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Arthrotec 50 modified-release tablets

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Pharmacy Only: Prescription

Updated on 17 October 2024

File name

Reg SPC AE 36_0 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 October 2024

File name

Reg PIL AE 36_0 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 29 May 2024

File name

Reg PIL AE 35_0 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 May 2024

File name

Reg PIL AE 33_1 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 April 2024

File name

Reg PIL AE 34_0 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 April 2023

File name

Reg SPC AE 35_2 50mg IE Clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 October 2022

File name

Reg SPC AE 34_2 50mg IE Clean.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 August 2022

File name

RegSPCAE33150mgIEClean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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:

Section 2: Updated with hydrogenated castor oil as an excipient with known effect.

Section 4.4: Updated warnings and precautions with hydrogenated castor oil, which may cause stomach upset and diarrhoea.

Section 10: Date of revision of the text. 

Updated on 30 August 2022

File name

RegPILAE31150mgIEClean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 10 January 2022

File name

Reg SPC AE 32_0 50mg IE CLEAN.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

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:

  • Section 4.6 – update fertility, pregnancy and lactation to add the risk of oligohydramnios/foetal renal dysfunction during the second trimester of pregnancy following the receipt of the FDA drug safety notification on 15th October 2020 and its reversible effect upon discontinuation of treatment.
  • Section 10 – update of revision date

The PIL is not affected

 

Updated on 15 March 2021

File name

DEC202070866_Reg SPC AE 31_2 50mg IE Effective-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

IE:

50mg:

- Update to Section 4.4 of the SPC to add a statement about the quantity of sodium for patients on a low sodium diet. Minor update to the lactose statement.

- Administrative update to Section 2 to align with QRD

Updated on 15 March 2021

File name

DEC202070866_Reg PIL AE 30_1 50mg IE-Effective-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 16 February 2021

File name

DEC202109406_Reg PIL AE 28_0 50mg IE -EFFECTIVE-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 15 January 2021

File name

DEC202070265_Reg SPC AE 29_1 50mg IE-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 January 2021

File name

DEC202070265_Reg PIL AE 25_1 50mg IE-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 June 2020

File name

DEC202039094_Reg SPC AE 28_1 50mg IE-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 June 2020

File name

DEC202039094_Reg PIL AE 23_1 50mg IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 June 2020

File name

DEC202034145_Reg SPC AE 26_1 50mg IE-clean.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 October 2019

File name

DEC201959822_Reg PIL AE 22_0 50mg IE_CLEAN.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 March 2019

File name

DEC201913193_Reg PIL AE 20_1 50mg IE_clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 March 2019

File name

DEC201913193_Reg SPC AE 24_1 50mg IE_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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:

Some of the adverse drug reactions in Section 4.8 have been re-assigned frequency category and rearranged in a tabular format by system organ class (SOC).

Updated on 03 August 2018

File name

Reg PIL AE 19_1 50mg IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 August 2018

File name

Reg SPC AE 23_2 50mg IE clean.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

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 4.3, 4.4, 4.6 updated to revise warnings related to teratogenicity with misoprostol use

Section 4.6 updated with possible risks with exposure to diclofenac/non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy and editorial changes

Section 4.8 updated ADRs and editorial changes

Updated on 03 July 2018

File name

Reg_SPC_AE_22_1_50mg_IE_clean.docx

Reasons for updating

  • Change to section 4.9 - Overdose

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:

Section 4.9 – symptoms of diclofenac overdose added.

Updated on 16 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 March 2017

Reasons for 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

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 15 March 2017

File name

PIL_10858_590.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 March 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 17 March 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 November 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 01 April 2014

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 20 February 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

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 13 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 02 December 2013

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.2, 4.3, 4.4, 4.8

Updated on 25 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 09 October 2013

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1: List of excipients updated

Updated on 04 October 2013

Reasons for updating

  • Change of inactive ingredient
  • Change to further information section
  • Change to date of revision

Updated on 25 January 2013

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 23 January 2013

Reasons for updating

  • Change to side-effects

Updated on 19 December 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

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 16 December 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 25 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC changes to sections 7 & 10

Updated on 25 February 2010

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 19 February 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 15 June 2009

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 09 December 2008

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 08 December 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to date of revision
  • Change to marketing authorisation holder address

Updated on 05 June 2008

Reasons for updating

  • Change of manufacturer

Updated on 30 July 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Correction of spelling/typing errors
  • Change to date of revision

Updated on 27 July 2007

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 08 May 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 May 2005

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)