SITAVIG Delayed-release tablet Ref.[28039] Active ingredients: Aciclovir

2.1 Basic Dosing Information

One SITAVIG 50 mg buccal tablet should be applied as a single dose to the upper gum region (canine fossa).

2.2 Administration Instructions

SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis lesions. The tablet should be applied with a dry finger immediately after taking it out of the blister. The tablet should be placed to the upper gum just above the incisor tooth (canine fossa) and held in place with a slight pressure over the upper lip for 30 seconds to ensure adhesion. For comfort the rounded side should be placed to the upper gum, but either side of the tablet can be applied. Tablet should be applied on the same side of the mouth as the herpes labialis symptoms.

Once applied, SITAVIG stays in position and gradually dissolves during the day. [See Clinical Pharmacology (12.3)]. In addition,

• SITAVIG should not be crushed, chewed, sucked or swallowed.
• Food and drink can be taken normally when SITAVIG is in place. Avoid any situations which may interfere with adhesion of the tablet such as chewing gum, touching or pressing the tablet after placement, wearing upper dentures, and brushing teeth. If the teeth need to be cleaned while the tablet is in place, rinse the mouth gently. Drink plenty of liquids in the case of dry mouth.
• If SITAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet cannot be repositioned, a new tablet should be placed.
• If SITAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied. [see Patient Counseling Information (17)].
• SITAVIG does not need to be reapplied if the tablet falls out or is swallowed after the first 6 hours.

Acyclovir absorption and systemic exposure following application of SITAVIG are minimal. Overdose is therefore unlikely [see Clinical Pharmacology (12.3)].

Symptomatic and supportive care is the basis for management.

SITAVIG should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature]; excursions between 15 and 30°C (59-86°F) permitted at room temperature.

Protect from moisture and keep out of reach of children.