EMTRIVA emtricitabine 200mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

emtricitabine, Quantity: 200 mg

Available from:

Gilead Sciences Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: crospovidone; povidone; microcrystalline cellulose; magnesium stearate; propylene glycol; purified water; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; indigo carmine; potable water; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Emtriva is indicated for the treatment of HIV in combination with other antiretroviral agents in adults and paediatric patients 12 years of age and older, weighing more than 33 kg. Evidence to support this claim is based on surrogate markers (plasma HIV RNA and CD4 count) in antiretroviral naive individuals and in antiretroviral experienced individuals with virological suppression (See Clinical Trials).

Product summary:

Visual Identification: Hard Gelatin Capsule with "200 mg" printed on a blue cap and "GILEAD" and corporate logo printed on a white body; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Patient Information leaflet

EMTRIVA Consumer Medicine Information v10.0 (4 July 2016) Page 1 of 4
EMTRIVA
 CAPSULES
_200 mg emtricitabine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about EMTRIVA
capsules. It does not contain all the
available information.
It does not take the place of talking
to your doctor or pharmacist about
your medical condition or treatment.
If you have further questions, please
ask your doctor or your pharmacist.
Keep this leaflet with your
EMTRIVA capsules. You may need
to read it again.
This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
WHAT EMTRIVA
CAPSULES ARE USED FOR
EMTRIVA is used to treat Human
Immunodeficiency Virus (HIV)
infection in adults and paediatric
patients 12 years of age or older who
weigh more than 33 kg. This
medicine must be taken in
combination with other anti-HIV
medicines.
EMTRIVA belongs to a group of
antiviral medicines, called nucleoside
reverse transcriptase inhibitors
(NRTIs).
This medicine is not a cure for HIV
infection. While taking EMTRIVA
you may still develop infections or
other illnesses associated with HIV
infection.
_HOW EMTRIVA WORKS _
HIV infection destroys CD4 T cells,
which are important to the immune
system. The immune system helps
fight infection. After a large number
of T cells are destroyed, acquired
immune deficiency syndrome
(AIDS) may develop.
EMTRIVA helps block HIV-1
reverse transcriptase, a viral
chemical in your body (enzyme) that
is needed for HIV-1 to multiply.
EMTRIVA lowers the amount of
HIV in the blood (viral load).
EMTRIVA may also help to increase
the number of T cells (CD4
+
cells),
allowing your immune system to
improve. Lowering the amount of
HIV in the blood lowers the chance
of death or infections that happen
when your immune system is weak
(opportunistic infections).
BEFORE YOU TAKE
EMTRIVA
_WHO MUST NOT TAKE IT _
DO NOT TAKE EMTRIVA IF YOU ARE
ALLERGIC TO:

emtricitabine or
�

Summary of Product characteristics

Emtriva Product Information v15.0 (22 January 2020)
1
AUSTRALIAN PRODUCT INFORMATION
EMTRIVA
®
(emtricitabine) capsules
1. NAME OF THE MEDICINE
EMTRIVA
®
(emtricitabine)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EMTRIVA is available as 200 mg hard capsules.
The active substance in EMTRIVA hard capsules is emtricitabine.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Each EMTRIVA capsule has a white opaque body with light blue opaque
cap. Each capsule
is printed with “200 mg” on the cap and “GILEAD” and [Gilead
logo] on the body in black
ink.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
EMTRIVA is indicated for the treatment of HIV in combination with
other antiretroviral
agents in adults and paediatric patients 12 years of age and older,
weighing more than 33 kg.
Evidence to support this claim is based on surrogate markers (plasma
HIV RNA and CD4
count) in antiretroviral naïve individuals and in antiretroviral
experienced individuals with
virological suppression (see section 5.1 Pharmacodynamic Properties,
Clinical Trials).
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
_Adults_
: The recommended dose of EMTRIVA is one 200 mg hard capsule, taken
orally once
daily.
_Paediatric patients (12 to 17 years inclusive): _
The recommended dose of EMTRIVA for
paediatrics weighing more than 33 kg is one 200 mg hard capsule, taken
orally once daily.
EMTRIVA may be taken with or without food.
_Elderly_
: No data are available on which to make a dose recommendation for
patients over the
age of 65 years.
_Renal _
_insufficiency:_
Emtricitabine
is
eliminated
by
renal
excretion
and
exposure
to
emtricitabine was significantly increased in patients with renal
impairment (see section 5.2
Emtriva Product Information v15.0 (22 January 2020)
2
Pharmacokinetic Properties). Dosing interval adjustment is required in
all patients with
creatinine clearance < 50 ml/min, as detailed Table 1 below.
The safety and efficacy of these dosing interval adjustment guidelines
have not been
clinic