Olanzapine Teva 10 mg orodispersible tablets


What is it and how is it used?

Olanzapine Teva belongs to a group of medicines called antipsychotics.

Olanzapine Teva is used to treat 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.

Olanzapine Teva is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.

What do you have to consider before using it?

Do not take Olanzapine Teva

  • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine Teva. An allergic reaction may be recognised 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) .

Take special care with Olanzapine Teva

  • Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Teva 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.
  • The use of Olanzapine Teva in elderly patients with dementia is not recommended as it may have serious side effects.

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

  • Diabetes
  • Heart disease
  • Liver or kidney disease
  • Parkinson’s disease
  • Epilepsy
  • Prostate problems
  • A blocked intestine (Paralytic ileus)
  • Blood disorders
  • Stroke or “mini” stroke (temporary symptoms of stroke)

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.

Olanzapine Teva is not for patients who are under 18 years.

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

You should tell your doctor if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Olanzapine Teva dose.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking medicines for Parkinson’s disease.

Taking Olanzapine Teva with food and drink
Do not drink any alcohol if you have been given Olanzapine Teva as Olanzapine Teva and alcohol together may make you feel drowsy.

Pregnancy and breast-feeding
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine when pregnant, unless you have discussed this with your doctor. You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Teva can pass into breast milk.

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

Important information about some of the ingredients of Olanzapine Teva
Olanzapine Teva also contains 1 mg D-glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product Olanzapine Teva 5 mg contains 0.4 mg tartrazine lake (E102) and may cause allergic reactions. Olanzapine Teva 15 mg contains 0.2 mg sunset yellow lake (E110) and may cause allergic reactions.

How is it used?

Always take Olanzapine Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Olanzapine Teva tablets to take and how long you should continue to take them. The daily dose of Olanzapine Teva is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.

You should take your Olanzapine Teva 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. Olanzapine Teva orodispersible tablets are for oral use.

Olanzapine Teva 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. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.

2. Carefully peel off the backing.

3. Gently push the tablet out.

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

If you take more Olanzapine Teva than you should
Patients who have taken more Olanzapine Teva 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 Olanzapine Teva
Take your tablets as soon as you remember. Do not take two doses in one day.

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

If you suddenly stop taking Olanzapine Teva, 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.

What are possible side effects?

Like all medicines, Olanzapine Teva can cause side effects, although not everybody gets them.

Very common side effects: affect 1 user in 10

  • Weight gain.
  • Sleepiness.
  • Increases in the levels of prolactin in the blood.

Common side effects: affect 1 to 10 users in 100

  • Changes in the levels of some blood cells and circulating fats.
  • Increases in the level of sugars in the blood and urine.
  • Feeling more hungry.
  • Dizziness.
  • Restlessness.
  • Tremor.
  • Muscle stiffness or spasm (including eye movements).
  • Problems with speech.
  • Unusual movement (especially of the face or tongue).
  • Constipation.
  • Dry mouth.
  • Rash.
  • Loss of strength.
  • Extreme tiredness.
  • Water retention leading to swelling of the hands, ankles or feet.
  • 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.
  • Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects: affect 1 to 10 users in 1,000

  • Slow heart rate.
  • Make you sensitive to sunlight.
  • Urinary incontinence.
  • Hair loss.
  • Absence or decrease in menstrual periods.
  • Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Other possible side effects: frequency cannot be estimated from the available data.

  • Allergic reaction (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.
  • Lowering of normal body temperature.
  • Seizures, usually associated with a history of seizures (epilepsy).
  • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
  • Spasms of the muscle of the eye causing rolling movement of the eye.
  • Abnormal rhythms of the heart.
  • Sudden unexplained death.
  • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.
  • 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.
  • Difficulty in passing urine.
  • 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 Olanzapine Teva may worsen the symptoms.

Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. Very rarely babies born to mothers who have taken Olanzapine Teva in the last stage of pregnancy (3 rd trimester) may have tremors, be sleepy or drowsy.

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

How should it be stored?

Keep out of the reach and sight of children.

Do not use Olanzapine Teva after the expiry date which is stated on the carton.

Do not store above 30°C.
Store in the original package in order to protect from light and moisture.

Please return left over medicine to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Olanzapine Teva is a medicine containing the active substance olanzapine. It is available as tablets (white and round: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg; pink and oval: 20 mg) and as round ‘orodispersible’ tablets (yellow: 5 and 10 mg; orange: 15 mg; green: 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olanzapine Teva is a ‘generic medicine’. This means that Olanzapine Teva is similar to ‘reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Olanzapine Teva is used to treat adults with schizophrenia. Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). Olanzapine Teva is also effective in maintaining improvement in patients who have responded to an initial course of treatment. Olanzapine Teva is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
The medicine can only be obtained with a prescription.

How is it used?

The recommended starting dose of Olanzapine Teva depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. The dose is adjusted depending on how well the patient responds to and tolerates the treatment. The usual dose range is between 5 and 20 mg per day. The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing. Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.

How does it work?

The active substance in Olanzapine Teva, olanzapine, is an antipsychotic medicine. It is known as an ‘atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other. It is thought that olanzapine’s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

How has it been studied?

Because Olanzapine Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i.e. that the medicines produce the same levels of the active substance in the body).

What benefits has it shown during the studies?

Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.

What is the risk associated?

Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. Therefore, the CHMP’s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk. The Committee recommended that Olanzapine Teva be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Teva to Teva Pharma BV on 12 December 2007.

This summary was last updated in 09-2008.