Neoclarityn Tablets *
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 04 October 2022

File name

633c59ba68e74.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Updated on 14 June 2022

File name

62a8c0b839a93.pdf

Reasons for updating

  • 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

PI update following PSUSA/00000962/202107

Updated on 14 June 2022

File name

62a8c0a473ebd.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 January 2022

File name

NEOCLARITYN 5mg-H-C-0314-IB-0098-SPC-en-CRT_Jan 2022_1642700044.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 20 January 2022

File name

QRD-IE-MT-NEOCLARITYN-30 FCT-LFT-CRT_1642700004.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to MA holder contact details

Updated on 10 May 2021

File name

NEOCLARITYN 5mg -H-C-0314-T-095-SPC-en-CRT_1620652195.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

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

 

Updated on 10 May 2021

File name

NEOCLARITYN 5mg FCT-H-C-0314-T-095-PIL-en-CRT_1620651980.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • Change to marketing authorisation holder

Updated on 24 February 2021

File name

QRD-IE-MT-Neoclarityn-FCT-LFT-WS1834-Feb21 (002)_1614186700.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains

Updated on 24 February 2021

File name

Neoclarityn-H-C-0314-WS-1834-SPC-5mgFCT-en-CS-CRT (002)_1614186542.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

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

 

Updated on 10 March 2020

File name

Neoclarityn 5mg FCT WS 1655 (002)_1583831755.pdf

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

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

Free text change information supplied by the pharmaceutical company

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.

 

Updated on 20 June 2019

File name

Neoclarityn FCT -MAH-SPC June 18_1561017121.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format

 

Updated on 16 July 2018

File name

Neoclarityn_Film_coated_Tablets-T-088-MAH-SPC-IE-en-CRT (2).docx

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

How to report a side effect

Updated on 10 July 2018

File name

Neoclarityn_Film_coated_Tablets-T-088-MAH-SPC-IE-en-CRT (2).docx

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH holder transferred

Updated on 10 July 2018

File name

Neoclarityn_Film_Coated_Tablets-T-088-MAH-PIL-IE-en-CRT (2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 December 2017

File name

PIL_14568_710.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 20 December 2017

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8 weight increased and increased appetite

Updated on 20 December 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 June 2017

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

4.4 Caution in patients with familial history of seizures,  Addition of Abnormal behaviour, aggression , frequency not known

Updated on 12 June 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 29 May 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4, 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.

Updated on 17 April 2015

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

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

Updated on 15 April 2015

Reasons for updating

  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to date of revision

Updated on 15 September 2014

Reasons for updating

  • Change to date of revision
  • Deletion of a pack size

Updated on 09 September 2014

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Approval of Type IB Variation- Variation Specifics 

Updated on 19 August 2014

Reasons for updating

  • Change to side-effects

Updated on 31 July 2014

Reasons for updating

  • 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

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

Updated on 07 October 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • 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 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 administrationhas 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

Updated on 04 October 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 20 February 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 September 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 October 2011

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to the Marketing Authorisation Holder in section 7 of the SmPC following approval of the transfer of ownership application to:

Merck Sharp & Dohme Ltd
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Updated on 17 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 25 October 2010

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 02 February 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 April 2008

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1

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

Updated on 26 September 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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 4.1 changed from:

Neoclarityn is indicated for the relief of symptoms associated with:

-                 allergic rhinitis (AR)
-                 chronic idiopathic urticaria (CIU)

to:

Neoclarityn is indicated for the relief of symptoms associated with:

-                 allergic rhinitis (see section 5.1)
-                 chronic idiopathic urticaria

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.

Updated on 09 February 2006

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 be renewed (B)

Updated on 21 February 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 17 February 2005

Reasons for updating

  • 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 be renewed (B)

Updated on 27 February 2004

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 18 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 08 August 2003

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 28 May 2003

Reasons for updating

  • New SPC for medicines.ie

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