Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
clozapine, Quantity: 200 mg
Pharmacor Pty Ltd
Tablet, uncoated
Excipient Ingredients: sodium starch glycollate type A; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate
Oral
50, 100
(S4) Prescription Only Medicine
Treatment with PHARMACOR CLOZAPINE is indicated only in people with treatment resistant schizophrenia, i.e. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.,Non-responsiveness is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations.,Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse effects (extrapyramidal side effects or tardive dyskinesia).
Visual Identification: Oval shaped, yellow tablet with 200 on one side and break line on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-09-17
PHARMACOR CLOZAPINE _CLOZAPINE _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMACOR CLOZAPINE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE . Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PHARMACOR CLOZAPINE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PHARMACOR CLOZAPINE IS USED FOR PHARMACOR CLOZAPINE is used in patients with schizophrenia for whom other antipsychotic medicines have not worked or have caused severe side effects. This medicine belongs to the group of medicines known as antipsychotics. This group of medicines is mainly used in the treatment of schizophrenia. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. This medicine is thought to work by correcting the chemical imbalances in the brain which may cause mental illness. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine in children under the age of 16 years. BEFORE YOU TAKE PHARMACOR CLOZAPINE _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PHARMACOR CLOZAPINE IF YOU HAVE AN ALLERGY TO: • any medicine containing clozapine • Přečtěte si celý dokument
Version No: 01 Page 1 AUSTRALIAN PRODUCT INFORMATION - PHARMACOR CLOZAPINE (CLOZAPINE) WARNING 1. NAME OF THE MEDICINE Clozapine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR CLOZAPINE is available in 4 strength for oral administration containing 25mg, 50 mg, 100 mg & 200 mg clozapine. PHARMACOR CLOZAPINE 25 mg: Each tablet contains 25 mg clozapine PHARMACOR CLOZAPINE 50 mg: Each tablet contains 50 mg clozapine PHARMACOR CLOZAPINE 100 mg: Each tablet contains 100 mg clozapine PHARMACOR CLOZAPINE 200 mg: Each tablet contains 200 mg clozapine Excipients with known effect: Tablets: Contains Sugars (as lactose monohydrate). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets, Uncoated PHARMACOR CLOZAPINE 25 mg- Round yellow, flat, beveled edge tablets engraved with 25 over a pressure sensitive break line on one face, the other face plain. PHARMACOR CLOZAPINE 50 mg- Round, yellow, flat, beveled edge tablets engraved with 50 over a pressure sensitive break line on one face. The other face plain. PHARMACOR CLOZAPINE 100 mg- Round yellow, flat, beveled edge tablets engraved with 100 over a pressure sensitive break line on one face. The other face plain. PHARMACOR CLOZAPINE 200 mg- Oval shaped, yellow tablets with "200” on one side and break line on other side. 1.1 _MYOCARDITIS/CARDIOMYOPATHY_: CASES OF MYOCARDITIS, SOME OF WHICH HAVE BEEN FATAL, AND CARDIOMYOPATHY HAVE BEEN REPORTED IN PATIENTS ON CLOZAPINE (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). Version No: 01 Page 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment with PHARMACOR CLOZAPINE is indicated only in people with treatment- resistant schizophrenia, i.e. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs. _Non-responsiveness _ is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs presc Přečtěte si celý dokument