Nevirapine 400mg modified-release tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Nevirapine

제공처:

Accord Healthcare Ltd

ATC 코드:

J05AG01

INN (국제 이름):

Nevirapine

복용량:

400mg

약제 형태:

Modified-release tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: ; GTIN: 5055565736258

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAPINE 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 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 prolonged-release tablets is and what it is used
for
2. What you need to know before you take Nevirapine prolonged-release
tablets
3. How to take Nevirapine prolonged-release tablets
4. Possible side effects
5. How to store Nevirapine prolonged-release tablets
6. Contents of the pack and other information
1.
WHAT NEVIRAPINE PROLONGED-RELEASE TABLETSIS AND WHAT IT IS USED FOR
Nevirapine 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 prolonged-release tablets helps
control HIV-1 infection.
Nevirapine 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 together
with other antiretroviral medicines. Your
doctor will recommend the best medicines for you.
Nevirapine prolonged-release tablets should only be used after a
two-week treatment with another type of
nevirapine medicine (imme

제품 특성 요약

OBJECT 1
NEVIRAPINE 400 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 12-Jan-2018 | Accord
Healthcare Limited
1. Name of the medicinal product
Nevirapine Accord 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
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, approx. 9.3 x 19.2 mm, biconvex
tablets debossed with 'H' on one side
and 'N1' on other side. The prolonged release tablet should not be
divided.
4. Clinical particulars
4.1 Therapeutic indications
Nevirapine 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).
Nevirapine 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 , may be checked for
their availability and used accordingly (see section 4.2).
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 prolonged-release tablets 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