Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: A. Menarini Farmaceutica Internazionale SRL, Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Priligy 30 mg film-coated tablets.
Priligy 60 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. The 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter and debossed with “30” inside a triangle on one side. The 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter and debossed with “60” inside a triangle on one side. |
Each film-coated tablet contains dapoxetine hydrochloride equivalent to 30 mg or 60 mg dapoxetine.
Excipient with known effect: Lactose. Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg tablet contains 91.75 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dapoxetine |
Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI). The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter’s action at pre- and postsynaptic receptors. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Lactose monohydrate |
Child-resistant PVC-PE-PVDC/Alu blister in compliance multi-fold packages of 1, 2, 3 and 6 film-coated tablets. Not all pack sizes may be marketed.
A. Menarini Farmaceutica Internazionale SRL, Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
PL 41549/0001
PL 41549/0002
Date of first authorisation: 17 December 2008
Date of last renewal: 17 December 2013
| Drug | Countries | |
|---|---|---|
| PRILIGY | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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