Clomid 50mg Tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 August 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Clomid (2).pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2023
File name
1.3.1.3 Package Leaflet (PIL text) Clomid (1).pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 06 April 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Clomid (1).pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- 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)
Updated on 06 April 2023
File name
1.3.1.3 Package Leaflet (PIL text) Clomid.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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 12 July 2021
File name
1.3.2 IE1248 Clomid PL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 12 July 2021
File name
IE1248 Clomid SmPC clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 06 July 2020
File name
1.3.2 Clomid pl IE968.pdf
Reasons for updating
- XPIL Removed
Updated on 29 January 2020
File name
1.3.2 Clomid pl IE968.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
Updated on 29 January 2020
File name
1.3.1 Clomid SmPC IE968.pdf
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
Legal category:Product subject to medical prescription which may not be renewed (A)
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
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Neoplasms benign, malignant and unspecified (incl. cysts and polyps) |
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Endocrine related or dependent tumors/neoplasms (see section 4.4) |
Updated on 19 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 October 2016
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
Updated on 18 October 2016
File name
PIL_12922_768.pdf
Reasons for updating
- New PIL for new product
Updated on 18 October 2016
Reasons for updating
- Change to side-effects
Updated on 26 October 2015
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
Increased transaminases have been reported.
Updated on 12 June 2014
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
Updated on 01 November 2013
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
Updated on 29 October 2013
Reasons for updating
- Change to side-effects
Updated on 23 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 20 March 2013
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
Section 4.4: Precautions updated regarding cases of hypertriglyceridemia.
Section 4.8: New paragraph Metabolism disorders: hypertriglyceridemia.
Updated on 04 January 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 20 October 2009
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
Additional warnings on use in pregnancy, OHSS, visual disturbances.
Updated on 04 April 2008
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
Updated on 18 March 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 14 February 2008
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
Updated on 21 March 2007
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
Updated on 16 June 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)