Section 7 - Marketing authorisation holder

The marketing authorisation holder has been updated to sanofi-aventis Ltd, T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland.

Section 8 - Marketing Authorisation Numbers

The marketing authorisation number has been updated from PA 7/63/1 to PA 540/186/1

Section 10 - Date of revision of the text

The date has been revised to June 2018

Section 2 Qualitative and Quantitative Composition

New text of “with known effect” has been added to the second paragraph of this section.

The word “the” has replaced the word “a” in the third paragraph of this section.

Section 4.2 Posology and Method of Administration

Sub-headings of “Posology” and “Paediatric population” have been added to this section.

A new sub-heading of “Method of administration”, together with corresponding text, has been added to this section.

Section 4.3 Contraindications

The previous first sentence of this section “Lysopadol Mint 20 mg Lozenges should not be used in patients known to be hypersensitive to ambroxol or any of the excipients” has been replaced with “Hypersensitivity to the active substance or to any of the excipients listed in section 6.1”.

Section 4.4 Special Warnings and Precautions for Use

The previous text of:

“Lysopadol Mint 20 mg Lozenges should not be used in children under 12 years of age.

There have been very few reports of severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants such as ambroxol hydrochloride. Mostly these could be explained by the severity of the patient’s underlying disease and/or concomitant medication.

In addition during the early phase of a Stevens-Johnson Syndrome or TEN a patient may first experience non-specific influenza-like prodromes like e.g. fever, aching body, rhinitis, cough and sore throat. Misled by these non-specific influenza-like prodromes it is possible that a symptomatic treatment is started with a cough and cold medication. Therefore if new skin or       mucosal lesions occur, medical advice should be sought immediately and treatment with ambroxol hydrochloride discontinued as a precaution.”

has been replaced with the text:

“There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.”

A new sub-heading of “Paediatric population”, together with corresponding text, has been added at the end of this section.

Section 4.6 Fertility, Pregnancy and Lactation

The “Fertility” sub-heading and corresponding text have now moved from being the first paragraph to being the final paragraph of this section.

A new sub-heading of “Breastfeeding” has replaced the previous sub-heading of “Lactation” in this section.

Section 4.8 Undesirable Effects

The frequency estimate details have been updated from:

“Very common: ≥ 10 %

Common: ≥ 1 % and < 10 %

Uncommon: ≥ 0.1 % and < 1 %

Rare: ≥ 0.01 % and < 0.1 %

Very rare: < 0.01 %

Not known: cannot be estimated from the available data.”

to:

“Very common (≥ 1/10)

Common (≥ 1/100 and < 1/10)

Uncommon (≥ 1/1,000 and < 1/100)

Rare (≥ 1/10,000 and < 1/1,000)

Very rare (< 1/10,000)

Not known (cannot be estimated from the available data).”

The text “, skin and subcutaneous tissue disorders” has been deleted from the “Immune system disorders” sub-heading.

The text “Rare: hypersensitivity reactions” has been added to the Immune system disorders sub-heading details.

The text “rash, urticaria” and “and other hypersensitivity” has been deleted from the Immune system disorders sub-heading details.  The text now reads “Not known: anaphylactic reactions including anaphylactic shock, angioedema, and pruritus”.

A new sub-heading “Skin and subcutaneous tissue disorders”, together with corresponding text, has been added to this section.

Section 5.2 Pharmacokinetic Properties

The sub-heading of “Metabolism and elimination” has been amended to “Biotransformation and elimination”.

Section 5.3 Preclinical Safety Data

The word “revealed” in the first sentence of this section has been amended to “reveal”.

Section 9 Date of First Authorisation/Renewal of the Authorisation

The word “last” has been replaced with the word “latest” in this section.

Section 10 Date of Revision of the Text

The date has been updated from May 2015 to May 2016.

Section 4.6 Fertility, Pregnancy and Lactation
The word 'Animal' has been replaced with 'Nonclinical' in the Fertility paragraph of this section.

The word 'Animal' has been replaced with 'Nonclinical' in the second sentence of the Pregnancy paragraph of this section.

Section 4.7 Effects on Ability to Drive and Use Machines
The text 'from post-marketing data' has been added to this section.

Section 4.8 Undesirable Effects
New text after ‘Not known: cannot be estimated from the available data’ in the Frequency estimate details has been added to this section, before the list of disorders.

The frequency of the side effect ‘Dry throat’ has changed from ‘Not known’ to ‘Rare’ in the Gastrointestinal disorders and respiratory, mediastinal and thoracic disorders sub-heading of this section.

A new final paragraph regarding the reporting of suspected adverse reactions has been added to this section.

Section 5.1 Pharmacodynamic Properties

The figures ‘05’ have been added to the ATC code details in this section.

Section 5.2 Pharmacokinetic Properties

The text ‘non-delayed’ has been replaced with ‘immediate release’ in the first sentence of the Absorption paragraph of this section.

The figure ‘3’ has been added to ‘8%’ in the final sentence of the fifth paragraph of this section i.e. to now read ‘Total clearance is in the range of 660 mL/min, with renal clearance accounting for approximately 83% of the total clearance’.

Section 10 Date of Revision of the Text

The date has been updated from July 2014 to May 2015.