LORAMYC

Gingival use. For adults only. Application of one muco-adhesive buccal tablet once a day for 7 to 14 days depending on the patient’s clinical response. It is preferable to apply the tablet in the morning, after brushing of the teeth, as during the night the salivary flow is less important.

Loramyc can be administered with food and drinks. In the event of clinical cure (defined as complete resolution of disease signs and symptoms) after 7 days of treatment, the use of LORAMYC can be stopped. In the case of the confluent/extensive (severe) OPC lesions, treatment should be continued until clinical cure or up to 14 days.

Method of administration:

LORAMYC should be applied to the upper gum just above the incisor tooth: • Once the tablet is removed from the bottle, it should be used immediately. It should be noted that the tablet has a rounded side and a flat side. • The rounded side of the tablet should be applied on the upper gum above an incisor tooth.

Hold the tablet in place for 30 seconds with a slight pressure of the finger over the upper lip. • If the tablet does not adhere properly, it should be repositioned. • If the tablet falls off within the first 6 hours but is not swallowed, it should be replaced immediately.

• If Loramyc is accidentally swallowed it is recommended to drink a glass of water. If swallowed within the first 6 hours after application, the tablet should be replaced only once. • With each application of LORAMYC, the tablet should be applied to alternate sides of the upper-gum.

Elderly population:

LORAMYC can be used by the elderly. There is no experience in children.

The safety of LORAMYC has been assessed in 462 patients enrolled in 3 clinical trials (462 patients including 315 HIV infected patients and 147 patients with head and neck cancer receiving radiotherapy) and from post-marketing experience.

The most frequently reported serious related adverse events included gastrointestinal disorders. Adverse reactions by system organ and frequency are listed below (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. Gastrointestinal disorders Common: nausea, diarrhea, abdominal pain, vomiting, dry mouth, oral discomfort, gingival pain Uncommon: glossodynia, gingival pruritus, mouth ulceration Nervous system disorders Common: headache, dysgeusia, ageusia Skin and subcutaneous tissue disorders Common: pruritus, rash Frequency unknown: Acute Generalised Exanthematous Pustulosis General disorders and administration site conditions Uncommon: application site irritation, fatigue, pain Infections and infestations Uncommon: upper respiratory tract infection Metabolism and nutrition disorders Uncommon: anorexia Vascular disorders Uncommon: hot flush 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. uk/yellowcard.

5). LORAMYC should not be given to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Local irritation after the application of LORAMYC has rarely been observed.

As with all drugs, hypersensitivity reactions may occur. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

As LORAMYC should be applied to the upper gum just above the incisor tooth: • All situations that could interfere with adhesion of the tablet should be avoided including touching or pressing the tablet already placed. Chewing gum should also be avoided.

• The tablet should not be sucked, chewed or swallowed. • If teeth brushing occur during the day, the tablet should not be touched, and the mouth should be rinsed with caution. • If the mouth is dry, it is recommended to moisten the gum before applying the mucoadhesive buccal tablet.

• Accidental ingestion of LORAMYC may occur. If LORAMYC is accidentally swallowed it is recommended to drink a glass of water. LORAMYC has shown a lower rate of clinical cure in patients with extensive or confluent OPC.

1. • Allergy to milk or milk derivatives. • In patients with liver dysfunction. 5).