Kwells 300 microgram tablets

  • Name:

    Kwells 300 microgram tablets

  • Company:
    info
  • Active Ingredients:

    Hyoscine hydrobromide

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/02/15

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Summary of Product Characteristics last updated on medicines.ie: 25/2/2015
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Bayer Limited

Bayer Limited

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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 25 February 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 February 2015 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 4.8 Undesirable effects the following information has been added:

4.8 Undesirable effects

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Updated on 25 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 28 January 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 8 March 2010 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In section 4.3 Prostatic enlargement, paralytic ileus, pyloric stenosis, myasthenia gravis and hepatic impairment have been added as contraindications

 

In section 4.4 warnings have been added about ulcerative colitis, Down’s Syndrome, diarrhoea, fever and hepatic impairment have been added.

 

In section 4.5 the following sentences have been added:

There may be an increased risk of side effects when given with MAOIs due to inhibition of drug-metabolising enzymes. 

There is an antagonism of effect of domperidone and metoclopramide on gastro-intestinal activity.

There could be a reduced effect of sublingual nitrate tablets due to failure to dissolve properly under the tongue owing to dry mouth.

A warning about grapefruit juice was also moved here.

 

In section 4.8 the following was added:

The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS II categories of frequency is not pertinent.

General: hyperthermia at high temperatures due to decreased sweating.

There have been rare reports of an increase in seizure frequency in epileptic patients (the same caution for this patient population is included in section 4.4).

 

An error has been corrected in section 4.9. Abuse has been amended to say absolute.

 

In section 5.2 the grapefruit juice warning has been removed. (Has been added above)

 

Section 10 has been updated to February 2010.

 

Updated on 5 March 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 January 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 2: Now reads: 'For a full list of excipients, see section 6.1'

Section 3: The following sentence has been added:

The scoreline is to allow breaking of the tablet into 2 for dosage purposes and ease of swallowing only.

Updated on 20 March 2009 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only