Zovirax 200 mg/5 mL Oral Suspension
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal 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 10 December 2021
File name
ie-spc-zoviraxos200mg5mlissue5draft1.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2021
File name
ie-pl-zoviraxos200mg5mlissue3draft3-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 - what the product contains
- Change to date of revision
Updated on 22 February 2021
File name
ie-spc-zoviraxos200mg 5mlissue4draft4-medicines.ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.1 - List of excipients
- 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 2, 4.4, 6.1 - Update to comply with EU excipient warnings guidance
Section 4.8 - Update to HPRA reporting details
Section 10 - Update to revision date
Updated on 26 January 2021
File name
ie-spc-zoviraxos200mg 5mlissue3draft2-medicines.ie.pdf
Reasons for updating
- 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
inclusion of measuring spoon to section 6.6.
Updated on 21 September 2015
File name
PIL_8244_227.pdf
Reasons for updating
- New PIL for new product
Updated on 21 September 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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 5.3 - Preclinical safety data
- 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
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
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 4.3 - Contraindications
- 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 4.3 – deletion of dosage information
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 31 March 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 29 October 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
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 02 June 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2006
Reasons for updating
- Improved electronic presentation
Updated on 17 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 10 October 2003
Reasons for updating
- Change to section 6.5 - Nature and contents of container
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)