Histaclar 10 mg Film-coated Tablets
*Company:
Gerard LaboratoriesStatus:
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 13 May 2024
File name
ie-combined-ie0647-v036-clean_PIL.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 04 March 2022
File name
ie-pl-ie0647-v032gv033-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to name of medicinal product
- Addition of manufacturer
Updated on 05 November 2018
File name
Package leaflet Loratadine.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 6 - what the product looks like and pack contents
Updated on 05 November 2018
File name
SUMMARY OF PRODUCT CHARACTERISTICS Loratadine.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)
Updated on 05 June 2018
File name
SmPC Histaclar.docx
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 June 2018
File name
Pil Histaclar.pdf
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 16 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2018
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 Undesirable effects
Tabulated list of adverse reactions
Frequencies are defined as very common ( ≥ 1/10), common ( ≥ 1/100 to <1/10), uncommon ( ≥ 1/1,000 to < 1/100), rare ( ≥ 1/10,000 to <1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Tabulated list of adverse reactions
Frequencies are defined as very common ( ≥ 1/10), common ( ≥ 1/100 to <1/10), uncommon ( ≥ 1/1,000 to < 1/100), rare ( ≥ 1/10,000 to <1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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System Organ Classes |
Common |
Uncommon |
Rare |
Very Rare |
Not known |
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Immune system disorders |
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anaphylaxis) |
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Nervous system disorders |
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Dizziness, convulsion
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Cardiac disorders |
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Tachycardia, palpitation |
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Gastrointestinal disorders |
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Nausea, dry mouth, gastritis |
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Hepatobiliary disorders |
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Abnormal hepatic function |
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Skin and subcutaneous tissue disorders |
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Rash, alopecia |
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General disorders and administration site conditions |
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Fatigue |
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Investigations |
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Weight increased |
10. Date of Revision of the Text
March December 20157
Updated on 15 January 2018
File name
PIL_9004_47.pdf
Reasons for updating
- New PIL for new product
Updated on 15 January 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to how the medicine works
- Change to date of revision
- Change to dosage and administration
Updated on 21 July 2015
Reasons for updating
- 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 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 4.6:
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/ neonatal toxicity of loratadine.There are no or limited amount of data from the use of loratadine 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 loratadine during pregnancy.
Breast-feeding
Physico-chemical data suggest excretion of lLoratadine/metabolites is excreted
inhuman breast milk. A risk to the newborns/infants cannot be excluded. Histaclar should The use of loratadine is not be used recommended during breast-feeding women.
Section 4.7:
In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine.Loratadine has no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Section 4.8:
Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).Other adverse reactions reported very rarely during the post-marketing period are listed in the following table by System Organ Class.
Tabulated list of adverse reactions
The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. Frequencies are defined as very common ( ≥ 1/10), common ( ≥ 1/100to <1/10), uncommon ( ≥ 1/1,000to < 1/100), rare ( ≥ 1/10,000to <1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Very Rare
Hypersensitivity reactions (including angioedema and
anaphylaxis)
Dizziness,
convulsion
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/ neonatal toxicity of loratadine.
As a precautionary measure, it is preferable to avoid the use of loratadine during pregnancy.
Breast-feeding
in
Section 4.7:
In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine.
Section 4.8:
Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).Other adverse reactions reported very rarely during the post-marketing period are listed in the following table by System Organ Class.
Tabulated list of adverse reactions
Very Rare
Hypersensitivity reactions (including angioedema and
anaphylaxis)
Dizziness,
convulsion
Updated on 29 June 2015
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 17 June 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.7 - 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- 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
All sections updated in line with Brand Leader
Updated on 08 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 11 June 2013
Reasons for updating
- SPC re-instated
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC retired in error. SPC re-uploaded.
Updated on 07 June 2013
Reasons for updating
- PIL re-instated
Updated on 03 February 2009
Reasons for updating
- Change to side-effects
- Addition of marketing authorisation holder
- PIL - Product no longer marketed in Ireland
Updated on 17 December 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Product no longer marketed in Ireland
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
section 4.8: updated in line with MedDRA terminology.
section 10: date of revision updated.
Updated on 26 January 2007
Reasons for updating
- Change of manufacturer
- Change to date of revision
- Change to storage instructions
Updated on 09 January 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 9 - Date of renewal of authorisation
- 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: lactose monohydrate
Section 3: the tablet can be divided into equal halves
Section 4.5: Interactions with known inhibitors included.
Updated on 04 September 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 July 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 July 2006
Reasons for updating
- Improved electronic presentation
Updated on 16 August 2005
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 July 2005
Reasons for updating
- Change to date of revision
- Change to warnings or special precautions for use
Updated on 22 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)