Indivina 1 mg/5 mg tablets *
Pharmacy Only: Prescription

Updated on 03 May 2022

File name

Indivina 1 5 mg tabl IE SPC 181121_1651573090.pdf

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 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

  • 4.4 Special warnings and precautions for use
    • Added under Other Conditions “Exogenous oestrogens may induce or exacerbate symptoms of hereditary and acquired”
    • Added under new section ALT Elevations “During clinical trials with patients treated for hepatitis C virus (HCV) infections with the combination regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medicinal products such as CHCs. Additionally, also in patients treated with glecaprevir/pibrentasvir, ALT elevations were observed in women using ethinylestradiolcontaining medications such as CHCs. Women using medicinal products containing oestrogens other than ethinylestradiol, such as estradiol, had a rate of ALT elevation similar to those not receiving any oestrogens; however, due to the limited number of women taking these other oestrogens, caution is warranted for co-administration with the combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir and also the regimen glecaprevir/pibrentasvir. See section 4.5.”
  • 4.5 Interaction with other medicinal products and other forms of interaction
    • Added under new section Pharmacodynamic interactions “During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medicinal products such as CHCs. Women using medicinal products containing oestrogens other than ethinylestradiol, such as estradiol, had a rate of ALT elevation similar to those not receiving any oestrogens; however, due to the limited number of women taking these other oestrogens, caution is warranted for co-administration with the combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir and also the regimen with glecaprevir/pibrentasvir (see section 4.4).”
  • 10 Date of revision of text
    • Changed to November 2021

Updated on 03 May 2022

File name

Indivina tabl IE PIL 181121_1651572714.pdf

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 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - what you need to know - warning and precautions 

WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIVINA;  Under “Stop taking Indivina and see a doctor immediately, if you notice any of the following when taking HRT” section 

- Added “swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema”

Section 2 - interactions with other medicines, food, drink

Under “Other medicines and Indivina; Some medicines may interfere with the effect of Indivina. This might lead to irregular bleeding. This applies to the following medicines:”

- Removed words “…and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such…”

- Added words “ Medicines for Hepatitis C virus (HCV) (such as combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as a regimen with glecaprevir/pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol. Indivina contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme can occur when using Indivina with this HCV combination regimen. Your doctor will advise you.”

Section 6

This leaflet was last revised changed to 18 November 2021.

Updated on 04 February 2021

File name

Indivina 1 5 mg tabl IE SPC 290121_1612450083.pdf

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Breast cancer section updated to include the results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.

4.5 Interaction with other medicinal products and other forms of interaction

Information on co-administerion of sex hormones and combinations of HIV protease inhibitors added.

4.8 Undesirable effects

Updated to include more detailed information on the risks of breast cancer associated with HRT.

Updated on 04 February 2021

File name

Indivina tabl IE PIL 070820_1612449989.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Updated information on breast cancer risks with HRT.

Updated on 28 January 2021

File name

Indivina tabl IE PIL 130418_1611825243.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Admistrative reorganisation of documents

Updated on 07 July 2016

Reasons for updating

  • New SPC for new product

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

Updated on 07 July 2016

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)

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 07 July 2016

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 03 September 2015

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 03 September 2015

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 28 February 2014

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated.  the product should now be stored below 25oC (previously 30oC)

Updated on 28 February 2014

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated.  the product should now be stored below 25oC (previously 30oC)

Updated on 02 May 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products

Updated on 02 May 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products