Nevirapine Aurobindo 200mg Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

NEVIRAPINE

Dostupné z:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC kód:

J05AG01

INN (Medzinárodný Name):

NEVIRAPINE 200 mg

Forma lieku:

TABLET

Zloženie:

NEVIRAPINE 200 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTIVIRALS FOR SYSTEMIC USE

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2013-05-03

Príbalový leták

Page
1
of
11 PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAPINE AUROBINDO 200 MG 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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Nevirapine Aurobindo is and what it is used for
2.
What you need to know before you take Nevirapine Aurobindo
3.
How to take Nevirapine Aurobindo
4.
Possible side effects
5.
How to store Nevirapine Aurobindo
6.
Contents of the pack and other information
1.
WHAT NEVIRAPINE AUROBINDO 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
reduces the amount of
viruses in the blood thus improving your medical condition.
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 Aurobindo helps control HIV-1 infection.
Nevirapine Aurobindo is indicated for the treatment of HIV-1 infected
adults, adolescents, and
children of any age. You must take Nevirapine Aurobindo together with
other antiretroviral
medicines. Your doctor will recommend the best medicines for you.
IF NEVIRAPINE AUROBINDO HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE
NOTE THAT ALL INFORMATION
IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLE

Súhrn charakteristických

Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine Aurobindo 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of nevirapine (as anhydrous).
Excipient with known effect: Each tablet contains 340 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, oval shaped, biconvex tablets, debossed with "J"
and "80" on either side of
break line on one side and with break line on the other side. The size
is 19.2 mm X 9.3 mm. The
score line is only to facilitate breaking for ease of swallowing and
not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nevirapine Aurobindo is indicated in combination with other
anti-retroviral medicinal products for
the treatment of HIV-1 infected adults, adolescents, and children of
any age (see section 4.4.).
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 Aurobindo should be administered by physicians who are
experienced in the treatment
of HIV infection.
Posology
_Patients 16 years and older_
The recommended dose of Nevirapine Aurobindo is one 200 mg 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 200 mg tablet twice daily, in combination with at
least two additional antiretroviral
agents.
If a dose is recognised as missed within 8 hours of when it was due,
the patient should take the
missed dose as soon as possible. If a dose is missed and it is more
than 8 hours later, the patient
should only take the next dose at the usual time.
Page 2 of 27
_Dose management considerations_
Patients experiencing rash during the 14-day lead-in period of 200
mg/day should not have t