Last Updated on eMC 15-05-2014 View medicine  | Napp Pharmaceuticals Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:24-01-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.1  Film coat has been updated to read:

225mg: Opadry 06B220001 (containing Macrogol 400, Hypromellose (E464_), Titanium Dioxide (E171), Iron Oxide (E172)

350mg: Opadry 06B220000 (containing Macrogol 400, Hypromellose (E464), Titanium Dioxide (E171), Iron Oxide (E172)

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:01-07-2006

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

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:01-07-2006

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

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:05-05-2006

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.

Reasons for adding or updating:

  • Change to joint SPC covering all presentations
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Reasons for adding or updating:

  • Change to joint SPC covering all presentations

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

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

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied