QUATOR Film-coated tablet Ref.[49901] Active ingredients: Tadalafil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Product name and form

Quator 10 mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Ochre to yellow, oval shaped film-coated tablet of approximately 11 × 6 mm. On one side debossed with “10”. The other side of the tablet is plain.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg tadalafil.

Excipient(s) with known effect: Each tablet contains 177 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tadalafil

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation.

List of Excipients

Tablet core:

Lactose monohydrate
Sodium laurilsulfate (E487)
Povidone K-12 (E1201)
Crospovidone (Type B) (E1202)
Sodium stearyl fumarate

Film-coating:

Polyvinyl alcohol (E1203)
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

Alu-Alu (Al-OPA/AL/PVC) blisters
PVC/ACLAR/PVC – Alu blisters
PVC/ACLAR/PVdC/PVC – Alu blisters

Pack sizes: 4x1, 12x1, 24x1, 36x1, 48x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0711/293/001

Date of first authorisation: 19th July 2019

Drugs

Drug Countries
QUATOR Austria, Estonia, Ireland, Lithuania, Poland

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.