Nevirapine 200 mg tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

NEVIRAPINE

Dostupno od:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC koda:

J05AG01

INN (International ime):

NEVIRAPINE 200 mg

Farmaceutski oblik:

TABLET

Sastav:

NEVIRAPINE 200 mg

Tip recepta:

POM

Područje terapije:

ANTIVIRALS FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2015-06-30

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEVIRAPINE 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.
-
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 of any age.
You must take Nevirapine together with other antiretroviral medicines.
Your doctor will recommend the
best medicines for you.
IF NEVIRAPINE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEVIRAPINE
DO NOT TAKE NEVIRAPINE
- if you are allergic to nevirapine or any of the other ingredients of
this medicine (listed in se

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of nevirapine (as anhydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Off-white to pale yellow colored, capsule shaped, biconvex tablets,
debossed with ‘H’ on one side and
‘7’ on the other side with score line on both sides.
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 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 4.2.).
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
_Patients 16 years and older_
The recommended dose of Nevirapine 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 recognized 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.
_Dose management considerations_
Patients experiencing rash during the 14-day lead-in period of 200
mg/day should not have their
Nevirapine dose increased until the rash has resolved. The isolated
rash should be closely monitored
(see section 4.4). The 200 mg once daily dosing regimen should not