LORAMYC 50 mg cpr buccogingiv muco-adh Fl/14

VIDAL
Medicines
Update of 15/01/2026

LORAMYC^®
miconazole

Forms and presentations

Buccogingival muco-adhesive tablet at 50 mg (with one convex face and one flat face engraved "L"; white to slightly yellow): Bottle of 14, with child-resistant cap.

Composition

	per tablet
Miconazole	50 mg

Excipients: hypromellose 2208, milk protein concentrate, corn starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, talc.

Excipients with known effect: lactose monohydrate, milk protein concentrate, sodium lauryl sulfate.

Indications

Loramyc is indicated for the treatment of oropharyngeal candidiasis in immunocompromised patients (see Pharmacodynamics).

Dosage and administration

Dosage

Gingival route.

Reserved for adults.

Application of one muco-adhesive buccal tablet once a day, for 7 to 14 days depending on clinical response. It is preferable to apply the tablet in the morning, after brushing the teeth, as salivary flow is lower at night. Loramyc may be administered with food and drinks.

In case of clinical cure (i.e. complete disappearance of signs and symptoms of the disease) after 7 days of treatment, Loramyc may be discontinued.

When the lesions of oropharyngeal candidiasis are extensive or confluent, treatment must be continued until clinical cure or for up to 14 days.

Method of administration:
Loramyc must be applied to the upper gum, just above the incisor:

• Once the tablet has been removed from the bottle, it must be used immediately. Note that the tablet has one convex face and one flat face.
  
• The convex face of the tablet must be applied to the upper gum above an incisor. Hold the tablet in place for 30 seconds by applying light finger pressure on the outside of the upper lip.
  
• If the tablet does not stick, it must be repositioned.
  
• If the tablet falls off but is not swallowed within the first 6 hours, it must be replaced immediately.
  
• If Loramyc is accidentally swallowed, it is recommended to drink a glass of water. If it is swallowed within the first 6 hours after application, the tablet should be replaced only once.
  
• At each new application of Loramyc, the tablet must be applied to the opposite side of the upper gum relative to the previous application.
  

Contraindications

This medicine must not be used in the following cases:

• Hypersensitivity to the active substance, to other imidazole derivatives, or to any of the excipients mentioned in the section Composition.
  
• Hypersensitivity to milk or milk derivatives.
  
• Hepatic impairment.
  
• In combination with vitamin K antagonists, sulfonylurea hypoglycaemic agents, cisapride, pimozide and ergot alkaloids: ergotamine, dihydroergotamine (see Interactions).
  

Warnings and precautions

The combination of Loramyc with halofantrine is not recommended (see Interactions).

The combination of Loramyc with phenytoin or fosphenytoin requires particular precautions.

This medicinal product is contraindicated in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).

Local irritation has rarely been observed after application of Loramyc.

This medicinal product contains 5,18 mg of sodium lauryl sulfate in a mucoadhesive buccogingival tablet.

Sodium lauryl sulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole-based formulations. If a reaction suggestive of hypersensitivity or irritation occurs, treatment must be discontinued.

Loramyc must be applied to the upper gum, just above the incisor:

• All situations that could disrupt the adhesion of the tablet should be avoided, such as touching or pressing the place where the tablet is placed. Chewing gum should also be avoided.
  
• The tablet must not be sucked, chewed or swallowed.
  
• If teeth are brushed during the day, care should be taken not to touch the tablet and to rinse the mouth carefully.
  
• If the mouth becomes dry, moisten the gum before applying the mucoadhesive buccogingival tablet.
  
• If the tablet falls out or is accidentally swallowed within the first 6 hours, it must be replaced immediately.
  
• Accidental ingestion of Loramyc may occur. If Loramyc is accidentally swallowed, it is recommended to drink a glass of water.
  

The clinical cure rate is lower in patients with extensive or confluent oropharyngeal candidiasis.

Interactions

Drug interactions
Miconazole is an inhibitor of cytochromes CYP2C9 and CYP3A4. No interaction study has been performed with Loramyc.
Although the systemic absorption of Loramyc has been insufficiently evaluated, the administration of medicinal products with a narrow therapeutic margin that are metabolised by CYP2C9 and CYP3A4 is contraindicated due to increased exposure (see Contraindications).

Contraindicated:

• Vitamin K antagonists: unpredictable haemorrhage, possibly serious.
  
• Cisapride: increased risk of ventricular arrhythmias, in particular torsades de pointes.
  
• Pimozide: increased risk of ventricular arrhythmias, in particular torsades de pointes.
  
• Ergot alkaloids (ergotamine and dihydroergotamine): risk of ergotism with necrosis of the extremities.
  
• Sulfonylurea hypoglycaemic agents: increased hypoglycaemic effect with possible occurrence of hypoglycaemic manifestations, even coma.
  

Not recommended:

• Halofantrine: increased risk of ventricular arrhythmias, particularly torsades de pointes.
  

Requiring precautions for use:

• Phenytoin (and, by extrapolation, fosphenytoin): increase in plasma concentrations of phenytoin, which may reach toxic values. Proposed mechanism: inhibition of hepatic metabolism of phenytoin. Close clinical monitoring, measurement of plasma phenytoin and possible dose adjustment of phenytoin during treatment with miconazole and after its discontinuation.
  

Fertility, pregnancy and breastfeeding

Pregnancy:

There are no sufficiently relevant data on the use of miconazole in pregnant women. Animal studies have not shown a teratogenic effect, but other effects on reproduction have been observed (see Preclinical safety). The risk in humans is unknown. Miconazole should be used during pregnancy only if necessary.

Breastfeeding:

There are no data on the excretion of miconazole into breast milk. Consequently, caution is required when prescribing to a woman who is breastfeeding.

In case of cisapride intake in the newborn or breastfed infant, administration of miconazole to the mother is contraindicated as a precaution, due to the potential risk of interaction in the child (torsades de pointes).

Fertility:

There are no available data concerning the effect of miconazole on fertility.

Driving and using machines

There is no study establishing whether Loramyc does or does not impair the ability to drive vehicles or use machines. Nevertheless, miconazole is known to have no effect on alertness or the ability to drive.

Adverse effects

The safety of Loramyc was evaluated in 740 patients included in five clinical studies. The most frequently observed serious adverse effects included gastrointestinal disorders.

Table of undesirable effects:

The following adverse effects were reported from 5 clinical studies conducted at the recommended dose of 50 mg per day for 7 or 14 days, with frequencies corresponding to: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).

System organ class	Common	Uncommon	Not known
Infections and infestations	Upper respiratory tract infections
Metabolism and nutrition disorders		Decreased appetite
Nervous system disorders	Headache Dysgeusia Ageusia
Vascular disorders		Hot flushes
Gastrointestinal disorders	Diarrhoea Vomiting Nausea Abdominal pain Glossodynia Dry mouth Discomfort in the mouth	Oral ulceration Gingival pain Gingival pruritus
Skin and subcutaneous tissue disorders	Skin rash Pruritus		Acute generalised exanthematous pustulosis Severe skin reactions* Fixed pigmented erythema
General disorders and administration site conditions	Pain at the application site Irritation at the application site, which may progress to ulceration or erosion Fatigue

^* Given the low systemic passage of miconazole when Loramyc 50 mg buccogingival mucoadhesive is administered, the occurrence of non-dose-dependent undesirable effects described with certain azole derivatives, such as severe skin reactions other than the one mentioned in the table above (Stevens-Johnson syndrome, toxic epidermal necrolysis), cannot be excluded.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

Pharmacodynamics

Pharmacotherapeutic class: Anti-infective for local oral treatment (ATC code: A01AB09).

Pharmacokinetics

The oral bioavailability of miconazole is low (25-30 %) because miconazole is poorly absorbed from the gastrointestinal tract. Most of the absorbed miconazole is metabolised by the liver. A proportion of less than 1 % of the administered dose is recovered unchanged in the urine.

In cases of renal impairment, the pharmacokinetics of miconazole are not significantly altered. There are no active metabolites and the elimination half-life is of the order of 20 hours.

A single administration of Loramyc containing 50 mg of miconazole to healthy subjects leads to a mean maximum salivary concentration of 15 µg/ml, reached 7 hours after tablet administration, with an area under the curve (AUC_{0-24 h}) of 55,23 µg.h/ml.

After application of a single Loramyc 50 mg tablet, salivary miconazole concentrations above 1 µg/ml (upper limit of the MIC value for Candida albicans strains Candida albicans) were reached within 1 hour and lasted on average 13 hours.

Plasma miconazole concentrations were undetectable as they were below the limit of quantification (0,4 µg/ml) in the majority of healthy subjects, confirming the low absorption of miconazole through the buccal mucosa and from the gastrointestinal tract after swallowing saliva.

After 7 days of treatment in patients, plasma miconazole concentrations were undetectable (limit of quantification: 0,2 ng/ml) in 21,5 % of patients and were negligible (below 10 ng/ml) in more than 90 % of patients.

Preclinical safety

In single and repeated dose toxicity studies and pre- and postnatal development studies, toxic effects were observed in animals (mouse, rat, rabbit, dog) only at doses higher (approximately 30 to > 900 times) the maximum recommended dose in humans (0,7 mg/kg).

Embryotoxic but not teratogenic effects of miconazole were observed in reproduction studies.

The standard battery of genotoxicity tests (Ames, chromosomal aberration, micronucleus) did not reveal any genotoxic potential.

Local tolerance studies (hamster cheek pouch and LLNA sensitisation test in mice) did not reveal any particular toxicity.

No carcinogenicity study has been conducted with miconazole.

Storage conditions

This medicinal product does not require any special precautions for storage regarding temperature.

Store the bottle tightly closed, protected from moisture.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements for disposal.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)

3400937723640 (2006, SmPC rev 01.12.2025).

Price:	64,69 euros (14 tablets).
Reimbursed by Social Security at 65 %. Collective.
Marketing authorisation holder: Vectans Pharma, 230, bureaux de la Colline, 92213 Saint-Cloud Cedex.

CSP
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63808 Cournon d'Auvergne cdx
Tel: 04 73 69 28 28. Fax: 04 73 69 93 15
Medical information and pharmacovigilance: Tel: 01 47 04 80 46