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Zithromax Powder for Oral Suspension 200 mg/5 ml

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Azithromycin Dihydrate

    *Additional information is available within the SPC or upon request to the company

Updated on 26 June 2023

File name

Reg SPC ZX 35_1 POS 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
  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 26 June 2023

File name

Reg PIL ZX 32_1 POS IE clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 14 February 2023

File name

DEC202102575_Reg SPC ZX 33_2 POS IE clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 15 January 2021

File name

DEC202102575_Reg SPC ZX 33_2 POS 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)

Updated on 15 January 2021

File name

DEC202102575_Reg PIL ZX 30_2 POS 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 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 May 2019

File name

DEC201928045_Reg SPC ZX 32_1 POS IE_clean.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 05 April 2019

File name

DEC201917487_Reg PIL ZX 29_1 POS IE clean.pdf

Reasons for updating

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

Updated on 05 April 2019

File name

DEC201917487_Reg SPC ZX 31_1 POS 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.8 DRESS frequency has been corrected from Very Rare to Rare

Updated on 30 October 2018

File name

Reg SPC ZX 30_1 POS 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 25 October 2018

File name

Reg PIL ZX 28_1 POS 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 23 July 2018

File name

Reg SPC ZX 29_0 POS IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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:

4.6. Fertility, pregnancy and lactation

Subsection on breast-feeding updated in line with CDS.

Updated on 15 May 2018

File name

Reg_SPC_ZX_28_0_POS_IE_Clean.docx

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 14 May 2018

File name

Reg_SPC_ZX_28_0_POS_IE_Clean.docx

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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:

4.5. Interactions with other medicinal products and other forms of interaction

Inclusion of colchicine

Updated on 08 May 2018

File name

Reg PIL ZX 27_0 POS IE clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 17 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 17 July 2017

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: Section 4.4 has been updated in line with the CDS

Updated on 14 July 2017

File name

PIL_9061_269.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 July 2017

Reasons for updating

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

Updated on 21 April 2017

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:

Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 20 April 2017

Reasons for updating

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

Updated on 08 March 2016

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:

Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 07 March 2016

Reasons for updating

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

Updated on 14 January 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 4.8 of the SmPC has been updated to add the Adverse Drug Reaction ‘DRESS’ and consequentially the Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity reactions.

Updated on 12 January 2016

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 16 December 2014

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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 of the SmPC has been updated to add text relating to use in the elderly.

·         Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity, hepatotoxicity. In     addition an enhanced precautionary text on prolongation of the QT interval has been added.

·         Section 4.5 of the SmPC has been updated to add precautionary text for Digoxin and to add text for

·         Atorvastin.

·         Section 4.6 ofthe SmPC has been updated to add text pertaining to breast milk and fertility.

·         Section 4.8 of the SmPC has been updated to add the Adverse Drug Reactions 'deafness', 'tinnitus'   and 'hearing impaired' to the Post-marketing subsection.

·         Section 5.1 of the SmPC now includes updated text on microbiology information.

·         Section 4.4 of the SmPC has been updated to draw attention to the possible fatal issue of QT prolongation

·         Section 5.1 of the SmPC now includes updated text on cardiac electrophysiology with regards to co-administration of azithromycin and chloroquine.

To align with CSP

Updated on 09 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 25 June 2014

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

update section 4.1 and 4.2 of the SmPC include the indication gonococcal infection treatment and relevant dosing included in section 4.2

Updated on 20 June 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to dosage and administration

Updated on 02 April 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 31 July 2012

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration

Updated on 22 July 2011

Reasons for updating

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

Updated on 05 February 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 03 November 2008

Reasons for updating

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

Updated on 27 September 2007

Reasons for updating

  • Change of special precautions for disposal

Updated on 30 July 2007

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to date of revision
  • Change from the BAN of the active substance to the rINN

Updated on 26 October 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 30 September 2004

Reasons for updating

  • New PIL for medicines.ie