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.

See clinical studies in section 5.2.

4.7 Effects on ability to drive and use machines
The clinical status of the patient and the adverse event profile of aciclovir should be borne in mind when considering the patients's ability to drive or operate machinery.

There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.

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 ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000.

Blood and lymphatic system disorders:
 
Very rare:
 Anaemia, leukopenia, thrombocytopenia
 
Immune system disorders:
 
Rare:
 Anaphylaxis
 
Psychiatric and nervous system disorders:
 
Common:
 Headache, dizziness
 
Very rare:
 Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.
 
The above events are generally reversible and are usually reported in patients with renal impairment, or with other predisposing factors (see 4.4 Special Warnings & Precautions for Use).
 
Respiratory, thoracic and mediastinal disorders:
 
Rare:
 Dyspnoea
 
Gastrointestinal disorders
 
Common:
 Nausea, vomiting, diarrhoea, abdominal pains
 
Hepato-biliary disorders
 
Rare:
 Reversible rises in bilirubin and liver related enzymes
 
Very rare:
 Hepatitis, jaundice
 
Skin and subcutaneous tissue disorders:
 
Common:
 Pruritus, rashes (including photosensitivity)
 
Uncommon:
 Urticaria. Accelerated diffuse hair loss.
 
Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to aciclovir therapy is uncertain.
 
Rare:
 Angioedema
 
Renal and urinary disorders:
 
Rare:
 Increases in blood urea and creatinine
 
Very rare:
 Acute renal failure, renal pain.
 
Renal pain may be associated with renal failure and crystalluria.
 
General disorders and administration site conditions:
 
Common:
 Fatigue, fever
 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare prof