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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 19/08/2009
SPC Glytrin, 400 micrograms per metered dose, sublingual spray

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/08/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1

Name changed from Glytrin Spray to Glytrin, 400 micrograms per metered dose, Sublingual Spray

Section 2

Following information added;

This product contains small amounts of ethanol (alcohol) less than 100mg per spray.

For full list of excipients, see Section 6.1

Following information removed;

On emetered dose with 8.8mg solution contains 400 micrograms glycerol trinitrate

Section 3

Folloiwing information added;

Metered dose oromucosal (sublingual) spray solution.
Small aerosol canister

Following information removed;

Sublingual spray

Section 6.4

Following information added;

Do not refrigerate or freeze.

Following information removed;

Protect from frost and direct heat or sunlight

Section 6.6

Following information added;

Glytrin is an aerosol spray and contains a pressurized liquid. Do not expose to temperature higher than 50ºC, and do not pierce the canister, even when empty. It should not be sprayed at a naked flame or any incandescent material. Patients, especially those who smoke, should be warned not to use Glytrin near a naked flame.

Following information removed;

Glytrin SPray is a pressurised container, which must not be pierced or bunt even after use. It should not be sprayed at a naked flame or any incandescent material. Patients, especially those who smoke should be warned not to use Glytrin Spray near a naked flame.
Updated on 05/07/2007 and displayed until 19/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of tongue blistering as an adverse reaction
Updated on 23/08/2006 and displayed until 05/07/2007
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   03/2005
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of active ingrediant from bANN to rINN
Updated on 12/09/2003 and displayed until 23/08/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 26/09/2002 and displayed until 12/09/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  glyceryl trinitrate