Viramune 400mg modified-release tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nevirapine

から入手可能:

Boehringer Ingelheim Ltd

ATCコード:

J05AG01

INN（国際名）:

Nevirapine

投薬量:

400mg

医薬品形態:

Modified-release tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: ; GTIN: 5012816050129

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAMUNE 400 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 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 adults,
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRAMUNE
DO NOT TAKE VIRAMUNE
-
if you are aller

製品の特徴

OBJECT 1
VIRAMUNE 400 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 28-Nov-2017 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Viramune 400 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 400 mg of nevirapine (as
anhydrous).
Excipient with known effect
Each prolonged-release tablet contains 400 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Yellow, oval, biconvex prolonged-release tablets. The
prolonged-release tablets are about 9.3 x 19.1 mm,
debossed with V04 on one side and the 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 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).
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
_Adults_
The recommended dose of Viramune 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 current