| Product Name: | Asenapine Maleate Sublingual Tablets |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg |
| Dosage Form: | Tablets (Sublingual) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antipsychotic |
| Indication: | Asenapine is used to treat schizophrenia in adults. It is also used alone or together with lithium or valproate to treat symptoms of psychotic (mental) disorders, such as mania or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Asenapine Maleate Sublingual Tablets 5mg
- Asenapine Maleate Sublingual Tablets 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Asenapine Maleate Sublingual Tablets 5mg
Each Sublingual tablet contains:
Asenapine Maleate
Equivalent Asenapine……………………………..5mg
Excipients.………………………………………………q.s.
Colour: Ferric Oxide Red - Asenapine Maleate Sublingual Tablets 10mg
Each Sublingual tablet contains:
Asenapine Maleate
Equivalent Asenapine……………………………..10mg
Excipients.………………………………………………q.s.
Colour: Indigo Carmine
THERAPEUTIC INDICATIONS:
Asenapine Maleate is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Place tablet under tongue and allow it to dissolve completely.
Do not eat or drink for 10 minutes.
Do not crush, chew or swallow tablet.
Warning: To be sold by retail on the prescription of a psychiatrist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.