NITROLINGUAL Sublingual spray Ref.[7281] Active ingredients: Glyceryl trinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: G. Pohl-Boskamp GmbH & CO KG., Kieler Strasse 11, 25551 Hohenlockstedt, Germany

Product name and form

Nitrolingual Pumpspray.

Pharmaceutical Form

Sublingual spray.

Qualitative and quantitative composition

Each metered dose contains 400 micrograms glyceryl trinitrate.

Excipients: contains 9.6 mg anhydrous ethanol per metered dose.

For the full list of 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

Medium-chain triglycerides
Ethanol (absolute)
Glycerol monocaprylocaprate
Peppermint oil
Sodium (S)-lactate
(S)-lactic acid

Pack sizes and marketing

Glass bottle with or without red plastic coating, fitted with metering pump. Each bottle contains 6.3 g, 12.1 g, 13.2 g, 15.4 g solution (equivalent to about 75, 180, 200 or 250 doses). Nitrolingual Pumpspray Duo pack contains a 6.3 g and a 15.4 g bottle.

Not all pack sizes may be marketed.

Marketing authorization holder

G. Pohl-Boskamp GmbH & CO KG., Kieler Strasse 11, 25551 Hohenlockstedt, Germany

Marketing authorization dates and numbers

PL 04719/0005

28 November 2005

Drugs

Drug Countries
NITROLINGUAL Austria, Australia, Germany, Estonia, Hong Kong, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Turkey, United Kingdom, United States, South Africa

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