Loramyc 50mg muco-adhesive buccal tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Miconazole

Disponible des:

Laboratoires BioAlliance Pharma

Codi ATC:

A01AB09

Designació comuna internacional (DCI):

Miconazole

Dosis:

50mg

formulario farmacéutico:

Muco-adhesive buccal tablet

Vía de administración:

Buccal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 12030200

Informació per a l'usuari

Miconazole Lauriad 50 mg, muco-adhesive buccal tablet
Package Leaflet
Vectans Pharma – PL 48654/0001 – Confidential
1/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORAMYC 50 MG, MUCO-ADHESIVE BUCCAL TABLET
Miconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even if their
symptoms are the same of yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist. See section 4.
IN THIS LEAFLET
:
1. What LORAMYC is and what it is used for.
2. Before you use LORAMYC.
3. How to use LORAMYC.
4. Possible side effects.
5. How to store LORAMYC.
6. Further information.
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. 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,
other medicines of the azoles group 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”).
TAKE SPECIAL CARE WITH LORAMYC 50 MG, TABLET
-
Avoid all situations that could interfere with adhesion of the

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loramyc 50 mg, muco-adhesive buccal tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of miconazole.
Excipients: lactose monohydrate, milk protein concentrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Muco-adhesive buccal tablet.
White to slightly yellow tablets with a rounded side and a flat side
debossed with “L”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of oropharyngeal candidiasis (OPC) in immunocompromised
patients (See
Section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 rep