Patient leaflet - Loramyc 50 mg Muco-adhesive buccal tablets
1. WHAT LORAMYC 50 mg, tablet IS AND WHAT IT IS USED FOR
This medicinal product is used for the treatment of fungal (yeast) infections of the mouth and the throat due to Candida in patients with reduced immune system.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LORAMYC 50 mg, tablet
Do not use LORAMYC 50 mg, tablet:
- If you are allergic (hypersensitive) to the active substance (miconazole), other similar antifungal medicines or any of the other ingredients of LORAMYC (listed in section 6),
- If you are allergic to milk or milk derivatives,
- If you suffer from liver failure (liver dysfunction)
- With oral anticoagulants (medicines that slow down blood clotting), hypoglycaemic sulfonamides (medicines used for the treatment of diabetes), cisapride (a medicine used for the treatment of gastro-oesophageal reflux), pimozide (a medicine used for the treatment of psychiatric disorders), and ergot alkaloids: ergotamine, dihydroergotamine (medicines used for the treatment of migraine) (see “Using other medicines”). Warnings and precautions
- Avoid all situations that could interfere with adhesion of the tablet: do not touch or press where the tablet is placed, avoid chewing-gum;
- If brushing your teeth during the day, be careful not to touch the tablet during brushing and be careful when rinsing your mouth;
- If your mouth is dry, humidify your gum before applying the tablet.
- I f LORAMYC is accidentally swallowed, it is recommended to drink a glass of water. If swallowed within the first 6 hours after application, it should be replaced only once.
- If the tablet falls off within the first 6 hours but is not swallowed, it should be replaced immediately. Other medicines and LORAMYC
LORAMYC must not be used if you are already using any of these medicines:
- oral anticoagulants (medicines that slow down blood clotting),
- cisapride (a medicine used for the treatment of gastro-oesophageal reflux),
- pimozide (a medicine used for the treatment of psychiatric disorders),
- hypoglycaemic sulfonamides (medicines used for the treatment of diabetes)
- ergot alkaloids: ergotamine, dihydroergotamine (medicines used for the treatment of migraine). LORAMYC is not recommended if you are already using:
- halofantrine (a medicine used for the treatment of malaria).
LORAMYC should be avoided if possible if you are already using:
- phenytoin (a medicine used for the treatment of epilepsy).
Please tell your doctor or your pharmacist if you are using or have recently used any other medicines including medicines obtained without a prescription.
LORAMYC with food and drink
LORAMYC can be used with food and drinks.
Pregnancy, breast-feeding and fertility
Pregnancy:
It is preferable to avoid the use of this medicine during pregnancy.
If you discover that you are pregnant during the treatment, consult your doctor. Only your doctor can consider the necessity to maintain the treatment.
Ask your doctor or your pharmacist for advice before taking any medicine.
Breast-feeding:
It is not known if LORAMYC passes into breast milk. Ask your doctor for advice before using this medicinal product. If your child is treated with a medicinal product which contains cisapride, you must not use this medicinal product during lactation.
Ask your doctor or your pharmacist for advice before using any medicine.
Driving and using machines:
LORAMYC is not expected to have any effects on the ability to drive or use machines.
Important information about some of the ingredients of LORAMYC 50 mg, tablet:
LORAMYC contains lactose, milk derivatives and sodium laurylsulfate
LORAMYC contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Do not use if you are allergic to milk or milk derivatives.
LORAMYC contains 5.18 mg of sodium laurylsulfate per tablet. Sodium laurylsulfate can cause local reactions (such as tingling or burning sensation) or increase reactions caused by other products when they are applied to the same area.
3. HOW TO USE LORAMYC 50 mg, tablet DO NOT SWALLOW LORAMYC Instructions for proper use
LORAMYC must be applied to the upper gum, just above a front tooth.
- Before applying the tablet, locate the area on the upper gum, above the front tooth.
- Open the bottle and take out a tablet. Apply the tablet immediately after taking it out from the bottle. You will notice that the tablet has a rounded side and a flat side marked with “L”;
- Place the rounded side on the upper gum;
- Hold the tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds. This will allow the tablet to stick to your gum. Avoid touching the tablet with your tongue for several minutes thereafter;
• Apply LORAMYC in the morning, preferably after brushing your teeth; do not suck, chew or swallow the tablet; - If you accidentally swallow a tablet of LORAMYC, drink a glass of water.
- With each application, use each alternate sides of your gum.
- Reposition the tablet if it does not adhere properly
The shape of the tablet may change due to absorbing saliva in order to fit your gum shape. Dosage
Always use LORAMYC exactly as described in this leaflet or as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
This medicine is only for adults.
The usual dose is one tablet of LORAMYC applied once a day.
Apply LORAMYC to the upper gum, in the morning, preferably after brushing your teeth. If you feel that the effect of LORAMYC 50 mg tablet is too strong or too weak, consult your doctor or your pharmacist. Duration of treatment
The usual duration of treatment is 7 to 14 days.
If you use or swallow more LORAMYC 50 mg tablet than you should:
In the event of overdose, you may experience nausea and vomiting.
Consult your doctor or your pharmacist immediately.
If you forget to use LORAMYC 50 mg tablet:
Do not take a double dose to make up for a forgotten tablet.
If you stop using LORAMYC 50 mg tablet:
Do not stop using this medicine except on your doctor’s advice. Stopping the course early may lead to the failure of the treatment.
If you have any further questions on the use of this product, ask your doctor or your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, LORAMYC 50 mg, tablet can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking LORAMYC 50 mg¸ muco-adhesive buccal tablet and contact your doctor immediately:
- An allergic skin reaction, that may include round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again (frequency unknown).
- Swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties (angio oedema, anaphylactic reactions) (very rare)
- An extremely intense allergic reaction with skin rashes*, commonly in the form of blisters or sores in the oral cavity and eyes, and other mucous membranes such as, for example, genitalia (frequency unknown)
- Severe extensive skin damage* (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis (TEN), frequency unknown)
* These severe skin reactions have been described with other products belonging to the same therapeutic class as LORAMYC upon administration through systemic route. Therefore, the occurrence of these side effects upon local administration of LORAMYC can’t be excluded, even though its systemic absorption is much lower. Tell your doctor or pharmacist if you notice any of the following side effects:
Common side effects (greater than 1 in 100, less than 1 in 10 patients) are:
- Nausea, diarrhoea, abdominal pain, vomiting, dry mouth, oral discomfort, gingival pain,
- Headache, change in taste,
- Itching, rash.
- Application site irritation (gum), fatigue, pain,
- Infection of nose and throat,
Uncommon side effects (greater than 1 in 1000, less than 1 in 100 patients) are:
- Tongue pain, gingival itching, mouth ulceration,
- Appetite loss,
- Hot flush.
Frequency Unknown:
- Rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Yellow Card Scheme Website: www .mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LORAMYC 50 mg tablet
Keep out of reach and sight of children.
This medicine does not require any special temperature storage conditions.
Keep in the bottle tightly closed in order to protect from moisture.
Do not use LORAMYC after the expiry date printed on the bottle and on the box. The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What LORAMYC contains:
The active substance is Miconazole.
Each muco-adhesive buccal tablet contains 50 mg of miconazole.
The other ingredients are hypromellose 2208, milk protein concentrate, maize starch, lactose monohydrate, sodium laurylsulfate, magnesium stearate, talc.
What LORAMYC looks like and contents of the pack
This medicine is a muco-adhesive buccal tablet, white to slightly yellow with a rounded side and a flat side marked with “L”. Each box of LORAMYC contains one bottle of 14 tablets.
Marketing authorisation holder:
Flynn Pharma Limited
5th Floor, 40 Mespil Road,
Dublin 4,
IRELAND, D04 C2N4
This medicine is authorised in the Member States of the EEA under the following names:
France, Germany, Italy, United Kingdom: Loramyc
This leaflet was last revised in March 2026.
Manufacturer:
Catalent Germany Schorndorf GmbH Steinbeisstraße 2
73614 Schorndorf
Postfach 1460
73603 Schorndorf
Germany
PRODUCT: Amends: Approval:
Indesign CC
FF141
LORAMYC 50 mg, muco-adhe-sive buccal tablet Leaflet UK
24.4.26
120x297 mm
1
28.4.26
Leaflet (PIL)
N
Calibri Family
Size 8pts (condensed)
Internal proof approval
External proof approval Signed (digitally)
Signed (digitally)