Excipients in the formulation

This product contains liquid maltitol, a source of fructose and therefore should not be given to those with a hereditary fructose intolerance.

This product contains parahydroxybenzoates which may cause allergic reaction (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance. Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppressant agent used in transplant patients have been shown when the drugs are coadministered. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.

An experimental study on five male subjects indicates that concomitant therapy with aciclovir increases AUC of totally administered theophylline with approximately 50%. It is recommended to measure plasma concentrations during concomitant therapy with aciclovir.
4.6 Fertility, pregnancy and lactation
Pregnancy

Aciclovir Suspension should only be used in pregnancy when the potential benefits outweigh the unknown risks.

Fertility

There is no evidence that Aciclovir Oral Suspension has any effect on female human fertility.

Breast-feeding

Aciclovir (200mg five times a day) has been detected in breast milk at concentrations ranging from 0.6 - 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3mg/kg/day. Therefore it is advised that the suspension is used with caution whilst breast feeding.
4.7 Effects on ability to drive and use machines
No effects are known
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 the lymphatic system disorders

Very rare: Anaemia, leukopenia, thrombocytopenia.

Immune System:

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 and Precautions for Use).

Respiratory, thoracic and mediastinal disorders

Rare: Dyspnoea.

Gastro-Intestinal

Common: Nausea, vomiting, diarrhoea, abdominal pains.

Hepato-biliary

Rare: Reversible rises in bilirubin and liver related enzymes.

Very rar