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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

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: 25/09/2009
SPC Phyllocontin Continus tablets 225mg, Phyllocontin Forte Continus tablets 350mg

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 25/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01-Jul-2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


List of Excipients

Hydroxyethylcellulose

Povidone [K25]

Cetostearyl Alcohol

Purified Talc

Magnesium Stearate

 

Film coat

Hypromellose [E464]

Polyethylene glycol 400

Opaspray M-1-3058 (containing Industrial Methylated Spirit

Hypromellose [E464], Titanium Dioxide [E171], Iron Oxide [E172]).

 
The list of excipients has been amended
Updated on 14/08/2006 and displayed until 25/09/2009
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 upadate to PHYLLOCONTIN CONTINUS 225 mg / PHYLLOCONTIN FORTE CONTINUS 350 mg , prolonged release tablets
Section 2 update to Aminophyllin hydrate 225 mg and added For a full list of excipients, see 6.1
Section 3 Prolonged release tablets added
Section 5.1 Added the Pharmaceutical group and ATC code
Section 6.6 Updated to  no special requirements
Section 10 Upadte revision of the text
Updated on 26/05/2006 and displayed until 14/08/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   05/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 (Posology and method of aministration) 
    Added  - statment that 225 mg tablet not a suitable starting dose for children under 40kg in weight.
    Removed - not recommended for children under 3  years of age.
Updated on 02/12/2005 and displayed until 26/05/2006
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/09/2005 and displayed until 02/12/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 19/09/2005 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Updated on 21/09/2004 and displayed until 19/09/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.9 - Overdose
Updated on 30/08/2002 and displayed until 21/09/2004
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 16/08/2001 and displayed until 30/08/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 25/09/2000 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 25/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  aminophylline hydrate