Nevirapine 200mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nevirapine anhydrous

Available from:

Wockhardt UK Limited

ATC code:

J05AG; J05AG01

INN (International Name):

Nevirapine anhydrous

Dosage:

200 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Non-nucleoside reverse transcriptase inhibitors; nevirapine

Authorization status:

Not marketed

Authorization date:

2014-05-16

Patient Information leaflet

Nevirapine 200mg Tablets
1.3 Product Information
Wockhardt UK Ltd
Page 2
April 2014
PACKAGE LEAFLET: INFORMATION FOR THE USER
[Product Name] 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, 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, pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
_{The name of this medicine is Nevirapine 200 mg Tablets. In the rest
of this leaflet _
_it will be called Nevirapine Tablets.} (IE AND UK ONLY) _
WHAT IS IN THIS LEAFLET:
1. What [Product Name] are and what they are used for
2. What you need to know before you take [Product Name]
3. How to take [Product Name]
4. Possible side effects
5. How to store [Product Name]
6. Contents of the pack and other information
1.
WHAT [PRODUCT NAME] ARE AND WHAT THEY ARE USED FOR
[Product Name] 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, [Product Name] helps control HIV-1
infection.
[Product Name] is indicated for the treatment of HIV-1 infected
adults, adolescents,
and children of any age.
You must take [Product Name] together with other antiretroviral
medicines. Your
doctor will recommend the best medicines for you.
IF [PRODUCT NAME] HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT
ALL

Summary of Product characteristics

Health Products Regulatory Authority
12 June 2019
CRN00943V
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nevirapine 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of anhydrous nevirapine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Off-white to pale yellow coloured, capsule shaped, biconvex tablets,
debossed with ‘H’ on one side and ‘7’ on the other side
with breakline on both sides. The tablets are approximately 14.7mm in
length and 5.7mm in width.
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 4.4.).
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 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 ra