Herpmed 50 mg - treatment for cold sores

Product Description

Drug indicated to combat cold sores.

Indications

Herpmed is indicated for the treatment of recurrent herpes labialis in immunocompetent adult patients suffering from frequent episodes of herpes.

Composition

Active ingredients

Each tablet contains 50 mg of aciclovir.

Excipients

Lactose (traces of lactose derived from milk protein concentrate).

Directions for use and Dosage

Dosage

It must be applied only once in the upper gum region (canine fossa). It must be applied within one hour of the onset of symptoms or prodromal signs. It can be applied within one hour of the onset of symptoms or prodromal signs. It can be taken with food and drink.

How to use

The tablet should be placed with dry fingers immediately after removing it from the blister. Apply the tablet to the upper gum above an incisor tooth (canine fossa); hold the tablet in place for 30 seconds, applying gentle pressure to the upper lip to ensure it adheres. For greater comfort, apply the tablet on the rounded side, although either side can be used. It can also be used if it adheres to the inside of the lip instead of the gum. Patients with dry mouth should drink a glass of water before applying the tablet to moisten the mucous membranes and thus promote adhesion of the tablet. Once applied, it remains in place and gradually dissolves over the course of the day. Once Herpmed is in place, food and drink can be consumed as normal. The tablet should not be sucked, chewed, or swallowed. Any situation that could compromise the adhesion of the tablet should be avoided:

• Touching or putting pressure on a tablet already in place;
• Chewing gum;
• Brushing teeth on the day of treatment;

If poor adhesion or detachment occurs within the first six hours after application, the same tablet should be replaced immediately. If the tablet cannot be replaced, a new tablet should be applied. If Herpmed is swallowed within the first six hours of application, the patient should drink a glass of water and a new tablet should be applied. The tablet should only be replaced once. If Labiriad falls off or is accidentally swallowed after six hours, the tablet should not be replaced.

Storage

Do not store above 30°C.

Warnings

Herpmed may be accidentally swallowed: in this case, it is recommended to drink a glass of water. There are no known cases of use of Herpmed in immunocompromised patients. Herpmed should not be used in immunocompromised patients as an increased risk of resistance to aciclovir cannot be ruled out. The efficacy of Herpmed applied to already formed vesicular lesions has not been demonstrated. Therefore, this medicine should only be used as soon as prodromal symptoms or signs appear. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interactions

No interaction studies have been performed with Herpmed. Aciclovir is eliminated primarily unchanged in the urine by active tubular secretion. Although plasma concentrations of aciclovir following the application of Herpmed are low, concomitant administration of any medicinal product that competes with its mechanism of action may increase the plasma concentration of aciclovir. However, due to the low dose and reduced systemic exposure of aciclovir following the application of Herpmed, clinically significant interactions are unlikely to occur.

Undesirable effects

The safety profile of Herpmed is based on a clinical study conducted in 775 patients, of whom 378 received Herpmed. Adverse reactions are listed below by system organ class and frequency: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The most frequently observed adverse reactions (ADRs) are general disorders and administration site conditions.

* Also common in the placebo-treated group ** Common in the placebo-treated group
Suspected drug-associated local adverse reactions are uncommon (<1%) and include nasopharyngitis, application site pain, application site irritation, aphthous stomatitis and gingival pain. The use of Herpmed has not been discontinued due to adverse reactions.

Overdose

Following the application of Herpmed, minimal absorption and systemic exposure of aciclovir are recorded. Therefore, overdose is unlikely.

Pregnancy and breastfeeding

Fertility

There is no experience of the effect of Herpmed mucoadhesive buccal tablet on female fertility in humans. In a study of 20 male patients with normal sperm counts, oral doses of aciclovir up to 1 g/day for up to six months had no clinically significant effect on sperm count, motility, or morphology.

Pregnancy

A large amount of data in pregnant women indicates that aciclovir does not cause malformative or fetal/neonatal toxicity. Consequently, Herpmed can be used during pregnancy if clinically needed.

Breastfeeding

Limited data in humans indicate that aciclovir passes into breast milk following systemic administration. Given the low rate of absorption, Herpmed can be considered during breastfeeding.

Format

2 tablets of 50 mg