What is it and how is it used?
Zalasta belongs to a group of medicines called antipsychotics.
Zalasta 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Zalasta 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 Zalasta
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Zalasta. 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 Zalasta
- Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Zalasta 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 Zalasta 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.
Zalasta is not for patients who are under 18 years.
Taking other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
Tell your doctor if:
- you are taking medicines for Parkinson’s disease,
- you are taking antidepressants or medicines taken for anxiety or to help you sleep(tranquillisers). You might feel drowsy if Zalasta is taken in combination with these medicines,
- if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Zalasta dose.
Taking Zalasta with food and drink
Zalasta may be taken with or without food.
Do not drink any alcohol if you have been given Zalasta as Zalasta and alcohol together may make you feel drowsy.
Pregnancy
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.
Breast-feeding
You should not be given this medicine when breast-feeding, as small amounts of Zalasta can pass into breast milk.
Driving and using machines
There is a risk of feeling drowsy when you are given Zalasta. If this happens do not drive or operate any tools or machines. Tell your doctor.
Important information about some of the ingredients of Zalasta
Zalasta 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 Zalasta exactly as your doctor has told you. You should check with your doctor or pharmacists if you are not sure.
Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them. The daily dose of Zalasta is between 5-20 mg.
Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.
You should take your Zalasta 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. You should swallow the tablets whole with water.
If you take more Zalasta than you should
Patients who have taken more Zalasta 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 Zalasta
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Zalasta
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Zalasta for as long as your doctor tells you.
If you suddenly stop taking Zalasta, 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, Zalasta 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 theblood 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 Zalasta 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
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Zalasta after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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?
Zalasta is a medicine containing the active substance olanzapine. It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘orodispersible’ tablets (5, 7.5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Zalasta is a ‘generic medicine’. This means that Zalasta 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?
Zalasta 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). Zalasta is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Zalasta 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 Zalasta 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 Zalasta, 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 Zalasta 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 Zalasta 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 Zalasta 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, Zalasta 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 Zalasta be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d.d., Novo mesto on 27 September 2007.
This summary was last updated in 09-2008.
Name
Zalasta 20 mg tablets
Composition
Each tablet contains 20 mg olanzapine.
Excipient:
Each tablet contains 323.5 mg lactose.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Tablet.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “20”.
