Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet
- Name:
Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet
- Company:
Chiesi Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/03/20

XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What Envarsus is and what it is used for
1. What Envarsus is and what it is used for
2. What you need to know before you take Envarsus
2. What you need to know before you take Envarsus
3. How to take Envarsus
3. How to take Envarsus
4. Possible side effects
4. Possible side effects
5. How to store Envarsus
5. How to store Envarsus
6. Contents of the pack and other information
6. Contents of the pack and other information
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Chiesi Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 16 March 2020 SPC
Reasons for updating
- 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 March 2020 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 8 August 2019 PIL
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 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 4 July 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 - Inclusion of Eye Disorders
Section 10 - Date of revision - June 2019
Updated on 4 May 2018 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Envarsus Prolonged-release tacrolimus tablets Patient Card
Updated on 4 May 2018 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Educational materials for the healthcare professional (doctor or pharmacist) Please read the full Summary of Product Characteristics before prescribing Envarsus
Updated on 17 August 2016 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 17 August 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 1 June 2016 PIL
Reasons for updating
- Change to date of revision
- Addition of joint PIL covering all presentations
Updated on 20 April 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2016 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 5.2 - Pharmacokinetic properties
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1 Name of the Medicinal Product - Envarsus 1 mg prolonged-release table
Envarsus 4 mg prolonged-release tablets has been added
Section 2 Qualitative and Quantitative composition - Envarsus 0.75 mg prolonged-release tablets,Envarsus 1 mg prolonged-release tablets Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate). Excipient with known effect: Each tablet contains 41.7 mg lactose (as monohydrate). Envarsus 4 mg prolonged-release tablets Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate). Excipient with known effect: Each tablet contains 104 mg lactose (as monohydrate). Has been adde
Section 3 Pharmaceutical Form - 1 mg:
Oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side. 4 mg:Oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side. – has been added
Section 4.4 Special warnings and precautions - Envarsus is not recommended for use in children below 18 years of age due to the limited data on safety and/or efficacy. Has been removed
Paediatric population
Envarsus is not recommended for use in children below 18 years of age due to the limited data on safety and/or efficacy- has been added
Section 4.5 - Interaction with other medicinal products and other forms of interaction- Paediatric population
Interaction studies have only been performed in adults has been added
Section 4.8 - Reporting of suspected adverse reactions - in the UK, Website: at www.mhra.gov.uk/yellowcard or in Ireland to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie. has been added
Section 5.1 Pharmacodynamic effect - new subheading has been added
Clinical efficacy and safety – new subheading has been added
Section 5.2 - Pharmacokinetic properties- Excretion changed to Elimination
Section 8 Marketing authorisation numbers(s) EU/1/14/935/001 changed to
0.75mg EU/1/14/935/001 1mg EU/1/14/935/004 4mg EU/1/14/935/007
Section 9 - Date of first authorisation: added Section 10 – November 2014 changed to April 2016
Updated on 13 November 2015 PIL
Reasons for updating
- Change to date of revision
Updated on 7 August 2015 SPC
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
Updated on 4 August 2015 PIL
Reasons for updating
- New PIL for new product
Educational materials for HCP (doctor/pharmacist)Risk Minimisation Materials
(Click to Download)
Envarsus Patient CardRisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines