Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 02/02/2012
SPC Viramune 200mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The main change is to bring the SPCin line with the prolonged release tablets by adding a warning about the possibility of granulocytopenia when nevirapine is administered with zidovudine in both sections 4.4 and 4.5.

Date of Revision amended in Section 10.
Updated on 19/07/2011 and displayed until 02/02/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1
VIRAMUNE changed to Viramune.

Section 4.1
VIRAMUNE changed to Viramune.

Section 4.2
VIRAMUNE changed to Viramune or nevirapine; Viramune may be taken with or without food moved from beginning of section to paragraph titled 'Method of administration' and information regarding missed dose clarified.

Section 4.3
VIRAMUNE changed to Viramune or nevirapine and minor editorial amendments made.

Section 4.4
VIRAMUNE changed to Viramune or nevirapine; dosage amended to dose; DMPA written in full as Depo-medroxyprogesterone acetate, medications or drug amended to medicinal product(s)

Section 4.5
VIRAMUNE changed to Viramune or nevirapine; intersubject amended to interpatient; drug amended to medicinal product.

Section 4.6
VIRAMUNE changed to Viramune or nevirapine; mL amended to ml.

Section 4.7
Section revised.

Section 4.8
VIRAMUNE changed to Viramune or nevirapine; trial amended to study; events amended to adverse reactions; drug amended to medicinal product; dosage amended to dose; asterisked information moved to be together instead of under type of reaction; some of the percentage data amended under hepatobiliary and skin and subcutaneous tissue disorders; myalgia moved from Common to Uncommon; Uncommon blood phosphorus decreased; blood pressure increase added.

Section 5.1
NNRTI amended to Antivirals for systemic use; drug or study medication amended to medicinal product; trial amended to study; VIRAMUNE changed to Viramune or nevirapine; mL amended to ml.

Section 5.2
VIRAMUNE changed to Viramune or nevirapine; subject amended to patient; drug amended to medicinal product; trial amended to study.

Section 9
Date of last renewal corrected.

Section 10
Date of revision of text amended.
Updated on 10/09/2010 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2
Change anhydrate to anhydrous.
Section 4.2
Moving of Dose management considerations paragraph, moving of paragrph on Paediatric dosing.
Section 4.4
Amendments in boxed paragraph at beginning of section and amendments in paragraph beginning "Female gender and higher CD4 counts..."
Section 4.6
Inclusion of fertility information.
Section 4.8
Addition of new headings (a, b, c etc) along with additions Immune system disorders, hepatobiliary disorders, Investigations and a few other amendments.
Section 4.9
Paragraph added regarding Paediatric population - overdose in newborn.
Section 5.1
Paragraph added - regarding Paediatric population and study BI 1100.1368, plus minor changes - inclusion of hyphens.
Section 5.2
Deletion of paragraph - regarding Study BI 1100.1368 and Paediatric patients changed to Paediatric population.
Section 5.3
Sentence deleted - regarding impaired fertility in rats
Section 10
Date of Revision amended
Updated on 23/06/2009 and displayed until 10/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4
The following paragraph regarding HDL-cholesterol added:
"In clinical studies, VIRAMUNE has been associated with an increase in HDL-cholesterol and an overall improvement in the total to HDL-cholesterol ration.  However, in the absence of specific studies with VIRAMUNE on modifying the cardiovascular risk in HIV infected patients, the clinical impact of these findings is not known.  The selection of antiretroviral drugs must be guided primarily by their antiviral efficacy.
 
Section 5.1 has been completely re-written.

Section 6.5
Amended to include reference to Treatment initiation pack and Maintenance pack.

Section 8
14 Tablet pack MA number added

Section 10
Date of revision amended
Updated on 03/06/2009 and displayed until 23/06/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following sentence has been added to both sections 4.2 and 4.4:

The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.


Date of revision amended.
Updated on 18/02/2009 and displayed until 03/06/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4
"Oral Contraceptives and other hormonal methods of birth control..."

Changed to:

"Hormonal methods of birth control other than DMPA"

Section 4.5
Section toally rewritten to be presented in a tabular format.

Section 10
Date of revision amended
Updated on 23/09/2008 and displayed until 18/02/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   02-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6 purple text added and struck out text deleted:

Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.  To date no other relevant epidemiological data are available. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).  There are no adequate and well-controlled studies in pregnant women. Therefore VIRAMUNE should only be used during pregnancy if the expected benefit justifies the possible risk to the child and  Caution should be exercised when prescribing VIRAMUNE to pregnant women (see section 4.4).  As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm3, these conditions should be taken in consideration on therapeutic decision (see section 4.4).

 

Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower the plasma concentrations of these medications (see sections 4.4 & 4.5).

 

Nevirapine readily crosses the placenta and is found in breast milk.

 

Results from a pharmacokinetic study (ACTG 250) of 10 HIV-1 infected pregnant women who were administered a single oral dose of 100 or 200 mg VIRAMUNE at a median of 5.8 hours before delivery, have shown that nevirapine readily crosses the placenta and is found in breast milk.

 

It is recommended that HIV infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving

VIRAMUNE.

Updated on 25/02/2008 and displayed until 23/09/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
License Renewal: SPC extensively revised throughout
Updated on 11/09/2007 and displayed until 25/02/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

-update regarding patients with pre-existing hepatic impairment (sections 4.3, 4.4 and 5.2)

-gender difference for clearance pharmacokinetics (section 5.2)

-interaction with DMPA (section 4.5)

-in-vitro susceptibility (section 5.1)

-warning re. rhabdomyolysis (section 4.4)

-interaction with tipranavir (section 4.5)
Updated on 20/04/2007 and displayed until 11/09/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 and 4.8 - the addition of class labelling concerning osteonecrosis
Updated on 08/02/2007 and displayed until 20/04/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.2 and 5.2 - changes to paediatric dosing
Updated on 17/09/2006 and displayed until 08/02/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   11/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 Interaction with other medicaments and other forms of interaction
 
Information on many of the interactions has been updated, for example where information from a larger number of patients is now available.  The wording of these sections has consequently changed.
 
The interactions affected are: zidovudine, nelfinavir, efavirenz, saquinavir, indinavir, ritonavir, nelfinavir, ketoconazole, oral contraceptives, methadone, clarithromycin, rifabutin.
Updated on 15/12/2005 and displayed until 17/09/2006
Reasons for adding or updating:
  • No reasons supplied
Updated on 24/06/2005 and displayed until 15/12/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/02/2005 and displayed until 24/06/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/01/2005 and displayed until 22/02/2005
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 02/03/2004 and displayed until 06/01/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 02/04/2003 and displayed until 02/03/2004
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 11/02/2002 and displayed until 02/04/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2001 and displayed until 11/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 14/12/2000 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/07/2000 and displayed until 14/12/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/01/2000 and displayed until 06/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 26/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  nevirapine anhydrate