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Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: + 44 1748 828 391
Medical Information Direct Line: 0800 0087 392
Medical Information e-mail: aspenglobal@professionalinformation.co.uk

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: 14/05/2012
SPC Lanoxin Tablets 0.25mg

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 14/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7.           Marketing Authorisation Holder changed from Aspen Europe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany

 

Aspen Pharma Trading Limited

12/13 Exchange Place,

I.F.S.C,

Dublin 1, Ireland

8.         Marketing Authorisation Number changed from  PL 35468/0005 to

PL 35468/0005 to

PL 39699/0010

 

 

 

10.       Date of Revision of the Text changed from 4 November 2009 to

16 February 2012

 

 

 

 
Updated on 08/03/2010 and displayed until 14/05/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7 Marketing Authorisation Holder

From GlaxoSmithKline to Aspen Europe GmbH
Updated on 19/05/2009 and displayed until 08/03/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Changes to the wording of section including update to medicines that reduce and increase serum levels of digoxin.
including addition of following text:

Section 5.2 - Digoxin is a substrate of P-glycoprotein. Thus, inhibitors of P-glycoprotein may increase blood concentrations of digoxin by enhancing its absorption and/or by reducing its renal clearance (See 5.2 Pharmacokinetic Properties).

addition of wording:

 

Pharmacokinetic Properties

Absorption

 

Intravenous administration of a loading dose produces an appreciable pharmacological effect within 5 to 30 minutes; this reaches a maximum in 1 to 5 hours. Upon oral administration, digoxin is absorbed from the stomach and upper part of the small intestine.

When digoxin is taken after meals, the rate of absorption is slowed, but the total amount of digoxin absorbed is usually unchanged. When taken with meals high in fibre, however, the amount absorbed from an oral dose may be reduced.

 

Elimination

 

 

The major route of elimination is renal excretion of the unchanged drug.

 

Digoxin is a substrate for P-glycoprotein. As an efflux protein on the apical membrane of enterocytes, P-glycoprotein may limit the absorption of digoxin. P-glycoprotein in renal proximal tubules appears to be an important factor in the renal elimination of digoxin (See 4.5 Interaction with other medicinal products and other forms of interaction)

Section 10 - 14 May 2009
Updated on 28/07/2008 and displayed until 19/05/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   05-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


This section has been updated to read as follows:

6.3 Shelf Life

Amber glass bottle: 60 months

Blister packs: 36 months


This section has been updated to read as follows:

6.5 Nature and Contents of Container

 

Amber glass bottle with low-density polyethylene snap fit closures

Pack sizes: 28, 50, 500 tablets

15 ml aAmber glass bottle with a clic-loc child resistant closure

Pack size: 56 tablets

Polypropylene containers with polyethylene snap fit closures

Pack sizes: 1000, 5000 tablets

White opaque PVC/aluminium foil blister

Pack sizes: 30, 60, 90, 120 tablets

Not all pack sizes are marketed.



This section has been amended to read as follows:

10. Date of Revision of the Text

 

21 May 20033 January 20085 June 2008
Updated on 22/01/2008 and displayed until 28/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

The following information has been included or updated: -

·         Updated oral loading information; differentiating between chronic cardiac failure in absence of supraventricular arrhythmia for adults and management of atrial fibrillation or flutter in adults and children over 10 years old. [Oral formulations only]

·         The maintenance dose for adults and children over 10 years old with heart failure has been changed to 125 - 250 micrograms (0.125 - 0.250 mg).

·         Further information is provided concerning the monitoring of serum digoxin concentration for both efficacy and toxicity.

·         Maintenance dosage instructions have been incorporated on the injection formulation to harmonise with all oral formulations, providing further clarity to benefit the healthcare professional.

·         Dilution instructions have been removed from this section in line with current SPC guidance, as it was considered duplication of the information already provided in section 6.6 (Instructions for use, handing and disposal). [Injection formulation only]

·         Other minor amendments have been made to provide clarity.

 

4.3 Contraindications

The hypersensitivity statement has been expanded to include hypersensitivity to any of the components of the product (i.e. the excipients in addition to the drug substance).

 

4.4 Special warnings and precautions

Warnings and precautions about the use of digoxin in heart failure associated with cardiac amyloidosis, myocarditis, beri-beri heart disease and constrictive pericarditis have been added. Additionally, an appropriate warning has been added to reflect the excipients with a known action included in the product, in accordance with current guidance (lactose and sucrose, where relevant).

 

4.8 Undesirable Effects

The adverse events have been updated in accordance with the MedDRA System Organ Class (SOC) and to include frequencies according to CIOMS classification and current guidance. Additionally, information related to adverse events experienced in an overdose has been moved to the appropriate SPC section (4.9 Overdose).

 

4.9 Overdose

This section has been updated to include further information on possible symptoms and signs in case of a digoxin overdose. This information was previously provided in SPC section 4.8 (Undesirable Effects).
Updated on 17/06/2003 and displayed until 22/01/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 04/06/2003 and displayed until 17/06/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 25/04/2003 and displayed until 04/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 30/05/2002 and displayed until 25/04/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/08/2001 and displayed until 30/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/08/2000 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  digoxin