INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PREXOLAN™ ODT 5 (orodispersible tablets)
PREXOLAN™ ODT 10 (orodispersible tablets)
PREXOLAN™ ODT 15 (orodispersible tablets)
PREXOLAN™ ODT 20 (orodispersible tablets)

SCHEDULING STATUS
S5

PROPRIETARY NAME
(and dosage form):

PREXOLAN™ ODT 5 (orodispersible tablets)
PREXOLAN™ ODT 10 (orodispersible tablets)
PREXOLAN™ ODT 15 (orodispersible tablets)
PREXOLAN™ ODT 20 (orodispersible tablets)

COMPOSITION
PREXOLAN ODT 5: Each orodispersible tablet contains
olanzapine 5 mg
PREXOLAN ODT 10: Each orodispersible tablet contains olanzapine 10 mg
PREXOLAN ODT 15: Each orodispersible tablet contains olanzapine 15 mg
PREXOLAN ODT 20: Each orodispersible tablet contains olanzapine 20 mg
Excipients: Colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mint flavouring (mint powder (E0613218) and talc.
Contains lactose.

PHARMACOLOGICAL CLASSIFICATION
A 2.6.5 Tranquillisers –miscellaneous structures

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Olanzapine is an atypical antipsychotic agent having affinity for 5HT
2A/2C, 5HT3, 5HT6, dopamine D4, D3, D1, D2, cholinergic muscarinic receptors (m1 –m5), ALPHA-1 (alpha1) adrenergic and histamine H1 receptors.
Further studies also demonstrate that olanzapine selectively interacts with the mesolimbic system without significantly interacting with the extrapyramidal system.
Olanzapine's antagonism of muscarinic receptors (m
1 - m5) may explain its anticholinergic effects. Olanzapine's antagonism of histamine H1 receptors may explain the somnolence observed with this medicine. Olanzapine's antagonism of adrenergic alpha1 receptors may explain the orthostatic hypotension observed with this medicine.

Pharmacokinetic properties
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food.
Olanzapine is metabolised in the liver by conjugative oxidative pathways. The major circulating metabolite is the 10-N-glucuronide which does not pass the blood-brain barrier. Other metabolites include the N-desmethyl and 2-hydroxymethyl metabolites neither of which has in vivo pharmacological activity. The predominant pharmacologic activity is from the parent compound.
After oral administration the elimination half-life of olanzapine in healthy subjects varies with age and gender.
  < 65 years > 65 years
Men 29 hours 49 hours
Women 39 hours 55 hours

The elimination half-life of olanzapine is about 1,5 times greater in the elderly (> 65 years) than in non-elderly subjects (< 65 years) (see WARNINGS).
Plasma clearance of olanzapine is higher in smokers (see Special precautions).
The pharmacokinetic characteristics of olanzapine are similar in patients with severe renal impairment and normal subjects, indicating that dosage adjustment based upon the degree of renal impairment is not required. In addition, olanzapine is not removed by haemodialysis. The effect of renal impairment on metabolite elimination has not been studied.
The plasma protein binding of olanzapine is about 93% over the concentration range of about 7 to about 1 000 ng/mL. Olanzapine is bound predominantly to albumin and alpha
1-acid-glycoprotein.

INDICATIONS
PREXOLAN ODT is indicated for the management of the manifestations of psychotic disorders.
Effectiveness for more than 6 weeks has not been established in controlled trials. It is recommended that responding patients be continued on PREXOLAN ODT at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
PREXOLAN ODT is also indicated for the treatment of acute mania in bipolar disorder and for preventing recurrence of manic or depressive episodes of bipolar disorder.

CONTRAINDICATIONS
Hypersensitivity to olanzapine or to any components of PREXOLAN ODT.
Patients with known risk of narrow-angle glaucoma.
Paediatric patients: safety and effectiveness in patients under 18 years of age has not been established.

WARNINGS
• Discontinuation reactions may occur, usually within a week of discontinuing PREXOLAN ODT. These reactions may consist of a cholinergic syndrome (diaphoresis, diarrhoea, sialorrhoea, nausea and vomiting, anxiety, agitation, insomnia and tremor). PREXOLAN ODT should therefore be gradually discontinued.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting have been reported very rarely when PREXOLAN ODT is stopped abruptly. Gradual dose reduction should be considered when discontinuing therapy.
Hyperprolactinaemia: PREXOLAN ODT elevates prolactin levels and a modest elevation persists during chronic administration. An increase in mammary gland neoplasms has been found in rodents after chronic administration of antipsychotic medicines such as PREXOLAN ODT and is considered to be prolactin mediated. The relevance for human risk of the finding of prolactin mediated endocrine tumours in rodents is unknown.
Neuroleptic malignant syndrome (NMS): NMS has occurred infrequently in association with PREXOLAN ODT. NMS is a potentially fatal symptom complex. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, rhabdomyolysis and acute renal failure. PREXOLAN ODT should be discontinued should any of the clinical manifestations of NMS or high fever without additional clinical manifestations of NMS be observed.
Tardive dyskinesia: PREXOLAN ODT is associated with a low incidence of treatment emergent dyskinesia. If signs or symptoms of tardive dyskinesia appear in a patient on PREXOLAN ODT, a dose reduction or discontinuation of treatment should be considered. However, some patients may benefit from continued treatment with PREXOLAN ODT despite the presence of the syndrome. The risk of tardive dyskinesia increases with long-term exposure and symptoms can temporarily deteriorate or even arise after discontinuation of treatment.
Hyperglycaemia and diabetes mellitus: There is an increased prevalence of diabetes amongst patients with schizophrenia. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with PREXOLAN ODT. Patients with an established diagnosis of diabetes mellitus who are started on PREXOLAN ODT should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes), who are starting treatment with PREXOLAN ODT should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. Patients who develop symptoms of hyperglycaemia during treatment with PREXOLAN ODT should undergo fasting blood glucose testing. In some cases, hyperglycaemia has resolved when PREXOLAN ODT was discontinued. However, some patients required continuation of anti-diabetic treatment despite discontinuation of PREXOLAN ODT.
Seizures: PREXOLAN ODT should be used cautiously in patients who have a history of seizures or who are subject to factors which may lower seizure threshold. Seizures have been reported to occur infrequently in patients treated with PREXOLAN ODT. In most cases, a history of seizures or risk factor for seizures was reported.
Hepatic impairment: Caution should be exercised in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve and in patients who are being treated with potentially hepatotoxic medicines. Periodic assessment of transaminases is recommended in patients with significant hepatic disease. A starting dose of 5 mg should be considered for patients with moderate hepatic impairment.
Safety experience in elderly patients with dementia-related psychosis: PREXOLAN ODT is not approved for treatment of patients with dementia-related psychosis. Risk factors that may predispose this patient population to increased mortality when treated with PREXOLAN ODT include age > 80 years, sedation, concomitant use of benzodiazepines, or presence of pulmonary conditions (e.g. pneumonia, with or without aspiration).
• Caution should be exercised in dosing the elderly, especially if there are other factors that might additively influence medicine metabolism and/or pharmacodynamic sensitivity (see Special precautions).

INTERACTIONS
Potential interactions affecting PREXOLAN ODT: Since PREXOLAN ODT is metabolised by CYP1A2, substances that specifically induce, inhibit or act as a substrate to this isoenzyme may affect the pharmacokinetics of PREXOLAN ODT.
Concomitant use of PREXOLAN ODT with: Other centrally acting agents - Given the primary CNS effects of PREXOLAN ODT, caution should be exercised when PREXOLAN ODT is taken in combination with other centrally acting agents (especially those that can cause CNS depression) and alcohol.
Fluoxetine - In combination with PREXOLAN ODT may cause an increase in the maximum concentration of olanzapine and a decrease in olanzapine clearance. The effect of repeat dosages and higher dosages of PREXOLAN ODT has not been evaluated. Combination therapy is not advised.
Levodopa - PREXOLAN ODT exhibits in vitro dopamine antagonism and may antagonise the effects of levodopa and dopamine agonists.
Antihypertensive agents - PREXOLAN ODT may enhance the effects of certain antihypertensive agents because of the potential for inducing hypotension. PREXOLAN ODT has alpha
1 adrenergic antagonist activity. Caution should be exercised in patients who receive treatment with medicinal products that can lower blood pressure by mechanisms other than alpha1 adrenergic antagonism.
Medicines that increase the QTc interval - Increased QTc interval has been reported. Caution should be exercised when PREXOLAN ODT is prescribed together with other medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Antacids - Single doses of antacid (aluminium, magnesium) or cimetidine do not affect the oral bioavailability of olanzapine. However, the concomitant administration of activated charcoal reduces the oral bioavailability of olanzapine by 50 to 60%. These medicines should be taken at least 2 hours before or after PREXOLAN ODT.
Inducers of CYP1A2 - The metabolism of olanzapine may be induced by concomitant smoking or by carbamazepine therapy causing slightly to moderately lower olanzapine plasma levels. Clinical monitoring is recommended and an increase of the PREXOLAN ODT dose may be considered if necessary.
Inhibitors of CYP1A2 - Known potent inhibitors of CYP1A2 activity may decrease PREXOLAN ODT clearance. Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine. The mean increase in olanzapine Cmax following fluvoxamine is 54% in female non-smokers and 77% in male smokers. The mean increase in olanzapine AUC was 52% and 108% respectively. A lower starting dose of PREXOLAN ODT should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin or ketoconazole. A decrease in the dose of PREXOLAN ODT should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Potential for PREXOLAN ODT to affect other medicines - No inhibition of the metabolism of imipramine/desipramine (P450-CYP2D6 or P450-CYP3A/1A2), warfarin (P450-CYP2C9), theophylline (P450-CYP1A2) or diazepam (P450-CYP3A4 and P450-CYP2C19) was evident. PREXOLAN ODT does not interact when co-administered with lithium or biperiden.
Studies in vitro using human liver microsomes, determined that olanzapine has little potential to inhibit the glucuronidation of valproate, the major metabolic pathway for valproate. Further, valproate was found to have little effect on the metabolism of olanzapine in vitro. Daily concomitant in vivo administration of 10 mg olanzapine for 2 weeks did not affect steady state plasma concentrations of valproate. Therefore concomitant PREXOLAN ODT administration does not require dosage adjustment of valproate.

PREGNANCY AND LACTATION
The safety of PREXOLAN ODT during pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
Psychotic disorders:
PREXOLAN ODT should be administered on a once a day schedule without regard to meals, beginning with an initial dose of 5 to 10 mg per day, with a target dose of 10 mg per day being reached within several days. Further dosage adjustments, if indicated, should occur at intervals of not less than one week.
Acute mania in bipolar disorder: PREXOLAN ODT should be administered on a once a day schedule without regard to meals, generally beginning with 10 mg. Dosage adjustments, within the dose range of 5 mg to 20 mg per day, if indicated, should occur at intervals of not less than 24 hours.
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg per day. For patients who have been receiving PREXOLAN ODT for treatment of manic episode, continue therapy for preventing recurrence at the same dose. An increase to a dose greater than the recommended starting dose, within the dose range of 5 mg to 20 mg per day, is advised only after appropriate clinical assessment, and should generally occur at intervals of not less than 24 hours.
A starting dose of 5 mg should be considered for patients with hepatic impairment and may also be considered for the elderly patient.
The safety of doses above 20 mg per day has not been evaluated in clinical trials.
Gradual tapering of the dose should be considered when discontinuing PREXOLAN ODT (see WARNINGS).
Improvement in the patient’s clinical condition may take several days to weeks.
Patients should be closely monitored during this period. PREXOLAN ODT should be placed in the mouth, where they will rapidly be dispersed in the saliva so that they can easily be swallowed. You can also place the tablet in a full glass or cup of water and stir. Drink it straight away.
The tablets should not be removed from the blister foil until immediately before administration.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
Blood and lymphatic system disorders
Frequent: Eosinophilia
Less frequent: Leucopenia, thrombocytopenia, neutropenia
Immune system disorders
Less frequent: Allergic reactions (e.g. anaphylactoid reaction, angioedema, pruritus, urticaria)
Metabolic and nutritional disorders
Frequent: Weight gain, increased appetite
Less frequent: Hyperglycaemia, hypertriglyceridaemia, diabetic ketoacidosis, diabetic coma, elevated cholesterol levels
Frequency unknown: Development or exacerbation of diabetes
Psychiatric disorders
Frequent: Personality disorder, hallucinations
Less frequent: Amnesia, anxiety, euphoria, hostility
Nervous system disorders
Frequent: Somnolence, dizziness, headache, akathisia, parkinsonism, dyskinesia, asthenia, agitation, abnormal gait, falls, tremor, speech
disorders
Less frequent: Articulation impairment, hypertonia, movement disorder, nervousness, myoclonus, insomnia, stuttering, extrapyramidal effects (neck rigidity, muscle spasms of face, neck or back), seizures, dystonia
Frequency unknown: Tardive dyskinesia, neuroleptic malignant syndrome, discontinuation symptoms (sweating, insomnia, tremor, anxiety, nausea and vomiting has been reported when PREXOLAN ODT is stopped abruptly)
Eye disorders
Frequent: Amblyopia
Cardiac disorders
Frequent: Chest pain
Less frequent: Bradycardia, tachycardia, QTc-prolongation
Frequency unknown: Ventricular tachycardia/fibrillation, sudden death
Vascular disorders
Frequent: Orthostatic hypotension, peripheral oedema
Less Frequent: Venous thromboembolism
Respiratory, thoracic and mediastinal disorders
Frequent: Rhinitis, pneumonia
Less frequent: Cough, pharyngitis
Gastrointestinal disorders
Frequent: Dry mouth, constipation
Less frequent: Abdominal pain, pancreatitis
Hepato-biliary disorders
Frequent: Transient asymptomatic elevations of hepatic transaminases (ALT, AST)
Less frequent: Hepatitis
Skin and subcutaneous tissue disorders
Frequent: Rash
Less frequent: Photosensitivity reaction, alopecia
Musculoskeletal, connective tissue and bone disorders
Less frequent: Extremity pain (other than joint), joint pain, rhabdomyolysis
Renal and urinary disorders
Frequent: Urinary incontinence
Less frequent: Urinary hesitation
Reproductive system and breast disorders
Less frequent: Menstrual changes, priapism
General disorders and administration site conditions
Less frequent: Fever, fatigue, oedema
Investigations
Frequent: Elevated prolactin levels, increased ALT, increased AST
Less frequent: High creatine phosphokinase, increased total bilirubin
Frequency unknown: Increased alkaline phosphokinase
Special precautions
Transaminase elevations:
Transient elevations of liver transaminases (ALT, AST) have been observed. Caution should therefore be exercised in patients with elevated ALT and/or AST in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve and in patients who are being treated with potentially hepatotoxic agents. In the event of elevated ALT and/or AST during treatment follow-up should be organised and dose reduction should be considered. In cases when hepatitis has been diagnosed PREXOLAN ODT treatment should be discontinued.
Orthostatic hypotension: PREXOLAN ODT may induce orthostatic hypotension associated with dizziness, tachycardia and in some patients, syncope, especially during the initial treatment period.
Body temperature regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing PREXOLAN ODT to patients who will be experiencing conditions which may contribute to an elevation in core body temperature.
Suicide: The possibility of suicide attempt is inherent in schizophrenia and close supervision of high risk patients should accompany PREXOLAN ODT treatment.
Other events observed in patients treated with PREXOLAN ODT in settings other than placebo-controlled clinical trials include a single case of exacerbation of pre-existing intracranial hypertension.
Concomitant illnesses: Clinical experience with PREXOLAN ODT in patients with concomitant illnesses is limited. As PREXOLAN ODT has demonstrated anticholinergic activity in vitro caution is advised when prescribing for patients with symptomatic prostatic enlargement, or paralytic ileus and related conditions. PREXOLAN ODT has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Because of the risk of orthostatic hypotension with PREXOLAN ODT, caution should be observed in cardiac patients.
Elderly patients: In clinical studies in general there was no indication of any different tolerability of PREXOLAN ODT in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to PREXOLAN ODT, should lead to consideration of a lower starting dose.
Patients with haematological disorders: Caution should be exercised when using PREXOLAN ODT in patients with low leucocyte and/or neutrophil counts due to any reason, patients with a history of medicine-induced bone marrow depression/toxicity, patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
The combined effects of age, smoking and gender could lead to substantial pharmacokinetic differences. The clearance in young smoking males, for example, may be 3 times higher than in elderly non-smoking females. Dosing modification may be necessary in patients who exhibit a combination of factors that may result in slower metabolism of PREXOLAN ODT. Use with caution when concomitantly used with CYP1A2 inducers and inhibitors (see INTERACTIONS).
Dysphagia: Oesophageal dysmotility and aspiration have been associated with antipsychotic medicines. PREXOLAN ODT should be used with caution in patients at risk for aspiration pneumonia.
Cerebrovascular adverse events (CVAE), including stroke, in elderly patients with dementia: Cerebrovascular adverse events (e.g. stroke, transient ischaemia attack), including fatalities, were reported especially in elderly patients with dementia-related psychosis. All patients who experienced a cerebrovascular event had pre-existing risk factors known to be associated with an increased risk for a CVAE (e.g. history of previous CVAE or transient ischaemic attack, hypertension, cigarette smoking) and presented with concurrent medical conditions and/or concomitant medications having a temporal association with CVAE. PREXOLAN ODT is not approved for the treatment of patients with dementia related psychosis.
Lactose: PREXOLAN ODT contains lactose. Patients with rare heredity problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take PREXOLAN ODT.

Effects on ability to drive and use machines
PREXOLAN ODT may cause somnolence. Patients should be cautioned about operating hazardous machinery including motor vehicles until they are reasonably certain that PREXOLAN ODT therapy does not affect them adversely.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Signs and symptoms
Frequently occurring symptoms of PREXOLAN ODT overdose (> 10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms and reduced level of consciousness ranging from sedation to coma. Other medically significant sequelae of PREXOLAN ODT overdose will include delirium, convulsion, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac dysrhythmias and cardiopulmonary arrest. Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1 500 mg.
Treatment
The possibility of multiple medicine involvement should be considered. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible dysrhythmias.
There is no specific antidote to PREXOLAN ODT, therefore appropriate symptomatic and supportive measures should be initiated. Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents. Induction of emesis is not recommended.
Do not use epinephrine (adrenaline), dopamine or other sympathomimetics with beta-agonist activity, since beta-stimulation may worsen hypotension in the setting of PREXOLAN ODT-induced alpha-blockade.
Close medical supervision and monitoring should continue until the patient recovers.

IDENTIFICATION
PREXOLAN ODT 5: Yellow, round, biconvex tablets, with dimensions: 6,0 mm + 0,1 mm in diameter and thickness 2,6 + 0,2 mm.
PREXOLAN ODT 10: Yellow, round flat tablets, with dimensions: 8,2 mm + 0,1 mm in diameter and thickness 2,4 + 0,2 mm.
PREXOLAN ODT 15: Yellow, round biconvex tablets, with dimensions: 10,0 mm + 0,1 mm in diameter and thickness 3,1 + 0,2 mm.
PREXOLAN ODT 20: Yellow, round flat tablets, with dimensions: 11,2 mm + 0,1 mm in diameter and thickness 2,7 + 0,2 mm.

PRESENTATION
PREXOLAN ODT 5: PA/ALU/PVC-Aluminium foil blisters strips presented in blisters of 7 tablets/blister or 10 tablets/blister packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 10: PA/ALU/PVC-Aluminium foil blisters strips presented in blisters of 7 tablets/blister or 10 tablets/blister packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 15: PA/ALU/PVC-Aluminium foil blisters strips presented in blisters of 7 tablets/blister or 10 tablets/blister packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 20: PA/ALU/PVC-Aluminium foil blisters strips presented in blisters of 7 tablets/blister or 10 tablets/blister packed into outer cartons of 28 or 30 tablets.
Not all packs and pack sizes are necessarily marketed.

STORAGE INSTRUCTIONS
Store at or below 30°C.
Protect from light.
Do not remove the tablets from the blisters until required for use.
PREXOLAN ODT should at all times be kept out of reach of children as even small doses may be fatal to them.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBERS
PREXOLAN ODT 5: 44/2.6.5/0915
PREXOLAN ODT 10: 44/2.6.5/0916
PREXOLAN ODT 15: 44/2.6.5/0917
PREXOLAN ODT 20: 44/2.6.5/0918

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THE PACKAGE INSERT
01 March 2013

<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<
PATIENT INFORMATION leaflet

Read this entire leaflet carefully before you start taking PREXOLAN ODT.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• PREXOLAN ODT has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
SCHEDULING STATUS S5

PROPRIETARY NAME
(and dosage form)
PREXOLAN ODT 5 (orodispersible tablets)
PREXOLAN ODT 10 (orodispersible tablets)
PREXOLAN ODT 15 (orodispersible tablets)
PREXOLAN ODT 20 (orodispersible tablets)
Olanzapine

WHAT PREXOLAN ODT CONTAINS
PREXOLAN ODT 5 contains olanzapine 5 mg per orodispersible tablet.
PREXOLAN ODT 10 contains olanzapine 10 mg per orodispersible tablet.
PREXOLAN ODT 15 contains olanzapine 15 mg per orodispersible tablet.
PREXOLAN ODT 20 contains olanzapine 20 mg per orodispersible tablet.
Other ingredients are colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mint flavouring (mint powder (E0613218)) and talc.
Contains lactose.

WHAT PREXOLAN ODT IS USED FOR
PREXOLAN ODT belongs to a group of medicines called antipsychotics.
• PREXOLAN ODT 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.
• PREXOLAN ODT is also 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.

BEFORE YOU TAKE PREXOLAN ODT
Do not take PREXOLAN ODT if you:
• Have a hypersensitivity or are allergic to PREXOLAN ODT or any of the other ingredients in PREXOLAN ODT. 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.
• Are a child under the age of 18 years.
• Have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
• > 80 years of age.
Take special care with PREXOLAN ODT:
If you suffer from any of the following illnesses, you should contact your doctor as soon as possible:
• The use of PREXOLAN ODT in elderly patients with mental deterioration (dementia) is not recommended as it may have serious side effects.
• Medicines of this type may cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
If this happens, contact your doctor at once.
• Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given PREXOLAN ODT, tell your doctor.
• If you are having any blood tests, tell your doctor you are using PREXOLAN ODT, because it sometimes causes changes in a variety of blood tests/results or investigations and your doctor should be made aware of this.

You should tell your doctor as soon as possible, if you suffer from any of the following illnesses:
• Seizures/fits or epilepsy
• High blood sugar levels or diabetes
• Increased levels of prolactin in the blood, found by blood test (hyperprolactinaemia)
• Problems with your liver (not functioning well)
• Heart disease
• Blood disorders
• If you are an elderly patient (> 65 years of age)
• Prostate problems
• A blocked intestine (paralytic ileus)
• Uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• Drop in blood pressure when standing up associated with dizziness, faster heart beat and fainting (orthostatic hypotension)
• Disruption of the body’s ability to reduce core body temperature (body temperature regulation)
• Cerebrovascular adverse events, including stroke, transient ischaemia attack (disturbances of body function lasting for less than 24 hours and caused by localised nervous system defects) in the elderly
• Difficulty in swallowing (risk of dysphagia)
• Suicide attempt while on PREXOLAN ODT therapy
• If you are a smoker cause the combined effects of age, smoking and gender could lead to slower metabolism of PREXOLAN ODT.

Taking PREXOLAN ODT with food and drink:
Do not drink any alcohol if you have been given PREXOLAN ODT as PREXOLAN ODT and alcohol together may make you feel drowsy.
The consumption of food does have an effect on PREXOLAN ODT.
You may take PREXOLAN ODT with or without food.

Pregnancy and Breastfeeding:
You should not take PREXOLAN ODT if you are pregnant or breastfeeding. Consult your doctor, pharmacist or other healthcare professional for advice before taking PREXOLAN ODT.
Tell your doctor if you are or think that you may be pregnant.

Driving and using machinery:
PREXOLAN ODT may cause you to feel sleepy.
Make sure you know how PREXOLAN ODT affects you before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Important information about some of the ingredients of PREXOLAN ODT:
PREXOLAN ODT contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking PREXOLAN ODT.

Taking other medicines with PREXOLAN ODT:
If you are taking medicines on a regular basis, including medicine you bought without a prescription, as well as complementary or traditional medicines, use of PREXOLAN ODT with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.
You might feel drowsy if PREXOLAN ODT 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:
• Fluoxetine (an antidepressant)
• Levodopa, normally given to patients suffering from Parkinson’s disease
• Any antihypertensive medication (used for high blood pressure)
• Medication that may prolong the QTc interval. Caution is advised in patients with slow heart beat, recent heart attack or uncompensated heart failure (a condition in which the heart can no longer pump enough blood to the rest of the body)
• Activated charcoal
• Carbamazepine for epilepsy as it can lower the effect of PREXOLAN ODT
• Fluvoxamine (an antidepressant), or other antidepressants, ciprofloxacin (an antibiotic), ketoconazole (an antifungal) or antacids, as it may be necessary to decrease/change your PREXOLAN ODT dose.
The dose of your PREXOLAN ODT may also be adjusted if you are a smoker, ensure your doctor is aware if you smoke.

HOW TO TAKE PREXOLAN ODT
Do not share medicines prescribed for you with any other people. It may harm them, even if their symptoms are the same as yours.
Always take PREXOLAN ODT exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Your doctor will decide how much PREXOLAN ODT you should take, usually PREXOLAN ODT tablets are taken once a day with or without meals.
You may start with an initial dose of 5 to 10 mg per day, with a target dose of 10 mg per day within several days. Depending on your response, your doctor will decide if the dose needs to be adjusted.
A starting dose of 5 mg should be considered for patients with liver problems and may also be considered for the elderly patient.
Place your PREXOLAN ODT orodispersible tablet in the mouth, where it will rapidly dissolve in the saliva so that you can easily swallow it.
Alternatively, you may disperse it in a full glass of water and then immediately drink it. Do not remove the tablets from the blister foil until immediately before you need to take it.
If you take more PREXOLAN ODT than you should:
Patients who have taken more PREXOLAN ODT 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: confusion, seizures fits), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration (the sucking in of fluid or a foreign body into the airway when drawing breath), high blood pressure or low blood pressure, abnormal rhythms of the heart.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.
If you forget to take PREXOLAN ODT:
If you miss a dose of PREXOLAN ODT, take it as soon as possible. Do not take a double dose to make up for forgotten individual doses. Just carry on with your next dose as normal.
Effect when treatment with PREXOLAN ODT is stopped:
Do not stop taking your tablets just because you feel better. It is important that you carry on taking PREXOLAN ODT for as long as your doctor tells you.
If you suddenly stop taking PREXOLAN ODT, symptoms such as sweating, unable to sleep, trembling, anxiety or nausea and vomiting might occur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS
PREXOLAN ODT can cause side effects.
Stop taking PREXOLAN ODT and see a doctor or go to a hospital straight away:
• If you get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction.
• If you have muscle weakness, tenderness or pain, feel unwell or have a high temperature. You may have a rare but serious illness that can be life-threatening called rhabdomyolysis.
• If you have a combination of fever, fast breathing, fast heart rate, sweating, muscle stiffness and drowsiness or sleepiness or confusion, difficulty in walking, shake or unusual muscle movements which you cannot control. In rare cases there may be rolling of the eyes. These could be signs of a serious condition known as neuroleptic malignant syndrome.
• If you get any pain in your chest or legs, or begin to have breathing difficulties. These could be signs of a blood clot.
• If you get a painful erection of the penis unrelated to sexual activity that will not go away.
• If you notice yellowing of your skin or eyes and your urine becomes darker in colour, high temperature, feel tired, lose your appetite, have stomach pain and feel sick. These could be signs of liver or pancreas problems.
Tell your doctor about any of the following side effects as soon as possible:
• If you have fits (seizures).
• Diabetes or the worsening of diabetes occasionally associated with ketoacidosis (ketones in the blood and urine shown in tests) or falling into a coma.
• If you have abnormal heart beat including a faster or slower than usual heart rate.
• Difficulty in passing urine (urinary hesitation).

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
Frequent side effects:
• Weight gain or feeling more hungry
• Sleepiness
• Dizziness
• Headache
• Restlessness
• Parkinsonism (a syndrome characterised by trembling, stiffness and balance disorder postural instability)
• Hallucinations
• Loss of strength
• Agitation
• Abnormal manner of walking (gait)
• Falls
• Problems with speech
• Poor or indistinct vision in an eye
• Water retention leading to swelling of the hands, ankles or feet
• Runny nose
• Dry mouth
• Constipation
• Rash
• Loss of bladder control (urinary incontinence)
• Lung infection (pneumonia)
• Increases in the levels of prolactin in the blood (found by blood test).

Less frequent side effects:
• Changes in the levels of some blood cells and circulating fats (found through blood tests)
• Memory loss
• Anxiety
• Mood changes (feeling high or hostile)
• Nervousness
• Stuttering
• Sudden unexplained death
• Cough
• Sensitivity to sunlight
• Hair loss
• Extremity pain (other than joint)
• Menstrual changes.

Not all side effects reported for PREXOLAN ODT are included in this leaflet. Should your general health worsen while taking PREXOLAN ODT, please consult your doctor, pharmacist or other healthcare professional for advice.

STORING AND DISPOSING OF PREXOLAN ODT
Store at or below 30°C.
Protect from light.
Do not remove the tablets from the blisters until required for use.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store in bathrooms.
Do not use after the expiry date stated on the label.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF PREXOLAN ODT
PREXOLAN ODT 5: PA/ALU/PVC Aluminium foil blisters strips packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 10: PA/ALU/PVC Aluminium foil blisters strips packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 15: PA/ALU/PVC Aluminium foil blisters strips packed into outer cartons of 28 or 30 tablets.
PREXOLAN ODT 20: PA/ALU/PVC Aluminium foil blisters strips packed into outer cartons of 28 or 30 tablets.
Not all packs and pack sizes are necessarily marketed.

IDENTIFICATION OF PREXOLAN ODT
PREXOLAN ODT 5: Yellow, round, biconvex tablets, with dimensions: 6,0 mm + 0,1 mm in diameter and thickness 2,6 + 0,2 mm.
PREXOLAN ODT 10: Yellow, round flat tablets, with dimensions: 8,2 mm + 0,1 mm in diameter and thickness 2,4 + 0,2 mm.
PREXOLAN ODT 15: Yellow, round biconvex tablets, with dimensions: 10,0 mm + 0,1 mm in diameter and thickness 3,1 + 0,2 mm.
PREXOLAN ODT 20: Yellow, round flat tablets, with dimensions: 11,2 mm + 0,1 mm in diameter and thickness 2,7 + 0,2 mm.

REGISTRATION NUMBERS
PREXOLAN ODT 5: 44/2.6.5/0915
PREXOLAN ODT 10: 44/2.6.5/0916
PREXOLAN ODT 15: 44/2.6.5/0917
PREXOLAN ODT 20: 44/2.6.5/0918

NAME AND ADDRESS OF REGISTRATION HOLDER
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION
01 March 2013

New addition to this site: March 2014
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2014