Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND Telephone: 0800 800 806 Fax: (09) 588 1398 Email: medinfo@janau.jnj.com
RESOTRANS 1 mg film-coated tablet.
RESOTRANS 2 mg film-coated tablet.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. 1 mg: white to off-white, round, biconvex tablets marked “PRU 1” on one side. 2 mg: pink, round, biconvex tablets marked “PRU 2” on one side. |
RESOTRANS is available as film-coated tablets containing 1 mg or 2 mg of prucalopride (as prucalopride succinate).
Excipient(s) with known effect:
Sugars as lactose.
Each 1 mg film-coated tablet contains 151.3 mg lactose monohydrate.
Each 2 mg film-coated tablet contains 167 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Prucalopride |
Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities. Prucalopride is a selective, high affinity serotonin (5-HT4) receptor agonist, which is likely to explain its prokinetic effects. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Coating: Hypromellose Additionally, in the coating, the 2 mg tablet contains iron oxide red, iron oxide yellow and indigo carmine C173015. |
Both strengths of RESOTRANS film-coated tablets are available in aluminium/aluminium perforated unit dose blisters containing 7 tablets. Each pack contains 28 film-coated tablets.
Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND
Telephone: 0800 800 806
Fax: (09) 588 1398
Email: medinfo@janau.jnj.com
Date of first approval: 26 April 2012
| Drug | Countries | |
|---|---|---|
| RESOTRANS | Mexico, New Zealand |
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