Indivina 2 mg/5 mg tablets *

Pharmacy Only: Prescription

• 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

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.

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 information on breast cancer risks associated with HRT.

Admistrative reorganisation of documents

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

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