Vibramycin Capsules 100mg

  • Name:

    Vibramycin Capsules 100mg

  • Company:
    info
  • Active Ingredients:

    Doxycycline hyclate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/06/19

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Summary of Product Characteristics last updated on medicines.ie: 27/6/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 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 28 June 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 June 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 January 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 16 January 2019 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·                  Sections 4.2 of the SPC is being revised to reflect paediatric use.

·                  Section 4.4 of the SPC is being revised to include severe skin reaction and myasthenia gravis.

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 1 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 1 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 16 July 2018 SmPC

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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

 

  1. Section 4.2 to include dosage recommendation for Rocky Mountain Spotted Fever (RMSF) in line with the CDS. (2017-0029534)
     
  2. To include a new adverse drug reaction of  “Skin hyperpigmentation” with a frequency of ‘rare’. Re-assign the frequency category from ‘not known’ to ‘rare’ for adverse drug reaction ‘Jarisch-Herxheimer reaction’ to section 4.8. In line with the CDS. (2017-0033637)

 

  1. Sections 4.1, 4.2, 4.3, 4.4 and 4.8 following the conclusion of Doxycycline UK/W/0090/pdWS Article 45. (2018-0039255)

Editorial change; section 4.8 to change the spelling of the text "discoloration" to "discolouration" to be consistent with other text in the SmPC. (2018-0036441)

Updated on 16 July 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects

Updated on 2 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

The SPC has been updated as follows:
s4.4 (Undesirable effects)
• Warning that patients with spirochete infections may experience a Jarisch-Herxheimer reaction shortly after treatment with doxycycline.
s4.8 (Undesirable effects)
• Addition of Jarisch-Herxheimer reaction (frequency unknown)

Updated on 2 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 30 May 2017 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

The following changes to the labelling have been approved.

The SPC has been updated as follows:

Section 4.4 and 4.5 – Reference to aspirin changed to salicylic acid

Section 4.8 – Addition of Erythematous oedema mainly of lower limb reported with an unknown frequency

Updated on 28 June 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4: Addition of warning of cases of benign intracranial hypertension (pseudotumor cerebri) which has been associated with the use of tetracyclines including doxycycline.

Section 4.8: The frequency category for the ADR "Photosensitivity reaction” has been re-assigned and the existing list of ADRs have been re-arranged by decreasing medical seriousness.

Updated on 27 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 17 May 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SmPC is being updated with the addition of adverse drug reaction (ADR) Pancreatitis with the frequency category of “Rare” under the System Organ Class (SOC) Gastrointestinal disorders.

Updated on 16 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 July 2015 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

Section 4.8: IMB name has been changed to HPRA with new contact details.

Updated on 28 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 23 December 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Section 4.8

Updated on 18 December 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Improved electronic presentation

Updated on 26 June 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 updated to include specific dosing information relating to the indication for treatment of infections due to susceptible strains of Bacillus anthracis

Section 4.8 updated to include DRESS with doxycycline.

Minor administrative updates have also been made.

Updated on 25 June 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 9 August 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

VM 040: Removal of acne as an indication and 50 mg dosing for acne from the SPC (sections 4.1 and 4.2 impacted) and PIL (Type II variation)*.

Updated on 5 August 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 20 August 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 December 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Additional text regarding warning for Clostridium Difficile associated diarrhoea.

Section 10 -
Revision of text date.

Updated on 2 December 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 4 March 2008 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section 9         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Section 10       DATE OF (PARTIAL) REVISION OF THE TEXT

Updated on 7 December 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 December 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)