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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 13/03/2017
SPC Arthrotec 75 modified-release tablets

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

Updated on 13/03/2017 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Mar-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



IE AE 56

Update sections 4.5 and 5.2 of the SPC to align with CDS - new safety information regarding interactions with potent CYP2C9 inhibitors; procedure UK/H/0136/001/II/040G 

IE AE 57

Update sections 4.6, 4.8 of the SPC in line with CDS - new safety information regarding the potential for reversible decreased fertility and spontaneous abortion with diclofenac/misoprostol; MRP procedure UK/H/0136/001/II/041

IE AE 58

Update section 4.8 of the SPC in line with CDS – ADRs added and ADR frequencies updated; MRP procedure UK/H/0136/001/II/042

IE AE 64

Update section 4.5 of the SPC in line with CDS – information regarding concomitant administration of diclofenac/misoprostol and aspirin; MRP procedure UK/H/0136/001/II/043

IE AE 65

Update section 4.8 of the SPC in line with CDS - additional information added for people aged 65 or over; MRP procedure UK/H/0136/001/II/044

IE AE 66

Update section 4.9 of the SPC in line with CDS - new safety information regarding the clinical signs of misoprostol overdose; MRP procedure UK/H/0136/001/II/045

IE AE 76

Update sections 4.4, 4.5 of the SPC following internal review and review of the French Thesaurus (concerning drug-drug interactions) and QRD updates; MRP procedure UK/H/0136/001/II/048G

Updated on 02/12/2013 and displayed until 13/03/2017
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
Date of revision of text on the SPC:   01-Nov-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to Sections 4.2, 4.3, 4.4, 4.8
Updated on 17/12/2012 and displayed until 02/12/2013
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Nov-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.4 – information on hepatic reactions added;
Section 4.8 – hepatic failure added as very rare and AST changed from unknown to common; Section 4.6 – heading updated to include Fertility;
Section 10 – date of revision added
Updated on 19/12/2011 and displayed until 17/12/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Sections 7 - updated with Pfizer Healthcare Ireland; Section 8 - updated with new PA number
Updated on 21/10/2011 and displayed until 19/12/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SmPC changes to sections 7 & 10
Updated on 04/11/2009 and displayed until 21/10/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08-Sep-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



4.8 - updated in line with latest MedDRA terminology

Updated on 05/10/2009 and displayed until 04/11/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

 SmPC

Section 3 - tablet marking description amended.
There was an update to description of tablet markings (at request of IMB).

Note
: this was to clarify the way in which the tablet markings are described. There has been no change to the actual tablet markings.


Section 10 - date last revised updated

Updated on 16/09/2009 and displayed until 05/10/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 5.2 - update to pharmacokinetic properties of diclofenac sodium

Updated on 18/08/2009 and displayed until 16/09/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 5.2 - clarification of food effect on diclofenac absorption

Updated on 11/08/2009 and displayed until 18/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   09-May-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.4: addition text regarding hypertension

Section 4.6: lactation section updated to reflect excretion of misoprostol acid and diclofenac in breast milk.

Updated on 19/01/2009 and displayed until 11/08/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7 - address updated to 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

Updated on 03/10/2007 and displayed until 19/01/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1 – the name has been updated to Arthrotec 75 modified-release tablets

2 – update to include amount of lactose

3 – Pharmaceutical form updated to modified-release tablet  

4.2 – undesirable effects may be minimised by using the lowest dose for the shortest duration necessary, monitoring to also include cardiac impairment

4.3 – deletion of lactation/breast-feeding, rewording of GI contraindication, addition of severe heart failure, severe renal and hepatic failure, treatment of peri-operative pain in the setting of coronary artery bypass graft surgery

4.4 – warnings: avoid use with concomitant NSAIDs/COX-2s; precautions: undesirable effects may be minimised by using the lowest dose for the shortest duration necessary, Renal/Cardiac/Hepatic section rewritten to provide updated advice on treatment and monitoring of patients with liver/heart/kidney impairments, including Pharmacovigilance Working Party text & CHMP Key elements, Blood system/Gastrointestinal, Skin reactions sections significantly expanded to provide advice on patients at most risk of developing complications, caution required and action to be taken if events occur, standard lactose warning added.

4.5 – update to spelling of ciclosporin, addition of warnings regarding tacrolimus, anti-coagulants, anti-platelet agents, antihypertensives and SSRIs. Expansion of section on renal function and ACE inhibitors.

4.6 – expansion of reason for contraindication, addition of advise to counsel women of childbearing age on the need for adequate contraception and direction to discontinue treatment if pregnancy is suspected

4.8 – addition of post-marketing adverse events: GI bleeding, sometimes fatal, particularly in the elderly, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, ulcerative stomatitis, gastritis, dermatitis exfoliative, erythema multiforme, urticaria, mucocutaneous reactions, changes in mood, thrombocytopenia, dyspnea, blurred vision, abnormal uterine contractions, uterine rupture/perforation, retained placenta, amniotic fluid embolism, incomplete abortion, premature birth, foetal death, uterine haemorrhage, birth defects, chills and fever. Data suggest that diclofenac, particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events.

6.1 – excipients split into core and mantle/coat and names updated in line with current regulatory guidance

6.6 – heading updated

9 – layout and dates updated

10 – date of revision updated

Updated on 17/02/2006 and displayed until 03/10/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 09/06/2005 and displayed until 17/02/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • 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 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 09/06/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Misoprostol
   Diclofenac Sodium