Neoclarityn Tablets

PI update following PSUSA/00000962/202107

Transfer of Marketing Authorisation from Merck Sharp & Dohme B.V to N.V. Organon.

Updated in line with the excipient guideline and minor editorial amendments made throughout the document.

Section 4.8 is updated to reflect an increased incidence of new-onset seizure in patients 0 to 19 years when receiving desloratadine compared with periods not receiving desloratadine based on the results of the final report from study (EUPAS15038).

Section 4.2 is updated to remove that “no data are available” in the paediatric population

               Section 4.4 is updated to include a cross reference to section 4.8 of the SmPC.

Section 4.8 is updated to reflect an increased incidence of new-onset seizure in patients 0 to 19 years when receiving desloratadine compared with periods not receiving desloratadine based on the results of the final report from study (EUPAS15038).

Section 4.2 is updated to remove that “no data are available” in the paediatric population

              Section 4.4 is updated to include a cross reference to section 4.8 of the SmPC.

Converted the SPC from word format to pdf file format

How to report a side effect

MAH holder transferred

Section 4.4, the reader is referred to. Section 5.2 for more information. Section 5.2, information on the pharmacokinetics in renally impaired patients is added. Date of revision is updated.

Update to SPC sections 4.5 Interactions with other medicinal products and other forms of interaction, 4.6, Pregnancy and Lactation, 4.8, Undesirable effects and 4.9 overdose. Revision date updated in section 10

Updates to SPC section 4.8 regarding side-effects (photosensitivity)

 Section 2 Qualitative and Quantitative Composition
·        A statement that the product contains lactose has been added

Excipients with known effect: This medicine contains lactose.

Section 4.1 Therapeutic indications 
·        The individual populations that Neoclarityn is indicated for has been added to the text

Neoclarityn is indicated in adults and adolescents aged 12 years and older for the relief of

symptoms associated with:

- allergic rhinitis (see section 5.1)

- urticaria (see section 5.1)

Section 4.2 Posology and method of administration 
·        The following text has been added to the beginning of section 4.2:

Posology

Adults and adolescents (12 years of age and over): Adults and adolescents (12 years of age and over):

The recommended dose of Neoclarityn is one tablet once a day.

, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).

This section has been moved from under paediatric population

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Paediatric population

 ·        A small section of text has been added to clarify the efficacy of use in children below the age of 12 years

The safety and efficacy of Neoclarityn 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available.

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

·        The title ‘Method of administration’ has been added at the end of the section with the following information underneath 

Oral use.

The dose can be taken with or without food.

Section 4.4 Special warnings and precautions for use

 ·        The following sentence has been removed from the beginning of this section of text as it has been moved to section 4.2

Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.

Section 4.6 Fertility, Pregnancy and Lactation

·        This section has been updated to include more information regarding the use of Neoclarityn with women who are pregnant, breast-feeding or during fertility.

Pregnancy

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of desloratadine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to

avoid the use of Neoclarityn during pregnancy.

Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not recommended.

Breast-feeding

Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breastfeeding women. Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made

whether to discontinue breast-feeding or to discontinue/abstain from Neoclarityn therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data available on male and female fertility.

Section 4.7 Effects on ability to drive and use machines

·        This section has been updated to include more information on the effects of Neoclarityn on the ability to drive and use machines.

Neoclarityn has no or negligible influence on the ability to drive and use machines based on clinical trials. In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine. However, p Patients should be informed that very rarely some most people do not

experience drowsiness, which may affect their ability to drive or use machines . Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines,

until they have established their own response to the medicinal product.

Section 4.8 Undesirable Effects

·        “Summary of the safety profile” has been added as a title for the starting paragraph.

·        The details for national reporting details for adverse events has been added to the end of the undesirable effects section

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via 

the Pharmacovigilance Section,

Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Section 5.1 Pharmacodynamic properties

·       The section has been split into two titled sections: ‘Mechanism of action’ and ‘Clinical efficacy and safety’

Section 5.2 Pharmacokinetic properties

 ·        The section has been split into 4 titled sections  ‘Absorption’, ‘Distribution’, ‘Biotransformation’, ’Elimination’

Changes throughout both the oral solution and film-coated tablet SmPCs:

The SmPC has been updated to align better with the QRD template and SmPC Guideline and other minor updates, this affects most sections throughout the SmPC. However the following change should be noted:

·        List of frequencies and definitions has been added for

indication for "Chronic Idiopathic Urticaria" changed to "Urticaria"

Section 5.1

The following paragraph has been added:

chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively. since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.

Section 10

Date of revision of text updated

Section 4.1 changed from:

Neoclarityn is indicated for the relief of symptoms associated with:

to:

Neoclarityn is indicated for the relief of symptoms associated with:

Section 4.2 changed from:

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal.

To:

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria (see section 5.1).

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Section 4.6 changed from:

Desloratadine was not teratogenic in animal studies. The safe use of the drug during pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not recommended.

To:

Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not recommended.

Section 4.8, first paragraph the abbreviations AR and CIU have now been changed to “allergic rhinitis” and “chronic idiopathic urticaria”

Section 5.1, paragraph 8 the abbreviation AR in the first sentence has been amended to “allergic rhinitis”

The following paragraph’s have also been added after paragraph 8:

In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.

Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.

Final paragraph in section 5.1 the abbreviation of CIU has been amended to “chronic idiopathic urticaria”..

Section 5.2, paragraph 2 abbreviation SAR has been amended to “seasonal allergic rhinitis”

Paragraph 2 the word “drug” is replaced by the word “medicine”

Paragraph 3 the word “drug” is replaced by the words “medicinal products” in the first sentence and the word “drug” is replaced by the words “medicinal product” in the second sentence.

Section 10 Date of revision of text updated.