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Arthrotec 75 modified-release tablets

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Pharmacy Only: Prescription

Updated on 17 October 2024

File name

clean effective Reg PIL AE 32_0 75mg IE.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address.

Updated on 17 October 2024

File name

clean effective Reg SPC AE 34_0 75mg IE.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 7 Change of MAH name and address. 

Updated on 24 May 2024

File name

Reg PIL AE 31_0 75mg 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 29_1 75mg IE CLEAN.pdf

Reasons for updating

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

Updated on 26 March 2024

File name

Reg PIL AE 3_0 175mg 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 33_2 75mg 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 32_1 75 mg 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

RegPILAE27175mgIEClean.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 30 August 2022

File name

RegSPCAE31175mgIEClean.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 10 January 2022

File name

Reg SPC AE 30_0 75mg 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 29_1 75mg IE-Effective-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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

75mg:

- 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 Sections 2, 4.1, 4.2, 4.3, 4.6, 4.7, 4.8, 5.1, 6.1 to align with QRD.

Updated on 15 March 2021

File name

DEC202070866_Reg PIL AE 26_1 75mg IE-Effective-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • 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 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 15 January 2021

File name

DEC202070265_Reg SPC AE 27_1 75mg 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 24_1 75mg 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 26_1 75mg 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 22_1 75mg 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 24_1 75mg 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

DEC201959913_Reg PIL AE 21_0 75mg 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 19_1 75mg 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

LiveRecovery save of DEC201913193_Reg SPC AE 22_1 75mg IE_clean.asd.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 20 July 2018

File name

Reg PIL AE 18_0 75mg 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 19 July 2018

File name

Reg SPC AE 21_1 75mg 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

Section 4.8 updated ADRs

Updated on 10 July 2018

File name

Reg_SPC_AE_20_2_75mg_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 13 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 13 March 2017

Reasons for 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

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 10 March 2017

File name

PIL_9950_471.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 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
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 17 March 2015

Reasons for updating

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

Updated on 04 November 2014

Reasons for updating

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

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 17 December 2012

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 03 December 2012

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 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 18 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 04 November 2009

Reasons for updating

  • 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

4.8 - updated in line with latest MedDRA terminology

Updated on 20 October 2009

Reasons for updating

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

Updated on 05 October 2009

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

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 05 October 2009

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 16 September 2009

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.2 - update to pharmacokinetic properties of diclofenac sodium

Updated on 18 August 2009

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.2 - clarification of food effect on diclofenac absorption

Updated on 11 August 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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: addition text regarding hypertension

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

Updated on 03 June 2009

Reasons for updating

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

Updated on 27 February 2009

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder address
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 20 January 2009

Reasons for updating

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

Updated on 19 January 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

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 19 June 2008

Reasons for updating

  • Change of manufacturer

Updated on 03 October 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 4.6 - 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

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

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 03 October 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change of trade or active ingredient name

Updated on 17 February 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 10 June 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 June 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 4.2 - 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

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)