This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). 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. Olanzapine administered with lithium or valproate resulted in increased levels (10%) of tremor, dry mouth, increased appetite, and weight gain. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. [7] Other side effects include low blood pressure with standing, allergic reactions, neuroleptic malignant syndrome, high blood sugar, seizures, and tardive dyskinesia. Name of the medicinal product 2. BEFORE USING THIS MEDICINE: There are no adequate and well-controlled studies in pregnant women. In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients. Keep this medicine out of sight and reach of children. It has the same dosage and frequency of administration as olanzapine coated tablets. 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. Avoid becoming overheated or dehydrated. Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. These measures will help to protect the environment. Take Zyprexa exactly as prescribed by your doctor. Excipient with known effect: Each coated tablet contains 102 mg lactose monohydrate. Not all pack sizes may be marketed. Pharmacological properties 6. Try to take your tablets at the same time each day. Drug class: Atypical antipsychotics. Do not take two doses in one day. Do not handle the tablets with wet hands as the tablets may breakup. You might feel drowsy if ZYPREXA VELOTAB is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers). Effects on fertility are unknown (see section 5.3 for preclinical information). It is known as an atypical antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. In two of two placebo- and two of three comparator-controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms. Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can. Excipient with known effect: Each coated tablet contains 178 mg lactose monohydrate. uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); confusion, unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself; low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed; or. ZYPREXA VELOTAB is available in packs containing 28, 35, 56, 70 or 98 tablets. 4. If this happens do not drive or operate any tools or machines. Contents of the pack and other information This leaflet was last revised in January 2021 ZY074 Eli Lilly and Company Limited Address In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes. However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism, all possible risk factors of VTE e.g., immobilisation of patients, should be identified and preventive measures undertaken. There is no specific antidote for olanzapine. In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months. Store at room temperature away from moisture, heat, and light. For centrally authorised veterinary medicines authorised or updated from February 2022, see theVeterinary Medicines Information website. Stroke or mini stroke (temporary symptoms of stroke), If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets). If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. How to store ZYPREXA VELOTAB Tolerance developed to the CNS depression. Swallow several times as the tablet dissolves. It will dissolve directly in your mouth, so that it can be easily swallowed. Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA. Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day. The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2). Absence or decrease in menstrual periods. Try to take your tablets at the same time each day. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed. Zyprexa Velotab must not be used in people who are hypersensitive (allergic) to olanzapine or any of the other ingredients. Like all medicines, this medicine can cause side effects, although not everybody gets them. 0.30 mg sodium methyl parahydroxybenzoate (E219), 0.10 mg sodium propyl parahydroxybenzoate (E217). We comply with the HONcode standard for trustworthy health information. Be careful if you drive or do anything that requires you to be alert. Tell your doctor immediately if you have: 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. Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression. However, the risk of tardive dyskinesia increases with long-term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered. Remove a Zyprexa Zydis orally disintegrating tablet from the package only when you are ready to take the medicine. ZYPREXA VELOTAB tablets break easily, so you should handle the tablets carefully. Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands. Olanzapine is metabolised in the liver by conjugative and oxidative pathways. Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. 1. Following short-term treatment (median duration 47 days), weight gain 7% of baseline body weight was very common (22.2%); 15% was common (4.2%); and 25% was uncommon (0.8%). What is the side effects of Zyprexa? When suggestions are available use up and down arrows to review and ENTER to select. Hair loss. The daily dose of ZYPREXA VELOTAB is between 5mg and 20mg. Each orodispersible tablet contains 15 mg olanzapine. Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident. 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. ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets. Zyprexa is also used together with fluoxetine (Prozac) to treat episodes of depression in adults and children at least 10 years old who have bipolar I disorder. Cardiovascular monitoring is necessary to detect possible arrhythmias. Start typing to retrieve search suggestions. 1. Zyprexa Velotab is a medicine that contains the active substance olanzapine. Zyprexa can be taken with or without food. While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events. The pharmacokinetic variability observed in the elderly is within the range for the non-elderly. ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg ja 20 mg ovat keltaisia suussa hajoavia tabletteja. In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment-emergent dyskinesia. How to take ZYPREXA VELOTAB 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. Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment. Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption. Absence or decrease in menstrual periods. weight gain (more likely in teenagers), increased appetite; headache, dizziness, drowsiness, feeling tired or restless; tremors or shaking, numbness or tingly feeling; This is not a complete list of side effects and others may occur. 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. In particular, tell your doctor if you are taking: Do not drink any alcohol if you have been given ZYPREXA VELOTAB as together with alcohol it may make you feel drowsy. The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure. carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) it may be necessary to change your ZYPREXA VELOTABdose. You and your doctor should check your weight regularly. Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting. Use all medications as directed and read all medication guides you receive. Medication may be only part of a complete program of treatment that also includes counseling and other psychological support programs. The active substance in Zyprexa Velotab, olanzapine, is an antipsychotic medicine. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine. Thus, no particular interaction is expected, as verified through in vivo studies, where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2), or diazepam (CYP3A4 and 2C19). 4. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially sodium-free. Check with your doctor or pharmacist if you are notsure. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4). People with this disease may also feel depressed, anxious ortense. 3Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high ( 6.2 mmol/l). 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database. If this happens after you have been given ZYPREXA VELOTAB tell your doctor. Tell your doctor. ZYPREXA VELOTABS: Store in the original package in order to protect from light and moisture. How quickly can acute migraines be treated. During treatment with olanzapine, adolescents gained significantly more weight compared with adults. Tell your doctor immediately if you have: Very common side effects (may affect more than 1in 10people) include weight gain; sleepiness; and increases in levels of prolactin in the blood. 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. It is thought that olanzapines beneficial effect is due to it blocking receptors for the neurotransmitters 5hydroxytrypamine (also called serotonin) and dopamine. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly. If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in. These symptoms can temporally deteriorate or even arise after discontinuation of treatment. However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions. In a 12 month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence. Uncommon side effects: affect 1 to 10 users in 1,000. Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. With long-term exposure (at least 24 weeks), 89.4% gained 7%, 55.3% gained 15% and 29.1% gained 25% of their baseline body weight. If you are diabetic, check your blood sugar levels on a regular basis while you are taking this medicine. ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg, and 20 mg orodispersible tablet is a 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. 1. ZYPREXA VELOTAB 5mg, 10mg, 15mg and 20mg are yellow orodispersible tablets. People with this disease may also feel depressed, anxious or tense. 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. Olanzapine can pass into breast milk. Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day. If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function. 16Elevated plasma prolactin levels were reported in 47.4% of adolescent patients. Zyprexa pregnancy and breastfeeding warnings. It does not matter whether you take them with or without food. ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics and is used to treat the following conditions: ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment. Weight should be monitored regularly, e.g., at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter. Each coated tablet contains 20 mg olanzapine. Potential for olanzapine to affect other medicinal products. ZYPREXA VELOTAB is available in packs containing 28, 35, 56, 70or 98tablets. High doses or long-term use of olanzapine can cause a serious movement disorder that may not be reversible. Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine. Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12 mg dose). Do not use this medicine after the expiry date, which is stated on the carton. Some fatal cases have been reported in this particular group of patients. It may be harmful for people who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. 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