Hepsera 10 mg tablets

  • Name:

    Hepsera 10 mg tablets

  • Company:
    info
  • Active Ingredients:

    Adefovir dipivoxil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 7/8/2019

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Gilead Sciences Ltd

Gilead Sciences Ltd

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Medicine Name Descovy 200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
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Medicine Name Harvoni 90 mg/400 mg film-coated tablets Active Ingredients Ledipasvir, Sofosbuvir
Medicine Name Hepsera 10 mg tablets Active Ingredients Adefovir dipivoxil
Medicine Name Odefsey 200 mg/25 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir alafenamide fumarate
Medicine Name Sovaldi 400 mg film coated tablets Active Ingredients Sofosbuvir
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Medicine Name Truvada film-coated tablets Active Ingredients Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Tybost 150mg film coated tablets Active Ingredients Cobicistat
Medicine Name Vemlidy 25 mg film coated tablets Active Ingredients Tenofovir alafenamide fumarate
Medicine Name Viread 245 mg film-coated tablets Active Ingredients Tenofovir disoproxil fumarate
Medicine Name Vosevi 400 mg/100 mg/100 mg film coated tablets Active Ingredients Sofosbuvir, Velpatasvir, Voxilaprevir
Medicine Name YESCARTA (axicabtagene ciloleucel) Active Ingredients Axicabtagene Ciloleucel
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Medicine Name Zydelig (idelalisib) 150mg Active Ingredients Idelalisib
1 - 0 of 24 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 8 August 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 August 2019 SmPC

Reasons for updating

  • 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

Section 4.8 of the SmPC was updated to combine the wording of the two adverse drug reactions “proximal renal tubulopathy” and “Fanconi syndrome” to one adverse drug reaction “Proximal renal tubulopathy (including Fanconi syndrome)” with a change in frequency from ‘unknown’ to ‘uncommon’

Updated on 5 July 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 24 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 9 August 2018 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 15 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 15 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 13 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 September 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 August 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.8: Change of name of the Irish regulatory agency from Irish Medicines Board to The Health Products Regulatory Authority (HPRA)

Updated on 14 August 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 29 April 2014 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


- Update to sections 4.4 & 4.8 of the SPC to inform that long term treatment with Hepsera may increase the risk of renal impairment and to strengthen the monitoring of the renal function, as requested by the CHMP, following the evaluation of the last periodic safety update report. 

- Section 4.8 of the SPC: update of the reporting of adverse event statement.

- Section 10: change to the date of revision.

Updated on 25 April 2014 PIL

Reasons for updating

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

Updated on 24 June 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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)

Free text change information supplied by the pharmaceutical company

Update to sections 4.1 and 4.2 of the SPC to reflect the evolving standard of care for HBV patients.  Namely that Hepsera treatment should only be initiated when the use of an alternative antiviral agent with a higher genetic barrier to resistance (i.e. Viread) is not available or appropriate, and the need for combination therapy in patients with decompensated liver disease.

Updated on 10 September 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

  • Re-wording of the paediatric license in section 4.2 to state Hepsera is not recommended for use in children below the age of 18 years due to limitations of the available data on safety and efficacy 
  • Update to section 5.1 to include long-term data from GS-US-103-0518
  • Date changed for the revision of the text (section 10)

Updated on 4 January 2012 SmPC

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • 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

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

3.       PHARMACEUTICAL form

 

4.4       Special warnings and precautions for use

 

General: Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should still be taken.

 

4.6     Fertility, pregnancy and lactation

 

The use of adefovir dipivoxil must be accompanied by the use of effective contraception.

 

Pregnancy

There are limited data on the use of adefovir dipivoxil in pregnant women.

 

Studies in animals administered adefovir intravenously have shown reproductive toxicity (see section 5.3).  Studies in orally dosed animals do not indicate teratogenic or foetotoxic effects.

 

Adefovir dipivoxil is not recommended during pregnancy and in women of childbearing potential not using contraception.  Adefovir dipivoxil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

 

There are no data on the effect of adefovir dipivoxil on transmission of HBV from mother to infant.  Therefore, the standard recommended procedures for immunisation of infants should be followed to prevent neonatal acquisition of HBV.

 

Breast‑feeding

A risk to the newborns/infants cannot be excluded.  It is recommended that mothers being treated with adefovir dipivoxil do not breast‑feed their infants.

 

Fertility

No human data on the effect of adefovir dipivoxil on fertility are available.  Animal studies do not indicate harmful effects of adefovir dipivoxil on male and female fertility.

 

4.8       Undesirable effects

 

Adverse events have been tabulated and brought in line with SPCs for our other products.

 

Section 10       Date of Revision

Updated on 3 January 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 11 August 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

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

Free text change information supplied by the pharmaceutical company

  • Update of section 4.5 to reflect available data on the co-administration of adefovir dipivoxil and pegylated interferon
  • Update of SPC section 4.2 to align the recommendations for treatment discontinuation with those for tenofovir disoproxil fumarate
  • Update to Date of Revision - to June 2009
  • Updated on 23 February 2009 PIL

    Reasons for updating

    • Change to further information section
    • Change to warnings or special precautions for use

    Updated on 23 February 2009 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

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

    Free text change information supplied by the pharmaceutical company

    The following is a summary of the amendments to the SPC:

    • Update of sections 4.2 and 5.1 of the SPC to reflect current data regarding the impact of the rtA181T mutation on the clinical response to adefovir dipivoxil
    • Update of section 4.4 to emphasise the need to monitor renal function prior to starting treatment with adefovir dipivoxil.

    Updated on 19 January 2009 PIL

    Reasons for updating

    • Change to further information section
    • Change to date of revision

    Updated on 19 January 2009 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
     
    • Update of section 5.1 of the SPC to reflect the paediatric weight and Body Mass Index (BMI) Z score data from Study GS-US-103-518 following up to 96 weeks of treatment with adefovir dipivoxil.
    Section 10
     
    • Change to date of revision of text - December 2008

    Updated on 22 October 2008 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 4.7 - Effects on ability to drive and use machines
    • Change to section 4.8 - Undesirable effects
    • Change to section 5.1 - Pharmacodynamic properties
    • Change to section 9 - Date of renewal of 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

     Section 4.4

     The following statements have been added.

     In patients at risk of renal impairment (see section 4.8), consideration should be given to more frequent monitoring of renal function.

     Adefovir dipivoxil should not be administered concurrently with tenofovir disoproxil fumarate (Viread).

     Co‑administration of 10 mg adefovir dipivoxil with medicinal products in these patients may lead to an increase in serum concentrations of either adefovir or a co‑administered medicinal product.  The renal function of these patients should be closely monitored with a frequency tailored to the individual patient¡¯s medical condition.

     The following statements have been deleted

     The renal function of these patients should be closely monitored with a frequency tailored to the individual patient¡¯s medical condition.

     Co‑administration of 10 mg adefovir dipivoxil with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either adefovir or a co‑administered medicinal product due to competition for this elimination pathway (see section 4.5).

     Apart from ibuprofen, lamivudine, paracetamol, trimethoprim/sulfamethoxazole and tacrolimus, the effect of co‑administration of 10 mg adefovir dipivoxil with medicinal products that are excreted renally or other medicinal products known to affect renal function has not been evaluated

    or tenofovir disoproxil fumarate).  In healthy volunteers, a single dose of adefovir dipivoxil given with tenofovir disoproxil fumarate does not result in a relevant drug-drug interaction with regard to pharmacokinetics.  However, the clinical safety, including potential renal effects of the co-administration of adefovir dipivoxil and tenofovir disoproxil fumarate is unknown.  Such co‑administration is only advisable if the patient is closely monitored

     Section 4.5

     The following statements have been deleted:

     Adefovir did not alter the pharmacokinetics of trimethoprim/sulfamethoxazole, paracetamol, ibuprofen, tenofovir disoproxil fumarate and tacrolimus, five medicinal products that also undergo or may affect tubular secretion.

     The pharmacokinetics of adefovir were unaltered when 10 mg adefovir dipivoxil was co‑administered with trimethoprim/sulfamethoxazole, paracetamol or tenofovir disoproxil fumarate (see section 4.4).  Comparisons with historical pharmacokinetic data from healthy subjects and HBV‑infected patients suggest that adefovir pharmacokinetics are also unaffected by tacrolimus co‑administration.

     Concomitant administration of 10 mg adefovir dipivoxil and 800 mg ibuprofen 3 times daily resulted in increases in AUC and Cmax of adefovir of 23 % and 33 %, respectively.  These increases are considered to be due to higher bioavailability rather than a reduction in renal clearance and are not considered clinically relevant.

     At doses of adefovir dipivoxil 6‑ to 12‑fold higher than the 10 mg dose recommended for the treatment of chronic hepatitis B, there were no interactions with zidovudine, nelfinavir, nevirapine, indinavir, efavirenz, delavirdine, or lamivudine.  Concomitant administration of 60 mg adefovir dipivoxil with saquinavir soft capsules resulted in an increase in adefovir AUC (20 %) and concomitant administration with didanosine buffered tablets resulted in an increase in didanosine AUC (29 %).  Neither of these increases in systemic exposure were considered clinically significant.

     Section 4.7

    The following statement has been added

    However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible influence on these abilities.

     Section 4.8

     The following statement was amended

     In patients with compensated liver disease, the most frequently reported adverse reactions during 48 weeks of adefovir dipivoxil therapy were asthenia (13 %), headache (9 %), abdominal pain (9 %) and nausea (5 %).

     The following study information was added:

    an open-label study in which pre‑ (n=226) and post‑liver transplantation patients (n=241) with lamivudine-resistant HBV were treated with 10 mg adefovir dipivoxil once daily, for up to 203 weeks (median 51 and 99 weeks, respectively).

    Frequencies are defined as ¡­..or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data).

     The following statements have been added or amended.

     Gastrointestinal disorders:

    Common (¡Ý 1/100, < 1/10): diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence.

    Frequency not known: pancreatitis.

    Renal and urinary disorders:

    Very common (¡Ý 1/10): increases in creatinine.

    Common (¡Ý 1/100, < 1/10): renal failure, abnormal renal function, hypophosphatemia.

    Frequency not known: Fanconi syndrome,

    General disorders and administration site conditions:

    Very common (¡Ý 1/10): asthenia.

    Exacerbation of hepatitis:

    Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with 10 mg adefovir dipivoxil (see section 4.4).

    Long‑term safety data in patients with compensated disease:

    In a long‑term safety study of 125 HBeAg negative patients with compensated liver disease, the adverse event profile was overall unchanged after a median exposure of 226 weeks.  No clinically significant changes in renal function were observed.  However, mild to moderate increases in serum creatinine concentrations, hypophosphatemia and a decrease in carnitine concentrations were reported in 3 %, 4 % and 6 % of patients, respectively, on extended treatment.

    In a long‑term safety study of 65 HBeAg positive patients with compensated liver disease (after a median exposure of 234 weeks), 6 patients (9 %) had confirmed increases in serum creatinine of at least 0.5 mg/dl from baseline with 2 patients discontinuing from the study due to the elevated serum creatinine concentration.  Patients with a confirmed increase in creatinine of ¡Ý 0.3 mg/dl by week 48 were at a statistically significant higher risk of a subsequent confirmed increase in creatinine of ¡Ý 0.5 mg/dl.  Hypophosphatemia and a decrease in carnitine concentrations were reported each in 3 % of patients on extended treatment.

    Safety in patients with decompensated disease:

    In patients with decompensated liver disease, the most frequently reported adverse reactions during up to 203 weeks of adefovir dipivoxil therapy were increased creatinine (7 %) and asthenia (5 %).  Renal toxicity is an important feature of the safety profile of adefovir dipivoxil in patients with decompensated liver disease.  In clinical studies of wait-listed and post-liver transplantation patients, four percent (19/467) of patients discontinued treatment with adefovir dipivoxil due to renal adverse events.

    Section 5.1

    Resistance mutations updated to include patient numbers and weeks of exposure.

    Sections 9 and 10 dates updated

    Updated on 21 April 2008 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 4.8 - Undesirable effects
    • 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

    Hepsera annexes updated after approval of variation II/33.

    Updated on 21 April 2008 PIL

    Reasons for updating

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

    Updated on 2 April 2008 SmPC

    Reasons for updating

    • Change to section 4.2 - Posology and method of administration
    • 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

    Updated after approval of variation II/30

    Updated on 16 January 2008 PIL

    Reasons for updating

    • Addition of marketing authorisation holder
    • Change due to user-testing of patient information

    Updated on 16 January 2008 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

    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 and 5.2 regarding patients with renal disease. This was requested by the CHMP following assessment of available data from Study GS-US-02-526.
  • Update of section 5.1 regarding HIV/HBV co-infected patients. This was requested by the CHMP following assessment of available data from Study GS-01-496i.
  • Updated on 1 September 2006 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

    Section 4.4 and 4.5 - Updated based on results from a pharmacokinetic drug-interaction study that investigated the potential interactions of adefovir dipivoxil with tenofovir disoproxil fumarate (GS-01-940). Co-administration of adefovir dipivoxil with tenofovir disoproxil fumarate did not result in any clinically significant interaction.

    Updated on 1 September 2006 PIL

    Reasons for updating

    • Change to further information section

    Updated on 9 May 2006 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 4.9 - Overdose
    • Change to section 5.1 - Pharmacodynamic properties

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

    Updated on 8 May 2006 PIL

    Reasons for updating

    • Change to side-effects

    Updated on 7 June 2005 PIL

    Reasons for updating

    • Change to further information section

    Updated on 15 September 2004 PIL

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 28 June 2004 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)

    Updated on 23 March 2004 SmPC

    Reasons for updating

    • Change to section 5.1 - Pharmacodynamic properties

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

    Updated on 20 August 2003 SmPC

    Reasons for updating

    • Correction of spelling/typing errors

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

    Updated on 25 June 2003 SmPC

    Reasons for updating

    • New SPC for medicines.ie

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