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Vibramycin Capsules 100mg

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Updated on 16 October 2024

File name

Reg SPC VM 27_0 Capsules IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 16 October 2024

File name

Reg PIL VM 23_0 Capsules IE clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 25 September 2024

File name

Reg PIL VM 22_2 Capsules IE clean.pdf

Reasons for updating

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

Updated on 25 September 2024

File name

Reg SPC VM 26_2 Capsules IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 14 February 2023

File name

DEC202162533_Reg SPC VM 25_1 Capsules IE clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 22 September 2021

File name

DEC202162533_Reg SPC VM 25_1 Capsules IE clean.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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: Addition of PK data on children and adolescents (2 to 18 years of age) in section 5.2.

Updated on 19 April 2021

File name

DEC202126280_Reg SPC VM 24_1 Capsules IE clean.pdf

Reasons for updating

  • 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:

Update of section 4.4 of the SmPC to revise the text for sodium content.

Updated on 19 April 2021

File name

DEC202126280_Reg PIL VM 21_1 Capsules IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 30 March 2020

File name

DEC202019674_Adv SPC VM 23_1 Capsules IE_clean.pdf

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 SmPC has been updated as follows:

4.4 – addition of a warning regarding systemic lupus erythematous

4.8 – addition of visual disturbances, link visual disturbances to cranial hypertension

Updated on 30 March 2020

File name

DEC202019674_Adv PIL VM 20_1 Capsules IE_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 June 2019

File name

DEC201933470_Adv PIL VM 19_1 capsules IE_clean.pdf

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

File name

DEC201933470_Adv SPC VM 22_1 capsules 100mg IE_clean.pdf

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

File name

DEC201901717_REG PIL VM 18_1_clean.pdf

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

File name

DEC201901717_REG SPC VM 21_1 IE_clean.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 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 09 August 2018

File name

Reg SPC VM 20_0 IE_clean.pdf

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 01 August 2018

File name

Reg PIL VM 17_0 IE_clean.pdf

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 01 August 2018

File name

Reg SPC VM 19_1 IE_clean.pdf

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

File name

Reg_SPC_VM_19_0_IE_clean.docx

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

File name

Reg PIL VM 16_0 IE_clean.pdf

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 02 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 January 2018

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 21 December 2017

File name

PIL_12690_816.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 December 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 30 May 2017

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

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

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

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

Reasons for updating

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

Updated on 30 July 2015

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

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 23 December 2013

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

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

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

Reasons for updating

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

Updated on 09 August 2010

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 05 August 2010

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

Reasons for updating

  • Correction of spelling/typing errors

Updated on 02 December 2008

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 02 December 2008

Reasons for updating

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

Updated on 04 March 2008

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 07 December 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 December 2007

Reasons for updating

  • New SPC for medicines.ie

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

Pfizer Healthcare Ireland Unlimited Company

Pfizer Healthcare Ireland Unlimited Company