister. Alternatively they can be dissolved in a glass of water, orange juice, apple juice, milk or coffee before taking.
• Unless your doctor tells you otherwise, you should not suddenly stop taking this medicine, 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 sweating, anxiety, nausea, vomiting, difficulty sleeping or tremor. When treatment with this medicine is stopped, it should be done gradually, following the instructions given by your doctor.

Warning!

• This medicine may cause drowsiness or dizziness. If affected do not drive or operate machinery. Alcohol should be avoided.
• This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing, especially when you first start taking the medicine. This may make you feel dizzy or unsteady. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass.
• This medicine can cause some people to put on weight. Talk to your doctor about this before you start treatment so that you can discuss strategies, such as diet and exercise, for minimising any weight gain.
• Your doctor may want to monitor your weight, blood sugar, cholesterol levels and liver function while you are taking this medicine.
• If you are over 65 years of age, your doctor may want to regularly monitor your blood pressure while you are taking this medicine.
• Consult your doctor immediately if you experience abnormal movements, particularly of the face, lips, jaw and tongue, while taking this medicine. These symptoms may be indicative of a rare side effect known as tardive dyskinesia, and your doctor may ask you to stop taking this medicine, or decrease your dose.
• Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and your treatment may need to be stopped.
• The components of tobacco smoke can cause this medicine to be removed from the body faster than normal. If you are a smoker, you should let your doctor know if you are giving up smoking while taking this medicine, as your dose of this medicine may possibly need to be altered.
• Zyprexa velotabs contain aspartame, which is a source of phenylalanine, and mannitol. They may not be suitable for people who cannot take phenylalanine or mannitol.
• Zyprexa velotabs also contain the preservatives sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people. An allergic reaction may cause an itchy rash or shortness of breath, and may occur as soon as you start treatment, or after you have taken the medicine for some time. Consult your doctor if you experience these symptoms.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• People with raised liver enzymes.
• People with raised levels of fats such as cholesterol or triglycerides in their blood.
• People with diabetes or who are at risk of developing diabetes.
• Enlarged prostate gland (prostatic hypertrophy).
• Failure of function of part of the gut causing an obstruction in the intestines (paralytic ileus).
• People with low levels of white blood cells in their blood (leucopenia or neutropenia).
• People with decreased production of blood cells by the bone marrow, eg due to chemotherapy, radiotherapy or illness.
• People with a history of decreased blood cell production caused by a medicine.
• People with diseases or conditions that involve increased production of blood cells or bone marrow tissue.
• People taking other medicines that can affect liver function or white blood cells.
• History of fits (seizures), eg epilepsy.
• People with an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• People taking medicines that can cause a 'prolonged QT interval' (your doctor will know, but see end of this factsheet for some examples).
• People with heart failure or an enlarged heart (cardiac hypertrophy).
• People with low levels of magnesium (hypomagnesaemia) or potassium (hypokalaemia) in their blood .
• People with risk factors for having a stroke, for example a history of stroke or mini-stroke (TIA), smoking, diabetes, high blood pressure (hypertension), or a type of irregular heartbeat called atrial fibrillation.

Not to be used in

• People with a known risk for closed-angle glaucoma.
• Women who are breastfeeding.
• Zyprexa injection should not be given to people with unstable medical conditions, such as a recent heart attack, unstable angina, very low blood pressure or a very slow heart rate, a heart condition called sick sinus syndrome, or following heart surgery.
• This medicine is not recommended for use in children and adolescents under 18 years of age, as its safety and effectiveness have not been established in this age group. However, Zyprexa tablets may sometimes be prescribed by specialists to treat schizophrenia or mania in children aged 12 to 18 years. This is an unlicensed use of the medicine.
• This medicine is not licensed or recommended for treating behavioural problems or psychosis in elderly people with dementia, as antipsychotic medicines such as this one have been shown to increase the risk of stroke and death in this group of patients.
• This medicine is not recommended for treating psychotic symptoms caused by dopamine agonist medicines in people with Parkinson's disease, as it may make the psychotic symptoms and Parkinson's symptoms worse.
• Zyprexa tablets contain lactose and are not suitable for people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. If you get pregnant or plan to get pregnant while taking this medicine you should seek medical advice from your doctor.
• This medicine passes into breast milk and could be harmful to a nursing infant. Women who need to take this medicine should not breastfeed their infants. Seek 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 individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Very common (affect more than 1 in 10 people)

• Sleepiness.
• Weight gain (see warning section above).
• High blood prolactin (milk producing hormone) level (hyperprolactinaemia). Rarely this may lead to symptoms such as breast enlargement or production of milk.

Common (affect between 1 in 10 and 1 in 100 people)

• Increased appetite.
• Raised blood sugar, cholesterol and triglyceride levels.
• Dizziness.
• Anxiety, restlessness and agitation (akathisia).
• Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
• A drop in blood pressure when moving from a lying down or sitting position to sitting or standing, which results in dizziness and lightheadedness (postural hypotension - see warning section above).
• Constipation.
• Dry mouth.
• Alteration in results of liver function tests.
• Increased number of blood cells called eosinophils in the blood (eosinophilia).
• Rash.
• Feeling weak or fatigued.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Decreased numbers of white blood cells in the blood (leucopenia or neutropenia). Tell your doctor if you get a fever, sore throat, mouth ulcers or other signs of infections while taking this medicine, as these symptoms could suggest a problem with your white blood cells.
• Slow heart rate (bradycardia).
• Abnormal heart rhythm seen as a 'prolonged QT interval' on a heart monitoring trace or ECG.
• Abnormal reaction of the skin to light, usually a rash (photosensitivity).
• Hair loss.

Frequency unknown

• Decreased numbers of blood cells called platelets in the blood (thrombocytopenia).
• Diabetes.
• Seizures.
• Blood clot in the blood vessels (thromboembolism), eg pulmonary embolism or deep vein thrombosis (DVT).
• Tardive dyskinesia (see warning section above).
• Neuroleptic malignant syndrome (see warning section above).
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Persistent painful erection of the penis (priapism).
• Difficulty passing urine.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

There may be an increased risk of drowsiness and sedation ifolanzapine is taken with any of the following (which can also causedrowsiness):

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

This medicine may enhance the blood pressure-lowering effects of certain medicines used to treat high blood pressure (antihypertensives). If you are taking medicines for high blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your blood pressure medicines may need adjusting.

There is an increased risk of a very slow heart rate, low blood pressure and slow, shallow breathing (respiratory depression) if benzodiazepines such as diazepam are given by injection to people who have been given olanzapine by injection.

The following medicines may reduce the breakdown of olanzapine by the liver. If you are prescribed any of these your doctor may need to reduceyour olanzapine dose:

• ciprofloxacin
• fluvoxamine.

The following medicines may increase the breakdown of olanzapine by the liver, which could make it less effective. Your doctor may need to increase your dose of olanzapine if you are also taking one of these medicines:

• carbamazepine
• ritonavir.

Activated charcoal, used to treat indigestion and wind, candecrease the absorption of olanzapine from the gut. If you you need to take activated charcoal while taking olanzapine, you should take it at least two hours before orafter your olanzapine.

Olanzapine may oppose the effect of medicines for Parkinson's disease that work by enhancing the activity of dopamine in the brain (dopamine agonists), for example levodopa, ropinirole, pergolide, bromocriptine.

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

There may be an increased risk of an abnormal heart rhythm(seen as a 'prolonged QT interval' on a heart monitoring trace or ECG) if olanzapine istaken with any of the following medicines:

• antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol
• the antihistamines astemizole, mizolastine or terfenadine
• atomoxetine
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
• certain other antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol
• cisapride
• intravenous erythromycin or pentamidine
• moxifloxacin
• medicines that can alter the levels of salts such as potassium or magnesium in your blood, eg diuretics such as furosemide.

There may be an increased risk of side effects on the liver ifolanzapine is taken with other medicines that may have adverse effects on theliver.

There may be an increased risk of a drop in white blood cellcount if olanzapine is taken with other medicines that may have this adverseeffect, in particular valproate. If you are taking olanzapine in combinationwith valproate it is important to tell your doctor if you experience any of thefollowing symptoms: sore throat, mouth ulcers, high temperature (fever), orgeneral illness or infection. Your doctor may want to take a blood test tocheck your blood cells.

Other medicines containing the same active ingredient

Olanzapine tablets and orodispersible tablets are also available without a brand name, ie as the generic medicine.