VIRAMUNE XR nevirapine 400 mg extended-release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nevirapine, Quantity: 400 mg

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

Nevirapine

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: lactose monohydrate; hypromellose; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

30 extended-release tablets, 10 extended-release tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of 2 months. Viramune XR (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of three years. Extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. Resistant virus emerges rapidly when Viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, Viramune should always be administered in combination with at least two additional antiretroviral agents.

Product summary:

Visual Identification: Yellow, oval, biconvex tablets debossed with V04 on one side and the BI tower logo on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-01-04

Patient Information leaflet

VIRAMUNE
® XR
V
I
R
A
M
U
N
E
X
R
C
M
I
0
1
3
5
-
0
7
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 TAKING VIRAMUNE XR?
Viramune XR contains the active ingredient nevirapine. Viramune XR is
used in the treatment of the infection caused by the Human
Immunodeficiency Virus (HIV-1). For more information, see Section 1.
Why am I taking Viramune XR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE VIRAMUNE XR?
Do not take Viramune XR if you have ever had an allergic reaction to
nevirapine or any of the ingredients listed at the end of the
CMI. Do not take Viramune XR if you have rare inherited conditions of
galactose intolerance, severe liver dysfunction or if you
previously experienced serious liver or skin reactions while taking
Viramune or Viramune XR.
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 take
Viramune XR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Viramune XR 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 TAKE VIRAMUNE XR?
Adults 16 years and older:
•
FIRST 14 DAYS: Take one nevirapine tablet or 20 mL Viramune oral
suspension once daily
•
AFTER THE FIRST 14 DAYS: Take one Viramune XR tablet once daily.
Children (aged 3 years or older) and adolescents to 15 years:
•
Your child's doctor will determine the dose of Viramune XR based on
your child's age and body weight, or body surface area.
•
FIRST 14 DAYS: Viramune oral suspension is given once daily.
•
AFTER THE FIRST 14 DAYS: Your child may be switched to Viramune XR
tablet, given once daily.
More instructions can be found in Section 4. How do I take Viramune
XR? in the full CMI.
5.
WHAT SHOULD I KNOW W

Summary of Product characteristics

VIRAMUNE PI0097-16
1
AUSTRALIAN
PRODUCT
INFORMATION
–
VIRAMUNE
®
ORAL
LIQUID,
VIRAMUNE
®
XR
(NEVIRAPINE) EXTENDED-RELEASE TABLETS
1 NAME OF THE MEDICINE
nevirapine (VIRAMUNE XR extended-release tablets)
nevirapine hemihydrate (VIRAMUNE oral suspension)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
VIRAMUNE is available as extended-release VIRAMUNE XR tablets or as a
suspension for oral
administration.
Each VIRAMUNE XR extended-release tablet contains 400 mg of
nevirapine.
Each 5 mL of the VIRAMUNE oral suspension contains 50 mg of nevirapine
(as nevirapine
hemihydrate).
Excipients with known effect:
Each VIRAMUNE XR extended-release 400 mg tablet contains 400 mg of
lactose monohydrate.
Each mL of VIRAMUNE oral suspension contains 150 mg sucrose, 162 mg
sorbitol, 1.8 mg of methyl
hydroxybenzoate and 0.24 mg of propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
400 mg extended-release tablets
Yellow, oval, biconvex tablets. The tablets are
debossed with “V04” on one side and the BI tower logo
on the other side.
Oral Suspension
White to off-white suspension containing nevirapine 10
mg/1mL (as nevirapine hemihydrate).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VIRAMUNE (nevirapine) oral suspension in combination with
antiretroviral agents is indicated for the
treatment of HIV-1 infection in adults and children over the age of 2
months.
VIRAMUNE XR (nevirapine) extended-release tablets in combination with
antiretroviral agents is
indicated for the treatment of HIV-1 infection in adults and children
over the age of three years.
Extended-release tablets are not suitable for the 14 day lead-in
period for patients starting
nevirapine. Other nevirapine formulations, such as immediate-release
tablets or oral suspension
should be used.
Resistant virus emerges rapidly when VIRAMUNE is administered as
monotherapy or in dual
combination
therapy
with
an
antiretroviral
agent.
Therefore,
VIRAMUNE
should
always
be
administered in combination with at least