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Clozaril 100mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Clozapine

    *Additional information is available within the SPC or upon request to the company

Updated on 04 July 2024

File name

ie-pil-clozaril 25mg 100mg-maht+malta-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 04 July 2024

File name

ie-smpc-clozaril 100mg-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 31 March 2022

File name

IE-PIL-Clozaril 25mg 100mg-clean-31Aug2021.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 April 2021

File name

IE-SmPC-Clozaril 100mg-14Ap2021-CRN00C61G-TIB-clean.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

Addition to section 1 of the Irish SmPCs only. The wording "Ireland – Clozaril Official Recommendations" which includes details of the Clozaril Patient Monitoring Service (CPMS)

Updated on 08 April 2021

File name

2410922_Clozapine_100mg_84_CH_P3.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 October 2019

File name

IE-SmPC-Clozaril 100mg-11Oct2019-CRN008WLL-WS582-(incl off rec).pdf

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)

Updated on 17 October 2019

File name

IE-PIL-Clozaril 25mg 100mg-11Oct2019-CRN008WLL-WS582-clean.pdf

Reasons for updating

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

Updated on 20 May 2019

File name

IE-PIL-Clozaril 25mg 100mg-15May2019-V094-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 May 2019

File name

IE-SmPC-Clozaril 100mg-15May2019-V094-(incl off rec).pdf

Reasons for updating

  • 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)

Updated on 15 March 2019

File name

IE-PIL-Clozaril 25mg 100mg-13Mar2019-CRN008JT7-clean.pdf

Reasons for updating

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

Updated on 15 March 2019

File name

IE-SmPC-Clozaril 100mg-13Mar2019-CRN008JT7-(incl off rec).pdf

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)

Updated on 15 March 2019

File name

IE-SmPC-Clozaril 25mg-13Mar2019-CRN008JT7-(incl off rec).pdf

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)

Updated on 17 December 2018

File name

IE-PIL-Clozaril 25mg 100mg-12Dec2018-CRN008Q7Q-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 17 December 2018

File name

IE-SmPC-Clozaril 100mg-12Dec2018-CRN008Q7Q-emc (inc off rec).pdf

Reasons for updating

  • 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)

Updated on 11 June 2018

File name

Upload IE-SmPC-Clozaril 100mg-01Jun2018-CRN2203852-emc (inc off rec).docx

Reasons for updating

  • 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 11 June 2018

File name

IE-PIL-Clozaril 25mg 100mg-01Jun2018-CRN2203852-emc.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 26 April 2018

File name

IE-PIL-Clozaril 25mg 100mg-08Mar2018-CRN2198661-emc.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 21 March 2018

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

3. PHARMACEUTICAL FORM

Tablets

Yellow, circular, flat tablet with bevelled edges. Coded “Z/A” with an angle score on one side and “SANDOZ CLOZ” in linear form on the reverse.

Updated on 20 March 2018

File name

PIL_16986_750.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects

Updated on 13 March 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Agranulocytosis
Clozaril can cause agranulocytosis. The incidence of agranulocytosis and the fatality rate in those developing agranulocytosis have decreased markedly since the institution of white blood cell (WBC) counts and absolute neutrophil count (ANC) monitoring. The following precautionary measures are therefore mandatory and should be carried out in accordance with official recommendations.

Because of the risks associated with Clozaril, its use is limited to patients in whom therapy is indicated as set out in section 4.1 and:
- who have initially normal leukocyte findings (WBC count ≥ 3500/mm3 (3.5x109/l)  and ANC ≥ 2000/mm3 (2.0x109/l), and
- in whom regular WBC counts and ANC can be performed weekly for the first 18 weeks and at least 4-week intervals thereafter. Monitoring must continue throughout treatment and for 4 weeks after complete discontinuation of Clozaril.

Patients with clozapine-induced myocarditis or cardiomyopathy should not be re-exposed to Clozaril.

Myocardial infarction
In addition, tThere have been post marketing reports of myocardial infarction including fatal cases. Causality assessment was difficult in the majority of these cases because of serious pre-existing cardiac disease and plausible alternative causes.

QT interval prolongation
As with other antipsychotics, caution is advised in patients with known cardiovascular disease or family history of QT prolongation.

Anticholinergic effects
Clozaril exerts anticholinergic activity, which may produce undesirable effects throughout the body. Careful supervision is indicated in the presence of prostatic enlargement and narrow-angle glaucoma. Probably on account of its anticholinergic properties, Clozaril has been associated with varying degrees of impairment of intestinal peristalsis, ranging from constipation to intestinal obstruction, faecal impaction, paralytic ileus, megacolon and intestinal infarction/ischaemia (see section 4.8). On rare

 

 

Falls
Clozaril may cause seizures, somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

 

Updated on 12 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects

Updated on 23 August 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

4.4     Special warnings and precautions for use

Cardiovascular disorders

 

In patients who are diagnosed with cardiomyopathy while on Clozaril treatment, there is potential to develop mitral valve incompetence. Mitral valve incompetence has been reported in cases of cardiomyopathy related to Clozaril treatment. These cases of mitral valve incompetence reported either mild or moderate mitral regurgitation on two-dimensional echocardiography (2DEcho) (see section 4.8).

4.8 Undesirable effects

Table 4: Treatment-emergent adverse experience frequency estimate from spontaneous and clinical trial reports

 

Adverse reactions are ranked under headings of frequency, using the following convention: Very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Infections and infestations

 

Not known:

Sepsis*

Blood and lymphatic system disorders

 

Common:

Leukopenia/decreased WBC/neutropenia, eosinophilia, leukocytosis

 

Uncommon:

Agranulocytosis

 

Rare:

Anaemia

 

Very rare:

Thrombocytopenia, thrombocythaemia

Immune system disorders

 

Not known:

Angioedema*, leukocytoclastic vasculitis*

Endocrine disorders

 

Not known:

Pseudophaeochromocytoma*

Metabolism and nutrition disorders

 

Common:

Weight gain

 

Rare:

Diabetes mellitus, impaired glucose tolerance

 

Very rare:

Hyperosmolar coma, ketoacidosis, severe hyperglycaemia, hypercholesterolemia, hypertriglyceridemia

Psychiatric disorders

 

Common:

Dysarthria

 

Uncommon:

Dysphemia

 

Rare:

Agitation, restlessness

Nervous system disorders

 

Very common:

Drowsiness/sedation, dizziness

 

Common:

Seizures/convulsions/myoclonic jerks, extrapyramidal symptoms, akathisia, tremor, rigidity, headache

 

Uncommon:

Neuroleptic malignant syndrome

 

Rare:

Confusion, delirium

 

Very rare:

Tardive dyskinesia, obsessive compulsive symptoms

 

Not known:

Cholinergic syndrome (after abrupt withdrawal)*, EEG changes*, pleurothotonus*

Eye disorders

 

Common:

Blurred vision

Cardiac disorders

 

Very common:

Tachycardia

 

Common:

ECG changes

 

Rare:

Circulatory collapse, arrhythmias, myocarditis, pericarditis/pericardial effusion

 

Very rare:

Cardiomyopathy, cardiac arrest

 

Not known:

Myocardial infarction which may be fatal*, chest pain/angina pectoris*, atrial fibrillation*, palpitations*, mitral valve incompetence associated with clozapine related cardiomyopathy*

Vascular disorders

 

Common:

Syncope, postural hypotension, hypertension

 

Rare:

Thromboembolism

 

Not known:

Hypotension*, Venous thromboembolism

Respiratory, thoracic and mediastinal disorders

 

Rare:

Aspiration of ingested food, pneumonia and lower respiratory tract infection which may be fatal

 

Very rare:

Respiratory depression/arrest

 

Not known:

Nasal congestion*

Gastrointestinal disorders

 

Very common

Constipation, hypersalivation

 

Common:

Nausea, vomiting, anorexia, dry mouth

 

Rare:

Dysphagia

 

Very rare:

Intestinal obstruction/paralytic ileus/faecal impaction, parotid gland enlargement,

 

Not known:

Diarrhoea*, abdominal discomfort/heartburn/dyspepsia*, colitis*

Hepatobiliary disorders

 

Common:

Elevated liver enzymes

 

Rare:

Pancreatitis, hepatitis, cholestatic jaundice

 

Very rare:

Fulminant hepatic necrosis

 

Not known:

Hepatic steatosis*, hepatic necrosis*, hepatotoxicity*, hepatic fibrosis*, hepatic cirrhosis*, liver disorders including those hepatic events leading to life-threatening consequences such as liver injury (hepatic, cholestatic and mixed), liver failure which may be fatal and liver transplant*.

Skin and subcutaneous tissue disorders

 

Very rare:

Skin reactions

 

Not known

Pigmentation disorder*

Musculoskeletal and connective tissue disorders

 

Not known:

Muscle weakness*, muscle spasms*, muscle pain*, systemic lupus erythematosus*

Renal and urinary disorders

 

Common:

Urinary retention, urinary incontinence

 

Very rare:

Interstitial nephritis

 

Not known:

Renal failure*, Nocturnal enuresis*

Pregnancy, puerperium and perinatal conditions

 

Not known:

Drug withdrawal syndrome neonatal (see 4.6)

Reproductive system and breast disorders

 

Very rare:

Priapism

 

Not known

Retrograde ejaculation*

General disorders and administration site conditions

 

Common:

Benign hyperthermia, disturbances in sweating/temperature regulation, fever, fatigue

 

Very rare:

Sudden unexplained death

Investigations

 

Rare:

Increased CPK

10. DATE OF REVISION OF THE TEXT

November 2016August 2017

Updated on 22 August 2017

Reasons for updating

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

Updated on 15 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 09 November 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

Correction to section 1 to include the Irish Official Recommendations for Clozaril

Updated on 07 November 2016

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 07 November 2016

Reasons for updating

  • New PIL for new product