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ZYPREXA 10 mg coated tablets Olanzapine
2015-01-29 20:02:37 来源: 作者: 【 】 浏览:340次 评论:0

For doctors

 

What is it and how is it used?

ZYPREXA belongs to a group of medicines called antipsychotics.

ZYPREXA 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.

ZYPREXA 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 ZYPREXA
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA.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 ZYPREXA
- Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA 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 ZYPREXA 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 Parkinsons 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.

ZYPREXA is not for patients who are under 18 years.

Taking other medicines
Only take other medicines while you are on ZYPREXA if your doctor tells you that you can. You might feel drowsy if ZYPREXA 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 ZYPREXA 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 ZYPREXA with food and drink
Do not drink any alcohol if you have been given ZYPREXA as ZYPREXA 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 ZYPREXA can pass into breast milk.

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

Important information about some of the ingredients of ZYPREXA
ZYPREXA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

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

You should take your ZYPREXA 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. ZYPREXA coated tablets are for oral use. You should swallow the ZYPREXA tablets whole with water.

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

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

If you suddenly stop taking ZYPREXA, 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, ZYPREXA 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 ZYPREXA 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 ZYPREXA 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 ZYPREXA after the expiry date, which is stated on the carton .

ZYPREXA should be stored in its original pack 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.

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For doctors

What is it?

Zyprexa is a medicine containing the active substance olanzapine. It is available as tablets (round and white: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg; pink and oval: 20 mg) and as a powder to be made up into a solution for injection.

What is it used for?

Zyprexa 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). Zyprexa is also effective in maintaining improvement in patients who have responded to an initial course of treatment. Zyprexa 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 with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Zyprexa is usually taken by mouth, but the injection can be used for the rapid control of agitation or disturbed behaviour in adults with schizophrenia or a manic episode, when taking the medicine by mouth is not appropriate.
The medicine can only be obtained with a prescription.

How is it used?

The recommended starting dose of Zyprexa tablets 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 according to how well the patient responds to and tolerates the treatment. The usual dose range is between 5 and 20 mg per day.
The usual dose when using the injection is 10 mg as a single injection into a muscle. This can be followed if needed by a further injection of 5 or 10 mg two hours later.
Lower doses may be needed for patients over 65 years of age (5 mg per day for the tablets and 2.5 to 5 mg for the injection) and for patients who have problems with their liver or kidneys (5 mg per day for both the tablets and injection).
In all cases, the maximum dose of Zyprexa that can be given in a day, using tablets or injection, is 20 mg.

How does it work?

The active substance in Zyprexa, 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 different 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-hydroxytrypamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

How has it been studied?

In schizophrenia, Zyprexa tablets have been studied in about 3,000 adults, in which their effectiveness was compared with that of placebo (a dummy treatment) or haloperidol (another antipsychotic medicine). All four studies lasted six weeks, but the patients stayed on the medicine for up to a year or more.
In the treatment of acute manic episodes in adults with bipolar disorder, Zyprexa tablets were compared with placebo, haloperidol or valproate (another medicine used in manic episodes) in five studies, including one where patients were also receiving other medicines. In the prevention of manic episodes, Zyprexa tablets were studied in 1,162 adults. Their effectiveness was compared with that of placebo or lithium (another medicine used in bipolar disorder).
The injection was studied in 581 adults with schizophrenia (compared with placebo or injected haloperidol) and 228 manic adults (compared with placebo or injected lorazepam, another medicine used in manic episodes).
In all studies, the effectiveness of Zyprexa was assessed using various symptom rating scales.

What benefits has it shown during the studies?

In all studies, Zyprexa as tablets and as injections was more effective at improving symptoms than placebo. Zyprexa tablets were at least as effective as the medicines they were compared with for the treatment of schizophrenia (haloperidol), the treatment of moderate to severe manic episodes (haloperidol and valproate), and the prevention of recurrence in patients with bipolar disorder (lithium). The injection was also shown to be more effective than lorazepam (at a relatively low dose) in manic patients, and as effective as haloperidol in schizophrenia.

What is the risk associated?

The most common side effects with Zyprexa (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain and raised levels of prolactin (a hormone). For the full list of all side effects reported with Zyprexa, see the Package Leaflet.
Zyprexa should not be used in people who may be hypersensitive (allergic) to olanzapine or any of the other ingredients. Zyprexa should not be used in patients at risk of narrow-angle glaucoma (raised pressure inside the eye).

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Zyprexa’s benefits are greater than its risks, in adults, for the treatment of schizophrenia, including the maintenance of clinical improvement during continuation therapy in patients who have shown an initial treatment response, the treatment of moderate to severe manic episode, the prevention of recurrence in patients with bipolar disorder, and for the injection, the rapid control of agitation or disturbed behaviour in patients with schizophrenia or a manic episode, when oral therapy is not appropriate. The Committee recommended that Zyprexa be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union to Eli Lilly Nederland BV for Zyprexa on 27 September 1996. The marketing authorisation was renewed on 27 September 2001 and on 27 September 2006.

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Name

 

ZYPREXA 10 mg coated tablets

 

Composition

 

Each coated tablet contains 10 mg olanzapine.

Excipient: Each coated tablet contains 312 mg lactose monohydrate.
For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Coated tablet

Round, white, coated tabletsimprinted with “LILLY” and a numeric identicode “4117”.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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