WELLVONE Oral suspension Ref.[6327] Active ingredients: Atovaquone

The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.

The 5 ml end (larger end) of the measuring spoon included in the pack must be used to measure the required dose.

Dosage in adults

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The recommended oral dose is 750 mg twice a day (1 × 5 ml morning and evening) administered with food each day for 21 days.

Higher doses may be more effective in some patients (see section 5.2).

Dosage in Children

Clinical efficacy has not been studied.

Dosage in Older people

There have been no studies of Wellvone in the elderly (see section 4.4).

Renal or hepatic impairment

Wellvone has not been specifically studied in patients with significant hepatic or renal impairment (see section 5.2 for pharmacokinetics in adults). If it is necessary to treat such patients with Wellvone, caution is advised and administration should be closely monitored. Wellvone contains benzyl alcohol (see section 4.4).

There is insufficient experience to predict the consequences or suggest specific management of atovaquone overdose. However, in the reported cases of overdosage, the observed effects were consistent with known undesirable effects of the drug. If overdosage occurs, the patient should be monitored and standard supportive treatment applied.

12 months.

After first opening, the suspension may be stored for up to 21 days.

Do not store above 25°C.

Do not freeze.

A 240 ml high density polyethylene bottle with child resistant polypropylene closure, containing 226 ml of atovaquone suspension.

A double ended measuring spoon (polypropylene) is included, however, only 5 ml end (larger end) of the measuring spoon must be used.

Do not dilute.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.