Emtriva 200 mg hard capsules

  • Name:

    Emtriva 200 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Emtricitabine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/05/19

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Summary of Product Characteristics last updated on medicines.ie: 9/5/2019

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Gilead Sciences Ltd

Gilead Sciences Ltd

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Medicine Name Emtriva 10 mg/ml oral solution Active Ingredients Emtricitabine
Medicine Name Emtriva 200 mg hard capsules Active Ingredients Emtricitabine
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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 10 May 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 9 May 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Type 1B variation for Emtriva 10 mg/mL oral solution to update the package information leaflet, labelling  and SmPC in accordance with the release of the Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.

 

In line with the aforementioned guidance the following wording has been added to section 2 of the PIL, sections 2 and 4.4 of the SmPC  and section 3 of the labeling for the Emtriva oral solution only;

Updated on 31 October 2018 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)

Updated on 14 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)

Free text change information supplied by the pharmaceutical company

Approval of MA Transfer application changing the Emtriva MA Holder (MAH) from Gilead Sciences International Ltd., Cambridge - UK (GSIL; ‘transferor’) to Gilead Sciences Ireland UC, Cork - Ireland (GSIUC; ‘transferee’) as a result of ‘BREXIT’. The full details of the new MAH is:

 

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Updated on 14 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 25 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 May 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 November 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 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 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

$0·Section 4.2 – dosage adjustment guidelines forpatients with creatinine clearance >30 ml/min$0$0·Section 4.5 and 5.1 – removal of “orzalcitabine”$0

Updated on 15 November 2016 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 May 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

·         Section 4.4

 

o    Revise the HIV class label wording on mitochondrial dysfunction following the review of existing data on mitochondrial toxicity including the Mitochondrial Toxicity in Children (MITOC) Study

o    The PILs were also updated accordingly

 

Updated on 13 May 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 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

Sections 4.4 & 4.8:

- Update to delete previous lipodystrophy class labelling text and, to add new class labelling regarding weight and metabolic parameters (blood lipids and glucose).

Section 10:

- Change to the date of revision to January 2016.

Updated on 12 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 9 July 2015 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

Sections 4.4 & 4.8:

- Removal of the warnings related to lactic acidosis

Section 10:

- Change to the date of revision to June 2015

Updated on 2 July 2015 PIL

Reasons for updating

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

Updated on 13 March 2015 PIL

Reasons for updating

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

Updated on 7 April 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 to section 4.4 of the SmPC “Special warnings and precautions for use” to revise the wording regarding the risk of sexual transmission of HIV infection following CHMP request adopted in December 2013.

Updated on 2 April 2014 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 24 June 2013 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


- Sections 4.4 and 4.8 of the SPC have been updated to include the below wording:

 

·         “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”

 

- Additional changes to sections 4.4 and 4.8 are as follows:

 

  • Expression of combination antiretroviral therapy (CART) was amended throughout sections 4.4 and 4.8 of the SPC

 

Section 10

 

- Change to date of revision to May 2013

Updated on 21 June 2013 PIL

Reasons for updating

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

Updated on 5 September 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • 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 3 – White opaque body with light blue opaque cap, of dimensions 19.4 mm x 6.9 mm

- Section 4.1 – Update to the indication statement ‘Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and children aged 4 months and over

- Section 4.2 – Additional statements for the Posology section - inclusion of paragraphs describing what to do when a dose of Emtriva is missed or when a patient vomits within an hour of taking Emtriva

- Section 4.2- Removal of statement that no data is available on which to make a dosage recommendation in paediatric patients with renal insufficiency

- Section 4.2- Addition of paragraph on dose recommendations in paediatric population......

Paediatric population: The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.

 

 

There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.  Therefore Emtriva is not recommended for use in those aged less than 4 months (for pharmacokinetic data in this age group, see section 5.2).

 

No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency.

 

Method of administration

Emtriva 200 mg hard capsules should be taken once daily, orally with or without food.

 

Emtriva is also available as a 10 mg/ml oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.  Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ml oral solution.  Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).

- Section 4.4- Co‑administration of other medicinal products- inclusion of the statement that Emtriva should not be taken with any medicinal products containing emtricitabine or lamivudine

- Section 4.4- Inclusion of statements on elderly and paediatric populations..........
 
Elderly: Emtriva has not been studied in patients over the age of 65.  Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with Emtriva.

 

Paediatric population: In addition to the adverse reactions experienced by adults, anaemia and skin discolouration occurred more frequently in clinical trials involving HIV infected paediatric patients (see section 4.8).

- Section 4.6 – Titled ‘Fertility, pregnancy and lactation’ – within this section amendments to the pregnancy, breast-feeding & fertility statements..........

Pregnancy
A moderate amount of data on pregnant women (between 300‑1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine.  Animal studies do not indicate reproductive toxicity.  The use of emtricitabine may be considered during pregnancy, if necessary.

 

 

Breast‑feeding

Emtricitabine has been shown to be excreted in human milk.  There is insufficient information on the effects of emtricitabine in newborns/infants.  Therefore Emtriva should not be used during breast-feeding.

 

As a general rule, it is recommended that HIV infected women do not breast‑feed their infants under any circumstances in order to avoid transmission of HIV to the infant.

 

Fertility

No human data on the effect of emtricitabine are available.  Animal studies do not indicate harmful effects of emtricitabine on fertility.

- Section 5.1 - Inclusion of statement ‘Paediatric population: There is no clinical experience of the use of emtricitabine in infants less than 4 months of age’

-
Section 5.2 – Inclusion of statements on gender, ethnicity and paediatric populations..........

Age:
Pharmacokinetic data are not available in the elderly (over 65 years of age). 

 

Gender: Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.

 

Ethnicity: No clinically important pharmacokinetic difference due to ethnicity has been identified.

 

Paediatric population: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.

 

- Section 6.5 – Addition of ‘polypropylene’ child resistant closure to HDPE bottle

- Section 10 – Change to the date of revision

Updated on 18 August 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 9 June 2011 PIL

Reasons for updating

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

Updated on 19 November 2010 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 of section 4.4 of the SPC to include a recommendation not to discontinue Emtriva in patients co-infected with HIV and HBV with advanced liver disease or cirrhosis.
  • Update of section 4.8 to add angioedema to the SPC in line with the CHMP’s request following the assessment of PSUR 8.
  • MAH also took this opportunity to update the term Pneumocystis carinii pneumonia in section 4.4 of the SPC as well as to correct a minor typographical error (section 4.4 of the SPC, to add an ’s’ after the word ’patient’ in the paragraph titled ’Patients co-infected with hepatitis B virus (HBV):’).
  • During the procedure, CHMP requested section 4.8 be updated in line with the SPC guideline, Rev 2, September 2009, including the recalculation of ADR frequencies
  • Updated on 14 September 2010 PIL

    Reasons for updating

    • Change to side-effects
    • Change to how the medicine works
    • Change to date of revision

    Updated on 5 January 2009 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

    Change to Section 10: Date of revision of text of the SPC.

    Updated on 5 January 2009 PIL

    Reasons for updating

    • Addition of manufacturer
    • Change to date of revision

    Updated on 9 October 2007 PIL

    Reasons for updating

    • Change to side-effects

    Updated on 9 October 2007 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

    Change to section 4.8 to include anaemia in adult patients

    Updated on 28 August 2007 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

      Section 4.2 and 5.2 - Changes made in light of the results from FTC-116 study.

    Updated on 29 March 2007 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

    MAH address updated to reflect new post code

    Updated on 29 March 2007 PIL

    Reasons for updating

    • Addition of marketing authorisation holder

    Updated on 9 March 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 & 4.8 updated to include osteonecrosis class labeling

    Updated on 9 March 2007 PIL

    Reasons for updating

    • Change to warnings or special precautions for use

    Updated on 1 September 2006 SmPC

    Reasons for updating

    • Change to section 6.3 - Shelf life

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

    Free text change information supplied by the pharmaceutical company

    Section 6.3 the shelf life has changed from 2 to 3 years

    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 4.2 - 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

    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
    • Change to further information section

    Updated on 7 June 2005 PIL

    Reasons for updating

    • Change to further information section

    Updated on 18 March 2005 SmPC

    Reasons for updating

    • 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)

    Updated on 5 January 2005 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)

    Updated on 5 January 2005 PIL

    Reasons for updating

    • Change to warnings or special precautions for use

    Updated on 27 August 2004 SmPC

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 5.3 - Preclinical safety data
    • Change to section 6.4 - Special precautions for storage

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

    Updated on 27 August 2004 PIL

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 12 January 2004 SmPC

    Reasons for updating

    • Correction of spelling/typing errors

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

    Updated on 8 January 2004 SmPC

    Reasons for updating

    • New SPC for new product

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