Olanzapine Mylan

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 2

1.  NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
Olanzapine Mylan 5 mg film-coated tablets 
Olanzapine Mylan 7.5 mg film-coated tablets 
Olanzapine Mylan 10 mg film-coated tablets 
Olanzapine Mylan 15 mg film-coated tablets 
Olanzapine Mylan 20 mg film-coated tablets 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
Each film-coated tablet contains 2.5 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 76 mg lactose (as monohydrate). 
The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin. 
 
Olanzapine Mylan 5 mg film-coated tablets 
Each film-coated tablet contains 5 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 152 mg lactose (as monohydrate). 
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin. 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
Each film-coated tablet contains 7.5 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 228 mg lactose (as monohydrate). 
The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin. 
 
Olanzapine Mylan 10 mg film-coated tablets 
Each film-coated tablet contains 10 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 304 mg lactose (as monohydrate). 
The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin. 
 
Olanzapine Mylan 15 mg film-coated tablets 
Each film-coated tablet contains 15 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 183 mg lactose (as monohydrate). 
The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin. 
 
Olanzapine Mylan 20 mg film-coated tablets 
Each film-coated tablet contains 20 mg olanzapine. 
Excipients with known effect 
Each film-coated tablet contains 244 mg lactose (as monohydrate). 
The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin. 
 
For the full list of excipients, see section 6.1. 
 
 
3.  PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Olanzapine Mylan 2.5 mg film-coated tablets 



 3

7.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “2.5” on one side and 
“G” on the other side. 
 
Olanzapine Mylan 5 mg film-coated tablets 
8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” 
on the other side. 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
9.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “7.5” on one side and 
“G” on the other side. 
 
Olanzapine Mylan 10 mg film-coated tablets 
10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and 
“G” on the other side. 
 
Olanzapine Mylan 15 mg film-coated tablets 
12.2 mm x 6.7 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 15” on 
one side and “G” on the other side. 
 
Olanzapine Mylan 20 mg film-coated tablets 
13.4 mm x 7.3 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 20” on 
one side and “G” on the other side. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1  Therapeutic indications 
 
Adults 
Olanzapine is indicated for the treatment of schizophrenia. 
 
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in 
patients who have shown an initial treatment response. 
 
Olanzapine is indicated for the treatment of moderate to severe manic episode. 
 
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). 
 
4.2  Posology and method of administration 
 
Adults 
Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. 
 
Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in 
combination therapy (see section 5.1). 
 
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients 
who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing 
recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine 
treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat 
mood symptoms, as clinically indicated. 
 
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily 
dosage may subsequently be adjusted on the basis of individual clinical status within the range 
5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after 
appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. 



 4

Olanzapine can be given without regards for meals as absorption is not affected by food.  
Gradual tapering of the dose should be considered when discontinuing olanzapine. 
 
Special populations 
 
Elderly  
A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and 
over when clinical factors warrant (see section 4.4). 
 
Renal and/or hepatic impairment  
A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic 
insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only 
increased with caution. 
 
Smokers  
The starting dose and dose range need not be routinely altered for non-smokers relative to smokers. 
The metabolism of olanzapine may be induced by smoking. Clinical monitoring is recommended and 
an increase of olanzapine dose may be considered if necessary (see section 4.5). 
 
When more than one factor is present which might result in slower metabolism (female gender, 
geriatric age, non-smoking status), consideration should be given to decreasing the starting dose. Dose 
escalation, when indicated, should be conservative in such patients (see sections 4.5 and 5.2). 
 
Paediatric population  
Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a 
lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations 
has been reported in short term studies of adolescent patients than in studies of adult patients (see 
sections 4.4, 4.8, 5.1 and 5.2). 
 
4.3  Contraindications 
 
Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section 
6.1. 
Patients with known risk of narrow-angle glaucoma. 
 
4.4  Special warnings and precautions for use 
 
During antipsychotic treatment, improvement in the patient's clinical condition may take several days 
to some weeks. Patients should be closely monitored during this period. 
 
Dementia-related psychosis and/or behavioural disturbances 
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. In placebo-
controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-
related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in 
olanzapine-treated patients compared to patients treated with placebo (3.5 % vs. 1.5 %, respectively). 
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or 
duration of treatment. Risk factors that may predispose this patient population to increased mortality 
include age >65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e.g., 
pneumonia, with or without aspiration), or concomitant use of benzodiazepines. However, the 
incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of 
these risk factors. 
 
In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischaemic 
attack), including fatalities, were reported. There was a 3-fold increase in CVAE in patients treated 
with olanzapine compared to patients treated with placebo (1.3 % vs. 0.4 %, respectively). All 
olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing 



 5

risk factors. Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE 
in association with olanzapine treatment. The efficacy of olanzapine was not established in these trials. 
 
Parkinson's disease 
The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with 
Parkinson's disease is not recommended. In clinical trials, worsening of Parkinsonian symptomatology 
and hallucinations were reported very commonly and more frequently than with placebo (see section 
4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms. In 
these trials, patients were initially required to be stable on the lowest effective dose of anti-
Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian 
medicinal products and dosages throughout the study. Olanzapine was started at 2.5 mg/day and 
titrated to a maximum of 15 mg/day based on investigator judgement. 
 
Neuroleptic Malignant Syndrome (NMS)  
NMS is a potentially life-threatening condition associated with antipsychotic medicinal products. Rare 
cases reported as NMS have also been received in association with olanzapine. 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, myoglobinuria (rhabdomyolysis), and acute renal 
failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained 
high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including 
olanzapine must be discontinued. 
 
Hyperglycaemia and diabetes 
Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with 
ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8). In 
some cases, a prior increase in body weight has been reported which may be a predisposing factor. 
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. 
measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually 
thereafter. Patients treated with any antipsychotic medicines, including olanzapine, should be observed 
for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) 
and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored 
regularly for worsening of glucose control. Weight should be monitored regularly, e.g. at baseline, 4, 
8 and 12 weeks after starting olanzapine treatment and quarterly thereafter. 
 
Lipid alterations 
Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-
controlled clinical trials (see section 4.8).  Lipid alterations should be managed as clinically 
appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development 
of lipids disorders. Patients treated with any antipsychotic medicines, including olanzapine, should be 
monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 
12 weeks after starting olanzapine treatment and every 5 years thereafter. 
 
Anticholinergic activity  
While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials 
revealed a low incidence of related events. 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. 
 
Hepatic function 
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen 
commonly, especially in early treatment. Caution should be exercised and follow-up organised 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 medicines. In cases where hepatitis 
(including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment 
should be discontinued. 



 6

 
Neutropenia 
Caution should be exercised in patients with low leukocyte and/or neutrophil counts for any reason, in 
patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced 
bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant 
illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with 
myeloproliferative disease. Neutropenia has been reported commonly when olanzapine and valproate 
are used concomitantly (see section 4.8). 
 
Discontinuation of treatment 
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported 
rarely (≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly. 
 
QT interval 
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] 
≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were 
uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in 
associated cardiac events compared to placebo. However, caution should be exercised when 
olanzapine is prescribed with 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. 
 
Thromboembolism 
Temporal association of olanzapine treatment and venous thromboembolism has been reported 
uncommonly (≥ 0.1% and < 1%). A causal relationship between the occurrence of venous 
thromboembolism and treatment with olanzapine has not been established. 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. 
 
General CNS activity 
Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination 
with other centrally acting medicines and alcohol. As it exhibits in vitro dopamine antagonism, 
olanzapine may antagonise the effects of direct and indirect dopamine agonists. 
 
Seizures 
Olanzapine should be used cautiously in patients who have a history of seizures or are subject to 
factors which may lower the seizure threshold. Seizures have been reported to occur uncommonly in 
patients when treated with olanzapine. In most of these cases, a history of seizures or risk factors for 
seizures were reported. 
 
Tardive Dyskinesia 
In comparator studies of one year or less duration, olanzapine was associated with a statistically 
significant lower incidence of treatment emergent dyskinesia. 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. 
These symptoms can temporally deteriorate or even arise after discontinuation of treatment. 
 
Postural hypotension 
Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials. It is 
recommended that blood pressure is measured periodically in patients over 
65 years. 
 
Sudden cardiac death  
In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in 
patients with olanzapine. In a retrospective observational cohort study, the risk of presumed sudden 
cardiac death in patients treated with olanzapine was approximately twice the risk in patients not using 



 7

antipsychotics. In the study, the risk of olanzapine was comparable to the risk of atypical 
antipsychotics included in a pooled analysis. 
 
Paediatric population 
Olanzapine is not indicated for use in the treatment of children and adolescents. Studies in patients 
aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic 
parameters and increases in prolactin levels (see sections 4.8 and 5.1). 
 
Lactose 
Olanzapine tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine.  
 
4.5  Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
Potential interactions affecting olanzapine  
Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this 
isoenzyme may affect the pharmacokinetics of olanzapine. 
 
Induction of CYP1A2  
The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to 
reduced olanzapine concentrations. Only slight to moderate increase in olanzapine clearance has been 
observed. 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). 
 
Inhibition of CYP1A2 
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of 
olanzapine. The mean increase in olanzapine Cmax following fluvoxamine was 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 olanzapine should be considered in patients who are using 
fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin. A decrease in the dose of 
olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated. 
 
Decreased bioavailability  
Activated charcoal reduces the bioavailability of oral olanzapine by 50 % to 60 % and should be taken 
at least 2 hours before or after olanzapine. 
 
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have 
not been found to significantly affect the pharmacokinetics of olanzapine. 
 
Potential for olanzapine to affect other medicinal products  
Olanzapine may antagonise the effects of direct and indirect dopamine agonists. 
 
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4). 
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). 
 
Olanzapine showed no interaction when co-administered with lithium or biperiden. 
 
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is 
required after the introduction of concomitant olanzapine. 
 



 8

General CNS activity 
Caution should be exercised in patients who consume alcohol or receive medicinal products that can 
cause central nervous system depression. 
 
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).  
 
QTc interval 
Caution should be used if olanzapine is being administered concomitantly with medicinal products 
known to increase QTc interval (see section 4.4). 
 
4.6  Fertility, pregnancy and lactation 
 
Pregnancy  
There are no adequate and well-controlled studies in pregnant women. Patients should be advised to 
notify their physician if they become pregnant or intend to become pregnant during treatment with 
olanzapine. Nevertheless, because human experience is limited, olanzapine should be used in 
pregnancy only if the potential benefit justifies the potential risk to the foetus. 
 
New born infants exposed to antipsychotics (including olanzapine) during the third trimester of 
pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that 
may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, 
hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns 
should be monitored carefully. 
 
Breast-feeding  
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk. Mean infant 
exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg). 
Patients should be advised not to breast feed an infant if they are taking olanzapine.  
 
Fertility 
Effects on fertility are unknown (see section 5.3 for preclinical information). 
 
4.7  Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. Because 
olanzapine may cause somnolence and dizziness, patients should be cautioned about operating 
machinery, including motor vehicles. 
 
4.8  Undesirable effects 
 
Summary of the safety profile 
 
Adults 
The most frequently (seen in ≥ 1 % of patients ) reported adverse reactions associated with the use of 
olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, 
cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, 
akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, 
anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 
4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma 
glutamyltransferase, high uric acid, high creatine phosphokinase and oedema. 
 
Tabulated list of adverse reactions 
The following table lists the adverse reactions  and laboratory investigations observed from 
spontaneous reporting and in clinical trials. Within each frequency grouping, adverse reactions are 
presented in order of decreasing seriousness. The frequency terms listed are defined as follows: Very 



 9

common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available). 
 
 

Very 
common 

Common Uncommon Rare Not known 

Blood and lymphatic system disorders  
 Eosinophilia 

Leukopenia10 
Neutropenia10 
 

 Thrombocytopenia11  

Immune system disorders  
  Hypersensitivity11  
Metabolism and nutrition disorders  
Weight gain1 Elevated cholesterol 

levels2,3 
Elevated glucose levels4 
Elevated triglyceride 
levels2,5 
Glucosuria  
Increased appetite 
 

Development or 
exacerbation of diabetes 
occasionally associated 
with ketoacidosis or 
coma, including some 
fatal cases (see section 
4.4)11  

Hypothermia12  

Nervous system disorders  
Somnolence Dizziness 

Akathisia6 
Parkinsonism6 
Dyskinesia6 

Seizures where in most 
cases a history of 
seizures or risk factors 
for seizures were 
reported11 
 
Dystonia (including 
oculogyration)11 
Tardive dyskinesia11 
 
Amnesia9 
 
Dysarthria 
Stuttering11 
Restless legs syndrome

Neuroleptic malignant 
syndrome (see section 
4.4)12  
 
Discontinuation 
symptoms7, 12 

 

Cardiac disorders  
  Bradycardia 

QTc prolongation (see 
section 4.4) 

Ventricular 
tachycardia/fibrillation
, sudden death (see 
section 4.4)11

 

Vascular disorders  
Orthostatic 
hypotension10 

 Thromboembolism 
(including pulmonary 
embolism and deep vein 
thrombosis) (see section 
4.4)

  

Respiratory, thoracic and mediastinal disorders 
  Epistaxis9  
Gastrointestinal disorders  
 Mild, transient 

anticholinergic effects 
including constipation 
and dry mouth 

Abdominal distension9 Pancreatitis11  



 10

Hepatobiliary disorders  
 Transient, 

asymptomatic 
elevations of hepatic 
aminotransferases 
(ALT, AST), especially 
in early treatment (see 
section 4.4) 

 Hepatitis (including 
hepatocellular, 
cholestatic or mixed 
liver injury)11 

 

Skin and subcutaneous tissue disorders  
 Rash Photosensitivity 

reaction 
Alopecia 

 Drug Reaction 
with Eosinophilia 
and Systemic 
Symptoms 
(DRESS)

Musculoskeletal and connective tissue disorders  
 Arthralgia9 Rhabdomyolysis11  
Renal and urinary disorders  
  Urinary incontinence, 

urinary retention 
Urinary hesitation11

  

Pregnancy, puerperium and perinatal conditions 
    Drug withdrawal 

syndrome 
neonatal (see 
section 4.6)

Reproductive system and breast disorders  
 Erectile dysfunction in 

males 
Decreased libido in 
males and females 

Amenorrhea 
Breast enlargement 
Galactorrhea in females 
Gynaecomastia/breast 
enlargement in males

Priapism12  

General disorders and administration site conditions  
 Asthenia 

Fatigue 
Oedema 
Pyrexia10 

   

Investigations  
Elevated 
plasma 
prolactin 
levels8 

Increased alkaline 
phosphatase10 
High creatine 
phosphokinase11 
High Gamma 
Glutamyltransferase10 
High Uric Acid10 
 

Increased total bilirubin   

 

1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) 
categories. 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 %). Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term 
exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 
 

2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were 
greater in patients without evidence of lipid dysregulation at baseline. 
 



 11

3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high 
(≥ 6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline 
(≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) were very common. 
 
4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l). 
Changes in fasting glucose from borderline at baseline (≥ 5.56-< 7 mmol/l) to high (≥ 7 mmol/l) were 
very common.  
 
5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high 
(≥ 2.26 mmol/l). Changes in fasting triglycerides from borderline at baseline 
(≥ 1.69 mmol/l-< 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common. 
 
6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was 
numerically higher, but not statistically significantly different from placebo. Olanzapine-treated 
patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of 
haloperidol. 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. 
 
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been 
reported when olanzapine is stopped abruptly. 
 
8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of 
normal range in approximately 30 % of olanzapine treated patients with normal baseline prolactin 
value. In the majority of these patients the elevations were generally mild, and remained below two 
times the upper limit of normal range.  
 
9 Adverse event identified from clinical trials in the Olanzapine Integrated Database. 
 
10 As assessed by measured values from clinical trials in the Olanzapine Integrated Database. 
 
11 Adverse event identified from spontaneous post-marketing reporting with frequency determined 
utilising the Olanzapine Integrated Database. 
 
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. 

 
Long-term exposure (at least 48 weeks) 
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, 
total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed 
9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 
6 months. 
 
Additional information on special populations 
In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher 
incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4). Very 
common adverse reactions associated with the use of olanzapine in this patient group were abnormal 
gait and falls. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and 
urinary incontinence were observed commonly.  
 
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with 
Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported 
very commonly and more frequently than with placebo. 
 
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine 
resulted in an incidence of neutropenia of 4.1 %; a potential contributing factor could be high plasma 



 12

valproate levels. Olanzapine administered with lithium or valproate resulted in increased levels 
(10 %) of tremor, dry mouth, increased appetite, and weight gain. Speech disorder was also reported 
commonly. During treatment with olanzapine in combination with lithium or divalproex, an increase 
of  7 % from baseline body weight occurred in 17.4 % of patients during acute treatment (up to 
6 weeks). Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with 
bipolar disorder was associated with an increase of  7 % from baseline body weight in 39.9 % of 
patients. 
 
Paediatric population 
Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years. 
Although no clinical studies designed to compare adolescents to adults have been conducted, data 
from the adolescent trials were compared to those of the adult trials.  
 
The following table summarises the adverse reactions reported with a greater frequency in adolescent 
patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term 
clinical trials in adolescent patients. Clinically significant weight gain (≥ 7 %) appears to occur more 
frequently in the adolescent population compared to adults with comparable exposures. 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.  
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to 
< 1/10). 
 
Metabolism and nutrition disorders 
Very common: Weight gain13, elevated triglyceride levels14, increased appetite. 
Common: Elevated cholesterol levels15
Nervous system disorders 
Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Gastrointestinal disorders 
Common: Dry mouth 
Hepatobiliary disorders 
Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). 
Investigations  
Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16. 

 

13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body 
weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 
25 % was common (2.5 %). 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.  
 
14  Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high 
(≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l - 
< 1.467 mmol/l) to high (≥ 1.467 mmol/l). 
 
15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high 
(≥ 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline 
at baseline (≥ 4.39-< 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common. 
 
16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 



 13

4.9  Overdose 
 
Signs and symptoms 
Very common symptoms in 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 overdose include delirium, convulsion, coma, possible 
neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, 
cardiac arrhythmias (< 2 % of overdose cases) 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 approximately 2 g of oral olanzapine. 
 
Management 
There is no specific antidote for olanzapine. Induction of emesis is not recommended. Standard 
procedures for management of overdose may be indicated (i.e. gastric lavage, administration of 
activated charcoal). The concomitant administration of activated charcoal was shown to reduce the 
oral bioavailability of olanzapine by 50 to 60 %. 
 
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. Do not use epinephrine, dopamine, or other sympathomimetic agents with beta 
agonist activity since beta stimulation may worsen hypotension. Cardiovascular monitoring is 
necessary to detect possible arrhythmias. Close medical supervision and monitoring should continue 
until the patient recovers. 
 
 
5.  PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC 
code: N05AH03. 
 
Pharmacodynamic effects  
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad 
pharmacologic profile across a number of receptor systems. 
 
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 
5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 
adrenergic; and histamine H1 receptors. Animal behavioural studies with olanzapine indicated 5HT, 
dopamine, and cholinergic antagonism, consistent with the receptor-binding profile. Olanzapine 
demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 
5 HT2 than D2 activity in vivo models. Electrophysiological studies demonstrated that olanzapine 
selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on 
the striatal (A9) pathways involved in motor function. Olanzapine reduced a conditioned avoidance 
response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect 
indicative of motor side-effects. Unlike some other antipsychotic agents, olanzapine increases 
responding in an “anxiolytic” test. 
 
In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, 
olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy. 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. 
 
Clinical efficacy 



 14

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. 
 
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related 
disorders which included 1,481 patients with varying degrees of associated depressive symptoms 
(baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary 
analysis of baseline to endpoint mood score change demonstrated a statistically significant 
improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1). 
 
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior 
efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 
3 weeks. Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the 
proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks. In a 
co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition 
of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms 
of mania than lithium or valproate monotherapy after 6 weeks. 
 
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. Olanzapine also 
showed a statistically significant advantage over placebo in terms of preventing either recurrence into 
mania or recurrence into depression. 
 
In a second 12 month recurrence prevention study in manic episode patients who achieved remission 
with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium 
alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar 
recurrence (olanzapine 30.0 %, lithium 38.3 %; p = 0.055). 
 
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a 
mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was 
not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, 
defined according to syndromic (diagnostic) criteria. 
 
Paediatric population 
Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in 
schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 
200 adolescents.  Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 
20 mg/day.  During treatment with olanzapine, adolescents gained significantly more weight compared 
with adults.  The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and 
prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.  There are no controlled 
data on maintenance of effect or long term safety (see sections 4.4 and 4.8). 
Information on long term safety is primarily limited to open-label, uncontrolled data. 
 
5.2  Pharmacokinetic properties 
 
Absorption 
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 
8 hours. The absorption is not affected by food. Absolute oral bioavailability relative to intravenous 
administration has not been determined. 
 
Distribution 
The plasma protein binding of olanzapine was about 93 % over the concentration range of about 7 to 
about 1000 ng/ml. Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein. 
 



 15

Biotransformation 
Olanzapine is metabolised in the liver by conjugative and oxidative pathways. The major circulating 
metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier. Cytochromes P450- 
CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl 
metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in 
animal studies. The predominant pharmacologic activity is from the parent olanzapine.  
 
Elimination 
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects 
varied on the basis of age and gender. 
 
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was 
prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr). The 
pharmacokinetic variability observed in the elderly is within the range for the non-elderly. In 
44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with 
any distinguishing profile of adverse events. 
 
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 
32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr). However, olanzapine (5-20 mg) 
demonstrated a comparable safety profile in female (n=467) as in male patients (n=869). 
 
Renal impairment 
In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no 
significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 
25.0 l/hr). A mass balance study showed that approximately 57 % of radiolabelled olanzapine 
appeared in urine, principally as metabolites. 
 
Hepatic impairment 
A small study of the effect of impaired liver function in 6 subjects with clinically significant (Childs 
Pugh Classification A (n = 5) and B (n = 1)) cirrhosis revealed little effect on the pharmacokinetics of 
orally administered olanzapine (2.5 – 7.5 mg single dose): Subjects with mild to moderate hepatic 
dysfunction had slightly increased systemic clearance and faster elimination half-time compared to 
subjects with no hepatic dysfunction (n = 3). There were more smokers among subjects with cirrhosis 
(4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %). 
 
Smoking 
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was 
prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr). 
 
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, 
and in non-smokers versus smokers. However, the magnitude of the impact of age, gender, or smoking 
on olanzapine clearance and half-life is small in comparison to the overall variability between 
individuals. 
 
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the 
pharmacokinetic parameters among the three populations. 
 
Paediatric population 
Adolescents (ages 13 to 17 years): The pharmacokinetics of olanzapine are similar between 
adolescents and adults. In clinical studies, the average olanzapine exposure was approximately 27 % 
higher in adolescents. Demographic differences between the adolescents and adults include a lower 
average body weight and fewer adolescents were smokers. Such factors possibly contribute to the 
higher average exposure observed in adolescents. 
 



 16

5.3  Preclinical safety data 
 
Acute (single-dose) toxicity 
Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, 
coma, tremors, clonic convulsions, salivation, and depressed weight gain. The median lethal doses 
were approximately 210 mg/kg (mice) and 175 mg/kg (rats). Dogs tolerated single oral doses up to 
100 mg/kg without mortality. Clinical signs included sedation, ataxia, tremors, increased heart rate, 
laboured respiration, miosis, and anorexia. In monkeys, single oral doses up to 100 mg/kg resulted in 
prostration and, at higher doses, semi-consciousness. 
 
Repeated-dose toxicity 
In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects 
were CNS depression, anticholinergic effects, and peripheral haematological disorders. Tolerance 
developed to the CNS depression. Growth parameters were decreased at high doses. Reversible effects 
consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and 
morphologic changes in vaginal epithelium and in mammary gland. 
 
Haematologic toxicity  
Effects on haematology parameters were found in each species, including dose-related reductions in 
circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, 
no evidence of bone marrow cytotoxicity was found. Reversible neutropenia, thrombocytopenia, or 
anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 
12- to 15-fold greater than that of a man given a 12 mg dose). In cytopenic dogs, there were no 
adverse effects on progenitor and proliferating cells in the bone marrow. 
 
Reproductive toxicity 
Olanzapine had no teratogenic effects. Sedation affected mating performance of male rats. Oestrous 
cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction 
parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose). In the offspring 
of rats given olanzapine, delays in foetal development and transient decreases in offspring activity 
levels were seen. 
 
Mutagenicity 
Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial 
mutation tests and in vitro and in vivo mammalian tests. 
 
Carcinogenicity 
Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic. 
 
 
6.  PHARMACEUTICAL PARTICULARS 
 
6.1  List of excipients 
 
Tablet core 
Lactose monohydrate 
Maize starch 
Maize starch, pregelatinised 
Crospovidone (Type A) 
Magnesium stearate 
 
Tablet coat 
Polyvinyl alcohol  
Titanium dioxide (E171) 
Talc (E553b) 
Soya lecithin (E322) 
Xanthan gum (E415) 



 17

 
6.2  Incompatibilities 
 
Not applicable. 
 
6.3  Shelf life 
 
Blisters 3 years. 
 
Bottles 3 years. After first opening use within 90 days. 
 
6.4  Special precautions for storage 
 
Do not store above 25 °C. 
 
6.5  Nature and contents of container 
 
Cold-formed aluminium/aluminium blister in cartons of 7 (10 mg only), 10, 28, 30, 35, 56, 70 and 
multipacks containing 70 (2 packs of 35) film-coated tablets. 
 
Cold-formed aluminium/aluminium perforated unit dose blisters in cartons of 28 x 1, 56 x 1 (7.5 mg 
only), 98 x 1 (5 mg, 7.5 mg and 10 mg only) and 100 x 1 (7.5 mg only) film-coated tablets. 
 
High Density Polyethylene (HDPE) bottle with polypropylene screw cap containing 100 (7.5 mg, 10 
mg, 15 mg and 20 mg only), 250 (2.5 mg and 5 mg only) and 500 (2.5 mg, 5 mg and 10 mg 
only) film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal 
 
No special requirements.  
 
 
7.  MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France. 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/475/001  
EU/1/08/475/002  
EU/1/08/475/003  
EU/1/08/475/004  
EU/1/08/475/005  
EU/1/08/475/006 
EU/1/08/475/007  
EU/1/08/475/008  
EU/1/08/475/009  
EU/1/08/475/010  
EU/1/08/475/011  
EU/1/08/475/012 
EU/1/08/475/013  



 18

EU/1/08/475/014  
EU/1/08/475/015  
EU/1/08/475/016  
EU/1/08/475/017 
EU/1/08/475/018  
EU/1/08/475/019  
EU/1/08/475/020  
EU/1/08/475/021  
EU/1/08/475/022  
EU/1/08/475/023  
EU/1/08/475/024 
EU/1/08/475/025  
EU/1/08/475/026  
EU/1/08/475/027  
EU/1/08/475/028  
EU/1/08/475/029 
EU/1/08/475/030  
EU/1/08/475/031  
EU/1/08/475/032  
EU/1/08/475/033  
EU/1/08/475/034 
EU/1/08/475/035 
EU/1/08/475/036 
EU/1/08/475/037 
EU/1/08/475/038 
EU/1/08/475/039 
EU/1/08/475/040 
EU/1/08/475/041 
EU/1/08/475/042 
EU/1/08/475/043 
EU/1/08/475/044 
EU/1/08/475/045 
EU/1/08/475/046 
EU/1/08/475/047 
EU/1/08/475/048 
EU/1/08/475/049 
EU/1/08/475/050 
EU/1/08/475/051 
EU/1/08/475/052 
EU/1/08/475/053 
EU/1/08/475/054 
EU/1/08/475/055 
EU/1/08/475/056 
EU/1/08/475/057 
EU/1/08/475/058 
EU/1/08/475/059 
EU/1/08/475/060 
EU/1/08/475/061 
EU/1/08/475/062 
EU/1/08/475/063 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 7 October 2008  
Date of latest renewal: 22 May 2013 
 



 19

 
10.  DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  



 20

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURERS RESPONSIBLE FOR BATCH 

RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING 
SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 



 21

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
McDermott Laboratories Ltd. t/a Gerard Laboratories 
35/36 Baldoyle Industrial Estate 
Grange road 
Dublin 13 
Ireland 
 
Generics [UK] Limited 
Station Close 
Potters Bar 
Hertfordshire 
EN6 1TL 
UK 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 
 
• Periodic Safety Update Reports 
 
At the time of granting the marketing authorisation, the submission of periodic safety update reports is 
not required for this medicinal product. However, the marketing authorisation holder shall submit 
periodic safety update reports for this medicinal product if the product is included in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published 
on the European medicines web-portal. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
  



 22

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 23

 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

 
 
 
 
 
 
 
 

A. LABELLING  
 



 24

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 2.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets 
28 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 



 25

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France  
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/08/475/001 
EU/1/08/475/002 
EU/1/08/475/003 
EU/1/08/475/004 
EU/1/08/475/035 
EU/1/08/475/036 
EU/1/08/475/056 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 2.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



 26

 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 27

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 2.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of 35) film-coated tablets  
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 28

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/047 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 2.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 



 29

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 2.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets  
Component of a multipack, not to be sold separately. 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 30

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France  
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/047 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 2.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
  



 31

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



 32

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
 CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets 
28 x 1 film-coated tablets 
98 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 



 33

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/08/475/007 
EU/1/08/475/008 
EU/1/08/475/009 
EU/1/08/475/010 
EU/1/08/475/037 
EU/1/08/475/038 
EU/1/08/475/053 
EU/1/08/475/061 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 34

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 35

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of 35) film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 36

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/048 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 37

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets 
Component of a multipack, not to be sold separately 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 38

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/048 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 39

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 5 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



 40

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 7.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets 
28 x 1 film-coated tablets 
56 x 1 film-coated tablets 
98 x 1 film-coated tablets 
100 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



 41

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/08/475/013 
EU/1/08/475/014 
EU/1/08/475/015 
EU/1/08/475/016 
EU/1/08/475/039 
EU/1/08/475/040 
EU/1/08/475/054 
EU/1/08/475/055 
EU/1/08/475/057 
EU/1/08/475/062 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 7.5 mg  
 



 42

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 43

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 7.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of 35) film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 
 IF APPROPRIATE 



 44

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/049 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 7.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 45

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 7.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets 
Component of a multipack, not to be sold separately 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 46

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/049 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 7.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 47

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOIL  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



 48

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 10 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 10 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
7 film-coated tablets 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets 
28 x 1 film-coated tablets 
98 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 



 49

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/018 
EU/1/08/475/019 
EU/1/08/475/020 
EU/1/08/475/021 
EU/1/08/475/022 
EU/1/08/475/041 
EU/1/08/475/042 
EU/1/08/475/058 
EU/1/08/475/063 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 10 mg  
 
 



 50

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 51

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 10 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 10 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of 35) film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 52

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/050 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 10 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 53

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 10 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 10 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets 
Component of a multipack, not to be sold separately 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 54

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/050 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 10 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 55

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 10 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
  



 56

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
 CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 15 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 15 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets  
28 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 57

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France  
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/025 
EU/1/08/475/026 
EU/1/08/475/027 
EU/1/08/475/028 
EU/1/08/475/043 
EU/1/08/475/044 
EU/1/08/475/059 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 15 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



 58

 
PC: {number} 
SN: {number} 
NN: {number} 
 



 59

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 15 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 15 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of 35) film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 60

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/051 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 15 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 61

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 15 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 15 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets 
Component of a multipack, not to be sold separately 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 62

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/051 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 15 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 63

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 15 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
  



 64

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON OF SINGLE PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 20 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 20 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
10 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
70 film-coated tablets 
28 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 



 65

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/08/475/030 
EU/1/08/475/031 
EU/1/08/475/032 
EU/1/08/475/033 
EU/1/08/475/045 
EU/1/08/475/046 
EU/1/08/475/060 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 66

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



 67

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 20 mg film-coated tablets 
olanzapine 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 20 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 70 (2 packs of35) film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 68

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/052 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 69

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 20 mg film-coated tablets 
olanzapine 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 20 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
35 film-coated tablets 
Component of a multipack, not to be sold separately 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 70

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/052 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 71

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 20 mg film-coated tablets 
olanzapine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
 
  



 72

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 2.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 2.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
250 film-coated tablets 
500 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 



 73

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/475/005 
EU/1/08/475/006 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 2.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 74

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
250 film-coated tablets 
500 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 



 75

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/011 
EU/1/08/475/012 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 76

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 7.5 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 7.5 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



 77

Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/08/475/017 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 7.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 78

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 10 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 10 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
100 film-coated tablets 
500 film-coated tablets 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 



 79

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 
 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/023 
EU/1/08/475/024 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 10 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
  



 80

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 15 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 15 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



 81

Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/029 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 15 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 82

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL AND CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olanzapine Mylan 20 mg film-coated tablets 
olanzapine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 20 mg olanzapine. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate and soya lecithin. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets  
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTEOF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED  
 OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening use within 90 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



 83

Do not store above 25C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 

 IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/08/475/034 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Olanzapine 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



 84

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



 85

Package leaflet: Information for the user 
 

Olanzapine Mylan 2.5 mg film-coated tablets 
Olanzapine Mylan 5 mg film-coated tablets 

Olanzapine Mylan 7.5 mg film-coated tablets 
Olanzapine Mylan 10 mg film-coated tablets 
Olanzapine Mylan 15 mg film-coated tablets 
Olanzapine Mylan 20 mg film-coated tablets 

 
Olanzapine 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
 
1. What Olanzapine Mylan is and what it is used for 
2. What you need to know before you take Olanzapine Mylan  
3. How to take Olanzapine Mylan 
4. Possible side effects 
5. How to store Olanzapine Mylan 
6. Contents of the pack and other information 
 
 
1. What Olanzapine Mylan is and what it is used for 
 
Olanzapine Mylan contains the active substance olanzapine. Olanzapine belongs to a group of 
medicines called antipsychotics and is used to treat the following conditions: 
 Schizophrenia, 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. 

 Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria. 
 
Olanzapine Mylan has been shown to prevent recurrence of these symptoms in patients with bipolar 
disorder whose manic episode has responded to olanzapine treatment. 
 
 
2. What you need to know before you take Olanzapine Mylan  
 
Do not take Olanzapine Mylan  
 
 if you are allergic (hypersensitive) to olanzapine, peanut or soya or any of the other ingredients 

of this medicine (listed in section 6). 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). 

 
Warnings and precautions  
Talk to your doctor or pharmacist before you take Olanzapine Mylan. 
 The use of Olanzapine Mylan in elderly patients with dementia is not recommended as it may 

have serious side effects. 



 86

 Medicines of this type may cause unusual movements mainly of the face or tongue. If this 
happens after you have been given Olanzapine Mylan 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. 

 Weight gain has been seen in patients taking Olanzapine Mylan. You and your doctor should 
check your weight regularly. Consider referral to a dietician or help with a diet plan if 
necessary. 

 High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients 
taking Olanzapine Mylan. Your doctor should do blood tests to check blood sugar and certain 
fat levels before you start taking Olanzapine Mylan and regularly during treatment.  

 Tell the doctor if you or someone else in your family has a history of blood clots, as medicines 
like these have been associated with the formation of blood clots.  

 
If you suffer from any of the following illnesses tell your doctor as soon as possible: 
 
 Stroke or “mini” stroke (temporary symptoms of stroke) 
 Parkinson’s disease 
 Prostate problems 
 A blocked intestine (Paralytic ileus) 
 Liver or kidney disease 
 Blood disorders 
 Heart disease 
 Diabetes 
 Seizures 
 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 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. 
 
Children and adolescents 
Olanzapine Mylan is not for patients who are under 18 years. 
 
Other medicines and Olanzapine Mylan 
Only take other medicines while you are on Olanzapine Mylan if your doctor tells you that you can. 
You might feel drowsy if Olanzapine Mylan is taken in combination with antidepressants or medicines 
taken for anxiety or to help you sleep (tranquillisers). 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
In particular, tell your doctor if you are taking: 
 medicines for Parkinson’s disease. 
 carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or 

ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Mylan dose. 
 
Olanzapine Mylan with alcohol 
Do not drink any alcohol if you have been given Olanzapine Mylan as together with alcohol it may 
make you feel drowsy. 
 
Pregnancy and breast-feeding 
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. You should not be given this medicine when 
breast-feeding, as small amounts of olanzapine can pass into breast milk. 
 



 87

The following symptoms may occur in newborn babies of mothers that have used Olanzapine Mylan 
in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, 
sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these 
symptoms you may need to contact your doctor. 
 
Driving and using machines 
There is a risk of feeling drowsy when you are given Olanzapine Mylan. If this happens do not drive 
or operate any tools or machines. Tell your doctor. 
 
Olanzapine Mylan contains lactose and soya lecithin 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. The tablet film-coating contains soya lecithin. If you are allergic 
to peanut or soya do not take these tablets. 
 
 
3. How to take Olanzapine Mylan  
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should 
continue to take them. The daily dose of olanzapine is between 5 mg and 20 mg. Consult your doctor 
if your symptoms return but do not stop taking Olanzapine Mylan unless your doctor tells you to. 
 
You should take your Olanzapine Mylan 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. Olanzapine Mylan tablets are for oral use. You should swallow the Olanzapine Mylan tablets 
whole with water. 
 
If you take more Olanzapine Mylan than you should 
 
Patients who have taken more olanzapine 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 if 
you experience any of the above symptoms. Show the doctor your pack of tablets. 
 
If you forget to take Olanzapine Mylan  
Take your tablets as soon as you remember. Do not take a double dose to make up for the forgotten 
tablet. 
 
If you stop taking Olanzapine Mylan 
Do not stop taking your tablets just because you feel better. It is important that you carry on taking 
Olanzapine Mylan for as long as your doctor tells you. 
 
If you suddenly stop taking Olanzapine Mylan, 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 medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 



 88

 
Tell your doctor immediately if you have:  
 unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the 

face or tongue; 
 blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) 

especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel 
through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any  

 of these symptoms seek medical advice immediately; 
 a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness 
 (the frequency of this side effect cannot be estimated from the available data) 
 

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. 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. 
 
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood 
cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the 
level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in 
the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); 
constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling 
of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in 
males and females or erectile dysfunction in males. 
 
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (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; seizures, usually associated with a history 
of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; 
problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; 
abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; 
hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such 
as an abnormal production of breast milk or abnormal growth.  
 
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. 
 
Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and 
Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face 
and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver 
enzymes seen in blood tests and an increase in a type of white blood cells (eosinophilia). 
 
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 Olanzapine Mylan may worsen the symptoms. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 



 89

 
5. How to store Olanzapine Mylan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date, which is stated on the carton or label after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25C. 
 
Bottles: After first opening use within 90 days. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Olanzapine Mylan contains 
 
- The active substance is olanzapine. Each Olanzapine Mylan tablet contains either 2.5 mg, 5 mg, 

7.5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your 
Olanzapine Mylan tablet pack. 

- The other ingredients are: 
(tablet core) lactose monohydrate (see section 2 ‘Olanzapine contains lactose’), maize starch, 
preglatinised maize starch, crospovidone type A, magnesium stearate and 
(tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), soya lecithin (E322) 
(see section 2 ‘Olanzapine Mylan contains soya lecithin’), xanthan gum (E415). 

 
What Olanzapine Mylan looks like and contents of the pack 
 
Olanzapine Mylan 2.5 mg are round, white film-coated tablets with sides that curve outwards, marked 
with “OZ over 2.5” on one side and “G” on the other side. 
Olanzapine Mylan 5 mg are round, white film-coated tablets with sides that curve outwards, marked 
with “OZ over 5” on one side and “G” on the other side. 
Olanzapine Mylan 7.5 mg are round, white film-coated tablets with sides that curve outwards, marked 
with “OZ over 7.5” on one side and “G” on the other side. 
Olanzapine Mylan 10 mg are round, white film-coated tablets with sides that curve outwards, marked 
with “OZ over 10” on one side and “G” on the other side. 
Olanzapine Mylan 15 mg are oval-shaped, white film-coated tablets with sides that curve outwards, 
marked with “OZ 15” on one side and “G” on the other side. 
Olanzapine Mylan 20 mg are oval-shaped, white film-coated tablets with sides that curve outwards, 
marked with “OZ 20” on one side and “G” on the other side. 
 
 
Blisters:  
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg is available in packs containing 10, 28, 30, 
35, 56, 70 (2 x 35 multipack) and 70 film-coated tablets.  
Olanzapine Mylan 10 mg is available in packs containing 7, 10, 28, 30, 35, 56, 70 (2 x 35) (multipack) 
and 70 film-coated tablets.  
 
Perforated unit dose blisters: 
Olanzapine Mylan 2.5 mg, 15 mg and 20 mg is available in packs containing 28 x 1 film-coated 
tablets. 
Olanzapine Mylan 5 mg and 10 mg is available in packs containing 28 x 1 and 98 x 1 film-coated 
tablets. 



 90

Olanzapine Mylan 7.5 mg is available in packs containing 28 x 1, 56 x 1, 98 x   and 100 x 1 film-
coated tablets. 
 
Bottles:  
Olanzapine Mylan 2.5 mg and 5.0 mg is available in packs containing 250 and 500 film-coated tablets.   
Olanzapine Mylan 7.5 mg, 15 mg and 20 mg is available in packs containing 100 film-coated tablets.   
Olanzapine Mylan 10 mg is available in packs containing 100 and 500 film-coated tablets. 
 
Marketing Authorisation Holder 
Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France. 
 
Manufacturer  
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland 
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 
België/Belgique/Belgien 
Mylan bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
BGP Products UAB  
Tel: +370 5 205 1288 

България 
Майлан ЕООД 
Тел: +359 2 44 55 400 
 
 

Luxembourg/Luxemburg 
Mylan bvba/sprl 
Tel: +32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Pharmaceuticals s.r.o. 
Tel: +420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 

Danmark 
BGP Products ApS 
Tlf: +45 28116932 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 

Deutschland 
Mylan Healthcare GmbH  
Tel: +49 800 0700 800 
 

Nederland 
Mylan BV 
Tel:  +31 (0)20 426 3300 

Eesti 
BGP Products Switzerland GmbH Eesti 
filiaal  
Tel: + 372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: + 47 66 75 33 00 
 

Ελλάδα  
Generics Pharma Hellas ΕΠΕ  
Τηλ:  +30 210 993 6410  
 

Österreich 
Arcana Arzneimittel GmbH 
Tel: +43 1 416 2418 

España 
Mylan Pharmaceuticals, S.L 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z.o.o. 
Tel:  + 48 22 546 64 00 

France 
Mylan S.A.S 

Portugal 
Mylan, Lda.



 91

Tel: +33 4 37 25 75 00 
 

Tel: + 351 21 412 72 56   

Hrvatska 
Mylan Hrvatska d.o.o.   
Tel: +385 1 23 50 599  
 

România 
BGP Products SRL 
Tel: +40 372 579 000 
 

Ireland 
Mylan Ireland Limited 
Tel: +353 (0) 87 1694982 
 

Slovenija 
Mylan Healthcare d.o.o. 
Tel: + 386 1 23 63 180 

Ísland 
BGP Products ApS 
Tel: +45 28116932 
(Danmörk) 
 

Slovenská republika 
Mylan s r.o.  
Tel: +421 2 32 199 100 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: +358 20 720 9555 

Κύπρος 
Pharmaceutical Trading Co. Ltd. 
Τηλ: +357 99403969 
 

Sverige 
Mylan AB  
Tel: + 46 855 522 750 
 

Latvija 
BGP Products SIA  
Tel: +371 676 055 80 
 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 
 

 
 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET