Neoclarityn 0.5mg/ml Oral Solution
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal 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 21 December 2022
File name
QRD-IE-MT-NEOCLARITYN-OS-LFT-Heist Name Change-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 June 2022
File name
NEOCLARITYN Oral Sol-H-C-0314-PSUSA-SPC-en-CRT_May 2022.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
QRD-IE-MT-NEOCLARITYN-OS-LFT-IB0098+PSUSA Update-CRT.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.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.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.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).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).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).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).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.
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
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
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 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 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
Merck Sharp & Dohme Ltd
Hertfordshire EN11 9BU
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)