Norvir 100mg Film-coated Tablets

  • Name:

    Norvir 100mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Ritonavir

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/07/20

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Summary of Product Characteristics last updated on medicines.ie: 21/7/2020

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AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Humira 20 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Humira 80 mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Kaletra 200 mg/50 mg film-coated tablets Active Ingredients Lopinavir, Ritonavir
Medicine Name Kaletra oral solution Active Ingredients Lopinavir, Ritonavir
Medicine Name Maviret 100 mg-40 mg film-coated tablets Active Ingredients Glecaprevir, Pibrentasvir
Medicine Name Norvir 100 mg powder for oral suspension Active Ingredients Ritonavir
Medicine Name Norvir 100mg Film-coated Tablets Active Ingredients Ritonavir
Medicine Name RINVOQ 15 mg prolonged-release tablets Active Ingredients Upadacitinib
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Skyrizi 75 mg solution for injection in pre-filled syringe Active Ingredients Risankizumab
Medicine Name Synagis Solution for Injection Active Ingredients Palivizumab
Medicine Name Venclyxto 10mg, 50mg and 100mg Film-coated Tablets Active Ingredients Venetoclax
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 21 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 21 July 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 July 2020 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

Uodate to include information regarding drug drug interaction with fostamatinib

Updated on 15 July 2020 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 15 July 2020 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)

Free text change information supplied by the pharmaceutical company

Update to  section 4.8 Undesirable effects of the SmPCs to add information regarding nephrolithiasis.  

Minor editorial formating changes

Updated on 7 November 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 September 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 27 September 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 July 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 July 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 9 May 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 9 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 8 May 2019 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

 

 

Section 4.3 – Contraindications and Section 4.5 - Interaction with other medicinal products and other forms of interaction

  • Updated to include contraindication regarding concomitant use of Norvir with lomitapide.

     

Section 10 - Date of Revision of the Text

  • Updated to 04/2019

Updated on 15 February 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 15 February 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2

Children and adolescents (2 years of age and above)

Updates made to reflect removal of Norvir Oral solution from marketing authorisation.  The Dosage conversion table refers to Norvir Powder for Oral Suspension instead of Norvir Oral Solution.

 

Section 4.5

Sub-section: Medicinal product that are affected by the use of ritonavir

 

The following statement has been removed:

“Norvir oral solution should not be co-administered with amprenavir oral solution to children due to the risk of toxicity from excipients in the two formulations”

 

Section 10

Date of Revision amended to 01 February 2019

 

Updated on 12 November 2018 SmPC

Reasons for updating

  • 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

Update to sections 4.4 and 4.8 to include autoimmune hepatitis.

 

Section 4.4

Immune Reconstitution Inflammatory Syndrome

 

-----------------

Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.

 ---------------------

Section 4.8

Description of selected adverse reactions

 ------------
 

Metabolic parameters

Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).

In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.  Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and can occur many months after initiation of treatment (see section 4.4).

---------------------

Updated on 26 September 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 26 September 2018 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 Interaction with other medicinal products and other forms of interaction

Information added regarding the following interactions:

  • Ibrutinib

    Serum concentrations of ibrutinib may be increased due to CYP3A inhibition by ritonavir, resulting in increased risk for toxicity including risk of tumor lysis syndrome.  Co‑administration of ibrutinib and ritonavir should be avoided.  If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.

     
  • Levothyroxine

    Post‑marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
    Thyroid‑stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending lopinavir/ritonavir treatment

     

Section 10 Date of Revision of the Text

Updated to 13 September 2018

Updated on 15 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 3 July 2018

Updated on 6 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 6 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 5 September 2017 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Section 4.3 - Contraindications
        Addition of  DDI with venetoclax to SmPC.
        The package Leaflet is updated accordingly.

Section 4.5 - Interaction with other medicinal products and other forms of interaction
        Addition of  DDI with venetoclax to SmPC.
        The package Leaflet is updated accordingly

Section 10 – Date of Revision of Text
        Updated to 08/2017

Updated on 5 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 September 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 5 September 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 20 July 2017 SmPC

Reasons for updating

  • 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 4.6 - Fertility, pregnancy and lactation

 

The following information has been updated as follows:

 

Was:

Pregnancy

A limited number (> 800) of pregnant women were exposed to ritonavir during pregnancy; a very limited number (< 300) were exposed during the first trimester.  These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.  These limited data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.  Animal data have shown reproductive toxicity (see 5.3).  The use of Norvir may be considered in pregnancy only when the benefits outweigh the risk to the foetus.

 

Ritonavir adversely interacts with oral contraceptives (OCs).  Therefore, an alternative, effective and safe method of contraception should be used during treatment.

 

Breastfeeding

It is not known whether this medicine is excreted in human milk.  Milk excretion has not been measured in the animal studies, however a study in rats showed some effects on offspring development during lactation which are compatible with excretion of ritonavir in milk in that species.  HIV infected women should not breast-feed their infants under any circumstances to avoid transmission of HIV. 

 

Updated to:

Pregnancy

A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester.  These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.  These data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.  Animal data have shown reproductive toxicity (see 5.3).  Norvir can be used during pregnancy if clinically needed.

 

Ritonavir adversely interacts with oral contraceptives (OCs).  Therefore, an alternative, effective and safe method of contraception should be used during treatment.

 

Breastfeeding

Limited published data reports that ritonavir is present in human milk.

 

There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.  Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants) and (3) serious adverse reactions in a breastfed infant,  HIV infected women should not breast feed their infants under any circumstances if they are receiving Norvir. 

 

Section 10 - Date of Revision of the Text

 

Changed to 13 July 17

 

 

 

Updated on 15 June 2017 SmPC

Reasons for 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

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

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 12 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 27 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 27 September 2016 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



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 May 2016 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

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

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 10 May 2016 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 3 March 2016 PIL

Reasons for updating

  • Change to drug interactions

Updated on 2 March 2016 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

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
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 4 January 2016 SmPC

Reasons for updating

  • 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

To update sections 4.4 and 4.8 of the SmPC  relating to information on lipodystrophy and metabolic parameters for HIV products

Updated on 24 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 28 September 2015 PIL

Reasons for updating

  • Change to drug interactions

Updated on 28 September 2015 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

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 August 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7   MARKETING AUTHORISATION HOLDER
Update to address

Updated on 7 August 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 12 December 2014 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Description of Change - Drug - drug interaction (Simeprevir)

Updated on 11 December 2014 PIL

Reasons for updating

  • Change to drug interactions

Updated on 23 June 2014 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
  • Change to improve clarity and readability

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

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 18 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 January 2014 SmPC

Reasons for 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

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

“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 24 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 6 September 2013 PIL

Reasons for updating

  • Change of distributor details

Updated on 20 March 2013 SmPC

Reasons for updating

  • 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 4.4
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 18 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 January 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

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 10 December 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 October 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 October 2012 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

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 3 October 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

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

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 26 September 2012 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to drug interactions
  • Change to date of revision

Updated on 20 August 2012 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)

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 July 2012 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 4.8 - 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

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 24 July 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 11 January 2012 SmPC

Reasons for updating

  • 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

In section 4.8, toxic epidermal necrolysis (TEN) has been added.

Updated on 6 January 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 December 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 6 December 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 8 June 2010 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 4 June 2010 PIL

Reasons for updating

  • New PIL for new product