Epivir Film-Coated Tablets 300mg

  • Name:

    Epivir Film-Coated Tablets 300mg

  • Company:
    info
  • Active Ingredients:

    Lamivudine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/02/19

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Summary of Product Characteristics last updated on medicines.ie: 26/2/2019

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ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Celsentri film-coated tablets Active Ingredients Maraviroc
Medicine Name Combivir Film-Coated Tablets Active Ingredients Lamivudine, Zidovudine
Medicine Name Dovato 50 mg/300 mg film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Epivir Film-Coated Tablets 150mg Active Ingredients Lamivudine
Medicine Name Epivir Film-Coated Tablets 300mg Active Ingredients Lamivudine
Medicine Name Epivir Oral Solution 10mg/ml Active Ingredients Lamivudine
Medicine Name Juluca 50 mg/25 mg film-coated tablets Active Ingredients Dolutegravir sodium, Rilpivirine Hydrochloride
Medicine Name Kivexa film-coated tablets Active Ingredients Abacavir Sulfate, Lamivudine
Medicine Name Retrovir Capsules 100mg Active Ingredients Zidovudine
Medicine Name Retrovir IV Active Ingredients Zidovudine
Medicine Name Retrovir Oral Solution Active Ingredients Zidovudine
Medicine Name Telzir 50mg/ml Oral Suspension Active Ingredients Fosamprenavir calcium
Medicine Name Telzir 700mg Film-Coated Tablets Active Ingredients Fosamprenavir calcium
Medicine Name Tivicay film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Triumeq 50 mg/600 mg/300 mg film-coated tablets Active Ingredients Abacavir Sulfate, Dolutegravir sodium, Lamivudine
Medicine Name Trizivir Film-Coated Tablets Active Ingredients Abacavir Sulfate, Lamivudine, Zidovudine
Medicine Name Ziagen Film-Coated Tablets 300mg Active Ingredients Abacavir Sulfate
Medicine Name Ziagen Oral Solution 20mg/ml Active Ingredients Abacavir Sulfate
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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 26 February 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 26 February 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 10 January 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 10 January 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • 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 17 September 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

SmPC Section 4.4 Warnings:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

SmPC Section 4.8 Undesirable events:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4).

Updated on 22 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 March 2018 SmPC

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 - how to report a side effect
  • 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

A minor amendment has been implemented in Section 4.4 and 4.5 to update the clinical terminology for ‘Pneumocystis carinii pneumonia’ to ‘Pneumocystis jiroveci pneumonia’.

Section 4.5 updated to add information regarding the interaction between lamivudine and sorbitol based on the results of Study 204857.

Section 4.8: MHRA reporting details has been updated to bring in line with EMA Appendix V.

Updated on 21 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 July 2016 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Update of sections 4.2, 4.4, 5.1 and 5.2 of the SmPC in order to add an administration recommendation, a warning regarding lower efficacy with the Epivir oral solution compared to Epivir tablets as well as efficacy and resistance data from a supplemental analysis of the ARROW study.

In addition, the Marketing authorisation holder (MAH) took the opportunity to make minor editorial changes in the SmPC.

Updated on 14 April 2016 SmPC

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

SmPC section 4.4: Mitochondrial dysfunction following exposure in utero

Updated on 13 April 2016 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 3 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

EU Labelling revisions on Lipodystrophy & Lactic Acidosis–PRAC recommendations

Updated on 2 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 25 September 2015 SmPC

Reasons for updating

  • 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

Section 5.1 – antiviral activity update

Updated on 11 May 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Update Section 4.6 of SmPC  to include WHO Breast-feeding guidance. 

Updated on 8 May 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 18 March 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Description of change to SPC:

Section 4.2 Update to Posology (dosing in paediatrics)

Section 4.8 Inclusion of Arrow trial data

Section 5.1 Inclusion of headings “Mechanism of action” and “Resistance” and “Clinical efficacy and safety”; inclusion of trial data

Section 5.2 Update to absorption data and added further information under “Special populations”

Updated on 18 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 31 October 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 31 October 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Description of change to SPC:

·         Update to section 4.2 – dosing in elderly

 

·         Update to section 4.6 of the SmPC to reflect updated exposure data relating to the use of lamivudine in the treatment of HIV-1 in pregnant women.  In addition the MAH took the opportunity to include a warning in section 4.5 of the SmPC regarding D/I with cytidine analogues and other medicinal products containing lamivudine, in line with existing warning in section 4.4. 

Updated on 15 May 2014 SmPC

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

Update section 4.4 of the SPC in order to include warnings regarding HIV transmission risk.
Update to section 10 for date of revision of the text.

Updated on 12 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 13 January 2014 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

.

Updated on 10 January 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 17 May 2013 SmPC

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

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

Free text change information supplied by the pharmaceutical company

·         The following text was added to section 4.4 of the SPC with regards to cladribine

The combination of lamivudine with cladribine is not-recommended (see section 4.5).

·         The following text was added to section 4.5 of the SPC with regards to autoimmune disorders

In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also support a possible interaction between lamivudine and cladribine. Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).

·         The approval date was updated in section 10

Updated on 16 May 2013 PIL

Reasons for updating

  • Change to drug interactions

Updated on 5 April 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

·         There are a number of editorial changes in sections 2, 4.3, 4.6, 5.2, 6.6 and 10

·         The following text has been added to section 4.4 in relation to autoimmune disorders

Autoimmune disorders (such as Graves’ disease, polymyositis and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

·         The following text has been added to section 4.8 in relation to autoimmune disorders

Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment

Updated on 4 April 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 23 February 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change due to harmonisation of patient information leaflet

Updated on 27 January 2011 SmPC

Reasons for updating

  • 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

 

4.8        Undesirable effects

·         Updated the format of the frequency categorisation

·         Added angiodema as a rare side effect

Updated on 2 December 2010 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Update to Section 7

Updated on 21 January 2010 SmPC

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 4.6 - Pregnancy and lactation

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,
-Warning/ Change in drug interactions (Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine)

Section 4.5 - Interaction with other medicinal products and other forms of interaction,

Section 4.6 - Pregnancy and lactation

 

Updated on 10 October 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

 

Addition of the following text:

 4.2              Posology and method of administration

………………….

To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.  For patients who are unable to swallow tablets, lamivudine is available as an oral solution. Alternatively, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).

 

5.2       Pharmacokinetic properties

…………………………………..

Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect.  This conclusion is based on the pharmacokinetic properties and physicochemical behaviour in water, and assumes that the patient crushes and transfers 100% of the tablet and ingests immediately.

Updated on 7 October 2008 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to how the medicine works

Updated on 26 August 2008 SmPC

Reasons for updating

  • 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 10:
 
Dtae change to March 2007

Updated on 9 July 2008 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 4 April 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Addition of the following to section 4.2

Duration of treatment:

In patients with HBeAg positive chronic hepatitis B (CHB) treatment should be administered for at least 3-6 months afterHBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion. This recommendation is based on limited data (see section 5.1).

 

Addition of the following wording to section 5.1:

Following HBeAg seroconversion, serologic response and clinical remission are generally durable after stopping lamivudine. However, relapse following seroconversion can occur. In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39% of the subjects. Therefore, following HBeAg seroconversion, patients should be periodically monitored to determine that serologic and clinical responses are being maintained. In patients who do not maintain a sustained serological response, consideration should be given to retreatment with either lamivudine or an alternative antiviral agent for resumption of clinical control of HBV.

Updated on 4 April 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 February 2007 SmPC

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 Addition of following:

Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

 

Section 4.8, addition of following:

Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (cART). The frequency of which is unknown (see section 4.4).

Updated on 16 August 2006 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 July 2006 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 26 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 July 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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