Neoclarityn 0.5mg/ml Oral Solution *
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 14 June 2022

File name

62a8c04785865.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

62a8c008d8062.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 January 2022

File name

QRD-IE-MT-NEOCLARITYN-OS-LFT-CRT_1642700095.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 10 May 2021

File name

NEOCLARITYN OS-H-C-0314-T-095-PIL-en-CRT_1620652836.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 10 May 2021

File name

NEOCLARITYN Oral Sol-H-C-0314-T-095-SPC-en-CRT_1620652587.pdf

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

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

 

Updated on 24 February 2021

File name

QRD-IE-MT-Neoclarityn OS-LFT- WS1834-Feb21 (002)_1614181396.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 24 February 2021

File name

Neoclarityn-H-C-0314-WS-1834-SPC OS-en-CS-CRT (002)_1614181026.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

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 updated  to include a description of the oral solution , Warning about high volume usage and warning about accumulation in young children are also included and editorial amendments also made throughout document.

 

Updated on 10 March 2020

File name

Neoclarityn OS WS 1655 (002)_1583832598.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

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

Updated on 20 June 2019

File name

Neoclarityn OS-MAH-SPC June 18 (003)_1561019756.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 20 June 2019

File name

Neoclarityn OS-MAH-SPC June 18_1561017225.

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_Oral_Solution-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_Oral_Solution-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_Oral_Solution_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_14566_659.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 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions

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 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

Sections 4.5, 4.6, 4.8 and 4.9, 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 18 September 2014

Reasons for updating

  • Change to date of revision
  • 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 4.1 Therapeutic indications

 

·        The individual populations that Neoclarityn is indicated for has been added to the text

 

Neoclarityn is indicated in adults, adolescents and children over the age of 1 year 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

Neoclarityn may be taken without regard to mealtime for the relief of symptoms associated with

allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).

Adults and adolescents 12 years of age and over

The recommended dose of Neoclarityn is 10 ml (5mg) oral solution once a day.

 

Paediatric population

 

·        A small section  of text has been deleted and the information changed to clarify the efficacy of use in children below the age of 1

The safety and efficacy of Neoclarityn 0.5 mg/ml oral solution in children below the age of 1 year have not been established. No data are available.

Adults and adolescents (12 years of age and over)

In adults and adolescents (12 years of age and over): The recommended dose of Neoclarityn is 10 ml

(5 mg) Neoclarityn oral solution once a day.

 

·        The age of children from 1 through to 11 years of age has also been added subjects that there are limited clinical trial experience with.;

 

 

·        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 oral solution in children under 1 year 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

 

·        The end paragraph under ‘Absorption’ has been updated with the following information

 

In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC and Cmax values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.

 

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 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 19 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 18 September 2009

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided