Volibris 5 mg and 10 mg film-coated tablets

  • Name:

    Volibris 5 mg and 10 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Ambrisentan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/19

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Summary of Product Characteristics last updated on medicines.ie: 12/11/2018

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 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 15 January 2019 PIL

Reasons for updating

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

Updated on 12 November 2018 PIL

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 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 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 1 June 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 30 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 May 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 May 2017 SmPC

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 4 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 May 2017 PIL

Reasons for updating

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

Updated on 1 December 2015 SmPC

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 PIL

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 PIL

Reasons for updating

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

Updated on 7 October 2014 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

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

Updated on 6 October 2014 PIL

Reasons for updating

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

Updated on 7 July 2014 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 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 4 July 2014 PIL

Reasons for updating

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

Updated on 3 May 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 3 May 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

7.       MARKETING AUTHORISATION HOLDER

 

Glaxo Group Ltd
980 Great West Road

Brentford
Middlesex
TW8 9GS
United Kingdom

Updated on 19 February 2013 SmPC

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

 

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GlaxoSmithKline Slovakia s. r. o.

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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 PIL

Reasons for updating

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

Updated on 30 August 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

 

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 PIL

Reasons for updating

  • Change of contraindications

Updated on 20 June 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

 

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 June 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

Change to:

 

 

Section 4.8 - Undesirable effects

 

Updated on 31 May 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 April 2012 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 10 April 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 6 October 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 11 May 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 25 August 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 3 March 2010 PIL

Reasons for updating

  • Change to drug interactions

Updated on 7 December 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 June 2009 PIL

Reasons for updating

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

Updated on 25 June 2008 PIL

Reasons for updating

  • New PIL for new product