Nevirapine 400mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nevirapine

Available from:

Mylan

ATC code:

J05AG01

INN (International Name):

Nevirapine

Dosage:

400mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5016695006970

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEVIRAPINE 400 MG PROLONGED-RELEASE TABLETS
(nevirapine anhydrous)
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 is and what it is used for
2.
What you need to know before you take Nevirapine
3.
How to take Nevirapine
4.
Possible side effects
5.
How to store Nevirapine
6.
Contents of the pack and other information
1.
WHAT NEVIRAPINE IS AND WHAT IT IS USED FOR
Nevirapine 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 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 (immediate-release tablets or suspension) unless
you are currently on nevirapine
and are switching to the prolonged-release form.
IF NEVIRAPINE HAS BEEN PRESCRIBED FO

Summary of Product characteristics

OBJECT 1
NEVIRAPINE 400 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 15-Dec-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Nevirapine 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 400 mg prolonged-release tablet contains 398 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
A white to off-white, oval-shaped prolonged-release tablet,
approximately 19 mm in length and 9 mm in
width, debossed with M on one side of the tablet and N403 on the 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
sections 4.2 and 4.4.).
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 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 agent