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Impexxia Olanzapine Tablets 5 mg_

NAFDAC Reg. No. C4-1004 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Impexxia Olanzapine Tablets 5 mg_
NAFDAC number
C4-1004
Active ingredient
Olanzapine
Strength
5 mg
Form
Tablet
Pack size
10 x 10's (in Alu-Alu blisters)
Manufacturer
Not listed
Applicant (holder)
Impexxia Pharma Ltd
Approved
27 Aug 2025
Status
Active View on NAFDAC ↗
Registration valid to
26 Aug 2030
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Impexxia Olanzapine Tablets 5 mg_ is on the NAFDAC register with an active registration (C4-1004). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Impexxia Olanzapine Tablets 5 mg_ is used for

From the official U.S. FDA label for olanzapine, the active ingredient registered with NAFDAC.

Boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. …
What it is used for

Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. …

Possible side effects

When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia ( 6.1 ) Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth ( 6.1 ) Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor ( 6.1 ) Manic or Mixed E …

Do not use if

None with olanzapine monotherapy. When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. …

Warnings

When using olanzapine and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). ( 5.1 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Olanzapine Tablets, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. …

Storage

Store olanzapine orally disintegrating tablets, USP at 20° to 25°C (68° to 77°F) [ see USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Impexxia Olanzapine Tablets 5 mg_

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Impexxia Olanzapine Tablets 5 mg_

What is in Impexxia Olanzapine Tablets 5 mg_?

Impexxia Olanzapine Tablets 5 mg_ contains Olanzapine (5 mg), as tablet, according to its NAFDAC registration record.

Is Impexxia Olanzapine Tablets 5 mg_ registered with NAFDAC?

Yes. Impexxia Olanzapine Tablets 5 mg_ is listed on the NAFDAC register under registration number C4-1004, and its registration is active as of 28 October 2026.

Has Impexxia Olanzapine Tablets 5 mg_ been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Impexxia Olanzapine Tablets 5 mg_ in our automatically synced alert list.

How can I check that my pack of Impexxia Olanzapine Tablets 5 mg_ is genuine?

Run a free authenticity scan with the NAFDAC number C4-1004, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Impexxia Olanzapine Tablets 5 mg_ used for?

Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in (Summarised from the official U.S. FDA label for olanzapine. Always follow your doctor or pharmacist.)

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