Rebetol 40 mg/ml oral solution

  • Name:

    Rebetol 40 mg/ml oral solution

  • Company:
    info
  • Active Ingredients:

    Ribavirin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/18

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Summary of Product Characteristics last updated on medicines.ie: 28/2/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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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 28 February 2019 SmPC

Reasons for updating

  • 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

Change to section 5.1 Pharmacodynamic properties and Change to section 10 - Date of revision of the text following approval of IA/0085 (Change in ATC Code)

 

Updated on 1 November 2018 PIL

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
  • Change to other sources of information section

Updated on 1 November 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder, Change due to harmonisation of SPC and Change to section 10 - Date of revision of the text  following approval of the MA Transfer

Updated on 28 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 February 2017 PIL

Reasons for updating

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

Updated on 16 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 November 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 4.3 - 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 5.2 - Pharmacokinetic properties
  • 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


Sections of SPC that have changed: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.2, 6.6
SPC Change Details: Change of indication to reflect that ribavirin is indicated in the treatment of hepatitis C in combination with other medicinal products and remove reference to the peginterferon used

 

Updated on 16 November 2015 PIL

Reasons for updating

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

Updated on 19 May 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

The changes made to the SmPC are as follows:

 

Section 4.8 Undesirable effects

 

tongue pigmentation’ has been added to table 4 (Adverse reactions reported during clinical trials or following the marketing use of Rebetol with pegylated interferon alfa-2b or interferon alfa-2b) in the System Organ Class of Gastro-intestinal disorders with a frequency of not known.

Updated on 19 May 2014 PIL

Reasons for updating

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

Updated on 27 January 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Addition of information on reporting a side effect.

Updated on 27 January 2014 SmPC

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

-        Sections 4.1, 4.4, 4.8 and 5.1 of the SmPC have been updated with long-term follow-up safety and efficacy data on the durability of virologic response and growth amongst paediatric patients from study P02538, submitted in accordance with Article 46 of Regulation (EC) 1901/2006, and study P01906, as requested in PSU066

·        In summary, the reversibility of growth inhibition was specifically investigated in the long term follow-up (LTFU) of studies P01906 (with interferon alfa-2b and ribavirin) and P02538. The final data reinforced this concern in paediatric subjects treated with peginterferon/ribavirin bitherapy, mainly in those treated for 48 weeks. In the final results the impact of the treatment on growth is demonstrated by a significant proportion of subjects (32%; 30/94) with a height deficit of >15 percentiles between pre-treatment baseline and the last visit in the LTFU. The long-term impact on growth is more marked in patients treated with peginterferon + ribavirin bitherapy for 48 weeks, of whom 40% had a decrease in height percentile >15 between baseline and the last visit in the LTFU.

·        The assessment of the long-term data from study P01906 led to the conclusion that some children who experienced a >15 percentiles decrease in height following a 1-year course of treatment with IntronA and ribavirin did not reach their projected final adult height 10-12 years after completing treatment, since most were found to have a decrease in their final adult height.

 

Overall, the data from the long-term follow-up are concerning since a permanent growth inhibition was observed in some children following therapy with ribavirin and standard or pegylated interferon. As reflected in the product information, it is agreed that initiation of therapy in children who have not reached their adult height should be restrictive and carefully considered on a case-by-case basis

 

-        Section 5.2 (Pharmacokinetic properties) of the SmPC was updated to include the findings from the crossover study of ribavirin in healthy adult subjects, the capsule and oral solution formulations were found to be bioequivalent.

 

-        The adverse event reporting statement has been added to section 4.8

-        Other updates to sections 2, 4.2 4.3, 5.2,  9.0 have been made to bring the text in line with the latest QRD template version 9.0

 

Updated on 12 July 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 21 June 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

Amendment as follows following change of ownership from SP to MSD:

Section 7 – Marketing Authorisation Holder:

 

SP Europe

Clos du Lynx 5

B-1200 Bruxelles

Belgium

 

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

 

Date of revision (section 10) also updated.

Updated on 21 June 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 19 April 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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

There have been minor editorial changes throughout the selected sections of the SmPC.

Updated on 18 April 2012 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 24 January 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

In section 7 MARKETING AUTHORISATION HOLDER the address has been updated.

In section 10 the revision date has changed to January 2012.

Updated on 23 January 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 28 September 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

4.6 Fertility, Prenancy and Lactation

 

Female patients: Rebetol must not be used by females who are pregnant (see sections 4.3, and 5.3). Extreme care must be taken to avoid pregnancy in female patients (see section 5.3). Rebetol therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Females of childbearing potential must use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time. If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus.

 

Male patients and their female partners: Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.3, and 5.3). Ribavirin accumulates intracellularly and is cleared from the body very slowly. It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus. Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Rebetol and for seven months after treatment. Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.


5.2 - The paragraph below has been added.

 

 

Transfer into seminal fluid: Seminal transfer of ribavirin has been studied. Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum. However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.

Updated on 26 September 2011 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to further information section

Updated on 30 August 2011 SmPC

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)

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precaution for use), a paragragh has been added on patients with substance use/abuse. The below wording has been added:

HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon. If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy. If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient. Patients should be closely monitored during therapy and even after treatment discontinuation. Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.

Updated on 30 August 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to marketing authorisation holder

Updated on 9 February 2011 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 9 February 2011 PIL

Reasons for updating

  • New PIL for new product