Tracleer 62.5 mg film-coated tablets
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

Updated on 29 May 2024
File name
IE-Tracleer-PIL-16May2024-1738-IG.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 May 2024
File name
IE Tracleer 62.5mg and 125mg SmPC -16May2024-1738-IG-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 29 March 2024
File name
Tracleer-SPC-08Feb2024-WS-2583.pdf
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: Breast Feeding
Updated on 29 March 2024
File name
IE-Tracleer-PIL-08Feb2024-WS-2583.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
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Section 2- Breast feeding concerns updated
Updated on 05 December 2023
File name
Tracleer Patient Card.pdf
Reasons for updating
- Add New Doc
Updated on 17 February 2023
File name
IE Tracleer 62.5mg-125 mg PIL 09Feb23 IB-WS-PIL-Combination and storage condition update.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Approval EMEA/H/C/xxxx/WS/2404 - Update to the storage conditions and combination of differing strengths into one PIL for film coated tablets.
Updated on 17 February 2023
File name
IE Tracleer 62.5mg and 125mg SmPC - 09Feb23 IB-WS-Combination and storage condition update.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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
Approval of EMEA/H/C/xxxx/WS/2404 - Update to the storage conditions and combination of differing strengths into one PIL for film coated tablets.
Updated on 21 July 2021
File name
NI and IE Tracleer 62.5mg and 125mg SmPC C02 Day27 21July21 Clean EDMS-ERI-205912247 V19.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
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Correction of male fertility wording and QRD update
Updated on 21 July 2021
File name
NI and IE Tracleer 62.5mg PIL C02 Day27 21July21 Clean EDMS-ERI-205912247 V19.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Removal of DE batch release site, changes in local representatives and QRD update
Updated on 02 March 2020
File name
Tracleer 62.5 & 125mg SmPC C01 CHMP 26 Feb 2020 - clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
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Editorial changes.
Updated on 02 March 2020
File name
Tracleer 62.5mg PIL C01 CHMP 26 Feb 2020 - clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Change to manufacturing site responsible for batch release.
Updated on 17 October 2019
File name
Tracleer-62.5 & 125 mg-SmPc-Sep 2019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
update of the excipients wording according to the Revised Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (EMA/CHMP/302620/2017).
Updated on 17 October 2019
File name
Tracleer-62.5 mg-PIL_Sep-Ireland 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 18 December 2018
File name
Tracleer 62.5 mg PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 21 November 2018
File name
EN_Tracleer_H-401_MAH transfer_clean_AppV_PI-I-III_November2018 PIL 62.5 mg.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 November 2018
File name
EN_Tracleer_H-401_MAH transfer_clean_AppV_PI-I-III_November2018 SPC.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- 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
Summary of Changes
Section 4.8:
Addition of:
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 national reporting system listed below.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
Section 7:
Removal of:
Actelion Registration Ltd
Chiswick Tower 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom
Addition of:
Janssen-Cilag International NV
Turnhoutseweg 30
B 2340 Beerse
Belgium
Section 10:
Date of revision of text: November 2018
Updated on 17 September 2018
File name
Tracleer 62.5-125 mg SmPC.pdf
Reasons for updating
- 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 03 September 2018
File name
Tracleer PIL 62.5 mg.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 14 August 2018
File name
Tracleer Package leaflet_62.5 mg_23October2017.pdf
Reasons for updating
- New PIL for new product
Updated on 13 August 2018
File name
Tracleer SmPC_23October2017.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2017
Reasons for updating
- 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
Updated on 01 December 2017
Reasons for updating
- Change to section 10 - Date of revision of the text
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Updated on 12 October 2017
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)
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Updated on 12 October 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Updated on 30 May 2017
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 30 May 2017
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 10 October 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 October 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Updated on 30 March 2016
Reasons for updating
- Change to joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 March 2016
Reasons for updating
- Change to joint SPC covering all presentations
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Updated on 02 September 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 02 September 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
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Updated on 18 June 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 18 June 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
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Updated on 28 April 2015
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 28 April 2015
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Updated on 25 June 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 25 June 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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Updated on 08 February 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 08 February 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
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Updated on 11 May 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 11 May 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
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Updated on 12 January 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 12 January 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
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Updated on 15 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 15 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
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Updated on 12 May 2010
Reasons for updating
- 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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Updated on 12 May 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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Updated on 04 February 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 04 February 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
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Updated on 03 August 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
The updated sections of the SmPC are:
4.4,
Pulmonary arterial hypertension associated with HIV infection
There is limited clinical study experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1). An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan with the maximum level during the first 4 days of treatment (see section 4.5). When treatment with Tracleer is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products. Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.;
4.5,
Interaction with other medicinal products and other forms of interaction
Cyclosporine A, : co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3). Indeed, when co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone. At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone. The mechanism of this interaction is
co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3). Indeed, when co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone. At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone. The mechanism of this interaction is
most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.. The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%. This is most likely due to induction of CYP3A4 by bosentan.
Antiretroviral agents,
Lopinavir+Ritonavir (and other boosted protease inhibitors): Co-administration of Tracleer 125 mg twice daily and lopinavir+ritonavir 400+100mg twice daily during 9.5 days in healthy volunteers, resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after Tracleer administered alone. On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with Tracleer administered alone. Inhibition by ritonavir of transport protein mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction. When administered concomitantly with lopinavir+ritonavir or other ritonavir-boosted protease inhibitors, the patient’s tolerability of Tracleer should be monitored.
Co-administration of Tracleer 125 mg twice daily and lopinavir+ritonavir 400+100mg twice daily during 9.5 days in healthy volunteers, resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after Tracleer administered alone. On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with Tracleer administered alone. Inhibition by ritonavir of transport protein mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction. When administered concomitantly with lopinavir+ritonavir or other ritonavir-boosted protease inhibitors, the patient’s tolerability of Tracleer should be monitored.After co-administration of Tracleer for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non significant extent (by approximately 14% and 17%, respectively). However, full induction by bosentan might not have been reached and further decrease of protease inhibitors cannot be excluded. Appropriate monitoring of the HIV therapy is recommended. Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4.).
Other antiretroviral agents:
No specific recommendation can be made with regard to other available antiretroviral agents due to the lack of data. It is emphasized that due to a marked hepatotoxicity of nevirapine that could cumulate with bosentan liver toxicity, this combination is not recommended.
5.1.
Pharmacodynamic properties
An open label, non-comparative study (AC-052-362; BREATHE-4) was performed in 16 patients with WHO Class III PAH associated with HIV infection. Patients were treated with Tracleer 62.5 mg bid for 4 weeks followed by 125 mg bid for a further 12 weeks. After 16 weeks treatment, there were significant improvements from baseline in exercise capacity: mean increase in 6-minute walk test: +91.4 meters from 332.6 meters on average at baseline (p < 0.001). No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also Section 4.4).
Updated on 03 August 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Free text change information supplied by the pharmaceutical company
The updated sections of the SmPC are:
4.4,
Pulmonary arterial hypertension associated with HIV infection
There is limited clinical study experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1). An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan with the maximum level during the first 4 days of treatment (see section 4.5). When treatment with Tracleer is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products. Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.;
4.5,
Interaction with other medicinal products and other forms of interaction
Cyclosporine A, : co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3). Indeed, when co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone. At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone. The mechanism of this interaction is
co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3). Indeed, when co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone. At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone. The mechanism of this interaction is
most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.. The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%. This is most likely due to induction of CYP3A4 by bosentan.
Antiretroviral agents,
Lopinavir+Ritonavir (and other boosted protease inhibitors): Co-administration of Tracleer 125 mg twice daily and lopinavir+ritonavir 400+100mg twice daily during 9.5 days in healthy volunteers, resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after Tracleer administered alone. On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with Tracleer administered alone. Inhibition by ritonavir of transport protein mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction. When administered concomitantly with lopinavir+ritonavir or other ritonavir-boosted protease inhibitors, the patient’s tolerability of Tracleer should be monitored.
Co-administration of Tracleer 125 mg twice daily and lopinavir+ritonavir 400+100mg twice daily during 9.5 days in healthy volunteers, resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after Tracleer administered alone. On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with Tracleer administered alone. Inhibition by ritonavir of transport protein mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction. When administered concomitantly with lopinavir+ritonavir or other ritonavir-boosted protease inhibitors, the patient’s tolerability of Tracleer should be monitored.After co-administration of Tracleer for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non significant extent (by approximately 14% and 17%, respectively). However, full induction by bosentan might not have been reached and further decrease of protease inhibitors cannot be excluded. Appropriate monitoring of the HIV therapy is recommended. Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4.).
Other antiretroviral agents:
No specific recommendation can be made with regard to other available antiretroviral agents due to the lack of data. It is emphasized that due to a marked hepatotoxicity of nevirapine that could cumulate with bosentan liver toxicity, this combination is not recommended.
5.1.
Pharmacodynamic properties
An open label, non-comparative study (AC-052-362; BREATHE-4) was performed in 16 patients with WHO Class III PAH associated with HIV infection. Patients were treated with Tracleer 62.5 mg bid for 4 weeks followed by 125 mg bid for a further 12 weeks. After 16 weeks treatment, there were significant improvements from baseline in exercise capacity: mean increase in 6-minute walk test: +91.4 meters from 332.6 meters on average at baseline (p < 0.001). No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also Section 4.4).
Updated on 19 August 2008
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
The European licence for bosentan has been extended from PAH WHO FC III to also include FC II. This has led to a change in Secton 4.1 Therapeutic indications 'Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1)."
As a consequence, sections 4.4, 4.8 and 5.1 of SmPC have been updated. Additionally, AnnexII has been amended using the standard text to reflect the latest version of RMP as agreed by the CHMP.
Updated on 19 August 2008
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
The European licence for bosentan has been extended from PAH WHO FC III to also include FC II. This has led to a change in Secton 4.1 Therapeutic indications 'Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1)."
As a consequence, sections 4.4, 4.8 and 5.1 of SmPC have been updated. Additionally, AnnexII has been amended using the standard text to reflect the latest version of RMP as agreed by the CHMP.
Updated on 14 May 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2008
Reasons for updating
- New SPC for medicines.ie
Janssen Sciences Ireland (a Johnson & Johnson Company)

Address:
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork P43 FA46Medical Information E-mail:
medinfo@its.jnj.comTelephone:
+353 1 4665200Website:
https://innovativemedicine.jnj.com/ireland/Medical Information Direct Line:
1800 709 122