Olenza belongs to a group of medicines called antipsychotics and is used to treat the following

conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.

• Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

Olenza has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.

Do not take Olenza

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

An allergic reaction may be recognized as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

• If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before you take Olenza

• The use of Olenza in elderly patients with dementia is not recommended as it may have serious side effects.

• Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olenza tell your doctor.

• Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.

• Weight gain has been seen in patients taking Olenza. You and your doctor should check your weight regularly.

• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olenza. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olenza and regularly during treatment.

• Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

If you suffer from any of the following illnesses tell your doctor as soon as possible:

• Stroke or “mini” stroke (temporary symptoms of stroke)

• Parkinson’s disease

• Prostate problems

• A blocked intestine (Paralytic ileus)

• Liver or kidney disease

• Blood disorders

• Heart disease

• Diabetes

• Seizures

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.

Children and adolescents

Olenza is not for patients who are under 18 years.

Other medicines and Olenza

Only take other medicines while you are on Olenza if your doctor tells you that you can. You might feel drowsy if Olenza is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking:

• medicines for Parkinson’s disease.

• carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olenza dose.

Olenza with alcohol

Do not drink any alcohol if you have been given Olenza as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of Olenza can pass into breast milk.

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

Driving and using machines

There is a risk of feeling drowsy when you are given Olenza. If this happens do not drive or operate any tools or machines. Tell your doctor.

Olenza contains aspartame

Patients who cannot take phenylalanine should note that Olenza contains aspartame, which is a

source of phenylalanine. May be harmful for people with phenylketonuria.

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Olenza tablets to take and how long you should continue to take them. The daily dose of Olenza is between 5 and 20 mg.

Consult your doctor if your symptoms return but do not stop taking Olenza unless your doctor tells you to.

You should take your Olenza tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food.

Olenza Oral Disintegrating  tablets are for oral use.

Olenza tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up.

1. Keep your hands dry.

2. Take the tablet Carefully out of the pocket

Put the tablet in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed. You can also place the tablet in a full glass or cup of water, orange juice, apple juice

or milk, and stir. With some drinks, the mixture may change color and possibly become cloudy. Drink it straight away.

If you take more Olenza than you should

Patients who have taken more Olenza than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate,

aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away. Show the doctor your pack of tablets.

If you forget to take Olenza

Take your tablets as soon as you remember. Do not take two doses in one day.

If you stop taking Olenza

Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olenza for as long as your doctor tells you.

If you suddenly stop taking Olenza, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:

• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;

• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) 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 combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood.

In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes;

increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual

movements (dyskinesias); problems with speech; constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet, fever,

jointpain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasm (including eye movements); spasms of the muscle of the eye causing rolling movement of the eye; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose: abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the

pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and

pains; and prolonged and/or painful erection.

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.

Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson’s disease Olenza may worsen the symptoms.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton.

Store below 25°C. Olenza should be stored in its original pack in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.