Viramune Suspension
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 August 2022
File name
V1b-EU-PIL-7.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 25 August 2022
File name
V1b-EU-SPC-35 - medicines.ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.4: Updated to remove information related to sexual transmission of HIV.
- Section 4.6: Updated to amend the wording regarding HIV transmission in breastfeeding women.
- Section 10 Date of revision of the SmPC has also been updated to 09 August 2022.
Updated on 23 March 2022
File name
V1b-EU-PIL-6.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 22 March 2022
File name
V1b-EU-SPC-34 - medicines.ie.pdf
Reasons for 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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC have been updated:
- Section 4.4: Updated to remove reference to delavirdine and boceprevir.
- Section 4.5: Updated to remove sections relating to delavirdine, boceprevir and telaprevir from the table of interactions.
- Section 5.1: Updated to remove reference to delavirdine.
Section 10 Date of revision of the SmPC has also been updated.
Updated on 31 August 2021
File name
A2b-EU-PIL-5.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to further information section
Updated on 26 August 2021
File name
V1b-EU-SPC-33 - medicines.ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- SmPC Heading: Updated to United Kingdom (Northern Ireland), Republic of Ireland and Malta.
- Section 4.8: Updated to show AE reporting details that include “(Northern Ireland)” to the United Kingdom information.
- Section 10 Date of revision of the SmPC has also been updated to 08 July 2021
- Section 4.4 under “Hypersensitivity” the word “this” was removed from the following sentence “should not take
this/be given this medicinal product.”
Updated on 29 September 2020
File name
V1b-All-PIL-4.pdf
Reasons for updating
- Change to section 6 - date of revision
- Addition of manufacturer
Updated on 20 November 2019
File name
50mg5ml solution PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Correction of spelling/typing errors
- Change to date of revision
Updated on 20 November 2019
File name
V1b-All-SPC-32-medicines.ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 2: The following text has been included, “This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’”.
- Section 4.4: Minor changes within the hypersensitivity section to align with updated European Commission Excipient guidelines.
- Section 10: Date of revision has been updated to 13/11/2019.
- Section 4.8 has been updated to include revised HPRA adverse reaction reporting information.
Updated on 01 October 2018
File name
V1b-All-SPC-31.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The change concerns the addition of ‘autoimmune hepatitis’ as an example of an autoimmune condition in sections 4.4 and 4.8 of the SmPCs.
Section 10 date of revision has been updated.
Updated on 18 May 2018
File name
V1b-All-PIL-2.pdf
Reasons for updating
- Change to other sources of information section
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 November 2017
File name
PIL_9178_280.pdf
Reasons for updating
- New PIL for new product
Updated on 30 November 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 28 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Editorial changes to headings in sections 2, 4.2, 5.2.
AE reporting details for UK and Malta have been updated in line with the current requirements (section 4.8)
Revised date in section 10
Updated on 10 February 2016
Reasons for updating
- Improved electronic presentation
Updated on 04 February 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to appearance of the medicine
Updated on 26 January 2016
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV-infected patients. The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with medicinal product related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to the measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8)
In clinical studies, Viramune has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio. However, in the absence of specific studies with nevirapine on modifying the cardiovascular risk in HIV-infected patients, the clinical impact of these findings is not known. The selection of antiretroviral medicinal products must be guided primarily by their antiviral efficacy.
Replaced with the following:
Weight and metabolic parameters:
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate.
In clinical studies, Viramune has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio. However, in the absence of specific studies, the clinical impact of these findings is not known. In addition, Viramune has not been shown to cause glucose disturbances.
Section 4.8
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV-infected patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Replaced with the following:
Metabolic parameters
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Section 10
Date of Revision of the SPC amended.
Updated on 08 September 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 September 2014
Reasons for updating
- Change to side-effects
Updated on 11 August 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 05 August 2014
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 AE reporting details have been amended to replace the IMB with the new details for the HPRA.
Section 10 date of revision updated.
Updated on 13 January 2014
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 06 January 2014
Reasons for 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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to drug interactions, including the addition of information regarding the interaction with emtricitabine and abacavir and elvitegravir/cobcistat.
Section 4.8
to amend information for the prolonged release tablets and for all formulations to add details of how to reports AEs to the Authorities, which will ultimately appear on all SPCs.
Section 10
Date of revision amended.
Updated on 11 September 2013
Reasons for 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of sentence in other warnings section:
“Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.”
4.5 Interaction with other medicinal products and other forms of interaction
The main changes are to update the interactions table in section 4.5 with information on the NNRTIs delavirdine, etravine and rilpivirine; deletion of nelfinavir; and addition of a new section for Antivirals for chronic hepatitis B and C (adefovir, boceprevir, entecavir, interferons, ribavirin, telaprevir and telbivudine).
4.8 Undesirable effects
Addition of sentence in “Description of selected adverse reactions” section:
“Autoimmune disorders (such as Graves’ disease) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment”
5.1 Pharmacodynamic properties
Section 5.1 has been completely revised with quite a lot of detail removed. A few typographical corrections have also been made.
5.2 Pharmacokinetic properties
Minor additions including the addition of “Gender and Elderly population” heading
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Change to “Date of latest renewal” to 20/12/2012
10. Date of revision
Updated to 07/2013
Updated on 04 September 2013
Reasons for updating
- Change to drug interactions
- Change to how the medicine works
- Change to MA holder contact details
Updated on 15 May 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 07 May 2013
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4
At the end of the Immune Reactivation Syndrome paragraph, the following sentence has been added:
Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Section 4.8
In the section entitled Description of selected adverse reactions
Autoimmune disorders (such as Graves’ disease) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Section 10
Date of revision amended to April 2013.
Updated on 31 January 2013
Reasons for updating
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 28 January 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - 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 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2
Minor editorial changes only
Section 4.2
Minor editorial changes including change in position of paragraph on use in Elderly.
Section 4.3
Minor editorial changes and changes to wording regarding St John's wort amended.
Section 4.4
Minor editorial changes and adverse events amended to adverse reactions.
Section 4.5
Minor editorial changes only.
Section 4.6
Minor editorial changes only.
Section 4.8
Minor formatting editorial changes, and removal of information previously referred to using asterisks to the paragraph Description of selected adverse reactions.
Section 5.1
Minor formatting editorial changes only.
Section 5.2
Minor formatting editorial changes only.
Section 6.6
Any unused product amended to Any unused medicinal product.
Section 9
Date of First Authorisation corrected.
Section 10
Date of revision amended.
Updated on 07 February 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to date of revision
- Change to MA holder contact details
Updated on 03 February 2012
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of Revision amended in Section 10.
Updated on 21 July 2011
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
- Correction of spelling/typing errors
Updated on 19 July 2011
Reasons for updating
- Change to section 1 - Name of 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 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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'.
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; reduce amended to eliminate; 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 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 4.9
VIRAMUNE changed to Viramune or nevirapine; dosage amended to dose.
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 6.3
Product amended to Medicinal Product.
Section 6.6
VIRAMUNE amened to Viramune; Dosage amended to dose.
Section 9
Date of last renewal corrected.
Section 10
Date of revision of text amended.
Updated on 06 October 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to MA holder contact details
Updated on 10 September 2010
Reasons for 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 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Moving of paragraph Paediatric Population beginning "The total daily dose...", moving of Dose management considerations paragraph.
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 03 August 2009
Reasons for updating
- Change to improve clarity and readability
Updated on 13 July 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4
The following text has been added:
In clinical studies, VIRAMUNE has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio. 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
Updated to include information from the 2NN and NEFA trials.
Updated on 28 May 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their VIRAMUNE dose increased until the rash has resolved. The isolated rash should be closely monitored (please refer to section 4.4).
Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their VIRAMUNE dose increased until the rash has resolved. The isolated rash should be closely monitored (please refer to section 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.
Updated on 24 April 2009
Reasons for updating
- Change to drug interactions
Updated on 27 February 2009
Reasons for 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
- SPC retired pending re-submission
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Hormonal methods of birth control other than DMPA should not be used as the sole method of contraception in women taking VIRAMUNE, since nevirapine might lower the plasma concentrations of these medications.
- Completely rewritten.
Updated on 23 September 2008
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6
Current available data on pregnant women indicate no malformative or foeto/neonatal toxicity. To date no other relevant epidemiological data are available. As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm3, these conditions should be taken into consideration on therapeutic decision (see section 4.4).
Updated on 22 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 07 May 2008
Reasons for updating
- Improved electronic presentation
Updated on 10 March 2008
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 (Therapeutic indication): Viramune was previously indicated for HIV-1 infected patients with advanced or progressive immunodeficiency. This has been amended to: "VIRAMUNE is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age."
Section 4.2 (Posology and method of administration) now includes dosing recommendations for patients wit renal impairment, including those requiring dialysis, and hepatic impairment.
Section 4.8 (Undesirable effects): Information on the frequency of adverse events has been updated, and the listing of adverse events observed in pooled clinical studies is now as given below:
Investigations
Common liver function tests abnormal
Blood and lymphatic system disorders
Common granulocytopenia*
Uncommon anaemia
* In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
Nervous system disorders
Common headache
Gastrointestinal disorders
Common vomiting, diarrhoea, abdominal pain, nausea
Skin and subcutaneous tissue disorders
Very common rash (13.6%)
Uncommon Stevens Johnson Syndrome/toxic epidermal necrolysis (0.1%),
angioneurotic oedema, urticaria
Musculoskeletal and connective tissue disorders
Common myalgia
Uncommon arthralgia
General disorders and administration site conditions
Common fever, fatigue
Immune system disorders
Common hypersensitivity
Not known drug rash with eosinophilia and systemic symptoms, anaphylaxis
Hepatobiliary disorders
Common hepatitis (1.4%)
Uncommon jaundice
Rare hepatitis fulminant
Updated on 29 August 2007
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
ection 4.4 (Special warnings and special precautions for use) now includes the following additional warning:
¡°Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with Viramune use.¡±
In addition, in relation to use in patients with hepatic dysfunction the following information has now been deleted ¡°Overall, the results suggest that patients with mild to moderate hepatic dysfunction, defined as child-pugh classification score ¡Ü 7, do not require an adjustment in Viramune dosing."
Section 4.5 (interactions with other medicinal products and other forms of interaction) has been updated to include information on tipranavir, and depo-medroxyprogesterone acetate (DMPA), as follows:
"Tipranavir: The data currently available appear to suggest no significant interaction between nevirapine and tipranavir co-administered with low dose ritonavir. However, these current data are limited and do not allow to draw a definitive conclusion on the interaction between nevirapine and tipranavir (co-administered with low dose ritonavir). Caution should be used when combining nevirapine with tipranavir (co-administered with low dose ritonavir)."
"DMPA: In a 12 week parallel group steady state study in HIV-infecyted women comparing the pharmacokinetic and pharmacodynamic effect of depo-medroxyprogesterone acetate (DMPA) alone (n=16) tpo DMPA added to a stable nevirapine regimen group (n=16) AUC, Cmax, Cmin, and half life did not change in the presence of nevirapine. Nevirapine co-administration did not alter the ovulation suppression effects of DMPA. Nevirapine pharmacokinetic parameters AUC and Cmax increased by 20% in the presence of DMPA; whilst statistically significant, this change in not considered clinically relevant.
In addition, information on interactions with contraceptives has been updated to state: "Appropriate doses for hormonal contraceptives (oral or other forms of application) other than DMPA in combination with nevirapine have not been established with respect to safety and efficacy". Information on use in combination with efavirenz has been updated to state: "Nevirapine in combination with efavirenz exhibited a strong antagonistic anti-HIV-1 activity in vitro."
Section 5.1 (Pharmacodynamic properties) has been updated to include information on in vitro HI susceptibility.
Section 5.2 (Pharmacokinetic properties): Information relating to pharmacokinetics in patients with hepatic impairment and females has been updated.
Updated on 09 March 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 (Special warnings and special precautions for use) and Section 4.8 (Undesirable effects) of the Summaries of Product Characteristics for Viramune Tablets and Viramune Oral Suspension have been updated with information on osteonecrosis, as follows:
Section 4.4:
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Section 4.8:
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). The frequency of this is unknown (see section 4.4).
Updated on 01 December 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 has been updated to include recommendations for dosing in children according to body surface area.
Furthermore, dosing recommendations are now provided for paediatric patients of all ages (previoulsy Viramune Suspension was recommended for paediatric patients aged 2 months and older).
Section 5.2 has been updated with new information regarding the pharmacokinetics of nevirapine in paediatric patients.
Updated on 18 August 2006
Reasons for updating
- Improved electronic presentation
Updated on 27 July 2006
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 (Interactions with other medicinal product and other forms of interaction):
Data relating to interactions between Viramune and the following drugs has been amended: Zidovudine; stavudine; efavirenz; saquinavir; indinavir; ritonavir; nelfinavir; oral contraceptives; methadone and clarithromycin.
The co-administration of Viramune and efaverenz is now not recommended because co-administration could lead to a higher risk of side effects and because co-administration does not improve efficacy of either NNRTI alone.
Updated on 13 June 2006
Reasons for updating
- Improved electronic presentation
Updated on 05 January 2006
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 August 2005
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 March 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 11 March 2004
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)