VEMLIDY tenofovir alafenamide (as fumarate) 25 mg tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

tenofovir alafenamide fumarate, Quantity: 28.04 mg (Equivalent: tenofovir alafenamide, Qty 25 mg)

Disponible des:

Gilead Sciences Pty Ltd

Designació comuna internacional (DCI):

tenofovir alafenamide fumarate

formulario farmacéutico:

Tablet

Composición:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Vía de administración:

Oral

Unidades en paquete:

30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

VEMLIDY is indicated for the treatment of chronic hepatitis B in adults.

Resumen del producto:

Visual Identification: Yellow, round, film-coated tablets, debossed with "GSI" on one side and "25" on the other side of the tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Estat d'Autorització:

Licence status A

Data d'autorització:

2017-02-22

Informació per a l'usuari

VEMLIDY®
1
VEMLIDY®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VEMLIDY?
VEMLIDY contains the active ingredient tenofovir alafenamide. VEMLIDY
is used for the treatment of chronic (long-lasting)
hepatitis B virus (HBV) in adults.
For more information, see Section 1. Why am I using VEMLIDY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VEMLIDY?
Do not use if you have ever had an allergic reaction to VEMLIDY or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
VEMLIDY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VEMLIDY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE VEMLIDY?
•
The usual dose is one VEMLIDY tablet orally, once daily.
More instructions can be found in Section 4. How do I use VEMLIDY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VEMLIDY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VEMLIDY.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how VEMLIDY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your VEMLIDY tablets in the bottle with the cap tightly closed
until you take them.
•
Keep VEMLIDY tablets in a cool, dry place where it stays below 30°C.
For more information, see Section 5. What should I know while using
VEMLIDY? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
The most common side effect of VEMLIDY is nausea.
For more information, including what to do if you have any side
effects, see Section 6. Are there any si

Fitxa tècnica

VEMLIDY Product Information v5.0 – (3 December 2021)
1
AUSTRALIAN PRODUCT INFORMATION – VEMLIDY
®
(TENOFOVIR ALAFENAMIDE) TABLETS
1
NAME OF THE MEDICINE
VEMLIDY (tenofovir alafenamide 25 mg).
The active substance in VEMLIDY tablets is tenofovir alafenamide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VEMLIDY is available as tablets. Each VEMLIDY tablet contains 25 mg of
tenofovir
alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate).
VEMLIDY tablets are
yellow, round, film-coated, debossed with “GSI” on one side and
“25” on the other side of
the tablet.
Contains lactose. For the full list of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
VEMLIDY tablets are yellow, round, film-coated, debossed with
“GSI” on one side and “25”
on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VEMLIDY is indicated for the treatment of chronic hepatitis B in
adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of VEMLIDY is one tablet once daily, with or
without food.
CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE
No data are available on which to make a dose recommendation for
patients younger than 18 years
(
_see Section 4.4 Special Warnings and Precautions for Use –
Paediatric Use_
).
ELDERLY
No dose adjustment is required in patients aged 65 years and above (
_see Section 5.2 _
_Pharmacokinetics, Special Populations_
).
RENAL IMPAIRMENT
No dose adjustment of VEMLIDY is required in patients with renal
impairment.
HEPATIC IMPAIRMENT
No dose adjustment of VEMLIDY is required in patients with hepatic
impairment (
_see _
_Section 5.2 Pharmacokinetics, Special Populations_
).
VEMLIDY Product Information v5.0 – (3 December 2021)
2
4.3
C
ONTRAINDICATIONS
VEMLIDY tablets are contraindicated in patients with known
hypersensitivity to the active
substance or to any other component of the tablets.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
EXACERBATION OF HEPATITIS AFTER DISCONTINUATION OF TREATMENT
Discontinuation of anti-hepatitis B therapy,