Bisolvon Oral Solution

  • Name:

    Bisolvon Oral Solution

  • Company:
    info
  • Active Ingredients:

    Bromhexine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/19

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Summary of Product Characteristics last updated on medicines.ie: 9/3/2018
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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 1 July 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 24 October 2018 PIL

Reasons for updating

  • XPIL Created

Updated on 9 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 9 March 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration

The previous text of “2 x 5 ml three times daily to 3 x 5 ml four times daily” has been deleted from next to “Adults and children over 12 years:”.

 

New tabulated text and non-tabulated text regarding the recommended daily dose has been added.

 

The symbol “≤” has been added to the “Children 5-12 years:” and “Children 2-5 years:” details, together with the text “Recommended total daily dose” and “(4 mg)”.

 

Previous text of “1 x” in front of “5 ml” has been deleted from the “Children 5 - ≤ 12 years” and “Children 2 ≤ 5 years” details.

 

New sentences regarding the measuring cup and Bisolvon being taken with or without food have been added.

 

A new sub-heading of “Additional information on specific populations” has been added.

 

The former word of “diabetics” has been replaced with “diabetes patients” in the final sentence of this section.

 

Section 4.3 Contraindications

The previous text of “should not be used” has been replaced with “is contraindicated” in the first sentence of this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

The previous text of “have been reported” has been replaced with “, such as ampicillin, amoxicillin, oxytetracycline or erythromycin, have been reported (see section 5.1)”.

 

A new final sentence regarding interaction studies has been added to this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

The previous text of “Animal studies” has been replaced with “Pre-clinical studies” in the second sentence of the Pregnancy paragraph.

 

The previous text of “animals” has been replaced with “pre-clinical studies” in the second sentence of the Lactation paragraph.

 

Section 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group and ATC code details have been added to the beginning of this section.

 

A new sub-heading of “Drug/drug interactions in Pharmacodynamics and Pharmacokinetics” has been added.

 

New text regarding bromhexine pharmacokinetics has been added as a final sentence to this section.

 

Section 5.2 Pharmacokinetic Properties

The sub-headings in this section have been reformatted i.e. they are now underlined.

 

The previous sub-heading of “General” has been replaced by “Linearity/Non-linearity” and the previous text of “There are no data for bromhexine pharmacokinetics in the elderly or in patients with renal or liver insufficiency” has been deleted.

 

A new sub-heading of “Special Populations” has been added.  Here, the previous text of “are not relevantly affected by co-administration of ampicillin or oxytetracycline” has been deleted and “There are no data for” and “in the elderly or in patients with renal or liver insufficiency” have been added.

 

The previous final sentence text of “Interaction studies with oral anticoagulants or digoxin were not performed” has been deleted.

 

Section 10 Date of Revision of the Text
The date has been amended from August 2017 to March 2018.

 

Updated on 8 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 March 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 15 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/25/2 has been replaced by PA 540/180/1.

Section 10 (Date of Revision of the Text) has been amended from April 2016 to August 2017.

Updated on 11 August 2017 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

Updated on 5 May 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 have been updated with information relating to severe cutaneous adverse reactions (SCARs).

Section 10, date of revision of the text has also been updated

Updated on 3 May 2016 PIL

Reasons for updating

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

Updated on 13 April 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to amend the information on adverse event reporting and now includes HPRA address details.

 

Section 10 has been updated to include the month of approval of the SPC i.e. from December 2013 to March 2015.

Updated on 2 April 2015 PIL

Reasons for updating

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

Updated on 20 December 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8 (Undesirable effects)
Update to section 4.8 with new pharmacovigilance wording

5.2 (Pharmacokinetic properties)
Update to section 5.2 to correct typographical errors:

10. Date of revision
Updated to December 2013

Updated on 17 December 2013 PIL

Reasons for updating

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

Updated on 25 March 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.6 has been re-written.

In section 4.7 the statement has been added “No studies on the effect on the ability to drive and use machines have been performed with BISOLVON.”

In addition, minor editorial revisions were made to sections 1, 2, 3, 4.2, 4.3, 6.2, 6.3, 7 and 9 of the SPC and to the headings for sections 4.1 and 9.

Section 10 has also been updated to March 2013.

Updated on 19 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 19 March 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SPC has been updated to include additional note at the end of the section:

*This adverse reaction has been observed in post-marketing experience. With 95 % certainty, the frequency category is not greater than rare (3/3,992), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 3,992 patients.

A few asterisks have been included in this section in order to make reference to the note at the end of the section.

A typographical error has also been corrected in Section 2.

Section 10 has been updated.

Updated on 9 September 2011 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.2 Pharmacokinetic Properties has been updated.
Section 10 –Date of revision of the text has been updated to August 2011.

Updated on 14 July 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 5 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 31 March 2010 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Details of Changes

4.6

Previous Wording

Available preclinical studies as well as clinical experience to date have shown no evidence of ill effects during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially

during the first trimester should be observed.

The drug is expected to enter breast milk and thus should be avoided during lactation.

Updated Wording

Bromhexine crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Clinical

experience to date has shown no evidence of harmful effects on the foetus during pregnancy. Nonetheless the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during

the first trimester, the use of BISOLVON is not recommended.

Bromhexine is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, BISOLVON is not recommended for use in nursing mothers.

4.8

Re-formatted using frequencies of undesirable effects.

4.9

Previous Wording

Toxic effects following overdosage have never been reported, but animal studies suggest that these may include listlessness, anorexia, ataxia, cyanosis, pulmonary rales, hypothermia, diuresis, respiratory failure,

convulsion or coma. These should be treated symptomatically.

Updated Wording

No specific overdose symptoms have been reported in man to date. Based on accidental

overdose and/or medication error reports the observed symptoms are consistent with the

known side effects of Bisolvon at recommended doses and may need symptomatic treatment.

Updated on 23 March 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 9 November 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2

Previous wording:     For excipients, see 6.1. 

Updated wording:     Excipients: Contains Maltitol Liquid

     
                       
For full list of excipients, see Section 6.1



Section 6.3

Previous wording:    Shelf life

                                       3 years.

                                        In-use: 12 months.


Updated wording:    Shelf life

       Unopened: 3 years.

       In-use: Use within 12 months of opening bottle.


Section 6.4

The following information has been removed:  This medicinal product does not require any special storage conditions. 


Section 9

Date of Last Renewal has been updated to 01 April 2008.

Section 10

Date of revision of the text has been updated to October 2009.



 



Updated on 3 June 2009 PIL

Reasons for updating

  • Change of manufacturer

Updated on 21 May 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 has been updated to now state:

 

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions”) the use of this product is contraindicated.

 

Section 4.4 has been updated to include the following warning:

 

                There have been very rare reports of severe skin lesions such as Stevens Johnson syndrome and Lyell’s syndrome in temporal association with the administration of mucolytic substances such as bromhexine. Mostly these could be explained by the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with bromhexine discontinued as a precaution.

Updated on 17 October 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 31 August 2006 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 August 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)