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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: 16/03/2017
SPC Arthrotec 50

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 16/03/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
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



The SPC has been updated as follows:

Sections 2, 4.2, 4.3, 4.4, 4.8, 6.1 – editorial and/or QRD updates

Section 4.4 – update to information regarding concomitant use systemic NSAIDS, patients with GI complications, concomitant use with oral anticoagulants

Section 4.5 – new safety information regarding interactions with potent CYP2C9 inhibitors, updated information on drug-drug interactions, information regarding concomitant administration of diclofenac/misoprostol and aspirin

Section 4.6 – new safety information regarding the potential for reversible decreased fertility and spontaneous abortion with diclofenac/misoprostol

Section 4.8 - additional information added for people aged 65 or over, ADRs added, frequencies of ADRs updated

Section 4.9 – new safety information regarding the clinical signs of misoprostol overdose and overdose management

Section 5.1 – ATC code updated

Section 5.2 – information added regarding diclofenac metabolism and CYP2C9
Updated on 20/02/2014 and displayed until 16/03/2017
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Feb-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to Section 4.5: Updated regarding the interaction with aspirin; Section 4.9: Updated regarding signs of overdose and effect of dialysis
Updated on 02/12/2013 and displayed until 20/02/2014
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 09/10/2013 and displayed until 02/12/2013
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Sep-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 6.1: List of excipients updated
Updated on 25/01/2013 and displayed until 09/10/2013
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-Jan-2013
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 25/01/2013
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 25/02/2010 and displayed until 21/10/2011
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 4.5 - 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
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company



4.2 - addition of cardiac impairment & cross reference to section 4.4

4.3 - deletion of lactation or breast feeding, addition of Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, Patients with severe renal and hepatic failure, expansion of active GI contraindication to include perforation

4.4 - expansion of warnings, especially kidney in line with Arthrotec 75 SmPC; addition of hypertension warning - blood pressure monitoring required; may prolong bleeding time; care required in elderly & patients treated with corticosteroids; addition of hypersensitivity warning; may mask fever or infection; excipient warning - sugars; monitor patients in long term treatment

4.5 - addition of information regarding potential interactions with tacrolimus, antidiabetic agents, anti-hypertensives including diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists (AIIA), antacids, quinolone antibiotics, mifepristone, corticosteroids

4.6 - expansion to explain contraindication in pregnancy, misoprostol metabolism and diclofenac excretion in milk, diarrhoea is a recognised side effect of misoprostol and could occur in infants of nursing mothers so Arthrotec shouldn't be administered to nursing mothers.

4.8 - conversion of adverse events to a table of frequencies and addition of the following adverse events in line with the Arthrotec 75 SmPC: hypotension, hypertension, palpitations, chest pain and cardiac failure, dyspnea, blurred vision, abnormal uterine contractions, uterine rupture/perforation, retained placenta, amniotic fluid embolism, incomplete abortion, premature birth, fetal death, uterine haemorrhage, birth defects, chills, fever, vasculitis, pneumonitis, cutaneous reactions (including rash and bullous eruptions with vesiculation and erythroderma), dermatitis exfoliative, mucocutaneous reactions, anaphylactoid systemic reactions, oedema of the face and tongue, hypotension and shock, changes in mood, tiredness, aseptic meningitis, proteinuria, haematuria, acute renal insufficiency, severe fulminant hepatitis, gastritis, exacerbation of colitis and Crohn’s disease.

Updated on 09/12/2008 and displayed until 25/02/2010
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 6.1 - List of excipients
  • 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
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1: name updated in line with current SPC guidelines to Arthrotec 50 modified-release tablets

Section 2: quantity of lactose monohydrate included

Section 3: pharmaceutical form updated inline with current SPC guidelines to modified-release

Section 4.2: administrative update to cross reference

Section 4.4: administrative update to cross reference and removal of lactose quantity

Section 6.1: update to excipient names: lactose monohydrate, povidone

Section 7: MAH address revised to 9 Riverwalk

Section 9: Date of last Renewal updated

Section 10: Date of partial revision to test updated

Updated on 27/07/2007 and displayed until 09/12/2008
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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1 administrative changes

Section 2 administrative changes

Section 3 administrative changes

Section 4.2 addition of instruction to use lowest dose to minimise side effects

Section 4.3 addition of contraindication: severe heart failure

Section 4.4 additional CV precautions, potential increased risk at high dose & long term treatment, use lowest dose for shortest time possible, avoid use with concomitant NSAIDs, potential for serious skin reactions

Section 4.5 rewording of text regarding use with anticoagulants, revised spelling of ciclosporin

Section 4.8 section on GI effects expanded, liver test terminology updated, oedema, hypertension & cardiac failure reported with NSAID treatment, suggested risk at high dose and in long term use

Section 6.1 administrative changes

Section 6.2 administrative changes

Section 6.3 administrative changes

Section 6.6 change to heading

Section 9 formatting change

Updated on 24/05/2005 and displayed until 27/07/2007
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 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 24/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Misoprostol
   Diclofenac Sodium