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.
ZYPREXA VELOTABS
3 years.
Not applicable.
ZYPREXA tablet
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 (hypromellose, titanium dioxide [E171], macrogol, polysorbate 80)
Carnauba wax
Edible blue ink (shellac, ethanol anhydrous, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium hydroxide, indigo carmine [E132])
ZYPREXA 15 mg coated tablets:
Hypromellose
Colour mixture light blue (titanium dioxide [E171], lactose monohydrate, hypromellose, triacetin, indigo carmine [E132])
Carnauba wax
ZYPREXA 20 mg coated tablets:
Hypromellose
Colour mixture pink (titanium dioxide [E171], macrogol, lactose monohydrate, hypromellose, synthetic red iron oxide)
Carnauba wax
ZYPREXA VELOTAB
Gelatin
Mannitol (E421)
Aspartame (E951)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
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. The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats). Dogs tolerated single oral doses up to 100 mg/kg without mortality. Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia. In monkeys, single oral doses up to 100 mg/kg resulted in prostration and, at higher doses, semi-consciousness.
Repeated-dose toxicity
In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders. Tolerance developed to the CNS depression. Growth parameters were decreased at high doses. Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Haematologic toxicity
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found. Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12 mg dose). In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Reproductive toxicity
Olanzapine had no teratogenic effects. Sedation affected mating performance of male rats. Oestrous cycles were affected at doses of 1.1 mg/kg (3-times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9-times the maximum human dose). In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Mutagenicity
Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Carcinogenicity
Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
23 February 2017
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
ZYPREXA tablets: Store in the original package in order to protect from light and moisture.
ZYPREXA VELOTABS: Store in the original package in order to protect from light and moisture.
ZYPREXA 2.5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA 5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA 7.5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA 10 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA 15 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA 20 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg, and 20 mg is supplied in aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Not all pack sizes may be marketed.
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 box
EU/1/96/022/029: ZYPREXA 2.5 mg coated tablets - 70 tablets per box
EU/1/96/022/035: ZYPREXA 2.5 mg coated tablets - 98 tablets per box
EU/1/96/022/004: ZYPREXA 5 mg coated tablets - 28 tablets per box
EU/1/96/022/020: ZYPREXA 5 mg coated tablets - 56 tablets per box
EU/1/96/022/024: ZYPREXA 5 mg coated tablets - 35 tablets per box
EU/1/96/022/030: ZYPREXA 5 mg coated tablets - 70 tablets per box
EU/1/96/022/036: ZYPREXA 5 mg coated tablets - 98 tablets per box
EU/1/96/022/011: ZYPREXA 7.5 mg coated tablets - 28 tablets per box
EU/1/96/022/006: ZYPREXA 7.5 mg coated tablets - 56 tablets per box
EU/1/96/022/025: ZYPREXA 7.5 mg coated tablets - 35 tablets per box
EU/1/96/022/031: ZYPREXA 7.5 mg coated tablets - 70 tablets per box
EU/1/96/022/037: ZYPREXA 7.5 mg coated tablets - 98 tablets per box
EU/1/96/022/009: ZYPREXA 10 mg coated tablets - 28 tablets per box
EU/1/96/022/010: ZYPREXA 10 mg coated tablets - 56 tablets per box
EU/1/96/022/026: ZYPREXA 10 mg coated tablets - 35 tablets per box
EU/1/96/022/032: ZYPREXA 10 mg coated tablets - 70 tablets per box
EU/1/96/022/038: ZYPREXA 10 mg coated tablets - 98 tablets per box
EU/1/96/022/012: ZYPREXA 15 mg coated tablets - 28 tablets per box
EU/1/96/022/021: ZYPREXA 15 mg coated tablets - 56 tablets per box
EU/1/96/022/027: ZYPREXA 15 mg coated tablets - 35 tablets per box
EU/1/96/022/033: ZYPREXA 15 mg coated tablets - 70 tablets per box
EU/1/96/022/039: ZYPREXA 15 mg coated tablets - 98 tablets per box
EU/1/96/022/014: ZYPREXA 20 mg coated tablets - 28 tablets per box
EU/1/96/022/022: ZYPREXA 20 mg coated tablets - 56 tablets per box
EU/1/96/022/028: ZYPREXA 20 mg coated tablets - 35 tablets per box
EU/1/96/022/034: ZYPREXA 20 mg coated tablets - 70 tablets per box
EU/1/96/022/040: ZYPREXA 20 mg coated tablets - 98 tablets per box
EU/1/99/125/001: 5 mg x 28 Velotabs
EU/1/99/125/005: 5 mg x 56 Velotabs
EU/1/99/125/009: 5 mg x 35 Velotabs
EU/1/99/125/013: 5 mg x 70 Velotabs
EU/1/99/125/017: 5 mg x 98 Velotabs
EU/1/99/125/002: 10 mg x 28 Velotabs
EU/1/99/125/006: 10 mg x 56 Velotabs
EU/1/99/125/010: 10 mg x 35 Velotabs
EU/1/99/125/014: 10 mg x 70 Velotabs
EU/1/99/125/018: 10 mg x 98 Velotabs
EU/1/99/125/003: 15 mg x 28 Velotabs
EU/1/99/125/007: 15 mg x 56 Velotabs
EU/1/99/125/011: 15 mg x 35 Velotabs
EU/1/99/125/015: 15 mg x 70 Velotabs
EU/1/99/125/019: 15 mg x 98 Velotabs
EU/1/99/125/004: 20 mg x 28 Velotabs
EU/1/99/125/008: 20 mg x 56 Velotabs
EU/1/99/125/012: 20 mg x 35 Velotabs
EU/1/99/125/016: 20 mg x 70 Velotabs
EU/1/99/125/020: 20 mg x 98 Velotabs
No special requirements.
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg ZYPREXA tablets:
| Date of first authorisation: Date of latest renewal: | 27 September 1996 27 September 2006 |
ZYPREXA VELOTABS:
| Date of first authorisation: Date of latest renewal: | 3 February 2000 27 September 2006 |
