Package leaflet: Information for the patient

Faringotricina 2.5 mg orodispersible tablets

tyrothricin
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

What Faringotricina is and what it is used for
What you need to know before using Faringotricina
How to use Faringotricina
Possible side effects
How to store Faringotricina
Contents of the pack and other information

1. What Faringotricina is and what it is used for

Faringotricina contains tyrothricin, an antibiotic capable of inhibiting bacterial growth.
This medicinal product is used for topical (local) treatment of bacterial infections of the mucous membrane lining the mouth (oral mucosa).
These infections, known as bacterial stomatitis, may affect the gums, tongue, and lips.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Faringotricina

Do not use Faringotricina

if you are allergic to tyrothricin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Faringotricina.
The use, especially if prolonged, of this medicine may lead to sensitization phenomena
(excessive reaction of the body to foreign substances it has come into contact with). In such a case,
discontinue treatment and consult your doctor, who will advise you on appropriate therapy.
Stop treatment and consult your doctor also if you do not feel better or feel worse after
a few days, as the infection might be caused by bacteria against which tyrothricin is
not effective.
Children
Talk to your doctor before using this medicine in very young children. In this age group,
this medicine should be administered only when strictly necessary and under medical supervision.
Other medicines and Faringotricina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only after consulting your doctor and under
his/her supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Faringotricina contains glucose, lactose and sucrose. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Faringotricina

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet every 30 minutes – 1 hour, to be slowly dissolved in the mouth.
The maximum dose is 10 tablets per day. Do not exceed the maximum dose.
Duration of treatment
The treatment should continue for two or more days, but only for short periods.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported rarely:

blackening of the tongue;
inflammation of the tongue (glossitis);
hypersensitivity reactions (excessive reaction of the body to this medicine).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Faringotricina

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Faringotricina contains

The active substance is tyrothricin. Each orodispersible tablet contains 2.5 mg of tyrothricin.
The other components are menthol, maize starch, gum arabic, glucose, lactose, magnesium stearate, sucrose.

Description of the appearance of Faringotricina and contents of the pack
Faringotricina 2.5 mg orodispersible tablets are supplied in a box containing 20 orodispersible tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)