Nevirapine Wockhardt 400 mg Prolonged-Release Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Nevirapine anhydrous

Disponible desde:

Wockhardt UK Limited

Código ATC:

J05AG; J05AG01

Designación común internacional (DCI):

Nevirapine anhydrous

Dosis:

400 milligram(s)

formulario farmacéutico:

Prolonged-release tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Non-nucleoside reverse transcriptase inhibitors; nevirapine

Estado de Autorización:

Not marketed

Fecha de autorización:

2017-09-01

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEVIRAPINE WOCKHARDT 400MG PROLONGED-RELEASE TABLETS
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 any further questions, 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 Nevirapine Wockhardt 400 mg Prolonged-Release Tablets are and
what they are
used for
2.
What you need to know before you take Nevirapine Wockhardt 400 mg
Prolonged-Release
Tablets
3.
How to take Nevirapine Wockhardt 400 mg Prolonged-Release Tablets
4.
Possible side effects
5.
How to store Nevirapine Wockhardt 400 mg Prolonged-Release Tablets
6.
Contents of the pack and other information
1.
WHAT NEVIRAPINE WOCKHARDT 400 MG PROLONGED-RELEASE TABLETS ARE AND
WHAT THEY
ARE USED FOR
Nevirapine Wockhardt 400 mg Prolonged-Release Tablets 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, Nevirapine Wockhardt
400 mg Prolonged-
Release Tablets helps control HIV-1 infection.
Nevirapine Wockhardt 400 mg Prolonged-Release Tablets is indicated for
the treatment of
HIV-1 infected adults, adolescents and children three years and above
and able to swallow
tablets. You must take Nevirapine Wockhardt 400 mg Prolonged-Release
Tablets together with
o

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ekstoniv 400 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 400 mg of nevirapine
(anhydrous).
Excipient(s) with known effect:
each prolonged-release tablet contains 375 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white oval shaped, biconvex tablets debossed with ‘H’
on one side and ‘N1’ on other side. Approximate
tablet dimensions are 19 x 9 x 7 mm.
Prolonged-release tablets should not be divided.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ekstoniv is indicated in combination with other anti-retroviral
medicinal products for the treatment of HIV-1 infected
adults, 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). A separate
treatment initiation pack with 200 mg Nevirapine tablets is available
for this lead-in period.
Most of the experience with nevirapine is in combination with
nucleoside reverse transcriptase inhibitors (NRTIs). The
choice of a subsequent therapy after nevirapine should be based on
clinical experience and resistance testing (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Nevirapine should be administered by physicians who are experienced in
the treatment of HIV infection.
Posology
_Adults_
The recommended dose of nevirapine for patients initiating nevirapine
therapy is one 200 mg immediate-release tablet
daily for the first 14 days (this lead-in period should be used
because it has been found to lessen the frequency of rash),
followed by one 400 mg prolonged-release tablet once daily, in
combination with at least two additional antiretroviral
agents.
Patients currently on a nev