Zovirax 800 mg Dispersible Tablets

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

SPC updates:
Section 6.5 - Update to foil blister pack details
Section 10 - Update to Date of Revision of the text

Minor editorial updates to following sections: 3, 4.3, 4.6, 5.1, 5.2, 5.3, 6.6

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

Update to MA holder contact details - Address change

Section 5.2  additional information

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

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).

Summary of changes due to the approval of the Renewal on 23/10/2009

 

Please note that the name change to the SPC and PL described below must be made also to the medicines.ie entry for this product, currently listed as ‘Zovirax Dispersible Tablets 800 mg’

 

 

SPC UPDATES

 

Section 1 NAME OF THE MEDICINAL PRODUCT

Changed from Zovirax Dispersible Tablets 800mg to (i.e. name, strength, dosage form):

Zovirax 800 mg Dispersible Tablets

 

Section 6.4 Special precautions for storage

Included reason for keeping blisters in the outer carton, i.e.:

‘in order to protect from light and moisture.’

 

Section 6.5 Nature and contents of container

Updated the description of the pack, i.e. that one tablet is included in each blister and that each pack of 35 tablets contains 7 blister strips.

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'.

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.