Epivir Oral Solution 10mg/ml

  • Name:

    Epivir Oral Solution 10mg/ml

  • 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

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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
1 - 0 of 18 items.Total: Infinity pages

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 2 - what you need to know - contraindications
  • Change to section 3 - use in children/adolescents
  • 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 14 February 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

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 18 May 2018 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 9 May 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

  • 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 4.2 - 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 - 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

Section 4.2 updated to recommend a 25% dose increase in children from 8 to 10 mg/kg/day.

Section 4.4 updated to add information regarding the interaction between lamivudine and sorbitol based on the results of Study 204857.

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 3 - use in children/adolescents
  • 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 10 - Date of revision of the text
  • Improved electronic presentation
  • 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

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 28 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 28 April 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to date of revision
  • Addition of information on reporting a side effect.

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 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 31 October 2014 PIL

Reasons for updating

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

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 of the SPC

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

·         The following text was added to section 4.8 of the SPC with regards 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 21 February 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change to Section 6.5

Updated on 20 October 2011 PIL

Reasons for updating

  • Change of manufacturer

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 16 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

Change to Section 7

Updated on 8 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



Changes:

 

Addition in red, deletion in blue

4.4          Special warnings and precautions for use

 

Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Interaction studies have only been performed in adults

 

Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently. Epivir is therefore not recommended to be used in combination with zalcitabine.

 

Co-administration of lamivudine with intravenous ganciclovir or foscarnet is not recommended.

 

(e.g. didanosine and zalcitabine) like

 

4.6          Pregnancy and lactation

 

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative toxicity. Epivir can be used during pregnancy if clinically needed.

 

For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.

 

Mitochondrial dysfunction:

Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).

 

Pregnancy: The safety of lamivudine in human pregnancy has not been established.  Reproductive studies in animals have not shown evidence of teratogenicity, and showed no effect on male or female fertility. Lamivudine induces early embryonic death when administered to pregnant rabbits at exposure levels comparable to those achieved in man. In humans, consistent with passive transmission of lamivudine across the placenta, lamivudine concentrations in infant serum at birth were similar to those in maternal and cord serum at delivery.

 

Although animal reproductive studies are not always predictive of the human response, administration is not recommended during the first three months of pregnancy.

 

Lactation:

Updated on 30 October 2008 SmPC

Reasons for updating

  • 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

5.1 regarding M184V resistance.

Updated on 22 October 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer
  • Change to improve clarity and readability

Updated on 2 September 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer
  • Change to improve clarity and readability

Updated on 4 April 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

  • Improved electronic presentation

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 26 September 2006 PIL

Reasons for updating

  • Improved electronic presentation

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 9 August 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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