Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg & 20 mg film-coated tablets

  • Name:

    Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg & 20 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Olanzapine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 7/8/2019

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Gerard Laboratories

Gerard Laboratories

Company Products

Medicine NameActive Ingredients
Medicine Name Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Active Ingredients Abacavir hydrochloride, Lamivudine
Medicine Name Agerdex 1mg Film Coated Tablets Active Ingredients Anastrozole
Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atazanavir Mylan 300 mg hard capsules Active Ingredients Atazanavir sulfate
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
1 - 0 of 116 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 8 August 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 January 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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 anhydrous per tablet.
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 anhydrous per tablet.
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 anhydrous per tablet.
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 anhydrous per tablet.
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 anhydrous per tablet.
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 anhydrous per tablet.
The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.

Excipients with known effect:

Each film-coated tablet contains 76 mg lactose anhydrous per tablet.
The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.

Each film-coated tablet contains 152 mg lactose anhydrous per tablet.
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin.

Each film-coated tablet contains 228 mg lactose anhydrous per tablet.
The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.

Each film-coated tablet contains 304 mg lactose anhydrous per tablet.
The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.

Each film-coated tablet contains 183 mg lactose anhydrous per tablet.
The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.

Each film-coated tablet contains 244 mg lactose anhydrous per tablet.
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
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, ellipticalellipse-shaped, normal convex, white film-coated tablets debossed “OZ over15” on one side and “G” on the other side.

Olanzapine Mylan 20 mg film-coated tablets
13.4 mm x 7.3 mm, eclipseellipse-shaped, normal convex, white film-coated tablets debossed “OZ over20” on one side and “G” on the other side.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core
Lactose monohydrate
Maize starch
Maize starch, pregelatinised
Crospovidone (tType A)
Magnesium stearate

Tablet coat
Opadry White OY-B-28920 containing:
Polyvinyl alcohol
Titanium dioxide (E171)
Talc (E553b)
Soya lecithin (E322)
Xanthan gum (E415)

10. DATE OF REVISION OF THE TEXT

January 20172018


Updated on 8 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 January 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 13 February 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2  Posology and method of administration

Special populations

Elderly patients:
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).

Patients with rRenal 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.

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.

4.8  Undesirable effects

          

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

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

 

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

 

 










Updated on 10 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 September 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects



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

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

 

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

 

 

Updated on 6 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 5 August 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2
Excipients with known effect:

Section 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.
8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” on the other side.
9.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “7.5” on one side and “G” on the other side.
10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and “G” on the other side.
12.2 mm x 6.7 mm, elliptical, normal convex, white film-coated tablets debossed “OZ” over “15” on one side and “G” on the other side.
13.4 mm x 7.3 mm, eclipse-shaped, normal convex, white film-coated tablets debossed “OZ” over “20” on one side and “G” on the other side.

Section 4.1
Adults
Olanzapine is indicated for the treatment of schizophrenia.

Section 4.2
[...]
Special populations

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).

Elderly patients:
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).

Patients with 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.

Gender:
The starting dose and dose range need not be routinely altered for female patients relative to male patients.

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).

Section 4.4
[...]
Dementia-related psychosis and/or behavioural disturbances
Olanzapine is not approved for the treatment of dementia-related psychosis and/or behavioural disturbances and is not recommended for use in this particular group of 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.
[...]
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, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicinal products 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.
[...]
Postural hypotension
Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials. As with other antipsychotics, it It is recommended that blood pressure is measured periodically in patients over 65 years.
[...]
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. Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1)

Section 4.5
Paediatric population:
Interaction studies have only been performed in adults.

Section 4.6
[...]
Neonates New born infants exposed to antipsychotics...

Fertility
Effects on fertility are unknown (see section 5.3 for preclinical information).

Section 4.8
"Not known" column added to the table.

Section 5.1
Pharmacotherapeutic group: psycholeptics, antipsychotics, dDiazepines, oxazepines, and thiazepines and oxepines, ATC code: N05AH03.
[...]
Paediatric population
Controlled efficacy data The experience in adolescents (ages 13 to 17 years) areis limited to short term studies efficacy data 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 and limited data on or long term safety (see sections 4.4 and 4.8).
Information on long term safety is primarily limited to open-label, uncontrolled data.

Section 6.5
For each strength, multipacks containing 70 (2 packs of 35) are specified.

Updated on 30 July 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 8 April 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.5, addition of new unit dose pack size of 98 x 1 for 5 mg, 7.5 mg and 10 mg strengths.

Updated on 25 February 2015 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 4 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 4 November 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to the SPC in line with the brand leader Zyprexa following the CHMP conclusion of 25/04/2013 [EMEA/H/C/xxxx/WS/0337]

Updated on 11 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 10 January 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Extensive updates to the SPC in line with the brand leader Zyprexa.

Updated on 11 November 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 November 2011 PIL

Reasons for updating

  • New PIL for new product