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SPC: ZYPREXA Coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ZYPREXA 2.5 mg coated tablets. ZYPREXA 5 mg coated tablets. ZYPREXA 7.5 mg coated tablets. ZYPREXA 10 mg coated tablets. ZYPREXA 15 mg coated tablets. ZYPREXA 20 mg coated tablets.

Qualitative and quantitative composition

ZYPREXA 2.5 mg coated tablets: Each coated tablet contains 2.5 mg olanzapine. Excipient with known effect: Each coated tablet contains 102 mg lactose monohydrate. ZYPREXA 5 mg coated tablets: Each coated ...

Pharmaceutical form

Coated tablet. ZYPREXA 2.5 mg coated tablets: Round, white, coated tablets imprinted with LILLY and a numeric identicode 4112. ZYPREXA 5 mg coated tablets: Round, white, coated tablets imprinted with ...

Therapeutic indications

Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment ...

Posology and method of administration

Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with known risk of narrow-angle glaucoma.

Special warnings and precautions for use

During antipsychotic treatment, improvement in the patients clinical condition may take several days to some weeks. Patients should be closely monitored during this period. Dementia-related psychosis and/or ...

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 ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including ...

Undesirable effects

Summary of the safety profile Adults The most frequently (seen in ≥1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, ...

Overdose

Signs and symptoms Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging ...

Pharmacodynamic properties

Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines ATC code: N05AH03 Pharmacodynamic effects Olanzapine is an antipsychotic, antimanic and mood stabilising agent ...

Pharmacokinetic properties

Absorption Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Absolute oral bioavailability relative ...

Preclinical safety data

Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain. ...

List of excipients

Tablet core: Lactose monohydrate Hyprolose Crospovidone Microcrystalline cellulose Magnesium stearate Tablet coat: ZYPREXA 2.5 mg , 5 mg, 7.5 mg and 10 mg coated tablets: Hypromellose Colour mixture white ...

Incompatibilities

Not applicable.

Shelf life

Shelf life ZYPREXA 2.5 mg coated tablets: 2 years. ZYPREXA 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg coated tablets: 3 years.

Special precautions for storage

Store in the original package in order to protect from light and moisture.

Nature and contents of container

Cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Marketing authorization number(s)

EU/1/96/022/002 ZYPREXA 2.5 mg coated tablets 28 tablets, per box. EU/1/96/022/019 ZYPREXA 2.5 mg coated tablets 56 tablets, per box. EU/1/96/022/023 ZYPREXA 2.5 mg coated tablets 35 tablets, per ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 September 1996 Date of latest renewal: 12 September 2006

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