Volibris 5 mg and 10 mg film-coated tablets

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Volibris 5 mg and 10 mg film-coated tablets

Company:
GlaxoSmithKline (Ireland) Ltd
Status:
No Recent Update
Legal Category:
Product subject to medical prescription which may not be renewed (A)
Active Ingredient(s):
Ambrisentan
*Additional information is available within the SPC or upon request to the company

Updated on 20 August 2024

File name

ie-pl-combined-volibris-issue10draft1- Master (1).pdf

Reasons for updating

Change to section 4 - how to report a side effect

Updated on 20 August 2024

File name

ie-spc-combined-volibris-issue8draft1- Master.pdf

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)

Updated on 22 March 2024

File name

ieukni-spc-combined-volibris-issue7draft1- Master.pdf

Reasons for updating

Change to section 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Type II variation for the above medicinal product

CHMP Opinion for Volibris – EMEA/H/C/000839/II/0067.

To update sections 4.8 and 5.1 of the SmPC following the assessment of Art 46 procedure (EMEA/H/C/000839) based on final results from study AMB114588; this is an open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired. In addition, the MAH took the opportunity to implement minor editorial changes to Annex II and to the Package Leaflet.

Updated on 06 October 2021

File name

ieukni-combined-spc-volibris-issue6draft1.pdf

Reasons for updating

Change to section 1 - Name of medicinal product
Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
Change to section 4.1 - Therapeutic indications
Change to section 4.2 - Posology and method of administration
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.8 - Undesirable effects
Change to section 4.9 - Overdose
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical safety data
Change to section 6.1 - List of excipients
Change to section 6.3 - Shelf life
Change to section 6.5 - Nature and contents of container
Change to section 6.6 - Special precautions for disposal and other handling
Change to section 8 - Marketing authorisation number(s)
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

Ambrisentan (Volibris) EMEA/H/C/000839
Extension of Marketing Authorisation to register 2.5 mg Film Coated Tablets, Grouped with
Type II Variation for a new Paediatric (8 to < 18 years) indication

Updated on 06 October 2021

File name

ieukni-combined-pl-volibris-issue9draft1.pdf

Reasons for updating

Change to Section 1 - what the product is
Change to section 1 - what the product is used for
Change to section 2 - what you need to know - warnings and precautions
Change to section 2 - use in children and adolescents
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - pregnancy, breast feeding and fertility
Change to section 2 - excipient warnings
Change to section 3 - use in children/adolescents
Change to section 3 - how to take/use
Change to section 3 - duration of treatment
Change to section 3 - overdose, missed or forgotten doses
Change to section 4 - possible side effects
Change to section 4 - how to report a side effect
Change to section 5 - how to store or dispose
Change to section 6 - what the product contains
Change to section 6 - what the product looks like and pack contents
Change to section 6 - manufacturer
Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Ambrisentan (Volibris) EMEA/H/C/000839
Extension of Marketing Authorisation to register 2.5 mg Film Coated Tablets, Grouped with
Type II Variation for a new Paediatric (8 to < 18 years) indication

Updated on 13 August 2021

File name

ie-pl-volibris-issue8draft1.pdf

Reasons for updating

Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Pil with change to section 6 was uploaded in Januray however-re loaded due to technical issue with Medicines.ie website

Updated on 23 February 2021

File name

ie-pl-volibris-issue8draft1 medie.pdf

Reasons for updating

Change to section 6 - manufacturer

Updated on 23 February 2021

File name

ie-pl-volibris-issue8draft1 medie.pdf

Reasons for updating

Change of manufacturer

Updated on 15 January 2019

File name

ie-pl-volibris-issue7draft1 - Meds ie.pdf

Reasons for updating

Change to section 6 - manufacturer
Change to section 6 - date of revision

Updated on 12 November 2018

File name

ie-pl-volibris-issue6draft1 - Meds ie.pdf

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 12 November 2018

File name

ie-spc-volibris-issue5draft1 - Meds ie.pdf

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 5.3 - Preclinical safety data
Change to section 7 - Marketing authorisation holder
Change to section 9 - Date of first authorisation/renewal of the 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

SPC:
- Section 4.2: Addition of following sentence: 'No clinical data are available (see section 5.3 regarding data available in juvenile animals).'
- Section 4.4: Addition of following sodium statement: 'Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free’.'
- Section 4.8: Reporting details for UK and IE markets separated - now a separate SPC per country.
- Section 5.3: final paragraph about juvenile rat study added.
- Section 7: MAH changed to GlaxoSmithKline Ireland Limited
- Section 9: Correction to the renewal date.

Updated on 01 June 2018

File name

ukie-spc-volibris.docx

Reasons for updating

New SPC for new product

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

Updated on 30 April 2018

Reasons for updating

New SPC for new product

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

Updated on 05 May 2017

Reasons for updating

New SPC for new product

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

Updated on 05 May 2017

Reasons for updating

Change to section 5.1 - Pharmacodynamic properties
Change to section 6.1 - List of excipients
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)

Free text change information supplied by the pharmaceutical company

Section 5.1 - correction of typographical error
Section 6.1 - replace MACROGOL/PEG3350 with MACROGOL 3350
Section 6.3 - increase in shelf life

Updated on 04 May 2017

File name

PIL_13293_568.pdf

Reasons for updating

New PIL for new product

Updated on 04 May 2017

Reasons for updating

Change to section 6 - what the product contains
Change to section 6 - date of revision

Updated on 01 December 2015

Reasons for updating

Change to section 4.1 - Therapeutic indications
Change to section 4.2 - Posology and method of administration
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.5 - 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 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 4.4 (wording under liver function referring HCPs to Section 4.8 of SmPC

Extension of indication for the treatment of pulmonary arterial hypertension (PAH), in adult patients of WHO Functional Class (FC) II to III including use in combination treatment; as a consequence sections 4.1, 4.2, 4.4, 4.5, 4.8 and 5.1 of the SmPC are updated

Updated on 27 November 2015

Reasons for updating

Change to, or new use for medicine
Change to side-effects
Change to how the medicine works
Change to date of revision
Change to MA holder contact details
Correction of spelling/typing errors

Updated on 15 June 2015

Reasons for updating

Change to date of revision
Addition of manufacturer
Addition of information on reporting a side effect.

Updated on 07 October 2014

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

To update section 4.8 of the SPC and Patient information leaflet to add “visual disturbance” as an ADR.

Updated on 06 October 2014

Reasons for updating

Change to side-effects
Change to date of revision
Correction of spelling/typing errors
Improved electronic presentation

Updated on 07 July 2014

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 4.8 – Undesirable effects - how to report a side effect
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical safety data
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 4.2 – amend wording under Dosing in patients with hepatic impairment

Section 4.5 – amend to wording around the effect of ambrisentan on xenobiotic transporters

Section 4.8 – QRD update (reporting of side effects info included)

Section 5.2 –update to wording on hepato-transporter & amendment to wording relating to metabolism in hepatic impairment

Section 5.3 - pre-clinical data update

Section 9 – Include latest renewal date

Updated on 04 July 2014

Reasons for updating

Change to further information section
Change to date of revision
Addition of information on reporting a side effect.

Updated on 03 May 2013

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

7. MARKETING AUTHORISATION HOLDER

Glaxo Group Ltd
980 Great West Road

Brentford
Middlesex
TW8 9GS
United Kingdom

Updated on 03 May 2013

Reasons for updating

Change to marketing authorisation holder

Updated on 19 February 2013

Reasons for updating

Change to section 1 - Name of medicinal product
Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
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 5.3 - Preclinical safety data
Change to section 6.1 - List of excipients
Change to section 6.5 - Nature and contents of container
Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Volibris 5mg SPC Summary of Changes

· There are a number of editorial changes in section 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 6.1, 6.5, 6.6

· Some of the sections were moved and added under new headings (no new information) in 4.2

· Section 4.4 includes the addition of a hypersensitivity to soya warning in the “Excipients” section.

Excipients

Volibris tablets contain lecithin derived from soya. If a patient is hypersensitive to soya, ambrisentan must not be used (see section 4.3).

· Section 4.5, has the addition of further headings and further drug interactions (Cyclosorine A, Rifampicin, Other targeted PAH treatments, Oral contraceptives)

4.5 Interaction with other medicinal products and other forms of interaction

Cyclosporine A

Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers. This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan. Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2). Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.

Rifampicin

Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphospho-glucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers. However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure. Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).

Other targeted PAH treatments

The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and phosphodiesterase type V inhibitors) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1). Therefore, caution is recommended in the case of co-administration.

Oral contraceptives

In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2). Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen- based contraceptives.

Ketoconazole

Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).

· Wording has been updated and expanded in Section 4.7

4.7 Effects on ability to drive and use machines

Ambrisentan has minor or moderate influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8). Patients should be aware of how they might be affected by ambrisentan before driving or using machines.

· Further undesirable effects have been added to 4.8

4.8 Undesirable effects

Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan. The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years (see section 4.4).

Decreased haemoglobin

In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4). The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan. Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks. A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.

·         Section 10 has been updated with the renewal approval date

10.     DATE OF REVISION OF THE TEXT

14/01/2013

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Volibris 10mg SPC Summary of Changes

·         There are a number of editorial changes in section 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 6.1, 6.5, 6.6

·         Some of the sections were moved and added under new headings (no new information) in 4.2

·         Section 4.4 includes the addition of a hypersensitivity to soya warning in the “Excipients” section
Excipients

Volibris tablets contain lecithin derived from soya. If a patient is hypersensitive to soya, ambrisentan must not be used (see section 4.3).

·         Section 4.5, has the addition of further headings and further drug interactions (Cyclosorine A, Rifampicin, Other targeted PAH treatments, Oral contraceptives)

4.5     Interaction with other medicinal products and other forms of interaction

Cyclosporine A

Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers. This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan. Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2). Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.

Rifampicin

Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphospho-glucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers. However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure. Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).

Other targeted PAH treatments

The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and phosphodiesterase type V inhibitors) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1). Therefore, caution is recommended in the case of co-administration.

Oral contraceptives

In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2). Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen- based contraceptives.

Ketoconazole

Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).

·         Wording has been updated and expanded in Section 4.7

4.7     Effects on ability to drive and use machines

Ambrisentan has minor or moderate influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8). Patients should be aware of how they might be affected by ambrisentan before driving or using machines.

·         Further undesirable effects have been added to 4.8

4.8 Undesirable effects

Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan. The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years (see section 4.4).

Decreased haemoglobin

In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4). The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan. Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks. A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.

·         Section 10 has been updated with the renewal approval date

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 April 2008

Date of latest renewal:

10.     DATE OF REVISION OF THE TEXT

14/01/2013

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Volibris 5mg and 10mg Label Summary of Changes

Minor editorial changes to the below sections

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.       NAME OF THE MEDICINAL PRODUCT

Volibris 5 mg film-coated tablets

ambrisentan

4.       PHARMACEUTICAL FORM AND CONTENTS

10x1 film-coated tablets.

30x1 film-coated tablets.

5.       METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6.       SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

12.       MARKETING AUTHORISATION NUMBER(S)

EU/1/08/451/001 10 film-coated tablets

EU/1/08/451/002 30 film-coated tablets

13.       BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.       NAME OF THE MEDICINAL PRODUCT

Volibris 10 mg film-coated tablets

ambrisentan

4.       PHARMACEUTICAL FORM AND CONTENTS

10x1 film-coated tablets.

30x1 film-coated tablets.

5.       METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6.       SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

12.       MARKETING AUTHORISATION NUMBER(S)

EU/1/08/451/003 10 film-coated tablets

EU/1/08/451/004 30 film-coated tablets

13.       BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1.         NAME OF THE MEDICINAL PRODUCT

Volibris 5 mg tablets

ambrisentan

4.         BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1.         NAME OF THE MEDICINAL PRODUCT

Volibris 10 mg tablets

ambrisentan

4.         BATCH NUMBER

Lot

Volibris 5mg and 10mg PIL Summary of Changes

·         Minor editorial changes in Introductions Section, Sections 1, 2, 3, 5 and 6

·         Section 4 was updated with minor editorial changes as well as adding additional side effects in line with section 4.8 of the SPC

4.       Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you and your doctor need to look out for:

Allergic reactions

This is an uncommon side effect that may affect up to one in 100 people. You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing

Swelling (odema), especially of the ankles and feet

This is a very common side effect that may affect more than one in 10 people

Heart failure

This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs. This is a common side effect that may affect up to one in 10 people

Anaemia (reduced number of red blood cells)

This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell. Sometimes this requires a blood transfusion. This is a common side effect that may affect up to one in 10 people

Hypotension (low blood pressure)

This can cause light-headedness. This is a common side effect that may affect up to one in 10 people

→Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.

It is important to have regular blood tests, to check for anaemia and that your liver is working properly. Make sure that you have also read the information in section 2 under ‘You will need regular blood tests’ and ‘Signs that your liver may not be working properly’.

Other side effects include

Very common side effects:

·         headache.

Common side effects:

·         abnormal blood test results for liver function
·         worsening shortness of breath shortly after starting Volibris
·         a runny or blocked nose, congestion or pain in the sinuses
·         constipation
·         pain in your stomach (abdomen)
·         chest pain or discomfort
·         flushing (redness of the skin)
·         palpitations (fast or irregular heart beats)
·         feeling sick or being sick (nausea or vomiting)
·         dizziness
·         diarrhoea
·         feeling tired or weak
·         nose bleed.

Uncommon side effects:

·         fainting.
·         liver injury
·         inflammation of the liver caused by the body’s own defences (autoimmune hepatitis).

→ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

·         Section 6 was updated with minor editorial changes and the updated renewal date was included

6.   Contents of the pack and other information

What Volibris contains

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol/polyethylene glycol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).

What Volibris looks like and contents of the pack

Volibris 5 mg film-coated tablet (tablet) is a pale pink, square, convex tablet engraved with ‘GS’ on one face and ‘K2C’ on the other.

Volibris 10 mg film-coated tablet (tablet) is a deep pink, oval, convex tablet engraved with ‘GS’ on one face and ‘KE3’ on the other.

Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Manufacturer

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
D-23843 Bad Oldesloe
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0) 10 85 52 00

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 52 00

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

cz.info@gsk.com

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)30 6938100

nlinfo@gsk.com

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

produkt.info@gsk.com

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

firmapost@gsk.no

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

estonia@gsk.com

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

Ελλάδα

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

es-ci@gsk.com

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

diam@gsk.com

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

medical.x.si@gsk.com

Ísland

GlaxoSmithKline ehf.

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This leaflet was last revised in January 2013

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

Updated on 18 February 2013

Reasons for updating

Change to, or new use for medicine
Change to side-effects

Updated on 30 August 2012

Reasons for updating

Change to section 4.3 - Contraindications
Change to section 5.1 - Pharmacodynamic properties

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

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4.3 Contraindications

• Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section 5.1)

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Idiopathic Pulmonary Fibrosis

A study of 492 patients (ambrisentan N=329, placebo N=163) with idiopathic pulmonary fibrosis (IPF), 11% of which had secondary pulmonary hypertension (WHO group 3), has been conducted, but was terminated early when it was determined that the primary efficacy endpoint could not be met (ARTEMIS-IPF study). Ninety events (27%) of IPF progression (including respiratory hospitalisations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group. Ambrisentan is therefore contraindicated for patients with IPF with or without secondary pulmonary hypertension (see section 4.3).

Updated on 14 August 2012

Reasons for updating

Change of contraindications

Updated on 20 June 2012

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Change to section 4.8 - Undesirable effects

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4.8 Undesirable effects

Respiratory, thoracic and mediastinal disorders
Epistaxis	Common³
Dyspnoea⁵	Common³
Upper respiratory (e.g. nasal⁶, sinus) congestion, sinusitis, nasopharyngitis, rhinitis	Common

Updated on 20 June 2012

Reasons for updating

Change to side-effects

Updated on 01 June 2012

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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Change to:

Section 4.8 - Undesirable effects

Updated on 31 May 2012

Reasons for updating

Change to side-effects

Updated on 16 April 2012

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New SPC for medicines.ie

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

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Updated on 01 June 2018

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Updated on 30 April 2018

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Updated on 05 May 2017

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Updated on 04 May 2017

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Updated on 01 December 2015

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Updated on 27 November 2015

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Updated on 15 June 2015

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Updated on 07 October 2014

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Updated on 06 October 2014

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Updated on 07 July 2014

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Updated on 04 July 2014

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Updated on 03 May 2013

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Updated on 03 May 2013

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