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ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
2015-01-29 20:02:00 来源: 作者: 【 】 浏览:355次 评论:0

For doctors

 

What is it and how is it used?

ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics.

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

Take special care with ZYPREXA VELOTAB

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

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 VELOTAB is not for patients who are under 18 years.

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

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

Important information about some of the ingredients of ZYPREXA VELOTAB Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.

ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people. An allergic reaction may be recognised as a rash, itching or shortness of breath. This may occur immediately or some time after you take ZYPREXA VELOTAB.

How is it used?

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

You should take your ZYPREXA VELOTAB 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 VELOTAB orodispersible tablets are for oral use.

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

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

If you suddenly stop taking ZYPREXA VELOTAB, 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 VELOTAB can cause side effects, although not everybody gets them.

Very common side effects: affect 1 user in 10

Common side effects: affect 1 to 10 users in 100

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

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

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 VELOTAB 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 VELOTAB 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 VELOTAB after the expiry date, which is stated on the carton .

ZYPREXA VELOTAB should be stored in its original pack in order to protect against 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 Velotab is a medicine that contains the active substance olanzapine. It is available as yellow, round ‘orodispersible’ tablets (5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.

What is it used for?

Zyprexa Velotab 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 Velotab is also effective in maintaining improvement in patients who have responded to an initial course of treatment. Zyprexa Velotab 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 Zyprexa Velotab 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 orodispersible 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 Zyprexa Velotab, 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?

Zyprexa Velotab contains the same active substance as another medicine called Zyprexa that has been authorised in the European Union (EU) since 1996. Because of this, the studies done with Zyprexa were used to support the use of Zyprexa Velotab. Three studies were also carried to show that, when taken by mouth, the two medicines produce equivalent levels of olanzapine in the blood.

What benefits has it shown during the studies?

Like Zyprexa, Zyprexa Velotab was more effective at improving symptoms than placebo (a dummy treatment). Zyprexa Velotab was as effective as the medicines that it was compared with for the treatment of adults with schizophrenia, the treatment of moderate to severe manic episodes in adults, and the prevention of recurrence in adults with bipolar disorder.

What is the risk associated?

The most common side effects with Zyprexa Velotab (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 Velotab, see the Package Leaflet.
Zyprexa Velotab should not be used in people who may be hypersensitive (allergic) to olanzapine or any of the other ingredients. Zyprexa Velotab 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 Velotab’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 and the prevention of recurrence in patients with bipolar disorder. The Committee recommended that Zyprexa Velotab be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU to Eli Lilly Nederland BV for Zyprexa Velotab on 3 February 2000. The marketing authorisation was renewed on 3 February 2005 and on 27 September 2006.

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Name

 

ZYPREXA VELOTAB 20 mg orodispersible tablets

 

Composition

 

Each orodispersible tablet contains 20 mg olanzapine.

Excipients: Each orodispersible tablet contains
1.60 mg aspartame,
0.30 mg sodium methyl parahydroxybenzoate,
0.10 mg sodium propyl parahydroxybenzoate.
For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Orodispersible tablet

Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.

 

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

 

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