EMTROC Film-coated tablet Ref.[50541] Active ingredients: Emtricitabine Tenofovir disoproxil

The dose of EMTROC TABLETS is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

Dose Adjustment for Renal Impairment

Significantly increased medicine exposures occurred when emtricitabine (200 mg) or tenofovir were administered to subjects with moderate to severe renal impairment (see CONTRAINDICATIONS).

If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Emtricitabine

Haemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour period starting within 1,5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.

Tenofovir disoproxil fumarate

Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir disoproxil fumarate, a four-hour haemodialysis session removes approximately 10% of the administered tenofovir dose.

Store at or below 25°C. Protect from light.

Keep the blisters in the carton until required for use.

Keep the containers tightly closed.

KEEP OUT OF REACH OF CHILDREN.

HDPE Container. Pack of 28 or 30 tablets: 75 ml white, heavy weight, round white HDPE bottle with 38-400 neck finish with a 38 mm white child resistant closure with pulp and heat seal liner containing a 3 g silica gel sachet.

Alu-Alu blister pack (10 × 10) tablets: Cold form laminate 25 micron OPA/45 micron Aluminium foil/60 micron PVC and plain 25 micron aluminium foil with 6-8 GSM HSL.