País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Clozapine 200mg;
Douglas Pharmaceuticals Limited
Clozapine 200 mg
200 mg
Tablet
Active: Clozapine 200mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium starch glycolate
Blister pack, PVC/PVDC/Al, 50 tablets
Prescription
Prescription
Taizhou Xingming Pharmaceutical Co., Ltd
The use of clozapine is indicated in the treatment of resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to or intolerant of classical antipsychotics. Non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two marketed antipsychotics prescribed for adequate durations. Intolerance is defined as the impossibility of achieving adequate clinical benefit with classical antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP tamper evident and child resistant cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP tamper evident and child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C
2003-06-25
CONSUMER MEDICINE INFORMATION CLOPINE® _Clozapine _ 25, 50, 100 and 200 mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking CLOPINE. This leaflet answers some common questions about CLOPINE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CLOPINE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT CLOPINE IS USED FOR CLOPINE tablets belong 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 only used in patients with schizophrenia for whom other antipsychotic medicines have not worked or have caused severe side effects. This medicine is thought to work by correcting the chemical imbalances in the brain, which may cause mental illness. Your doctor may have prescribed it for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. CLOPINE is not recommended for use in children or adolescents under the age of 16, as there is not enough information on its use in that age group. BEFORE YOU TAKE CLOPINE _ _ _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • the active ingredient, clozapine • any of the other ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to this medicine may include: • breathing problems such as shortness of breath, wheezing, difficulty breathing • skin rash, itching or hives • swelling of the face, lips, tongue or other parts Leer el documento completo
1 | P a g e NEW ZEALAND DATA SHEET Clopine® can cause agranulocytosis. Its use should be limited to patients: - with schizophrenia who are non-responsive to or intolerant of classical antipsychotic agents, or with schizophrenia or schizoaffective disorder who are at risk of recurrent suicidal behaviour _(see section 4.1),_ - who have initially normal leukocyte findings (white blood cell count (WBC) ≥ 3500/mm 3 (3.5 x 10 9 /L), and absolute neutrophil counts (ANC) ≥ 2000/mm 3 (2.0 x 10 9 /L)), - and in whom regular white blood cell counts and absolute neutrophil counts can be performed as follows: weekly during the first 18 weeks of therapy, and at least every 4 weeks thereafter throughout treatment. Monitoring must continue throughout treatment and for 4 weeks after complete discontinuation of Clopine (see section 4.4). Prescribing physicians should comply fully with the required safety measures. At each consultation, a patient receiving Clopine should be reminded to contact the treating physician immediately if any kind of infection begins to develop. Particular attention should be paid to flu-like complaints such as fever or a sore throat and to other evidence of infection, which may be indicative of neutropenia (see section 4.4). Close monitoring of bowel habits is also recommended for any signs of constipation or gastrointestinal hypomotility. Clopine must be prescribed and dispensed in accordance with appropriate local guidelines. The following conditions apply to the sale, supply and use of Clopine in New Zealand under the consent notice from Medsafe. Douglas draws prescribers, nurses and patients’ attention to the following criteria: Clozapine may only be initiated and prescribed by: - Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry (i.e. psychiatrist); - Medical practitioners employed as registrars in the branch of psychiatry, or nurse pra Leer el documento completo