ZAPONEX Orodispersible tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zaponex 12.5 mg orodispersible tablets. Zaponex 25 mg orodispersible tablets. Zaponex 50 mg orodispersible tablets. Zaponex 100 mg orodispersible tablets. Zaponex 200 mg orodispersible tablets.
Qualitative and quantitative composition
Zaponex 12.5 mg orodispersible tablets Each orodispersible tablet contains 12.5 mg clozapine. <u>Excipient(s) with known effect:</u> Each orodispersible tablet contains 1.6 mg aspartame (E951). Zaponex ...
Pharmaceutical form
Orodispersible tablet. <u>Zaponex 12.5 mg orodispersible tablets:</u> Yellow, round, flat orodispersible tablets of approximately 6.5 mm of diameter. The tablets are debossed with C7PN on one side and ...
Therapeutic indications
Treatment-resistant schizophrenia Clozapine is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other ...
Posology and method of administration
Posology The dosage must be adjusted individually. For each patient the lowest effective dose should be used. For doses not realisable/practicable with one strength, other strengths of this medicinal product ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Patients unable to undergo regular blood tests. History of toxic or idiosyncratic granulocytopenia/agranulocytosis ...
Special warnings and precautions for use
Agranulocytosis Clozapine can cause agranulocytosis. The incidence of agranulocytosis and the fatality rate in those developing agranulocytosis have decreased markedly since the institution of white blood ...
Interaction with other medicinal products and other forms of interaction
Contraindication of concomitant use Substances known to have a substantial potential to depress bone marrow function must not be used concurrently with clozapine (see section 4.3). Long-acting depot antipsychotics ...
Fertility, pregnancy and lactation
Pregnancy For clozapine, there are only limited clinical data on exposed pregnancies. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Owing to the ability of clozapine to cause sedation and lower the seizure threshold, activities such as driving or operating machinery should be avoided, especially during the initial weeks of treatment. ...
Undesirable effects
Summary of the safety profile For the most part, the adverse event profile of clozapine is predictable from its pharmacological properties. An important exception is its propensity to cause agranulocytosis ...
Overdose
In cases of acute intentional or accidental clozapine overdose for which information on the outcome is available, mortality to date is about 12%. Most of the fatalities were associated with cardiac failure ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05AH02 Mechanism of action Clozapine has been shown to be an antipsychotic agent that is different from classic ...
Pharmacokinetic properties
Absorption The absorption of orally administered clozapine is 90 to 95%; neither the rate nor the extent of absorption is influenced by food. Clozapine is subject to moderate first-pass metabolism, resulting ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential (for reproductive toxicity, see ...
List of excipients
Mannitol (E421) Cellulose, microcrystalline Silica, colloidal anhydrous Crospovidone (type A) Aspartame (E951) Peppermint flavour (contains maltodextrin, starch sodium octenyl succinate (E 1450) and glyceryl ...
Incompatibilities
Not applicable.
Shelf life
PVC/PVDC/Al blisters: 2 years. HDPE containers: 2 years.
Special precautions for storage
PVC/PVDC/Al blisters: This medicinal product does not require any special storage conditions. HDPE containers: This medicinal product does not require any special storage conditions.
Nature and contents of container
Zaponex 12.5 mg orodispersible tablets are available in either: PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets. PVC/PVDC/Al perforated unit-dose ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Leyden Delta BV, Neerbosscheweg 620, 6544 LL, Nijmegen, The Netherlands
Marketing authorization number(s)
Zaponex 12.5 mg orodispersable tablets: PL 32553/0004 Zaponex 25 mg orodispersable tablets: PL 32553/0005 Zaponex 50 mg orodispersable tablets: PL 32553/0006 Zaponex 100 mg orodispersable tablets: PL 32553/0007 ...
Date of first authorization / renewal of the authorization
29/03/2019
Date of revision of the text
31/07/2020
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