Clarityn 10 mg Tablets

  • Name:

    Clarityn 10 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Loratadine

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/08/19

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Summary of Product Characteristics last updated on medicines.ie: 1/8/2019

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Bayer Limited

Bayer Limited

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1 - 0 of 74 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 August 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 1 August 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 7 November 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Deletion of a pack size

Updated on 7 November 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Updated on 28 March 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

'Weight increased' added to undesirable effects

Updated on 28 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 8 November 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update of Therapeutic indications and Posology and method of administration

Updated on 25 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 October 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 23 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 23 November 2015 SmPC

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 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.6         Fertility, pregnancy and lactation

 

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ 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 Clarityn during pregnancy.

 

Breastfeeding

Physico-chemical data suggest excretion of loratadine/metabolites in human milkLoratadine is excreted in breast milk. A risk to the newborns/infants cannot be excluded. Therefore, the use of Clarityn is not recommended should not be used duringin breast-feeding women.

 

Fertility

There are no data available on male and female fertility.

 

4.7       Effects on ability to drive and use machines

 

In clinical studies that assessed driving ability, no impairment was observed in patients receiving loratadine. Clarityn 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.

 

4.8       Undesirable effects

 

 

 

System Organ Class

Frequency

Adverse Experience Term

 

Immune system disorders

Very rare

Hypersensitivity reactions (including angioedema and Aanaphylaxis)

Nervous system disorders

Very rare

Dizziness, convulsion

Cardiac disorders

Very rare

Tachycardia, palpitation

Gastrointestinal disorders

Very rare

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Very rare

Abnormal hepatic function

Skin and subcutaneous

tissue disorders

Very rare

Rash, alopecia

General disorders and administration

site conditions

Very rare

Fatigue

 

 

4.9        Overdose

 

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.

 

In the event of overdosage, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

 

6.1       List of excipients

 

Lactose mMonohydrate

Maize sStarch

Magnesium sStearate

 

6.3       Shelf life

 

3 Years36 months

 

8.         MARKETING AUTHORISATION NUMBER(S)

 

PA 1410/075/001

 

10.       DATE OF REVISION OF THE TEXT

 

November 2015November 2014

 

Updated on 20 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 11 December 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 December 2014 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided