VITRAKVI 25 mg hard capsules
*Company:
Bayer LimitedStatus:
No Recent UpdateLegal 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.