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Clomid 50mg Tablets

  • Name:

    Clomid 50mg Tablets

  • Company:
    info
  • Active Ingredients:

    Clomiphene Citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 29/1/2020

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When a pharmaceutical company changes any document, 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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 29 January 2020 PIL

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

Updated on 29 January 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 4.2

Long-term cyclic therapy: 

 

Not recommended.

Efficacy and safety of clomifene for more than 6 treatment cycles have not been demonstrated

 

Section 4.4

There was no difference in reported incidence of birth defects whether Clomid was given before the 19th day after conception or between the 20th and 35th day after conception.  This incidence is within the anticipated range of general population.

 

Ovarian Cancer:   There have been rare reports of ovarian cancer with fertility drugs; infertility itself is a primary risk factor

 

Patients with rare hereditary problems of fructose/galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

Section 4.8

Neoplasms benign, malignant and unspecified (incl. cysts and polyps)

 

 

 

 

Endocrine related or dependent tumors/neoplasms

 (see section 4.4)

Updated on 19 October 2016

Reasons for updating

  • New SmPC for new product

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

Updated on 19 October 2016 SPC

Reasons for updating

  • 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

Additional adverse events included to section 4.8

Updated on 18 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 October 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 October 2015 SPC

Reasons for updating

  • 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 4.8

 

Increased transaminases have been reported.

Updated on 12 June 2014 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Type IAIN.B.II.f.1.a variation to reduce the shelf life of the finished product from 5 years to 3 years.

Updated on 1 November 2013 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.I.4 Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data (CCDS v4).

Updated on 29 October 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 23 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 March 2013 SPC

Reasons for updating

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

SPC updated in line with Company Core Data Sheet version 3:-

Section 4.4: Precautions updated regarding cases of hypertriglyceridemia.

Section 4.8: New paragraph Metabolism disorders: hypertriglyceridemia.

Updated on 4 January 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 20 October 2009 SPC

Reasons for updating

  • 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

Update Section 4.3, 4.4, 4.5, 4.6, 4.8
Additional warnings on use in pregnancy, OHSS, visual disturbances.

Updated on 4 April 2008 SPC

Reasons for updating

  • 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

Update Section 4.4 Special Warnings and Precautions for use

Updated on 18 March 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 February 2008 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2 - excipients included.
Section 10 - Date of revision

Updated on 21 March 2007 SPC

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

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of Revision

Updated on 16 June 2005 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 16 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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