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Drynol 20 mg tablets

  • Name:

    Drynol 20 mg tablets

  • Company:
    info
  • Active Ingredients:

    Bilastine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/08/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 21/11/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
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1 - 0 of 31 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 18 August 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

The change is to update the Patient Leaflet by listing serious or life-threatening side effects at the beginning of section 4 - Possible side effects, irrespective of the frequency.

Updated on 21 November 2019 PIL

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated regarding use in the paediatric population.

Updated on 21 November 2019 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 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

The SmPC has been updated regarding use in the paediatric population including treatment, warnings and precautions, interactions, side-effects, overdose, pharmacodynamic and pharmacokinetic properties. 

Updated on 14 March 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 March 2019 SPC

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

  • Update to section 4.8 of the SmPC, to add the adverse reaction "vomiting" with the frequency not known. 

Updated on 17 May 2018 SPC

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

Update of section 4.8 of the SmPC, to add the adverse reaction “Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, rash, localised oedema/local swelling and erythema)” with a frequency not known.

Updated on 8 May 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 February 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 28 February 2017 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • 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

The following changes (shown in italics) have been made.

Section 4.6 Fertility, pregnancy and lactation

Breast-feeding

The excretion of bilastine in milk has not been studied in humans. "Available pharmacokinetic data in animals have shown excretion of bilastine in milk (see section 5.3)" has been added.

Section 5.3 Preclinical safety data

The following information has been added "In a lactation study, bilastine was identified in the milk of nursing rats administered a single oral dose (20 mg/kg). Concentrations of bilastine in milk were about half of those in maternal plasma. The relevance of those results for humans is unknown"

Updated on 15 December 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Section 5.1 Pharmacodynamic properties
  • Wording added: A post-authorization study in 146 elderly patients showed no differences in the safety profile with respect to the adult population.
  • Section 5.2 Pharmacokinetic properties
  • Wording amended: Only limited pharmacokinetic data are available in subjects older than 65 years.
  • Administrative (QRD) updates Sections 4.2, 5.1 and 5.2

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

Free text change information supplied by the pharmaceutical company

Update following results of the Post-Authorisation Safety Study in elderly :

 

  • Section 5.1 Pharmacodynamic properties
  • Wording added: A post-authorization study in 146 elderly patients showed no differences in the safety profile with respect to the adult population.
  • Section 5.2 Pharmacokinetic properties
    •
  • Wording amended: Only limited pharmacokinetic data are available in subjects older than 65 years.
    •
  • Administrative (QRD) updates
    Sections 4.2, 5.1 and 5.2

Updated on 15 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 December 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 3 - how to take/use

Updated on 8 December 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 8 December 2015 SPC

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

This is to update sections 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1, 6.5, 6.6, 9 and 10 of the SmPC in line with the latest EU QRD template.  The changes are to amend the wording to align to the standard texts and includes an update to section 4.8 on the reporting of suspected adverse reactions. 

Updated on 28 March 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 16 February 2012 SPC

Reasons for updating

  • 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

The following changes have been made:

  • Update to section 5.2 Pharmacokinetic properties to include the results of 2 new pharmacokinetic studies
  • Re-order section 5.2 with subheadings.

Updated on 10 February 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 30 August 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 5 July 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 July 2011 SPC

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