Gilead Sciences Ltd

- 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.....

- 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 C_max and C_min 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

• 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.

Change of MA Holder Post Code

MAH contact details updated to reflect new post code as issued by the post office