Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 20/01/2010
SPC Feldene Capsules, Feldene I.M. Intramuscular Injection, Feldene MELT

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 20/01/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   08-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - piroxicam should be administered with caution to patients who are known to be poor CYP2C9 metabolisers

Section 5.2 - piroxicam metabolism is primarily mediated by cytochrome P450 CYP 2C9 in the liver. Poor CYP2C9 metabolizers should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.
Updated on 13/01/2010 and displayed until 20/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5 - number of capsules in the container has been revised to 30

Section 10 - date last updated
Updated on 31/07/2009 and displayed until 13/01/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products 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 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SmPC - changes are extensive as they include the Referral text - refer to SmPC for full details

Section 1 - update to name to include strength and pharmaceutical form

Section 3 - administrative update

Section 4.1 - acute indications deleted, no longer a first line treatment option

Section 4.2 - includes deletion of posology relating to acute indications, maximum recommended daily dose restricted to 20 mg, prescription only to be initiated by physician's with experience

Section 4.3 - expansion of active and current GI contraindications, hypersensitivity to include skin reactions, addition of concomitant use with NSAIDs, aspirin at analgesic doses, anticoagulants, last trimester of pregnancy

Section 4.4 - extensive updates to sections on GI and skin reactions, addition of warning that Feldene may impair female fertility

Section 4.5 - addition of tacrolimus, antiplatelet agents, SSRIs, cardiac glycosides, revised text for anticoagulants, aspirin and other NSAIDs

Section 4.6 - explanation of the contraindication in last trimester of pregnancy, not recommended during pregnancy unless benefit outweighs risk

Section 4.7 - updated with NSAIDs class text - undesirable effects are possible, if affected don't drive or operate machinery

Section 6.3 administrative update

 

6.5: updated with description of replacement pack size - blister strip PVC/PVdC and paper foil laminate containing 10 units. Each pack contains 30 units (3 x strips of 10 tablets).

Section 9 - update to date last renewed

Section 10 - update to date last updated
Updated on 25/06/2007 and displayed until 31/07/2009
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 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2  undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms

Section 4.3  addition of severe heart failure

Section 4.4  same statement as above for 4.2, expanded precautions & warnings for patients with CV risk

Section 4.8  addition of adverse events hypertension & cardiac failure, clinical trial & epidemiological data suggest that some NSAIDs may be associated with a small increased risk of arterial thrombotic events

Sections 1-4.2, 5.1, 5.2, 6.1, 6.3-6.5, 8 & 9  Reference to Feldene Dispersible tablets has been removed from
Updated on 20/09/2006 and displayed until 25/06/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Date of revision of text on the SPC:   10/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to capsule shell colour.
Updated on 13/09/2005 and displayed until 20/09/2006
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations

Active Ingredients/Generics

 
  piroxicam