Lactation

Following oral administration of 200mg five times a day, aciclovir has been detected in human breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg bodyweight/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.

4.7 Effects on ability to drive and use machines
Aciclovir for infusion is generally used in an in-patient hospital population and information on ability to drive and operate machinery is not usually relevant. There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. However, aciclovir can cause reversible neurological reactions such as confusion, hallucinations, agitation, tremors, somnolence, psychosis and coma, which can all affect the ability to drive and use machinery.

4.8 Undesirable effects
The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.

The following convention has been used for the classification of undesirable effects in terms of frequency:-

Very common ≥ 1/10, common ≥1/100 and <1/10, uncommon ≥1/1,000 and <1/100, rare ≥1/10,000 and <1/1,000, very rare <1/10,000.

Blood and lymphatic system disorders

Uncommon: Decreases in haematological indices (anaemia, thrombocytopenia, leucopenia).

Immune system disorders

Very rare: Anaphylaxis.

Psychiatric and nervous system disorders

Very rare: Headache, dizziness, confusion, hallucinations, agitation, tremor, ataxia, dysarthria, somnolence, psychotic symptoms, encephalopathy, convulsions and coma.

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

Vascular disorders

Common: Phlebitis.

Respiratory, thoracic and mediastinal disorders

Very rare: Dyspnoea.

Gastrointestinal disorders

Common: Nausea, vomiting

Very rare: Diarrhoea, abdominal pain.

Hepato-biliary disorders

Common: Reversible increases in liver-related enzymes

Very rare: Reversible increases in bilirubin, hepatitis and jaundice.

Skin and subcutaneous tissue disorders

Common: Rashes including photosensitivity, urticaria, pruritus

Very rare: Angioedema.

Renal and urinary disorders

Common: Increases in blood urea and creatinine

Rapid increases in blood urea and creatinine levels are believed to be related to peak plasma levels and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one hour period.

Very rare: Renal impairment, acute renal failure, renal pain

Adequate hydration of the patient should be maintained. Renal impairment developing during trea