Zovirax 200 mg Dispersible Tablets

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

Updated on 04 May 2021

File name

ie-pl-zoviraxtabs200mgissue3draft1-medicines.ie.pdf

Reasons for updating

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

Updated on 04 May 2021

File name

ie-spc-zoviraxtabs200mgissue4draft3-medicines.ie.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • 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

Sec 4,2 and 4,4, - addtion of Sodium as excipient with know effect

sec 4.8 - update to HPRA reporting details

sec 5.2 - update to PK sections

sec 6.2- update to highligh no special requirements for use of handling the product is required

Updated on 24 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 24 August 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

SPC updates:
Section 6.5 - Update to foil blister pack details. Deletion of text relating to amber glass bottle
Section 10 - Update to Date of Revision of the text

Updated on 21 September 2015

File name

PIL_13671_633.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 September 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 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

Minor editorial updates to following sections: 1, 2, 4.6, 5.1, 5.2, 5.3, 6.5

Section 4.2 – Update to Dosage for Infants and Children, Addition regarding Administration, Minor editorial update

Section 4.8 – Minor editorial update, Addition of ADR reporting details

Section 6.6 – Update to information on administration


Updated on 21 September 2015

Reasons for updating

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

Updated on 21 July 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Update to MA holder contact details - Address change

Updated on 20 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 08 August 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1 – update to the indication

Section 5.2 – additional information

Updated on 08 August 2014

Reasons for updating

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

Updated on 11 October 2012

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Changes to:

 

Section 4.3  - Contraindications,

Section 4.4  - Special warnings and precautions for use,

Section 4.6  - Pregnancy and lactation,

Section 5.3  - Preclinical safety data

Updated on 05 October 2012

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 18 November 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 02 December 2010

Reasons for updating

  • Change to side-effects

Updated on 10 September 2010

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Under the subheading ‘Dosage in the elderly’ updated the wording to read:

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in renal impairment below). Adequate hydration should be maintained.

 

Under the subheading ‘Dosage in renal impairment’ added the following warning:

Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained.

 

4.4 Special warnings and precautions for use

Under the new subheading Use in patients with renal impairment and in elderly patients’ added the following warning:

Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8).

 

4.8 Undesirable Effects

Regarding the adverse events listed under Psychiatric and nervous system disorders’, updated the wording to read:

The above events are generally reversible and usually reported in patients with renal impairment, or with other predisposing factors (see section 4.4).

Updated on 27 April 2009

Reasons for updating

  • Change to side-effects

Updated on 01 April 2009

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: Addition of renal pain as a very rare undesirable effect with the following statement added: 'Renal pain may be associated with renal failure'.

Updated on 05 September 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 September 2008

Reasons for updating

  • PIL re-instated

Updated on 14 June 2007

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

5.3       Preclinical safety data

 

There is no information on the effect of aciclovir oral formulations or i.v. for infusion on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

 

NON-CLINICAL INFORMATION

      Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not is unlikely to pose a genetic risk to man.

 

      Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

 

      Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.

Updated on 22 May 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 01 September 2006

Reasons for updating

  • Improved electronic presentation

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

Updated on 07 July 2003

Reasons for updating

  • New SPC for medicines.ie

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