Viramune Suspension

  • Name:

    Viramune Suspension

  • Company:
    info
  • Active Ingredients:

    nevirapine hemihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/11/19

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Actilyse Active Ingredients Alteplase
Medicine Name Actilyse Cathflo 2 mg Active Ingredients Alteplase
Medicine Name APTIVUS 100 mg/ml oral solution Active Ingredients Tipranavir
Medicine Name Aptivus 250 mg soft capsules Active Ingredients Tipranavir
Medicine Name Atrovent 250 UDVs, 250 micrograms/1ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent Inhaler CFC-Free Active Ingredients ipratropium bromide monohydrate
Medicine Name Catapres Ampoules Active Ingredients Clonidine hydrochloride
Medicine Name Catapres Tablets 100 micrograms Active Ingredients Clonidine hydrochloride
Medicine Name Giotrif 20 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 30 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 40 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 50 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Glyxambi 10 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Glyxambi 25 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Jardiance 10 mg and 25 mg Film-Coated Tablets Active Ingredients Empagliflozin
Medicine Name Jentadueto 2.5 mg/850 mg film-coated tablets and Jentadueto 2.5 mg/1,000 mg film-coated tablets Active Ingredients Linagliptin, Metformin Hydrochloride
Medicine Name Metalyse 10,000 units Active Ingredients Tenecteplase
Medicine Name Metalyse 8,000 units Active Ingredients Tenecteplase
Medicine Name Micardis 20 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 40 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 80 mg Tablets Active Ingredients Telmisartan
Medicine Name MicardisPlus 40 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/25 mg Active Ingredients Hydrochlorothiazide, Telmisartan
1 - 0 of 48 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 November 2019 PIL

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 SmPC

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 1 October 2018 SmPC

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 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 30 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 November 2017 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 November 2017 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 February 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 26 January 2016 SmPC

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

Following class labelling procedure sections 4.4 and 4.8 updated.

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 8 September 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 September 2014 SmPC

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

Very minor typographical change to section 4.1, at the end of paragraph 1 "(see section 4.4)." amended to "(see section 4.2)."

Updated on 11 August 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 5 August 2014 SmPC

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 to add class labelling on the risk of sexual transmission

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 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 6 January 2014 SmPC

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

Sections 4.4 and 4.5
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 SmPC

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

4.4 Special warnings and precautions for use
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 4 September 2013 PIL

Reasons for updating

  • Change to drug interactions
  • Change to how the medicine works
  • Change to MA holder contact details

Updated on 15 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 7 May 2013 SmPC

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 SPC has been upaded to include the new class labelling regarding the risk of Graves' disease in the setting of immune reactivation.

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 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 28 January 2013 SmPC

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

This update is following renewal of the Marketing Authorisation - many of the changes are minor editorial changes.
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 7 February 2012 PIL

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 3 February 2012 SmPC

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

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 21 July 2011 PIL

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 SmPC

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

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'.

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 6 October 2010 PIL

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 SmPC

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

Section 4.2
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 3 August 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 13 July 2009 SmPC

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 SmPC

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)

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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 PIL

Reasons for updating

  • Change to drug interactions

Updated on 27 February 2009 SmPC

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

Section 4.4 (Special Warnings and Precautions for use)
 - 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.
 
Section 4.5 (Interactions with other medications and other forms of interaction)
 - Completely rewritten.

 

Updated on 23 September 2008 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 May 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 March 2008 SmPC

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 SmPC

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 9 March 2007 SmPC

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 1 December 2006 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 July 2006 SmPC

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.

It is now recommended that due to high intersubject variability some patients receiving Viramune and rifabutin concomitantly may experience large increases in rifabutin exposure and may be at risk for rifabutin toxicity. Therefore, caution should be used in concomitant administration of Viramune and rifabutin.
 

Updated on 13 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 January 2006 SmPC

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 SmPC

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 SmPC

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 2 March 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 March 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)