Revised SPC: Emtriva (emtricitabine) – all products

SPCs for all products containing emtricitabine have been updated in section 4.4 to include information about mitochondrial dysfunction following exposure in utero.

The updated SPCs for combination products containing emtricitabine are:

• Truvada film-coated tablets (200 mg emtricitabine / 245 mg of tenofovir disoproxil)

• Eviplera 200 mg/25 mg/245 mg film coated tablets (200 mg of emtricitabine, 25 mg

 of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil [as fumarate].)

• Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets (150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil)

• Atripla 600 mg/200 mg/245 mg film coated tablets (600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil [as fumarate].)