Package leaflet: Information for the patient

Corti-Fluoral 1.2 mg/ml + 5.34 mg/ml oral mucosal solution

diflucortolone valerate + josamycin propionate
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Corti-Fluoral is and what it is used for

Corti-Fluoral is a medicine containing two active substances: diflucortolone, which belongs to the category of corticosteroids (corticosteroid hormones), and josamycin, which belongs to the category of macrolide antibiotics, for local treatment of the oral mucosa.
Corti-Fluoral is used to treat the following conditions:

periodontal diseases (alveolar pyorrhea, i.e. inflammation of the tissues anchoring the tooth to the bone);
periodontitis (inflammation of the tissues surrounding the tooth root);
gingivitis (inflammation of the gums);
fusospirochaetal stomatitis (mouth inflammation caused by specific bacteria);
aphthous stomatitis (mouth inflammation with formation of small ulcers);
inflammatory and ulcerative lesions of the oral mucosa of any other origin, including those due to certain diseases such as pemphigus (a skin disease, often autoimmune, characterized by blister formation) and erythema multiforme (a skin disease characterized by red, target- or ring-shaped lesions).

2. What you need to know before using Corti-Fluoral

Do not use Corti-Fluoral

if you are allergic to diflucortolone valerate, josamycin propionate or any of the other ingredients of this medicine (listed in section 6);
if there are tuberculous, luetic (syphilis-related) or viral lesions (such as vaccinia pustules, herpes zoster, varicella) in the area to be treated.

Warnings and precautions
Talk to your doctor or pharmacist before using Corti-Fluoral.
The use, especially if prolonged, of topical products may lead to sensitization reactions.
It cannot be ruled out that treatment, particularly if prolonged, with josamycin—as with other antibiotics (even those belonging to the same group)—may lead to the development of resistant bacteria and fungi. Should this occur, discontinue treatment and consult your doctor, who will prescribe appropriate therapy.
Contact your doctor if blurred vision or other visual disturbances occur.
For people engaged in sports activities
The use of this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children
This medicine should be used in pediatric patients only when strictly necessary and under direct medical supervision.
Other medicines and Corti-Fluoral
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking an antihistamine called terfenadine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine only when strictly necessary and under direct medical supervision.
Driving and using machines
Corti-Fluoral does not impair the ability to drive vehicles or operate machinery.

3. How to use Corti-Fluoral

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is two applications per day, one in the morning and one in the evening.
In acute cases or particularly severe conditions, apply the medicine several times a day.
Method of use
Place a few drops of the solution onto a cotton swab and apply it to the affected area.
In cases of gingivitis or periodontitis, gently massage with the cotton swab, ensuring deep penetration of the
medicine into the gingival pockets. In these cases, use the medicine also during routine dental hygiene by placing 2–3 drops of the solution onto the toothbrush, together with or after toothpaste, and gently rubbing. This method is also beneficial in cases of aphthae predominantly located on the gums. In such cases, massage gently using a soft-bristled toothbrush.
Do not swallow the medicine. Corti-Fluoral is for oral mucosa use only.
If you use more Corti-Fluoral than you should
There are no known cases of overdose with this medicine. Accidental ingestion of the entire contents of the bottle is
unlikely to cause toxic effects.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Locally, rare episodes of burning and irritation may occur.
The following may occur with unknown frequency (frequency cannot be estimated from the available data): Blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Corti-Fluoral

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and on the
carton after “Expiry”. The expiry date refers to the last day of that month.
Do not store above 25°C.

6. Package contents and other information

What Corti-Fluoral contains

The active substances are diflucortolone valerate and josamycin propionate. 1 ml of solution contains 1.2 mg of diflucortolone valerate and 5.34 mg of josamycin propionate, equivalent to 5.00 mg of josamycin base. The other components are: saturated fatty acid triglycerides.

Description of the appearance of Corti-Fluoral and contents of the pack
Oral mucosa solution in a 10 ml bottle.
Marketing Authorization Holder
Teofarma S.r.l., Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Manufacturer
BERLIMED SA, c/ Francisco Alonso s/n, 28806 Alcalá de Henares – Madrid/Spain