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AbbVie Limited

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 428 7900
Fax: +353 1 428 7940
Summary of Product Characteristics last updated on medicines.ie: 15/06/2017
SPC Norvir 100mg Film-coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 15/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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:   02-Jun-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.3 - Contraindications

·         The list of medicinal products which Norvir should not be co-administered with has been updated to include

o    Ranolazine (medical product class: antianginal)
Rationale: Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life-threatening reactions (see section 4.5).

o    Lurasidone (medical product class: Antipsychotics/ Neuroleptics)
Rationale: Increased plasma concentrations of lurasidone which may increase the potential for serious and/or life-threatening reactions (see section 4.5).



Section 4.5 -  Interaction with other medicinal products and other forms of interaction

 

·    The following medicinal products have been added to the Interaction table:

o    Ranolazine (Due to CYP3A inhibition by ritonavir, concentrations of ranolazine are expected to increase.  The concomitant administration with ranolazine is contraindicated (see section 4.3).)

o    Lurasidone (Due to CYP3A inhibition by ritonavir, concentrations of lurasidone are expected to increase.  The concomitant administration with lurasidone is contraindicated (see section 4.3).)

·    Information relating to Fluticasone propionate aqueous spray has been updated to read:

Inhaled, injectable or intranasal fluticasone propionate, budesonide, triamcinolone

Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression (plasma cortisol levels were noted to be decreased 86% in the above study) have been reported in patients receiving ritonavir and inhaled or intranasal fluticasone propionate; similar effects could also occur with other corticosteroids metabolised by CYP3A e.g., budesonide and triamcinolone.  Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).  A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).  Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may be required over a longer period.   

 

 

 

 

Section 10 – Date of Revision of Text

 

·    Updated to 02 June 2017

Updated on 27/09/2016 and displayed until 15/06/2017
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:   15-Sep-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



SmPC updated to reflect approval of V142

 

The following is a summary of the changes

 

4.4      Special warnings and precautions for use

 

The following warning has been added:

Riociguat

The concomitant use of ritonavir is not recommended due to potiential increase in riociguat exposure (see section 4.5).


 

Vorapaxar

The concomitant use of ritonavir is not recommended due to potential increase in vorapaxar exposure (see section 4.5).

 

 

4.5          Interaction with other medicinal products and other forms of interaction

The following interactions have been added:

 

Afatinib

20 mg, single dose

40 mg, single dose

40 mg, single dose

200 q12h/1h before

200 q12h/ co-administered

200 q12h/6h after

↑ 48%

 

↑ 19%

 

↑ 11%

↑ 39%

 

↑ 4%

 

↑ 5%

Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P‑gp inhibition by ritonavir.  The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.  Caution should be exercised in administering afatinib with Norvir (refer to the afatinib SmPC).  Monitor for ADRs related to afatinib.

 

Ceritinib

Serum concentrations may be increased due to CYP3A and P‑gp inhibition by ritonavir.  Caution should be exercised in administering ceritinib with Norvir.  Refer to the ceritinib SmPC for dosage adjustment recommendations.  Monitor for ADRs related to ceritinib.

Vorapaxar

Serum concentrations may be increased due to CYP3A inhibition by ritonavir.  Coadministration of vorapaxar and Norvir should be avoided (refer to the vorapaxar SmPC).

Riociguat

Serum concentrations may be increased due to CYP3A and P-gp inhibition by ritonavir.  The coadministration of riociguat with Norvir is not recommended (see section 4.4 and refer to riociguat SmPC).

 

 

 

 

 

 

 

Updated on 11/05/2016 and displayed until 27/09/2016
Reasons for adding or 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
Date of revision of text on the SPC:   02-May-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.3
information regarding the interaction between ritonavir and dronedarone and the contraindication with colchicine in patients with renal or hepatic impairment

Section 4.4
- Immune Reactivation Syndrome changed to Immune Reconstitution Inflammatory Syndrome
- The following statement added under Interactsions with other medicinal products:

Colchicine

Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir (see sections 4.3 and 4.5).

Section 4.5
- information regarding the interaction between ritonavir and dronedarone and the contraindication with colchicine in patients with renal or hepatic impairment

Updated on 02/03/2016 and displayed until 11/05/2016
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
Date of revision of text on the SPC:   18-Feb-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.4
Information added regarding drug-drug interaction between delamanid and ritonavir:

"Co‑administration of delamanid with a strong inhibitor of CYP3A (ritonavir) may increase exposure to delamanid metabolite, which has been associated with QTc prolongation.  Therefore, if co-administration of delamanid with lopinavir/ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.5 and refer to the delamanid Summary of Product Characteristics)."

Section 4.5
Information added regarding drug-drug interaction between delamanid and ritonavir



Minor editorial and formatting changes have been made throughout the document.

Updated on 04/01/2016 and displayed until 02/03/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Dec-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

To update sections 4.4 and 4.8 of the SmPC  relating to information on lipodystrophy and metabolic parameters for HIV products
Updated on 28/09/2015 and displayed until 04/01/2016
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:   17-Sep-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.4

Addition of the following:

Bedaquiline: Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions. Therefore, combination of bedaquiline with ritonavir should be avoided. However, if the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution. More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline Summary of Product Characteristics).


Section 4.5
Addition of the following (under "Ritonavir effects on Non-antiviral Co-administered Medical Products"

Bedaquiline
No interaction study is available with ritonavir only. In an interaction study of single-dose bedaquiline and multiple dose lopinavir/ritonavir, the AUC of bedaquiline was increased by 22%. This increase is likely due to ritonavir and a more pronounced effect may be observed during prolonged co-administration. Due to the risk of bedaquiline related adverse events, co-administration should be avoided. If the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution. More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline Summary of Product Characteristics).
Updated on 13/08/2015 and displayed until 28/09/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   24-Jul-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 7   MARKETING AUTHORISATION HOLDER
Update to address
Updated on 12/12/2014 and displayed until 13/08/2015
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   20-Nov-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Description of Change - Drug - drug interaction (Simeprevir)

Updated on 23/06/2014 and displayed until 12/12/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Date of revision of text on the SPC:   25-Mar-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



To update the SPC section, 4.4, according to CHMP request class label risk of sexual HIV transmission.
To update SPC in line with QRD V9

Updated on 30/01/2014 and displayed until 23/06/2014
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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   18-Dec-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



-          Section 4.2

“Elderly” replaced with “Older people”.

-          Section 4.3

Addition of the following contraindications:

“Quetiapine: Increased plasma concentrations of quetiapine which may lead to coma.  The concomitant administration with quetiapine is contraindicated (see section .4.5).”

“Avanafil: Increased plasma concentrations of avanafil (see section 4.4. and 4.5).”

Vardenafil: Increased plasma concentrations of vardenafil (see section 4.4. and 4.5).”

-          Section 4.4

Addition of the following text under PDE5 inhibitors:

“Concomitant use of avanafil or vardenafil with ritonavir is contraindicated.”

-          Section 4.5

Under “Antipsychotics/Neuroleptics” addition of the following text:

“Quetiapine: Due to CYP3A inhibition by ritonavir, concentrations of quetiapine are expected to increase.  Concomitant administration of Norvir and quetiapine is contraindicated as it may increase quetiapine-related toxicity.”

Under section “Phosphodiesterase (PDE5) inhibitors” addition of the following text:

“Avanafil: 50, single dose, 600 q12h, ↑ 13-fold, ↑ 2.4-fold. Concomitant use of avanafil with ritonavir is contraindicated (see section 4.3).”

Vardenafil:

Deleted text: “The concomitant use of vardenafil and ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer should be with caution at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring for adverse reactions (see section 4.4).”

New text: “Concomitant use of vardenafil with ritonavir is contraindicated (see section 4.3).”

-          Section 4.8

Addition of the following text:

“Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme or directly to the IMB Pharmacovigilance Section:

Irish Medicines Board,
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
website: www.imb.ie
e-mail:
imbpharmacovigilance@imb.ie

                -          Section 6.5

Update of the wording of the pack size to the following:

“Multipack containing 450 ml (5 bottles of 90 ml)  oral solution plus five 7.5 ml dosing syringes.”

Updated on 20/03/2013 and displayed until 30/01/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   17-Jan-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



 

Section 4.4
The following has been added under the heading "Immune Reactivation Syndrome":


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 can occur many months after initiation of treatment.

Section 4.8
The following has been added
Autoimmune disorders (such as Graves’ disease) have also been reported; however, the reported time to onset is more variable and can occur many months after initiation of treatment.

Updated on 25/01/2013 and displayed until 20/03/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   24-Oct-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



In section 7. Marketing Authorisation Holder

The previous name and address:

Abbott Laboratories Limited

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire,

SL6 4XE     

United Kingdom

is changing to:

AbbVie Ltd

Maidenhead

SL6 4XE

United Kingdom

Updated on 08/10/2012 and displayed until 25/01/2013
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Sep-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Typographical error in section 4.3 Contradications. An Alpha symbol in the table did not display correctly and appeared as a box. This has now been corrected.
Updated on 03/10/2012 and displayed until 08/10/2012
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
Date of revision of text on the SPC:   13-Sep-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Under Section ‘4.4 Special warnings and precautions for use’ the following sentence has been added:

 

Rivaroxaban: It is not recommended to use ritonavir in patients receiving rivaroxaban, due to the risk of increased bleeding (see section 4.5).

 

Under Section ‘4.5 Interaction with other medicinal products and other forms of interaction’ the following information has been added to the tables:

 

Medicinal Product  Interactions – Ritonavir with Antiretroviral Agents Other Than Protease Inhibitors

Co-administered Medicinal Product

Dose of Co-administered Medicinal Product (mg)

Dose of NORVIR (mg)

Medicinal Product

Assessed

AUC

Cmin

Raltegravir

400 single

100 q12h

Raltegravir

↓ 16%

↓ 1%

 

Co-adminsitration of ritonavir and raltegravir results in a minor reduction in raltegravir levels

 

 

Ritonavir effects on Non-antiretroviral Co-administered Medicinal Products

Co-administered Medicinal Products

Dose of Co-administered Medicinal Products (mg)

Dose of NORVIR (mg)

Effect on Co-administered Medicinal Products AUC

Effect on Co-administered Medicinal Products Cmax

Anticoagulant

 

Rivaroxaban

10, single dose

600 q12h

↑ 153%

↑ 55%

 

Inhibition of CYP3A and P-gp lead to increased plasma levels and pharmacodynamic effects of rivaroxaban which may lead to an increased bleeding risk. Therefore, the use of ritonavir is not recommended in patients receiving rivaroxaban.

 

Updated on 20/08/2012 and displayed until 03/10/2012
Reasons for adding or updating:
  • 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:   20-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Correction of error in Section 4.8 Undesirable effects and Section 10. Date of revision of the text.
Updated on 31/07/2012 and displayed until 20/08/2012
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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



In section 4.2 (Posology and Method of Administration) changes for administration with saquinavir, tipranavir and darunavir.

In section 4.4 (Special Warnings and Precautions for Use) updates regarding use with tenofovir disoproxil fumarate.

In section 4.8 (Undesirable Effects) the table has been updated for adverse reactions.

Updated on 11/01/2012 and displayed until 31/07/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

In section 4.8, toxic epidermal necrolysis (TEN) has been added.
Updated on 07/12/2011 and displayed until 11/01/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   22-Nov-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.5: The addition of interaction statements for fentanyl, dasatinib, nilotinib, tadalafil, bosentan and colchicine.

Updated on 08/06/2010 and displayed until 07/12/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Ritonavir