VITRAKVI 25 mg hard capsules

*
Pharmacy Only: Prescription
  • Company:

    Bayer Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 01 August 2024

File name

20240722_SmPC_CC_VIT_001+002_REC31251.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

REC31251

Sections 4.8, 5.1 and 10 have been updated on account of the annual renewal.

Updated on 23 August 2023

File name

20230816_SmPC_CC_VIT1+2_II_Var-0030.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 23 August 2023

File name

20230816_SmPC_CC_VIT1+2_II_Var-0030.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 4.5 - 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 9 - Date of first authorisation/renewal of the authorisation
  • 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

REC 31376, 31002, 31003, 30523, 31375, 31108, 31379, 31582

Updated on 23 August 2023

File name

20230816_PL_CC_VIT1+2_Var-0030.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

Free text change information supplied by the pharmaceutical company

REC 31376, 31002, 31003, 30523, 31375, 31108, 31379, 31582

Note:

Text in black = unchanged text

Text in blue = added text

Text in red with strikethrough = deleted text

 

2.      What you need to know before you take VITRAKVI

Tests and checks

VITRAKVI can increase the amount of the liver enzymes ALT and AST and bilirubin in your blood. Your doctor will do blood tests before and during treatment to check the level of ALT, AST and bilirubin and check how well your liver is working.

 

4.      Possible side effects

Very common (may affect more than 1 in 10 people):

-                diarrhoea

-                [….]

 

Common (may affect up to 1 in 10 people):

-                you may bruise or bleed more easily, which could be symptoms of reduced number of platelets (thrombocytopenia)

-                [….]

 

Not known (not known how often they occur)

-                you may experience a combination of tiredness, upper right stomach pain, loss of appetite, nausea or vomiting, yellowing of your skin or eyes, bruising or bleeding more easily, and dark urine. These could be symptoms of liver problems.

[….]

 

6.      Contents of the pack and other information

[….]

This leaflet was last revised in 08/2023.

Updated on 08 May 2023

File name

20220926_SmPC_CC_VIT1+2_IB_BEC 20848.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

Uploaded to coincide with product launch.

Updated on 08 May 2023

File name

20220926_PL_CC_VIT1+2_IB_BEC 20848.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Uploaded to coincide with product launch.