TRANSIDERM NITRO Transdermal patch Ref.[27764] Active ingredients: Glyceryl trinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Product name and form

Transiderm Nitro 5.

Transiderm Nitro 10.

Pharmaceutical Form

Transdermal patch.

Qualitative and quantitative composition

Transiderm Nitro 5: Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.

Transiderm Nitro 10: Nitroglycerin on lactose 500mg equivalent to nitroglycerin 50mg.

For excipients see section 6.1.

Active Ingredient Description
Glyceryl trinitrate

Glyceryl trinitrate is a vasodilator and is used for angina of effort. Vasodilation is achieved by the releasing of free redical nitric oxide which activates guanylate cyclase and increases synthesis of guanosine 3′ and 5′-monophosphate with resultant effects on the phosphorylation of proteins in smooth muscle. If taken in excess, its vasodilatory effect can cause headache.

List of Excipients

Lactose
Silicone oil
Silica dioxide
Ethylene-vinyl acetate copolymer
Silicone-based adhesive (medical adhesive CH15)

Pack sizes and marketing

Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*).

Transiderm Nitro 5 only: 28 or 30 sealed patches in each cardboard container.

Transiderm Nitro 10 only: 28 sealed patches in each cardboard container.

* Aluminium 12µm ± 10%, polyethylene 16G/m² ± 20%, surlyn 20G/m² ± 15%.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Marketing authorization dates and numbers

PL 00101/0464
PL 00101/0465

22 June 2004

Drugs

Drug Countries
TRANSIDERM-NITRO Australia, Finland, Ireland, Netherlands, United Kingdom

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