Viramune 100mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nevirapine

Available from:

Boehringer Ingelheim Ltd

ATC code:

J05AG01

INN (International Name):

Nevirapine

Dosage:

100mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5012816050143

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAMUNE 100 MG PROLONGED-RELEASE TABLETS
nevirapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Viramune is and what it is used for
2.
What do you need to know before you take Viramune
3.
How to take Viramune
4.
Possible side effects
5.
How to store Viramune
6.
Contents of the pack and other information
1.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
Viramune belongs to a group of medicines called antiretrovirals, used
in the treatment of Human
Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Reverse transcriptase is an
enzyme that HIV needs in order to multiply. Nevirapine stops reverse
transcriptase from working. By
stopping reverse transcriptase from working, Viramune helps control
HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adolescents
and children three years and
above and able to swallow tablets. You must take Viramune together
with other antiretroviral
medicines. Your doctor will recommend the best medicines for you.
Viramune prolonged-release tablets should only be used after a
two-week treatment with another type
of Viramune (immediate-release tablets or suspension) unless you are
currently on Viramune and are
switching to the prolonged-release form.
IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS LEAFL

Summary of Product characteristics

OBJECT 1
VIRAMUNE 100 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 28-Nov-2017 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Viramune 100 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 100 mg of nevirapine (as
anhydrous).
Excipient with known effect
Each prolonged-release tablet contains 100 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Yellow, round and biconvex prolonged-release tablets. The
prolonged-release tablets are approximately 9
mm in diameter, debossed with V01 on one side and company symbol on
the other side. The prolonged-
release tablet should not be divided.
4. Clinical particulars
4.1 Therapeutic indications
Viramune is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adolescents and children three years and above and able
to swallow tablets (see section
4.2).
Prolonged-release tablets are not suitable for the 14-day lead-in
phase for patients starting nevirapine.
Other nevirapine formulations, such as immediate-release tablets or
oral suspension should be used (see
section 4.2).
Most of the experience with Viramune is in combination with nucleoside
reverse transcriptase inhibitors
(NRTIs). The choice of a subsequent therapy after Viramune should be
based on clinical experience and
resistance testing (see section 5.1).
4.2 Posology and method of administration
Viramune should be administered by physicians who are experienced in
the treatment of HIV infection.
Posology
_Paediatric population_
Children three years and older and adolescents
Viramune prolonged-release tablets may be dosed based on a patient's
weight or body surface area (BSA).
Lead-in dosing with Viramune 200 mg tablets or Viramune 50 mg/5 ml
oral suspension (first 14 days):
All paediatric patients should initiate therapy with 150 mg/m
2
(calculated using the Mosteller formula) or
4 mg/k